Docstoc

SDTM Terminology 2008-09-24 - EVS

Document Sample
SDTM Terminology 2008-09-24 - EVS Powered By Docstoc
					The controlled terminology in this spreadsheet supports Study Data Tabulation Model (SDTM) Implementation
Guide Version 3.1.1 (IG 3.1.1). It represents all SDTM controlled terminology developed and in production to
date, comprising SDTM Packages 1, 2A & 2B and Labtest Packages 1 & 2. Additional SDTM Terminology is in
development (SDTM Package 3, Labtest Package 3) and will be moved into production in the fall of 2008. This
will be the final major release of terminology for SDTM IG 3.1.1. Any future additions to the 3.1.1 terminology
set will be handled via a terminology maintenance process to be implemented later this year.

                      Column

Code (Column A)




Codelist Code (Column B)




Codelist Extensible (Yes/No) (Column C)




Codelist Name (Column D)




CDISC Submission Value (Column E)
CDISC Preferred Term (Column F)




CDISC Synonym(s) (Column G)




CDISC Definition (Column H)



NCI Preferred Term (Column I)


Pre-release / Production (Column J)



Notes (Reference for CDISC PT) (Column K)
dsheet supports Study Data Tabulation Model (SDTM) Implementation
nts all SDTM controlled terminology developed and in production to
  2B and Labtest Packages 1 & 2. Additional SDTM Terminology is in
Package 3) and will be moved into production in the fall of 2008. This
ogy for SDTM IG 3.1.1. Any future additions to the 3.1.1 terminology
 ntenance process to be implemented later this year.

                                      Description

             Unique numeric code randomly generated by NCIt and
             assigned to individual CDISC controlled terms
             Unique numeric code assigned to the SDTM parent codelist
             names. This code is repeated for each controlled term (aka
             permissible value) belonging to a codelist. As of 9/22/2008,
             this code was dropped for parent codelist entries, where it
             created confusion. **NOTE - light blue highlighting is used to
             identify the beginning of a new SDTM codelist and its
             applicable term set.
             Defines if controlled terms may be added to the codelist. New
             terms may be added to existing codelist values as long as they
             are not duplicates or synonyms of existing terms. The
             expectation is that sponsors will use the published controlled
             terminology as a standard baseline and codelists defined as
             “extensible” (or "Yes") may have terms added by the sponsor
             internally.

             Contains the descriptive name of the codelist which is also
             referred to as the codelist label in the SDTM IG. As with the
             Codelist Code, the Codelist Name is repeated for each
             controlled term belonging to a codelist.

             IMPORTANT COLUMN: Currently (as per SDTMIG 3.1.1) this
             is the specific value expected for submissions. Each value
             corresponds to an SDTM Codelist Name as indicated by light
             blue shading.

             **NOTE - when a Submission Value in Column E is shaded
             yellow, this indicates when a particular value differs from the
             CDISC Preferred Term in Column F. This is either due to: (a)
             an existing external reference noted in the SDTMIG 3.1.1 (e.g.
             see rows 63-67, 524, 645 and 721); or (b) where Test names
             are identified and repeated following a list of corresponding
             Test Codes (e.g. see TSPARM rows 746-767, VSTEST rows
             807-819, LBTEST rows 916-1004, and EGTEST rows 1222-
             1267). In many cases the discrepancies between the
             Submission Value and Preferred Term will be rectified in a
             future version release.
This is the CDISC preferred name for a term as identified in
the NCI Thesaurus (NCIt) environment and to which numeric
codes (Column A) are assigned. In most cases, the Preferred
Term or PT is redundant with the "CDISC Submission Value" in
Column E.

This identifies the applicable synonyms for a CDISC Preferred
Term in Column F.                            **NOTE - this is
especially important in instances where a Test name or
Parameter Test name contains a corresponding Test Code or
Parameter Test Code. Examples include: TSPARM rows 746-
767, VSTEST rows 807-819, LBTEST rows 916-1004 and
EGTEST rows 1222-1267

This identifies the CDISC definition for a particular term. In
many cases an existing NCI definition has been used. The
source for a definition is noted in parentheses (e.g. NCI,
CDISC glossary, FDA)

This is the NCI preferred name for a term as identified in NCIt

This indicates the workflow status for a particular term.
**NOTE - all terms in this spreadsheet are currently in
"Production"

Contains additional reference information for a particular term
as identified in SDTMIG 3.1.1
Code     Codelist   Codelist     Codelist Name       CDISC Submission Value   CDISC Preferred Term       CDISC Synonym(s)          CDISC Definition
         Code       Extensible
                    (Yes/No)

C66767              No           Action Taken with   ACN                      ACN                        Action Taken with Study   The reason that changes were made to the therapy under study. (NCI)
                                 Study Treatment                                                         Treatment

C49503   C66767                  Action Taken with   DOSE INCREASED           DOSE INCREASED                                       An indication that a medication schedule was modified by addition; either by changing the
                                 Study Treatment                                                                                   frequency, strength or amount. (NCI)




C49504   C66767                  Action Taken with   DOSE NOT CHANGED         DOSE NOT CHANGED                                     An indication that a medication schedule was maintained. (NCI)
                                 Study Treatment




C49505   C66767                  Action Taken with   DOSE REDUCED             DOSE REDUCED                                         An indication that a medication schedule was modified by subtraction, either by changing the
                                 Study Treatment                                                                                   frequency, strength or amount. (NCI)




C49501   C66767                  Action Taken with   DRUG INTERRUPTED         DRUG INTERRUPTED                                     An indication that a medication schedule was modified by temporarily terminating a prescribed
                                 Study Treatment                                                                                   regimen of medication. (NCI)


C49502   C66767                  Action Taken with   DRUG WITHDRAWN           DRUG WITHDRAWN                                       An indication that a medication schedule was modified through termination of a prescribed
                                 Study Treatment                                                                                   regimen of medication. (NCI)




C48660   C66767                  Action Taken with   NOT APPLICABLE           NOT APPLICABLE             NA                        Determination of a value is not relevant in the current context. (NCI)
                                 Study Treatment




C17998   C66767                  Action Taken with   UNKNOWN                  UNKNOWN                    U; Unknown                Not known, not observed, not recorded, or refused. (NCI)
                                 Study Treatment




C66768              No           Outcome of Event    OUT                      OUT                        Outcome of Event          A condition or event that is attributed to the adverse event and is the result or conclusion of the
                                                                                                                                   adverse event. (NCI)

C48275   C66768                  Outcome of Event    FATAL                    FATAL                      Grade 5; 5                The termination of life as a result of an adverse event. (NCI)




C49494   C66768                  Outcome of Event    NOT RECOVERED/NOT        NOT RECOVERED/NOT                                    One of the possible results of an adverse event outcome that indicates that the event has not
                                                     RESOLVED                 RESOLVED                                             improved or recuperated. (NCI)




C49498   C66768                  Outcome of Event    RECOVERED/RESOLVED       RECOVERED/RESOLVED                                   One of the possible results of an adverse event outcome that indicates that the event has
                                                                                                                                   improved or recuperated. (NCI)




C49495   C66768                  Outcome of Event    RECOVERED/RESOLVED       RECOVERED/RESOLVED WITH                              One of the possible results of an adverse event outcome where the subject recuperated but
                                                     WITH SEQUELAE            SEQUELAE                                             retained pathological conditions resulting from the prior disease or injury. (NCI)




C49496   C66768                  Outcome of Event    RECOVERING/RESOLVIN      RECOVERING/RESOLVING                                 One of the possible results of an adverse event outcome that indicates that the event is
                                                     G                                                                             improving. (NCI)




C17998   C66768                  Outcome of Event    UNKNOWN                  UNKNOWN                    U; Unknown                Not known, not observed, not recorded, or refused. (NCI)




C66780              Yes          Age Span            AGESPAN                  AGESPAN                    Age Span                  Subgroups of populations based on age. (NCI)

C27954   C66780                  Age Span            ADOLESCENT (12-17        ADOLESCENT (12-17 YEARS)                             A juvenile between the onset of puberty and maturity; in the state of development between
                                                     YEARS)                                                                        puberty and maturity. (NCI)
C49685   C66780        Age Span              ADULT (18-65)           ADULT (18-65)                                    A person from 18 years to 65 years of age. (NCI)

C49683   C66780        Age Span              CHILDREN (2-11 YEARS)   CHILDREN (2-11 YEARS)                            A person from 2 years to 11 years of age. (NCI)

C16268   C66780        Age Span              ELDERLY (> 65)          ELDERLY (> 65)                                   An age group comprised by people 65 years of age and older. (NCI)

C49641   C66780        Age Span              IN UTERO                IN UTERO                                         The period of time during which the embryo or foetus is present in the uterus of the female.
                                                                                                                      Also describes the location of the embryo or foetus as being in the uterus in contrast to outside
                                                                                                                      the uterus (ex utero). (NCI)


C49643   C66780        Age Span              INFANT AND TODDLER (28 INFANT AND TODDLER (28                            A person from 28 days to 23 months of age. (NCI)
                                             DAYS - 23 MONTHS)      DAYS - 23 MONTHS)
C16731   C66780        Age Span              NEWBORN (0-27 DAYS)    NEWBORN (0-27 DAYS)                               An infant during the first month after birth. (NCI)

C49642   C66780        Age Span              PRETERM NEWBORN         PRETERM NEWBORN INFANTS                          An infant born prior to completion of the normal gestation period. (NCI)
                                             INFANTS
C66781            No   Age Unit              AGEU                    AGEU                       Age Unit              Those units of time that are routinely used to express the age of a person. (NCI)

C25301   C66781        Age Unit              DAYS                    DAYS                                             The time for Earth to make a complete rotation on its axis; ordinarily divided into twenty-four
                                                                                                                      hours. This also refers to a specific day. (NCI)




C25529   C66781        Age Unit              HOURS                   HOURS                                            A unit measure of time equal to 3,600 seconds or 60 minutes. It is approximately 1/24 of a
                                                                                                                      median day. (NCI)




C29846   C66781        Age Unit              MONTHS                  MONTHS                                           One of the 12 divisions of a year as determined by a calendar. It corresponds to the unit of
                                                                                                                      time of approximately to one cycle of the moon's phases, about 30 days or 4 weeks. (NCI)




C29844   C66781        Age Unit              WEEKS                   WEEKS                                            Any period of seven consecutive days. (NCI)




C29848   C66781        Age Unit              YEARS                   YEARS                                            The period of time that it takes for Earth to make a complete revolution around the sun,
                                                                                                                      approximately 365 days; a specific one year period. (NCI)




C66797            No   Category for          IECAT                   IECAT                      Category for          A collection of criteria on which subjects are evaluated and that must be met by all study
                       Inclusion/Exclusion                                                      Inclusion/Exclusion   subjects. (NCI)



C25370   C66797        Category for          EXCLUSION               EXCLUSION                                        List of characteristics in a protocol, any one of which may exclude a potential subject from
                       Inclusion/Exclusion                                                                            participation in a study. (CDISC glossary)




C25532   C66797        Category for          INCLUSION               INCLUSION                                        The criteria in a protocol that prospective subjects must meet to be eligible for participation in a
                       Inclusion/Exclusion                                                                            study. NOTE: Exclusion and inclusion criteria define the study population. See also exclusion
                                                                                                                      criteria. (CDISC glossary)




C66783            No   CDISC System Organ SOC                        SOC                        CDISC System Organ    Terms at the highest level of the CDISC system organ class terminology.
                       Class                                                                    Class

C35814   C66783        CDISC System Organ BLOOD AND LYMPHATIC        BLOOD AND LYMPHATIC                              Any deviation from the normal structure or function of the blood or lymphatic system that is
                       Class              SYSTEM DISORDERS           SYSTEM DISORDERS                                 manifested by a characteristic set of symptoms and signs. (NCI)

C3079    C66783        CDISC System Organ CARDIAC DISORDERS          CARDIAC DISORDERS                                Any deviation from the normal structure or function of the cardiac system that is manifested by
                       Class                                                                                          a characteristic set of symptoms and signs. (NCI)
C49399   C66783        CDISC System Organ CONGENITAL, FAMILIAL       CONGENITAL, FAMILIAL AND                         A class of disorders that encompasses conditions resulting from a congenital, familial
                       Class              AND GENETIC                GENETIC DISORDERS                                hereditary trait or genetic abnormality as is manifested by a characterstic set of symptoms and
                                          DISORDERS                                                                   signs. (NCI)
C49400   C66783        CDISC System Organ EAR AND LABYRINTH          EAR AND LABYRINTH                                Any deviation from the normal structure or function of the ear or labyrinth that is manifested by
                       Class              DISORDERS                  DISORDERS                                        a characteristic set of symptoms and signs. (NCI)
C3009    C66783        CDISC System Organ ENDOCRINE DISORDERS        ENDOCRINE DISORDERS                              Any deviation from the normal structure or function of the endocrine system that is manifested
                       Class                                                                                          by a characteristic set of symptoms and signs. (NCI)
C26767   C66783        CDISC System Organ EYE DISORDERS              EYE DISORDERS                                    Any deviation from the normal structure or function of the eye that is manifested by a
                       Class                                                                                          characteristic set of symptoms and signs. (NCI)

C2990    C66783        CDISC System Organ GASTROINTESTINAL           GASTROINTESTINAL                                 Diseases of the digestive tract (oral cavity to anus) and associated organs (salivary glands,
                       Class              DISORDERS                  DISORDERS                                        liver, pancreas). (NCI)

C49401   C66783        CDISC System Organ GENERAL DISORDERS          GENERAL DISORDERS AND                            A class of disorders that encompasses conditions of a general kind that result from a disease,
                       Class              AND ADMINISTRATION         ADMINISTRATION SITE                              the treatment of disease or administration of treatment at a particular site and are manifested
                                          SITE CONDITIONS            CONDITIONS                                       by a characteristic set of symptoms and signs. (NCI)
C3959    C66783        CDISC System Organ HEPATOBILIARY              HEPATOBILIARY DISORDERS                          Any deviation from the normal structure or function of the liver or biliary tract that is manifested
                       Class              DISORDERS                                                                   by a characteristic set of symptoms and signs. (NCI)
C3507    C66783        CDISC System Organ IMMUNE SYSTEM              IMMUNE SYSTEM DISORDERS                          A disorder resulting from an abnormality in the immune system. -- 2003 (NCI)
                       Class              DISORDERS
C26726   C66783        CDISC System Organ INFECTIONS AND          INFECTIONS AND                                          A disorder resulting from the presence and activity of a microbial, viral, or parasitic agent. It
                       Class              INFESTATIONS            INFESTATIONS                                            can be transmitted by direct or indirect contact. -- 2003 (NCI)



C49402   C66783        CDISC System Organ INJURY, POISONING AND   INJURY, POISONING AND                                   A class of disorders that encompasses conditions resulting from an injury, poisoning or
                       Class              PROCEDURAL              PROCEDURAL                                              procedure. (NCI)
                                          COMPLICATIONS           COMPLICATIONS
C41198   C66783        CDISC System Organ INVESTIGATIONS          INVESTIGATIONS                                          The act or process of a systematic and thorough examination; research, study; the process of
                       Class                                                                                              inquiring into or following up, intended to develop facts. (NCI)


C49403   C66783        CDISC System Organ METABOLISM AND          METABOLISM AND NUTRITION                                A class of disorders that encompasses conditions occurring as a result of metabolic dysfunction
                       Class              NUTRITION DISORDERS     DISORDERS                                               or deviation from the normal nutritional requirements. (NCI)

C27574   C66783        CDISC System Organ MUSCULOSKELETAL AND MUSCULOSKELETAL AND                                         Any deviation from the normal structure or function of the musculoskeletal or connective tissue
                       Class              CONNECTIVE TISSUE   CONNECTIVE TISSUE                                           that is manifested by a characteristic set of symptoms and signs. (NCI)
                                          DISORDERS           DISORDERS

C3262    C66783        CDISC System Organ NEOPLASMS BENIGN,       NEOPLASMS BENIGN,                                       An abnormal tissue growth resulted from uncontrolled cell proliferation. Benign neoplastic cells
                       Class              MALIGNANT AND           MALIGNANT AND                                           resemble normal cells without exhibiting significant cytologic atypia, while malignant ones
                                          UNSPECIFIED (INCL       UNSPECIFIED (INCL CYSTS                                 exhibit overt signs such as dysplastic features, atypical mitotic figures, necrosis, nuclear
                                          CYSTS AND POLYPS)       AND POLYPS)                                             pleomorphism, and anaplasia. Representative examples of benign neoplasms include
                                                                                                                          papillomas, cystadenomas, and lipomas; malignant neoplasms include carcinomas, sarcomas,
                                                                                                                          lymphomas, and leukemias. -- 2004 (NCI)




C26835   C66783        CDISC System Organ NERVOUS SYSTEM          NERVOUS SYSTEM                                          Any deviation from the normal structure or function of the nervous system that is manifested by
                       Class              DISORDERS               DISORDERS                                               a characteristic set of symptoms and signs. (NCI)

C49404   C66783        CDISC System Organ PREGNANCY,              PREGNANCY, PUERPERIUM                                   A class of conditions associated with pregnancy, puerperium and perinatal status. (NCI)
                       Class              PUERPERIUM AND          AND PERINATAL CONDITIONS
                                          PERINATAL CONDITIONS

C2893    C66783        CDISC System Organ PSYCHIATRIC             PSYCHIATRIC DISORDERS                                   Any deviation from the normal structure or function of the brain and a psychiatric condition, that
                       Class              DISORDERS                                                                       results in an impairment of an individual's normal cognitive, emotional, or behavioral
                                                                                                                          functioning, and is caused by physiological or psychosocial factors. (NCI)
C3430    C66783        CDISC System Organ RENAL AND URINARY       RENAL AND URINARY                                       Disorders of any part of the urologic system. (NCI)
                       Class              DISORDERS               DISORDERS
C49405   C66783        CDISC System Organ REPRODUCTIVE SYSTEM     REPRODUCTIVE SYSTEM AND                                 Any deviation from the normal structure or function of the reproductive system or breast that is
                       Class              AND BREAST DISORDERS    BREAST DISORDERS                                        manifested by a characteristic set of symptoms and signs. (NCI)

C27669   C66783        CDISC System Organ RESPIRATORY,            RESPIRATORY, THORACIC                                   Any deviation from the normal structure or function of the respiratory system including the
                       Class              THORACIC AND            AND MEDIASTINAL                                         thorax and mediastinum that is manifested by a characteristic set of symptoms and signs. (NCI)
                                          MEDIASTINAL             DISORDERS
                                          DISORDERS
C3371    C66783        CDISC System Organ SKIN AND                SKIN AND SUBCUTANEOUS                                   Any deviation from the normal structure or function of the skin or subcutaneous tissue that is
                       Class              SUBCUTANEOUS TISSUE     TISSUE DISORDERS                                        manifested by a characteristic set of symptoms and signs.(NCI)
                                          DISORDERS
C20188   C66783        CDISC System Organ SOCIAL CIRCUMSTANCES    SOCIAL CIRCUMSTANCES                                    A set of concepts that results from or is influenced by criteria or activities associated with the
                       Class                                                                                              social environment of a person. (NCI)
C25218   C66783        CDISC System Organ SURGICAL AND MEDICAL    SURGICAL AND MEDICAL                                    A particular course of action intended to achieve a result. (NCI)
                       Class              PROCEDURES              PROCEDURES
C35117   C66783        CDISC System Organ VASCULAR DISORDERS      VASCULAR DISORDERS                                      Any deviation from the normal structure or function of the vascular system that is manifested
                       Class                                                                                              by a characteristic set of symptoms and signs. (NCI)


C66784            No   Common Terminology TOXGR                   TOXGR                      Common Terminology          A standard terminology developed to report adverse events occurring in cancer clinical trials.
                       Criteria for Adverse                                                  Criteria for Adverse Events Common terminology criteria for adverse events (CTCAE) are used in study adverse event
                       Events                                                                                            summaries and Investigational New Drug reports to the Food and Drug Administration. The
                                                                                                                         CTCAE contain a grading scale for each adverse event term representing the severity of the
                                                                                                                         event. (NCI)




C41338   C66784        Common Terminology 1                       MILD                       Grade 1; 1                   A type of adverse event that is usually transient and may require only minimal treatment or
                       Criteria for Adverse                                                                               therapeutic intervention. The event does not generally interfere with usual activities of daily
                       Events                                                                                             living.




C41339   C66784        Common Terminology 2                       MODERATE                   Grade 2; 2                   A type of adverse event that is usually alleviated with additional specific therapeutic
                       Criteria for Adverse                                                                               intervention. The event interferes with usual activities of daily living, causing discomfort but
                       Events                                                                                             poses no significant or permanent risk of harm to the research participant.




C41340   C66784        Common Terminology 3                       SEVERE                     Grade 3; 3                   A type of adverse event that requires intensive therapeutic intervention. The event interrupts
                       Criteria for Adverse                                                                               usual activities of daily living, or significantly affects clinical status. The event possesses a
                       Events                                                                                             significant risk of harm to the research participant and hospitalization may be required.




C41337   C66784        Common Terminology 4                       LIFE THREATENING           Grade 4; 4                   An adverse event, and/or its immediate sequelae, which is associated with an imminent risk of
                       Criteria for Adverse                                                                               death or which is associated with physical or mental disabilities that affect or limit the ability of
                       Events                                                                                             a person to perform activities of daily living (eating, ambulation, toileting, etc.) See NCI
                                                                                                                          Common Terminology Criteria for Adverse Events.




C48275   C66784        Common Terminology 5                       FATAL                      Grade 5; 5                   The termination of life as a result of an adverse event. (NCI)
                       Criteria for Adverse
                       Events
C66785            Yes   Control Type   TCNTRL    TCNTRL    Control Type; Type of     Comparator against which the study treatment is evaluated (e.g., concurrent (placebo, no
                                                           Control                   treatment, dose-response, active), external (historical, published literature).




C49649   C66785         Control Type   ACTIVE    ACTIVE                              A type of control, which has a demonstrated effect, administered as a comparator, to subjects
                                                                                     in a clinical trial. [From ICH E10].



C41132   C66785         Control Type   NONE      NONE                                No person or thing, nobody, not any. (NCI)
C49648   C66785         Control Type   PLACEBO   PLACEBO                             Use of an inactive compound identical in appearance to drug or treatment being tested in
                                                                                     experimental research, which may or may not be known to the physician and/or subject,
                                                                                     administered to distinguish between drug action and suggestive effect of the drug or treatment
                                                                                     under study. The effects of the active drug or treatment are compared to the effects of the
                                                                                     placebo. (NCI)




C66786            No    Country        COUNTRY   COUNTRY   Country                   A collective generic term that refers here to a wide variety of dependencies, areas of special
                                                                                     sovereignty, uninhabited islands, and other entities in addition to the traditional countries or
                                                                                     independent states. (NCI)


C17884   C66786         Country        ABW       ABW       ARUBA                     Island in the Caribbean Sea, north of Venezuela.




C16267   C66786         Country        AFG       AFG       AFGHANISTAN               A country in Southern Asia, north and west of Pakistan, east of Iran.




C16292   C66786         Country        AGO       AGO       ANGOLA                    A country in Southern Africa, bordering the South Atlantic Ocean, between Namibia and
                                                                                     Democratic Republic of the Congo.




C20133   C66786         Country        AIA       AIA       ANGUILLA                  An island in the Caribbean Sea, east of Puerto Rico.




C44481   C66786         Country        ALA       ALA       ALAND ISLANDS             An archipelago in the Baltic Sea at the entrance to the Gulf of Bothnia between Sweden and
                                                                                     Finland.




C16271   C66786         Country        ALB       ALB       ALBANIA                   A country in Southeastern Europe, bordering the Adriatic Sea and Ionian Sea, between Greece
                                                                                     and Serbia and Montenegro.




C16289   C66786         Country        AND       AND       ANDORRA                   A country in Southwestern Europe, between France and Spain.




C16904   C66786         Country        ANT       ANT       NETHERLANDS ANTILLES A country in the Caribbean, comprising two island groups in the Caribbean Sea - one includes
                                                                                Curacao and Bonaire north of Venezuela; the other is east of the Virgin Islands.




C17232   C66786         Country        ARE       ARE       UNITED ARAB EMIRATES A country in the Middle East, bordering the Gulf of Oman and the Persian Gulf, between Oman
                                                                                and Saudi Arabia.




C16305   C66786         Country        ARG       ARG       ARGENTINA                 A country in Southern South America, bordering the South Atlantic Ocean, between Chile and
                                                                                     Uruguay.




C16306   C66786         Country        ARM       ARM       ARMENIA                   A country in Southwestern Asia, east of Turkey.




C17739   C66786         Country        ASM       ASM       AMERICAN SAMOA            A group of islands in the South Pacific Ocean, about half way between Hawaii and New
                                                                                     Zealand.




C18007   C66786         Country        ATA       ATA       ANTARCTICA                The continent lying mostly south of the Antarctic Circle.




C20105   C66786         Country        ATF       ATF       FRENCH SOUTHERN           Islands in the southern Indian Ocean, south of Africa, about equidistant between Africa,
                                                           TERRITORIES               Antarctica, and Australia.
C16303   C66786   Country   ATG   ATG   ANTIGUA AND BARBUDA Islands between the Caribbean Sea and the North Atlantic Ocean, east-southeast of Puerto
                                                            Rico.




C16311   C66786   Country   AUS   AUS   AUSTRALIA                 The continent between the Indian Ocean and the South Pacific Ocean.




C16312   C66786   Country   AUT   AUT   AUSTRIA                   A country in Central Europe, north of Italy and Slovenia.




C16316   C66786   Country   AZE   AZE   AZERBAIJAN                A country in Southwestern Asia, bordering the Caspian Sea, between Iran and Russia.




C16371   C66786   Country   BDI   BDI   BURUNDI                   A country in Central Africa, east of Democratic Republic of the Congo.




C16329   C66786   Country   BEL   BEL   BELGIUM                   A country in Western Europe, bordering the North Sea, between France and the Netherlands.




C16333   C66786   Country   BEN   BEN   BENIN REPUBLIC            A country in Western Africa, bordering the North Atlantic Ocean, between Nigeria and Togo.




C16369   C66786   Country   BFA   BFA   BURKINA FASO              A country in Western Africa, north of Ghana.




C16323   C66786   Country   BGD   BGD   BANGLADESH                A country in Southern Asia, bordering the Bay of Bengal, between Burma and India.




C16368   C66786   Country   BGR   BGR   BULGARIA                  A country in Southeastern Europe, bordering the Black Sea, between Romania and Turkey.




C16322   C66786   Country   BHR   BHR   BAHRAIN                   An archipelago in the Persian Gulf, east of Saudi Arabia.




C16321   C66786   Country   BHS   BHS   BAHAMAS                   A chain of islands in the North Atlantic Ocean, southeast of Florida.




C16361   C66786   Country   BIH   BIH   BOSNIA-HERZEGOVINA        A country in Southeastern Europe, bordering the Adriatic Sea and Croatia.




C16372   C66786   Country   BLR   BLR   BELARUS                   A country in Eastern Europe, east of Poland.




C16331   C66786   Country   BLZ   BLZ   BELIZE                    A country in Central America, bordering the Caribbean Sea, between Guatemala and Mexico.




C16334   C66786   Country   BMU   BMU   BERMUDA                   No Definition




C16359   C66786   Country   BOL   BOL   BOLIVIA                   A country in Central South America, southwest of Brazil.




C16364   C66786   Country   BRA   BRA   BRAZIL                    A country in Eastern South America, bordering the Atlantic Ocean.




C16324   C66786   Country   BRB   BRB   BARBADOS                  An island between the Caribbean Sea and the North Atlantic Ocean, northeast of Venezuela.
C16367   C66786   Country   BRN   BRN   BRUNEI                    A country in Southeastern Asia, bordering the South China Sea and Malaysia.




C16336   C66786   Country   BTN   BTN   BHUTAN                    A country in Southern Asia, between China and India.




C20104   C66786   Country   BVT   BVT   BOUVET ISLAND             An island in the South Atlantic Ocean, south-southwest of the Cape of Good Hope (South
                                                                  Africa).




C16363   C66786   Country   BWA   BWA   BOTSWANA                  A country in Southern Africa, north of South Africa.




C16409   C66786   Country   CAF   CAF   CENTRAL AFRICAN           A country in Central Africa, north of Democratic Republic of the Congo.
                                        REPUBLIC




C16380   C66786   Country   CAN   CAN   CANADA                    A country in Northern North America, bordering the North Atlantic Ocean on the east, North
                                                                  Pacific Ocean on the west, and the Arctic Ocean on the north, north of the conterminous US.




C16445   C66786   Country   CCK   CCK   COCOS (KEELING)           A group of islands in the Indian Ocean, south of Indonesia, about halfway from Australia to Sri
                                        ISLANDS                   Lanka.




C17181   C66786   Country   CHE   CHE   SWITZERLAND               A country in Central Europe, east of France, north of Italy.




C16427   C66786   Country   CHL   CHL   CHILE                     A country in Southern South America, bordering the South Atlantic Ocean and South Pacific
                                                                  Ocean, between Argentina and Peru.




C16428   C66786   Country   CHN   CHN   CHINA                     A country in Eastern Asia, bordering the East China Sea, Korea Bay, Yellow Sea, and South
                                                                  China Sea, between North Korea and Vietnam.




C16762   C66786   Country   CIV   CIV   COTE D'IVOIRE             A country in Western Africa, bordering the North Atlantic Ocean, between Ghana and Liberia.




C16379   C66786   Country   CMR   CMR   CAMEROON                  A country in Western Africa, bordering the Bight of Biafra, between Equatorial Guinea and
                                                                  Nigeria.




C17266   C66786   Country   COD   COD   DEMOCRATIC REPUBLIC A country in Central Africa, northeast of Angola.
                                        OF THE CONGO




C16467   C66786   Country   COG   COG   CONGO                     A country in Western Africa, bordering the South Atlantic Ocean, between Angola and Gabon.




C16469   C66786   Country   COK   COK   COOK ISLANDS              A group of islands in the South Pacific Ocean, about one-half of the way from Hawaii to New
                                                                  Zealand.




C16449   C66786   Country   COL   COL   COLOMBIA                  A country in Northern South America, bordering the Caribbean Sea, between Panama and
                                                                  Venezuela, and bordering the North Pacific Ocean, between Ecuador and Panama.




C16458   C66786   Country   COM   COM   COMOROS                   A group of islands in the Mozambique Channel, about two-thirds of the way between northern
                                                                  Madagascar and northern Mozambique.




C16382   C66786   Country   CPV   CPV   CAPE VERDE                A group of islands in the North Atlantic Ocean, west of Senegal.




C16470   C66786   Country   CRI   CRI   COSTA RICA                A country in Central America, bordering both the Caribbean Sea and the North Pacific Ocean,
                                                                  between Nicaragua and Panama.
C16477   C66786   Country   CUB   CUB   CUBA                 An island between the Caribbean Sea and the North Atlantic Ocean, 150 km south of Key
                                                             West, Florida.




C44482   C66786   Country   CXR   CXR   CHRISTMAS ISLAND     An Australian-administered island in the eastern Indian Ocean south of Java, Indonesia.




C16391   C66786   Country   CYM   CYM   CAYMAN ISLANDS       An island group in the Caribbean Sea, nearly one-half of the way from Cuba to Honduras.




C16480   C66786   Country   CYP   CYP   CYPRUS               An island in the Mediterranean Sea, south of Turkey.




C17668   C66786   Country   CZE   CZE   CZECH REPUBLIC       A country in Central Europe, southeast of Germany.




C16636   C66786   Country   DEU   DEU   GERMANY              A country in Central Europe, bordering the Baltic Sea and the North Sea, between the
                                                             Netherlands and Poland, south of Denmark.




C16506   C66786   Country   DJI   DJI   DJIBOUTI             A country in Eastern Africa, bordering the Gulf of Aden and the Red Sea, between Eritrea and
                                                             Somalia.




C16519   C66786   Country   DMA   DMA   DOMINICA             An island between the Caribbean Sea and the North Atlantic Ocean, about one-half of the way
                                                             from Puerto Rico to Trinidad and Tobago.




C16496   C66786   Country   DNK   DNK   DENMARK              A country in Northern Europe, bordering the Baltic Sea and the North Sea, on a peninsula north
                                                             of Germany (Jutland); also includes two major islands (Sjaelland and Fyn).




C16520   C66786   Country   DOM   DOM   DOMINICAN REPUBLIC   A country comprising the eastern two-thirds of the island of Hispaniola, between the Caribbean
                                                             Sea and the North Atlantic Ocean, east of Haiti.

C16274   C66786   Country   DZA   DZA   ALGERIA              A country in Northern Africa, bordering the Mediterranean Sea, between Morocco and Tunisia.




C16528   C66786   Country   ECU   ECU   ECUADOR              A country in Western South America, bordering the Pacific Ocean at the Equator, between
                                                             Colombia and Peru.




C16530   C66786   Country   EGY   EGY   EGYPT                A country in Northern Africa, bordering the Mediterranean Sea, between Libya and the Gaza
                                                             Strip.




C16558   C66786   Country   ERI   ERI   ERITREA              A country in Eastern Africa, bordering the Red Sea, between Djibouti and Sudan.




C20113   C66786   Country   ESH   ESH   WESTERN SAHARA       A country in Northern Africa, bordering the North Atlantic Ocean, between Mauritania and
                                                             Morocco.




C17152   C66786   Country   ESP   ESP   SPAIN                A country in Southwestern Europe, bordering the Bay of Biscay, Mediterranean Sea, North
                                                             Atlantic Ocean, and Pyrenees Mountains, southwest of France.




C16562   C66786   Country   EST   EST   ESTONIA              A country in Eastern Europe, bordering the Baltic Sea and Gulf of Finland, between Latvia and
                                                             Russia.




C16563   C66786   Country   ETH   ETH   ETHIOPIA             A country in Eastern Africa, west of Somalia.




C16584   C66786   Country   FIN   FIN   FINLAND              A country in Northern Europe, bordering the Baltic Sea, Gulf of Bothnia, and Gulf of Finland,
                                                             between Sweden and Russia.
C16582   C66786   Country   FJI   FJI   FIJI                      An island group in the South Pacific Ocean, about two-thirds of the way from Hawaii to New
                                                                  Zealand.




C17954   C66786   Country   FLK   FLK   FALKLAND ISLANDS          Islands in the South Atlantic Ocean, east of southern Argentina.




C16592   C66786   Country   FRA   FRA   FRANCE                    A country in Western Europe, bordering the Bay of Biscay and English Channel, between
                                                                  Belgium and Spain, southeast of the UK; bordering the Mediterranean Sea, between Italy and
                                                                  Spain.



C16573   C66786   Country   FRO   FRO   FAROE ISLANDS             An island group between the Norwegian Sea and the North Atlantic Ocean, about one-half of
                                                                  the way from Iceland to Norway.




C17881   C66786   Country   FSM   FSM   MICRONESIA,         An island group in the North Pacific Ocean, about three-quarters of the way from Hawaii to
                                        FEDERATED STATES OF Indonesia.




C16596   C66786   Country   GAB   GAB   GABON                     A country in Western Africa, bordering the Atlantic Ocean at the Equator, between Republic of
                                                                  the Congo and Equatorial Guinea.




C17233   C66786   Country   GBR   GBR   UNITED KINGDOM            A country in Western Europe, comprising islands, including the northern one-sixth of the island
                                                                  of Ireland, between the North Atlantic Ocean and the North Sea, northwest of France.




C16634   C66786   Country   GEO   GEO   GEORGIA                   A country in Southwestern Asia, bordering the Black Sea, between Turkey and Russia.




C64375   C66786   Country   GGY   GGY   GUERNSEY                  The island of Guernsey and the other Channel Islands represent the last remnants of the
                                                                  medieval Dukedom of Normandy, which held sway in both France and England. Guernsey is a
                                                                  British crown dependency, but is not part of the UK.



C26330   C66786   Country   GHA   GHA   GHANA                     A country in Western Africa, bordering the Gulf of Guinea, between Cote d'Ivoire and Togo.




C16638   C66786   Country   GIB   GIB   GIBRALTAR                 A dependency in Southwestern Europe, bordering the Strait of Gibraltar, on the southern coast
                                                                  of Spain.




C16655   C66786   Country   GIN   GIN   GUINEA                    A country in Western Africa, bordering the North Atlantic Ocean, between Guinea-Bissau and
                                                                  Sierra Leone.




C16651   C66786   Country   GLP   GLP   GUADELOUPE                Islands in the eastern Caribbean Sea, southeast of Puerto Rico.




C16598   C66786   Country   GMB   GMB   GAMBIA                    A country in Western Africa, bordering the North Atlantic Ocean and Senegal.




C16656   C66786   Country   GNB   GNB   GUINEA-BISSAU             A country in Western Africa, bordering the North Atlantic Ocean, between Guinea and Senegal.




C16557   C66786   Country   GNQ   GNQ   EQUATORIAL GUINEA         A country in Western Africa, bordering the Bight of Biafra, between Cameroon and Gabon;
                                                                  composed of a mainland portion and five inhabited islands.




C16645   C66786   Country   GRC   GRC   GREECE                    A country in Southern Europe, bordering the Aegean Sea, Ionian Sea, and the Mediterranean
                                                                  Sea, between Albania and Turkey.

C16647   C66786   Country   GRD   GRD   GRENADA                   An island between the Caribbean Sea and Atlantic Ocean, north of Trinidad and Tobago.




C16646   C66786   Country   GRL   GRL   GREENLAND                 An island between the Arctic Ocean and the North Atlantic Ocean, northeast of Canada.
C16654   C66786   Country   GTM   GTM   GUATEMALA              A country in Central America, bordering the Caribbean Sea, between Honduras and Belize and
                                                               bordering the North Pacific Ocean, between El Salvador and Mexico.




C16593   C66786   Country   GUF   GUF   FRENCH GUIANA          A country in Northern South America, bordering the North Atlantic Ocean, between Brazil and
                                                               Suriname.




C16652   C66786   Country   GUM   GUM   GUAM                   Island in the North Pacific Ocean, about three-quarters of the way from Hawaii to the
                                                               Philippines.




C16657   C66786   Country   GUY   GUY   GUYANA                 A country in Northern South America, bordering the North Atlantic Ocean, between Suriname
                                                               and Venezuela.




C16695   C66786   Country   HKG   HKG   HKG; HONG KONG         A special administrative region of China, bordering the South China Sea and China.




C20106   C66786   Country   HMD   HMD   HEARD ISLAND AND       Islands in the Indian Ocean, about two-thirds of the way from Madagascar to Antarctica.
                                        MCDONALD ISLANDS
C16694   C66786   Country   HND   HND   HONDURAS               A country in Central America, bordering the Caribbean Sea, between Guatemala and
                                                               Nicaragua and bordering the North Pacific Ocean, between El Salvador and Nicaragua.




C16474   C66786   Country   HRV   HRV   CROATIA                A country in Southeastern Europe, bordering the Adriatic Sea, between Bosnia and
                                                               Herzegovina and Slovenia.




C16660   C66786   Country   HTI   HTI   HAITI                  A country comprising the western one-third of the island of Hispaniola, between the Caribbean
                                                               Sea and the North Atlantic Ocean, west of the Dominican Republic.




C16699   C66786   Country   HUN   HUN   HUNGARY                A country in Central Europe, northwest of Romania.




C16728   C66786   Country   IDN   IDN   INDONESIA              A country in Southeastern Asia, comprising the archipelago between the Indian Ocean and the
                                                               Pacific Ocean.




C16727   C66786   Country   IND   IND   INDIA                  A country in Southern Asia, bordering the Arabian Sea and the Bay of Bengal, between Burma
                                                               and Pakistan.




C16365   C66786   Country   IOT   IOT   BRITISH INDIAN OCEAN   An archipelago in the Indian Ocean, about one-half the way from Africa to Indonesia.
                                        TERRITORY




C16757   C66786   Country   IRL   IRL   IRELAND                A country in Western Europe, occupying five-sixths of the island of Ireland in the North Atlantic
                                                               Ocean, west of Great Britain.




C16755   C66786   Country   IRN   IRN   IRAN                   A country in the Middle East, bordering the Gulf of Oman, the Persian Gulf, and the Caspian
                                                               Sea, between Iraq and Pakistan.




C16756   C66786   Country   IRQ   IRQ   IRAQ                   A country in the Middle East, bordering the Persian Gulf, between Iran and Kuwait.




C16704   C66786   Country   ISL   ISL   ICELAND                A country in Northern Europe, island between the Greenland Sea and the North Atlantic Ocean,
                                                               northwest of the UK.




C16760   C66786   Country   ISR   ISR   ISRAEL                 A country in the Middle East, bordering the Mediterranean Sea, between Egypt and Lebanon.




C16761   C66786   Country   ITA   ITA   ITALY                  A country in Southern Europe, occupying a peninsula extending into the central Mediterranean
                                                               Sea, northeast of Tunisia.




C16763   C66786   Country   JAM   JAM   JAMAICA                An island in the Caribbean Sea, south of Cuba.
C16765   C66786   Country   JOR   JOR   JORDAN                    A country in the Middle East, northwest of Saudi Arabia.




C16764   C66786   Country   JPN   JPN   JAPAN                     A country in Eastern Asia, occupying an island chain between the North Pacific Ocean and the
                                                                  Sea of Japan, east of the Korean Peninsula.




C64374   C66786   Country   JRE   JRE   JERSEY                    Jersey and the other Channel Islands represent the last remnants of the medieval Dukedom of
                                                                  Normandy that held sway in both France and England. Jersey is a British crown dependency,
                                                                  but is not part of the UK.



C20107   C66786   Country   KAZ   KAZ   KAZAKHSTAN                A country in Central Asia, northwest of China.




C16769   C66786   Country   KEN   KEN   KENYA                     A country in Eastern Africa, bordering the Indian Ocean, between Somalia and Tanzania.




C16771   C66786   Country   KGZ   KGZ   KYRGYZSTAN                A country in Central Asia, west of China.




C16378   C66786   Country   KHM   KHM   CAMBODIA                  A country in Southeastern Asia, bordering the Gulf of Thailand, between Thailand, Vietnam,
                                                                  and Laos.




C16639   C66786   Country   KIR   KIR   KIRIBATI                  A group of 33 coral atolls in the Pacific Ocean, straddling the equator; the capital Tarawa is
                                                                  about one-half of the way from Hawaii to Australia.




C17885   C66786   Country   KNA   KNA   SAINT KITTS AND NEVIS     Islands in the Caribbean Sea, about one-third of the way from Puerto Rico to Trinidad and
                                                                  Tobago.




C16774   C66786   Country   KOR   KOR   SOUTH KOREA               A country in Eastern Asia, occupying the southern half of the Korean Peninsula, bordering the
                                                                  Sea of Japan and the Yellow Sea.

C16775   C66786   Country   KWT   KWT   KUWAIT                    A country in the Middle East, bordering the Persian Gulf, between Iraq and Saudi Arabia.




C16780   C66786   Country   LAO   LAO   LAO PEOPLE'S        A country in Southeastern Asia, northeast of Thailand, west of Vietnam.
                                        DEMOCRATIC REPUBLIC




C16784   C66786   Country   LBN   LBN   LEBANON                   A country in the Middle East, bordering the Mediterranean Sea, between Israel and Syria.




C16791   C66786   Country   LBR   LBR   LIBERIA                   A country in Western Africa, bordering the North Atlantic Ocean, between Cote d'Ivoire and
                                                                  Sierra Leone.




C16793   C66786   Country   LBY   LBY   LIBYAN ARAB               A country in Northern Africa, bordering the Mediterranean Sea, between Egypt and Tunisia.
                                        JAMAHIRIYA
C17113   C66786   Country   LCA   LCA   SAINT LUCIA               A country in the Caribbean, occupying an island between the Caribbean Sea and North Atlantic
                                                                  Ocean, north of Trinidad and Tobago.




C16794   C66786   Country   LIE   LIE   LIECHTENSTEIN             A country in Central Europe, between Austria and Switzerland.




C17163   C66786   Country   LKA   LKA   SRI LANKA                 A country in Southern Asia, occupying an island in the Indian Ocean, south of India.




C16787   C66786   Country   LSO   LSO   LESOTHO                   A country in Southern Africa, an enclave of South Africa.




C16799   C66786   Country   LTU   LTU   LITHUANIA                 A country in Eastern Europe, bordering the Baltic Sea, between Latvia and Russia.
C16803   C66786   Country   LUX   LUX   LUXEMBOURG               A country in Western Europe, between France, Belgium, and Germany.




C16783   C66786   Country   LVA   LVA   LATVIA                   A country in Eastern Europe, bordering the Baltic Sea, between Estonia and Lithuania.




C16807   C66786   Country   MAC   MAC   MACAO                    A country in Eastern Asia, bordering the South China Sea and China.




C16878   C66786   Country   MAR   MAR   MOROCCO                  A country in Northern Africa, bordering the North Atlantic Ocean and the Mediterranean Sea,
                                                                 between Algeria and Western Sahara.




C16874   C66786   Country   MCO   MCO   MONACO                   A country in Western Europe, bordering the Mediterranean Sea on the southern coast of
                                                                 France, near the border with Italy.




C16871   C66786   Country   MDA   MDA   MOLDOVA, REPUBLIC OF A country in Eastern Europe, northeast of Romania.




C16808   C66786   Country   MDG   MDG   MADAGASCAR               A country in Southern Africa, occupying an island in the Indian Ocean, east of Mozambique.




C16815   C66786   Country   MDV   MDV   MALDIVES                 A country in Southern Asia, occupying a group of atolls in the Indian Ocean, south-southwest of
                                                                 India.




C16850   C66786   Country   MEX   MEX   MEXICO                   A country in Central America, bordering the Caribbean Sea and the Gulf of Mexico, between
                                                                 Belize and the US and bordering the North Pacific Ocean, between Guatemala and the US.




C16822   C66786   Country   MHL   MHL   MARSHALL ISLANDS         A group of atolls and reefs in the North Pacific Ocean, about one-half of the way from Hawaii to
                                                                 Australia.




C17654   C66786   Country   MKD   MKD   REPUBLIC OF              A country in Southeastern Europe, north of Greece.
                                        MACEDONIA




C16816   C66786   Country   MLI   MLI   MALI                     A country in Western Africa, southwest of Algeria.




C16817   C66786   Country   MLT   MLT   MALTA                    A country in Southern Europe, occupying islands in the Mediterranean Sea, south of Sicily
                                                                 (Italy).




C16370   C66786   Country   MMR   MMR   MYANMAR                  A country in Southeastern Asia, bordering the Andaman Sea and the Bay of Bengal, between
                                                                 Bangladesh and Thailand.




C64378   C66786   Country   MNE   MNE   MONTENEGRO               A republic in Southeastern Europe, bordering the Adriatic Sea, between Albania and Bosnia
                                                                 and Herzegovina. Formerly part of Serbia and Montenegro (Federation Republic of
                                                                 Yugoslavia).



C16875   C66786   Country   MNG   MNG   MONGOLIA                 A country in Northern Asia, between China and Russia.




C17882   C66786   Country   MNP   MNP   NORTHERN MARIANA         A country in the Pacific, comprising islands in the North Pacific Ocean, about three-quarters of
                                        ISLANDS                  the way from Hawaii to the Philippines.




C16882   C66786   Country   MOZ   MOZ   MOZAMBIQUE               A country in Southern Africa, bordering the Mozambique Channel, between South Africa and
                                                                 Tanzania.




C16826   C66786   Country   MRT   MRT   MAURITANIA               A country in Northern Africa, bordering the North Atlantic Ocean, between Senegal and
                                                                 Western Sahara.




C16876   C66786   Country   MSR   MSR   MONTSERRAT               A country in the Caribbean, occupying an island in the Caribbean Sea, southeast of Puerto
                                                                 Rico.
C16823   C66786   Country   MTQ   MTQ   MARTINIQUE       An island in the Caribbean Sea, north of Trinidad and Tobago.




C16827   C66786   Country   MUS   MUS   MAURITIUS        A country in Southern Africa, occupying an island in the Indian Ocean, east of Madagascar.

C16813   C66786   Country   MWI   MWI   MALAWI           A country in Southern Africa, east of Zambia.




C16814   C66786   Country   MYS   MYS   MALAYSIA         A country in Southeastern Asia, occupying a peninsula and the northern one-third of the island
                                                         of Borneo, bordering Indonesia and the South China Sea, south of Vietnam.




C16828   C66786   Country   MYT   MYT   MAYOTTE          A country in Southern Africa, occupying an island in the Mozambique Channel, about one-half
                                                         of the way from northern Madagascar to northern Mozambique.




C16891   C66786   Country   NAM   NAM   NAMIBIA          A country in Southern Africa, bordering the South Atlantic Ocean, between Angola and South
                                                         Africa.




C16913   C66786   Country   NCL   NCL   NEW CALEDONIA    A country in the Pacific, comprised of islands in the South Pacific Ocean, east of Australia.




C16916   C66786   Country   NER   NER   NIGER            A country in Western Africa, southeast of Algeria.




C16919   C66786   Country   NFK   NFK   NORFOLK ISLAND   A country in the Pacific, occupying an island in the South Pacific Ocean, east of Australia.




C16917   C66786   Country   NGA   NGA   NIGERIA          A country in Western Africa, bordering the Gulf of Guinea, between Benin and Cameroon.




C16915   C66786   Country   NIC   NIC   NICARAGUA        A country in Central America, bordering both the Caribbean Sea and the North Pacific Ocean,
                                                         between Costa Rica and Honduras.




C16918   C66786   Country   NIU   NIU   NIUE             A country in the Pacific, occupying an island in the South Pacific Ocean, east of Tonga.




C16903   C66786   Country   NLD   NLD   NETHERLANDS      A country in Western Europe, bordering the North Sea, between Belgium and Germany.




C16920   C66786   Country   NOR   NOR   NORWAY           A country in Northern Europe, bordering the North Sea and the North Atlantic Ocean, west of
                                                         Sweden.




C16901   C66786   Country   NPL   NPL   NEPAL            A country in Southern Asia, between China and India.




C16896   C66786   Country   NRU   NRU   NAURU            A country in Oceania, occupying an island in the South Pacific Ocean, south of the Marshall
                                                         Islands.




C16914   C66786   Country   NZL   NZL   NEW ZEALAND      A country in the Pacific, comprised of islands in the South Pacific Ocean, southeast of
                                                         Australia.




C16933   C66786   Country   OMN   OMN   OMAN             A country in the Middle East, bordering the Arabian Sea, Gulf of Oman, and Persian Gulf,
                                                         between Yemen and the United Arab Emirates.




C16949   C66786   Country   PAK   PAK   PAKISTAN         A country in Southern Asia, bordering the Arabian Sea, between India on the east and Iran and
                                                         Afghanistan on the west and China in the north.




C16951   C66786   Country   PAN   PAN   PANAMA           A country in Central America, bordering both the Caribbean Sea and the North Pacific Ocean,
                                                         between Colombia and Costa Rica.
C16993   C66786   Country   PCN   PCN   PITCAIRN              A country in the Pacific, comprised of islands in the South Pacific Ocean, about midway
                                                              between Peru and New Zealand.




C16972   C66786   Country   PER   PER   PERU                  A country in Western South America, bordering the South Pacific Ocean, between Chile and
                                                              Ecuador.




C16978   C66786   Country   PHL   PHL   PHILIPPINES           A country in Southeastern Asia, comprised of an archipelago between the Philippine Sea and
                                                              the South China Sea, east of Vietnam.




C17733   C66786   Country   PLW   PLW   PALAU                 A country in the Pacific, comprising a group of islands in the North Pacific Ocean, southeast of
                                                              the Philippines.




C16952   C66786   Country   PNG   PNG   PAPUA NEW GUINEA      A country in Southeastern Asia, comprising a group of islands and including the eastern half of
                                                              the island of New Guinea, between the Coral Sea and the South Pacific Ocean, east of
                                                              Indonesia.



C17002   C66786   Country   POL   POL   POLAND                A country in Central Europe, east of Germany.




C17043   C66786   Country   PRI   PRI   PUERTO RICO           An island between the Caribbean Sea and the North Atlantic Ocean, east of the Dominican
                                                              Republic.




C16773   C66786   Country   PRK   PRK   NORTH KOREA           A country in Eastern Asia, occupying the northern half of the Korean Peninsula, bordering the
                                                              Korea Bay and the Sea of Japan, between China and South Korea.




C17006   C66786   Country   PRT   PRT   PORTUGAL              A country in Southwestern Europe, bordering the North Atlantic Ocean, west of Spain.




C16953   C66786   Country   PRY   PRY   PARAGUAY              A country in Central South America, northeast of Argentina.




C20110   C66786   Country   PSE   PSE   PALESTINIAN           A collective name for the West Bank and the Gaza Strip, two territories in Palestine.
                                        TERRITORY, OCCUPIED




C16594   C66786   Country   PYF   PYF   FRENCH POLYNESIA      An archipelago in the South Pacific Ocean, about one-half of the way from South America to
                                                              Australia.




C17045   C66786   Country   QAT   QAT   QATAR                 A country in the Middle East, occupying a peninsula bordering the Persian Gulf and Saudi
                                                              Arabia.




C17095   C66786   Country   REU   REU   REUNION               An Southern Africa, occupying an island in the Indian Ocean, east of Madagascar.




C17108   C66786   Country   ROU   ROU   ROMANIA               A country in Southeastern Europe, bordering the Black Sea, between Bulgaria and Ukraine.




C17111   C66786   Country   RUS   RUS   RUSSIAN FEDERATION    A country in Northern Asia (that part west of the Urals is sometimes included with Europe),
                                                              bordering the Arctic Ocean, between Europe and the North Pacific Ocean.




C17112   C66786   Country   RWA   RWA   RWANDA                A country in Central Africa, east of Democratic Republic of the Congo.




C17117   C66786   Country   SAU   SAU   SAUDI ARABIA          A country in the Middle East, bordering the Persian Gulf and the Red Sea, north of Yemen.




C64377   C66786   Country   SCG   SCG   SERBIA                A republic in Southeastern Europe, bordering the Adriatic Sea, between Albania and Bosnia
                                                              and Herzegovina. Formerly part of Serbia and Montenegro (Federation Republic of
                                                              Yugoslavia).
C17170   C66786   Country   SDN   SDN   SUDAN                A country in Northern Africa, bordering the Red Sea, between Egypt and Eritrea.




C17121   C66786   Country   SEN   SEN   SENEGAL              A country in Western Africa, bordering the North Atlantic Ocean, between Guinea-Bissau and
                                                             Mauritania.




C17134   C66786   Country   SGP   SGP   SINGAPORE            A country in Southeastern Asia, comprised of islands between Malaysia and Indonesia.




C20111   C66786   Country   SGS   SGS   SOUTH GEORGIA AND    A group of islands in the South Atlantic Ocean, east of the tip of South America.
                                        THE SOUTH SANDWICH
                                        ISLANDS



C17164   C66786   Country   SHN   SHN   SAINT HELENA         Islands in the South Atlantic Ocean, about midway between South America and Africa.




C17178   C66786   Country   SJM   SJM   SVALBARD AND JAN     Islands between the Arctic Ocean, Barents Sea, Greenland Sea, and Norwegian Sea, northeast
                                        MAYEN                of Iceland and north of Norway.




C17148   C66786   Country   SLB   SLB   SOLOMON ISLANDS      A group of islands in the South Pacific Ocean, east of Papua New Guinea.




C17130   C66786   Country   SLE   SLE   SIERRA LEONE         A country in Western Africa, bordering the North Atlantic Ocean, between Guinea and Liberia.




C16532   C66786   Country   SLV   SLV   EL SALVADOR          A country in Central America, bordering the North Pacific Ocean, between Guatemala and
                                                             Honduras.




C17115   C66786   Country   SMR   SMR   SAN MARINO           A country in Southern Europe, an enclave in central Italy.




C17149   C66786   Country   SOM   SOM   SOMALIA              A country in Eastern Africa, bordering the Gulf of Aden and the Indian Ocean, east of Ethiopia.




C17165   C66786   Country   SPM   SPM   SAINT PIERRE AND     A country in Northern North America, comprised of islands in the North Atlantic Ocean, south of
                                        MIQUELON             Newfoundland (Canada).




C17116   C66786   Country   STP   STP   SAO TOME AND         A country in Western Africa, comprised of islands in the Gulf of Guinea, straddling the Equator,
                                        PRINCIPE             west of Gabon.




C17175   C66786   Country   SUR   SUR   SURINAME             A country in Northern South America, bordering the North Atlantic Ocean, between French
                                                             Guiana and Guyana.




C17669   C66786   Country   SVK   SVK   SLOVAKIA             A country in Central Europe, south of Poland.




C17138   C66786   Country   SVN   SVN   SLOVENIA             A country in Central Europe, bordering the Adriatic Sea, between Austria and Croatia.




C17180   C66786   Country   SWE   SWE   SWEDEN               A country in Northern Europe, bordering the Baltic Sea, Gulf of Bothnia, Kattegat, and
                                                             Skagerrak, between Finland and Norway.




C17179   C66786   Country   SWZ   SWZ   SWAZILAND            A country in Southern Africa, between Mozambique and South Africa.




C17129   C66786   Country   SYC   SYC   SEYCHELLES           A country in Eastern Africa, comprised of a group of islands in the Indian Ocean, northeast of
                                                             Madagascar.
C17182   C66786   Country   SYR   SYR   SYRIAN ARAB REPUBLIC A country in the Middle East, bordering the Mediterranean Sea, between Lebanon and Turkey.




C17224   C66786   Country   TCA   TCA   TURKS AND CAICOS          Two island groups in the North Atlantic Ocean, southeast of The Bahamas.
                                        ISLANDS




C16412   C66786   Country   TCD   TCD   CHAD                      A country in Central Africa, south of Libya.




C17202   C66786   Country   TGO   TGO   TOGO                      A country in Western Africa, bordering the Bight of Benin, between Benin and Ghana.




C17192   C66786   Country   THA   THA   THAILAND                  A country in Southeastern Asia, bordering the Andaman Sea and the Gulf of Thailand,
                                                                  southeast of Burma.




C17183   C66786   Country   TJK   TJK   TAJIKISTAN                A country in Central Asia, west of China.




C17704   C66786   Country   TKL   TKL   TOKELAU                   A group of three atolls in the South Pacific Ocean, about one-half of the way from Hawaii to
                                                                  New Zealand.




C17223   C66786   Country   TKM   TKM   TURKMENISTAN              A country in Central Asia, bordering the Caspian Sea, between Iran and Kazakhstan.




C17200   C66786   Country   TLS   TLS   TIMOR-LESTE               A country in Southeastern Asia, northwest of Australia in the Lesser Sunda Islands at the
                                                                  eastern end of the Indonesian archipelago. East Timor includes the eastern half of the island of
                                                                  Timor, the Oecussi (Ambeno) region on the northwest portion of the island of Timor, and the
                                                                  islands of Pulau Atauro and Pulau Jaco.




C17205   C66786   Country   TON   TON   TONGA                     An archipelago in the South Pacific Ocean, about two-thirds of the way from Hawaii to New
                                                                  Zealand.
C17217   C66786   Country   TTO   TTO   TRINIDAD AND TOBAGO       Islands between the Caribbean Sea and the North Atlantic Ocean, northeast of Venezuela.




C17221   C66786   Country   TUN   TUN   TUNISIA                   A country in Northern Africa, bordering the Mediterranean Sea, between Algeria and Libya.




C17222   C66786   Country   TUR   TUR   TURKEY                    A country in southeastern Europe and southwestern Asia (that portion of Turkey west of the
                                                                  Bosporus is geographically part of Europe), bordering the Black Sea, between Bulgaria and
                                                                  Georgia, and bordering the Aegean Sea and the Mediterranean Sea, between Greece and
                                                                  Syria.



C17225   C66786   Country   TUV   TUV   TUVALU                    An island group consisting of nine coral atolls in the South Pacific Ocean, about one-half of the
                                                                  way from Hawaii to Australia.




C17184   C66786   Country   TWN   TWN   TAIWAN                    A group of islands bordering the East China Sea, Philippine Sea, South China Sea, and Taiwan
                                                                  Strait, north of the Philippines, off the southeastern coast of China.




C17185   C66786   Country   TZA   TZA   TANZANIA, UNITED          A country in Eastern Africa, bordering the Indian Ocean, between Kenya and Mozambique.
                                        REPUBLIC OF
C17228   C66786   Country   UGA   UGA   UGANDA                    A country in Eastern Africa, west of Kenya.




C17229   C66786   Country   UKR   UKR   UKRAINE                   A country in Eastern Europe, bordering the Black Sea, between Poland and Russia.




C20112   C66786   Country   UMI   UMI   UNITED STATES MINOR       The U.S. Minor Outlying Islands consist of Baker Island, Howland Island, Jarvis Island,
                                        OUTLYING ISLANDS          Johnston Atoll, Kingman Reef, Midway Island, Navassa Island, Palmyra Atoll, and Wake Island
                                                                  (Wake Atoll).

C17244   C66786   Country   URY   URY   URUGUAY                   A country in Southern South America, bordering the South Atlantic Ocean, between Argentina
                                                                  and Brazil.
C17234   C66786   Country   USA   USA   UNITED STATES             A country in North America, bordering both the North Atlantic Ocean and the North Pacific
                                                                  Ocean, between Canada and Mexico.
C17246   C66786         Country           UZB                UZB                UZBEKISTAN                     A country in Central Asia, north of Afghanistan.




C17249   C66786         Country           VAT                VAT                VATICAN CITY STATE             An enclave of Rome (Italy).




C17114   C66786         Country           VCT                VCT                SAINT VINCENT AND THE A country in the Caribbean, comprised of islands in the Caribbean Sea, north of Trinidad and
                                                                                GRENADINES            Tobago.




C17250   C66786         Country           VEN                VEN                VENEZUELA                      A country in Northern South America, bordering the Caribbean Sea and the North Atlantic
                                                                                                               Ocean, between Colombia and Guyana.

C17653   C66786         Country           VGB                VGB                VIRGIN ISLANDS,BRITISH Islands between the Caribbean Sea and the North Atlantic Ocean, east of Puerto Rico.




C17255   C66786         Country           VIR                VIR                VIRGIN ISLANDS, U.S.           Islands between the Caribbean Sea and the North Atlantic Ocean, east of Puerto Rico.




C17252   C66786         Country           VNM                VNM                VIETNAM                        A country in Southeastern Asia, bordering the Gulf of Thailand, Gulf of Tonkin, and South
                                                                                                               China Sea, alongside China, Laos, and Cambodia.




C17247   C66786         Country           VUT                VUT                VANUATU                        A group of islands in the South Pacific Ocean, about three-quarters of the way from Hawaii to
                                                                                                               Australia.




C17259   C66786         Country           WLF                WLF                WALLIS AND FUTUNA              Islands in the South Pacific Ocean, about two-thirds of the way from Hawaii to New Zealand.




C17740   C66786         Country           WSM                WSM                SAMOA                          A group of islands in the South Pacific Ocean, about one-half of the way from Hawaii to New
                                                                                                               Zealand.




C17264   C66786         Country           YEM                YEM                YEMEN                          A country in the Middle East, bordering the Arabian Sea, Gulf of Aden, and Red Sea, between
                                                                                                               Oman and Saudi Arabia.




C17151   C66786         Country           ZAF                ZAF                SOUTH AFRICA                   A country in Southern Africa, at the southern tip of the continent of Africa.




C17267   C66786         Country           ZMB                ZMB                ZAMBIA                         A country in Southern Africa, east of Angola.




C17268   C66786         Country           ZWE                ZWE                ZIMBABWE                       A country in Southern Africa, between South Africa and Zambia.




C66787            Yes   Diagnosis Group   TDIGRP             TDIGRP             Diagnosis Group                A grouping of individuals on the basis of a shared procedure or disease, or lack thereof (e.g.
                                                                                                               healthy volunteers, type 2 diabetic subjects, subjects with renal cell cancer). Standardized
                                                                                                               naming systems are available that define the groups within which a subject should be placed.
                                                                                                               (NCI)
C49651   C66787         Diagnosis Group   HEALTHY SUBJECTS   HEALTHY SUBJECTS                                  An individual who is or becomes a participant in a research study and has no significant health-
                                                                                                               related issues. (NCI)
C66788            Yes   Dictionary Name   DICTNAM            DICTNAM            Dictionary Name; Name of       A name given to a reference source that lists words and gives their meaning. (NCI)
                                                                                Dictionary



C49471   C66788         Dictionary Name   COSTART            COSTART            Coding Symbols for a           A terminology developed and used by the Food and Drug Administration (FDA) for the coding,
                                                                                Thesaurus of Adverse           filing and retrieving of post marketing adverse reaction reports. (NCI)
                                                                                Reaction Terms
C49474   C66788         Dictionary Name   ICD                ICD                International Classification   A system of categories to which morbid entries are assigned according to established criteria.
                                                                                of Diseases                    Included is the entire range of conditions in a manageable number of categories, grouped to
                                                                                                               facilitate mortality reporting. It is produced by the World Health Organization (from ICD-10, p1).
                                                                                                               The Clinical Modifications, produced by the United States Dept. of Health and Human Services,
                                                                                                               are larger extensions used for morbidity and general epidemiological purposes, primarily in the
                                                                                                               U.S. (MSH2005_2004_10_12)
C49476   C66788         Dictionary Name   LOINC              LOINC              Logical Observation            Published by the The Regenstrief Institute, the Logical Observation Identifiers Names and
                                                                                Identifiers Names and          Codes covers clinical and clinical laboratory terminology. (NCI)
                                                                                Codes
C43820   C66788         Dictionary Name   MedDRA             MedDRA             Medical Dictionary for         MedDRA is an international medical terminology designed to support the classification,
                                                                                Regulatory Activities          retrieval, presentation, and communication of medical information throughout the medical
                                                                                                               product regulatory cycle. MedDRA was developed under the auspices of the International
                                                                                                               Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals
                                                                                                               for Human Use (ICH). The MedDRA Maintenance and Support Services Organization (MSSO)
                                                                                                               holds a contract with the International Federation of Pharmaceutical Manufacturers
                                                                                                               Associations (IFPMA) to maintain and support the implementation of the terminology. (NCI)

C53489   C66788         Dictionary Name   SNOMED             SNOMED             Systematized                   A multiaxial, hierarchical classification system for diseases in man developed by the College of
                                                                                Nomenclature of Medicine       American Pathologists. (NCI)
C49468   C66788         Dictionary Name        WHOART                WHOART                    World Health Organization   A terminology implemented by the World Health Organization to describe adverse reactions to
                                                                                               Adverse Reaction Terms      a prescribed medication or treatment regimen. (NCI)

C49475   C66788         Dictionary Name        WHODD                 WHODD                     World Health Organization   A reference source of drugs and drug associated information maintained by the World Health
                                                                                               Drug Dictionary             Organization. (NCI)

C66789            No    Not Done               ND                    ND                        Not Done                    Indicates a task, process or examination that has either not been initiated or completed. (NCI)

C49484   C66789         Not Done               NOT DONE              NOT DONE                                              Indicates a task, process or examination that has either not been initiated or completed. (NCI)




C66790            Yes   Patient Ethnic Group   ETHNIC                ETHNIC                    Patient Ethnic Group        A social group characterized by a distinctive social and cultural tradition maintained from
                                                                                                                           generation to generation, a common history and origin and a sense of identification with the
                                                                                                                           group; members of the group have distinctive features in their way of life, shared experiences
                                                                                                                           and often a common genetic heritage; these features may be reflected in their experience of
                                                                                                                           health and disease. (NCI)
C17459   C66790         Patient Ethnic Group   HISPANIC OR LATINO    HISPANIC OR LATINO                                    A person of Mexican, Puerto Rican, Cuban, Central or South American or other Spanish culture
                                                                                                                           or origin, regardless of race. (NCI)




C41222   C66790         Patient Ethnic Group   NOT HISPANIC OR LATINO NOT HISPANIC OR LATINO                               A person not of Cuban, Mexican, Puerto Rican, South or Central American, or other Spanish
                                                                                                                           culture or origin, regardless of race. An arbitrary ethnic classification. (NCI)




C43234   C66790         Patient Ethnic Group   NOT REPORTED          NOT REPORTED              Not reported                Not provided or available




C17998   C66790         Patient Ethnic Group   UNKNOWN               UNKNOWN                   U; Unknown                  Not known, not observed, not recorded, or refused. (NCI)


C66726            Yes   Pharmaceutical         FRM                   FRM                       Pharmaceutical Dosage       The form of the completed pharmaceutical product, e.g. tablet, capsule, injection, elixir,
                        Dosage Form                                                            Form; Dose Form             suppository. Dosage form can have a significant effect on the onset, duration and intensity of
                                                                                                                           the pharmacological action of a drug. A pharmaceutical dosage form controls the rate at which
                                                                                                                           the drug is released into the biological fluids. This release rate affects its intrinsic absorption
                                                                                                                           pattern and therefore, the bioavailability of the drug.
C42887   C66726         Pharmaceutical         AEROSOL               AEROSOL                                               A product that is packaged under pressure and contains therapeutically active ingredients that
                        Dosage Form                                                                                        are released upon activation of an appropriate valve system; it is intended for topical
                                                                                                                           application to the skin as well as local application into the nose (nasal aerosols), mouth (lingual
                                                                                                                           aerosols), or lungs (inhalation aerosols). (FDA)




C42888   C66726         Pharmaceutical         AEROSOL, FOAM         AEROSOL, FOAM                                         A dosage form containing one or more active ingredients, surfactants, aqueous or non-aqueous
                        Dosage Form                                                                                        liquids, and the propellants; if the propellant is in the internal (discontinuous) phase (i.e., of the
                                                                                                                           oil-in-water type), a stable foam is discharged, and if the propellant is in the external
                                                                                                                           (continuous) phase (i.e., of the water-in-oil type), a spray or a quick-breaking foam is
                                                                                                                           discharged. (FDA)


C42960   C66726         Pharmaceutical         AEROSOL, METERED      AEROSOL, METERED                                      A pressurized dosage form consisting of metered dose valves which allow for the delivery of a
                        Dosage Form                                                                                        uniform quantity of spray upon each activation. (NCI)




C42971   C66726         Pharmaceutical         AEROSOL, POWDER       AEROSOL, POWDER                                       A product that is packaged under pressure and contains therapeutically active ingredients, in
                        Dosage Form                                                                                        the form of a powder, that are released upon activation of an appropriate valve system. (NCI)




C42889   C66726         Pharmaceutical         AEROSOL, SPRAY        AEROSOL, SPRAY                                        An aerosol product which utilizes a compressed gas as the propellant to provide the force
                        Dosage Form                                                                                        necessary to expel the product as a wet spray; it is applicable to solutions of medicinal agents
                                                                                                                           in aqueous solvents. (NCI)




C42892   C66726         Pharmaceutical         BAR, CHEWABLE         BAR, CHEWABLE                                         A solid dosage form usually in the form of a rectangle that is meant to be chewed. (NCI)
                        Dosage Form




C42890   C66726         Pharmaceutical         BEAD                  BEAD                                                  A solid dosage form in the shape of a small ball. (NCI)
                        Dosage Form




C43451   C66726         Pharmaceutical         BEAD, IMPLANT,        BEAD, IMPLANT, EXTENDED                               A small sterile solid mass consisting of a highly purified drug intended for implantation in the
                        Dosage Form            EXTENDED RELEASE      RELEASE                                               body which would allow at least a reduction in dosing frequency as compared to that drug
                                                                                                                           presented as a conventional dosage form. (NCI)




C42891   C66726         Pharmaceutical         BLOCK                 BLOCK                                                 Solid dosage form, usually in the shape of a square or rectangle. (NCI)
                        Dosage Form
C25158   C66726   Pharmaceutical   CAPSULE                  CAPSULE                    A solid pharmaceutical dosage form that contains medicinal agent within either a hard or soft
                  Dosage Form                                                          soluble container or shell, usually used for the oral administration of medicine. The shells are
                                                                                       made of a suitable form of gelatin or other substance. (NCI)




C42895   C66726   Pharmaceutical   CAPSULE, COATED          CAPSULE, COATED            A solid dosage form in which the drug is enclosed within either a hard or soft soluble container
                  Dosage Form                                                          or "shell" made from a suitable form of gelatin; additionally, the capsule is covered in a
                                                                                       designated coating. (NCI)




C42896   C66726   Pharmaceutical   CAPSULE, COATED          CAPSULE, COATED PELLETS    A solid dosage form in which the drug is enclosed within either a hard or soft soluble container
                  Dosage Form      PELLETS                                             or "shell" made from a suitable form of gelatin; the drug itself is in the form of granules to which
                                                                                       varying amounts of coating have been applied. (NCI)




C42917   C66726   Pharmaceutical   CAPSULE, COATED,         CAPSULE, COATED,           A solid dosage form in which the drug is enclosed within either a hard or soft soluble container
                  Dosage Form      EXTENDED RELEASE         EXTENDED RELEASE           or "shell" made from a suitable form of gelatin; additionally, the capsule is covered in a
                                                                                       designated coating, and which releases a drug (or drugs) in such a manner to allow at least a
                                                                                       reduction in dosing frequency as compared to that drug (or drugs) presented as a conventional
                                                                                       dosage form. (NCI)


C42902   C66726   Pharmaceutical   CAPSULE, DELAYED         CAPSULE, DELAYED RELEASE   A solid dosage form in which the drug is enclosed within either a hard or soft soluble container
                  Dosage Form      RELEASE                                             made from a suitable form of gelatin, and which releases a drug (or drugs) at a time other than
                                                                                       promptly after administration. Enteric-coated articles are delayed release dosage forms. (NCI)




C42904   C66726   Pharmaceutical   CAPSULE, DELAYED         CAPSULE, DELAYED RELEASE   A solid dosage form in which the drug is enclosed within either a hard or soft soluble container
                  Dosage Form      RELEASE PELLETS          PELLETS                    or "shell" made from a suitable form of gelatin; the drug itself is in the form of granules to which
                                                                                       enteric coating has been applied, thus delaying release of the drug until its passage into the
                                                                                       intestines. (NCI)



C42916   C66726   Pharmaceutical   CAPSULE, EXTENDED        CAPSULE, EXTENDED          A solid dosage form in which the drug is enclosed within either a hard or soft soluble container
                  Dosage Form      RELEASE                  RELEASE                    made from a suitable form of gelatin, and which releases a drug (or drugs) in such a manner to
                                                                                       allow a reduction in dosing frequency as compared to that drug (or drugs) presented as a
                                                                                       conventional dosage form. (NCI)



C42928   C66726   Pharmaceutical   CAPSULE, FILM COATED,    CAPSULE, FILM COATED,      A solid dosage form in which the drug is enclosed within either a hard or soft soluble container
                  Dosage Form      EXTENDED RELEASE         EXTENDED RELEASE           or "shell" made from a suitable form of gelatin; additionally, the capsule is covered in a
                                                                                       designated film coating, and which releases a drug (or drugs) in such a manner to allow at least
                                                                                       a reduction in dosing frequency as compared to that drug (or drugs) presented as a
                                                                                       conventional dosage form. (NCI)


C42936   C66726   Pharmaceutical   CAPSULE, GELATIN         CAPSULE, GELATIN COATED    A solid dosage form in which the drug is enclosed within either a hard or soft soluble container
                  Dosage Form      COATED                                              made from a suitable form of gelatin; through a banding process, the capsule is coated with
                                                                                       additional layers of gelatin so as to form a complete seal. (NCI)




C42954   C66726   Pharmaceutical   CAPSULE, LIQUID FILLED   CAPSULE, LIQUID FILLED     A solid dosage form in which the drug is enclosed within a soluble, gelatin shell which is
                  Dosage Form                                                          plasticized by the addition of a polyol, such as sorbitol or glycerin, and is therefore of a
                                                                                       somewhat thicker consistency than that of a hard shell capsule; typically, the active ingredients
                                                                                       are dissolved or suspended in a liquid vehicle. (NCI)



C45414   C66726   Pharmaceutical   CEMENT                   CEMENT                     A substance that serves to produce solid union between two surfaces. (NCI)
                  Dosage Form




C42678   C66726   Pharmaceutical   CIGARETTE                CIGARETTE                  A narrow tube filled with material that is capable to burn with release of therapeutically-active
                  Dosage Form                                                          substance(s) during the process of smoking. Cigarette is a very efficient drug-delivery inhaler
                                                                                       system for fast-acting substances.(FDA)




C60884   C66726   Pharmaceutical   CLOTH                    CLOTH                      A large piece of relatively flat, absorbent material that contains a drug. It is typically used for
                  Dosage Form                                                          applying medication or for cleansing. (FDA)




C60891   C66726   Pharmaceutical   CONCENTRATE              CONCENTRATE                A liquid preparation of increased strength and reduced volume which is usually diluted prior to
                  Dosage Form                                                          administration. (NCI)




C42900   C66726   Pharmaceutical   CONE                     CONE                       A solid dosage form bounded by a circular base and the surface formed by line segments
                  Dosage Form                                                          joining every point of the boundary of the base to a common vertex. A cone (usually containing
                                                                                       antibiotics) is normally placed below the gingiva after a dental extraction. (NCI)




C42919   C66726   Pharmaceutical   CORE, EXTENDED           CORE, EXTENDED RELEASE     An ocular system placed in the eye from which the drug diffuses through a membrane at a
                  Dosage Form      RELEASE                                             constant rate over a specified period. (NCI)

C28944   C66726   Pharmaceutical   CREAM                    CREAM                      A semisolid emulsion of either the oil-in-water or the water-in-oil type, ordinarily intended for
                  Dosage Form                                                          topical use. (NCI)
C60897   C66726   Pharmaceutical   CREAM, AUGMENTED     CREAM, AUGMENTED          A cream dosage form that enhances drug delivery. Augmentation does not refer to the strength
                  Dosage Form                                                     of the drug in the dosage form. NOTE: CDER has decided to refrain from expanding the use of
                                                                                  this dosage form due to difficulties in setting specific criteria that must be met to be considered
                                                                                  augmented. (FDA)



C42901   C66726   Pharmaceutical   CRYSTAL              CRYSTAL                   A naturally produced angular solid of definite form in which the ultimate units from which it is
                  Dosage Form                                                     built up are systematically arranged; they are usually evenly spaced on a regular space lattice.




C45415   C66726   Pharmaceutical   CULTURE              CULTURE                   The propagation of microorganisms or of living tissue cells in special media conducive to their
                  Dosage Form                                                     growth. (NCI)




C47890   C66726   Pharmaceutical   DIAPHRAGM            DIAPHRAGM                 A device usually dome-shaped, worn during copulation over the cervical mouth for prevention
                  Dosage Form                                                     of conception or infection. (NCI)




C43525   C66726   Pharmaceutical   DISC                 DISC                      A circular plate-like organ or structure. (FDA)
                  Dosage Form




C42679   C66726   Pharmaceutical   DOUCHE               DOUCHE                    A liquid preparation, intended for the irrigative cleansing of the vagina, that is prepared from
                  Dosage Form                                                     powders, liquid solutions, or liquid concentrates and contains one or more chemical substances
                                                                                  dissolved in a suitable solvent or mutually miscible solvents. (NCI)




C42763   C66726   Pharmaceutical   DRESSING             DRESSING                  The application of various materials for protecting a wound.(FDA)
                  Dosage Form




C17423   C66726   Pharmaceutical   DRUG DELIVERY SYSTEM DRUG DELIVERY SYSTEM      Modern technology, distributed with or as a part of a drug product that allows for the uniform
                  Dosage Form                                                     release or targeting of drugs to the body. (FDA)




C42912   C66726   Pharmaceutical   ELIXIR               ELIXIR                    A clear, pleasantly flavored, sweetened hydroalcoholic liquid containing dissolved medicinal
                  Dosage Form                                                     agents; it is intended for oral use. (NCI)




C42913   C66726   Pharmaceutical   EMULSION             EMULSION                  A dosage form consisting of a two-phase system comprised of at least two immiscible liquids
                  Dosage Form                                                     (1), one of which is dispersed as droplets (internal or dispersed phase) within the other liquid
                                                                                  (external or continuous phase), generally stabilized with one or more emulsifying agents. Note
                                                                                  1: A liquid is pourable; it flows and conforms to its container at room temperature. It displays
                                                                                  Newtonian or pseudoplastic flow behavior. Note 2: Emulsion is used as a dosage form term
                                                                                  unless a more specific term is applicable, e.g. cream, lotion, ointment. (NCI)

C42915   C66726   Pharmaceutical   ENEMA                ENEMA                     A rectal preparation for therapeutic, diagnostic, or nutritive purposes. (NCI)
                  Dosage Form




C42929   C66726   Pharmaceutical   EXTRACT              EXTRACT                   A concentrated preparation of vegetable or animal drugs obtained by removal of the active
                  Dosage Form                                                     constituents of the respective drugs with a suitable menstrua, evaporation of all or nearly all of
                                                                                  the solvent, and adjustment of the residual masses or powders to the prescribed standards.
                                                                                  (NCI)



C60926   C66726   Pharmaceutical   FIBER, EXTENDED      FIBER, EXTENDED RELEASE   A slender and elongated solid thread-like substance that delivers drug in such a manner to
                  Dosage Form      RELEASE                                        allow a reduction in dosing frequency as compared to that drug (or drugs) presented as a
                                                                                  conventional dosage form. (FDA)




C42932   C66726   Pharmaceutical   FILM                 FILM                      A thin layer or coating. (NCI)
                  Dosage Form




C42920   C66726   Pharmaceutical   FILM, EXTENDED       FILM, EXTENDED RELEASE    A drug delivery system in the form of a film that releases the drug over an extended period in
                  Dosage Form      RELEASE                                        such a way as to maintain constant drug levels in the blood or target tissue. (NCI)




C42984   C66726   Pharmaceutical   FILM, SOLUBLE        FILM, SOLUBLE             A thin layer or coating which is susceptible to being dissolved when in contact with a liquid.
                  Dosage Form                                                     (NCI)
C60927   C66726   Pharmaceutical   FOR SOLUTION         FOR SOLUTION               A product, usually a solid, intended for solution prior to administration. (FDA)
                  Dosage Form




C60928   C66726   Pharmaceutical   FOR SUSPENSION       FOR SUSPENSION             A product, usually a solid, intended for suspension prior to administration. (FDA)
                  Dosage Form




C60929   C66726   Pharmaceutical   FOR SUSPENSION,      FOR SUSPENSION, EXTENDED   A product, usually a solid, intended for suspension prior to administration; once the suspension
                  Dosage Form      EXTENDED RELEASE     RELEASE                    is administered, the drug will be released at a constant rate over a specified period. (FDA)




C42933   C66726   Pharmaceutical   GAS                  GAS                        Any elastic aeriform fluid in which the molecules are separated from one another and have free
                  Dosage Form                                                      paths. (NCI)




C42934   C66726   Pharmaceutical   GEL                  GEL                        A semisolid (1) dosage form that contains a gelling agent to provide stiffness to a solution or a
                  Dosage Form                                                      colloidal dispersion (2). A gel may contain suspended particles. Note 1: A semisolid is not
                                                                                   pourable; it does not flow or conform to its container at room temperature. It does not flow at
                                                                                   low shear stress and generally exhibits plastic flow behavior. Note 2: A colloidal dispersion is a
                                                                                   system in which particles of colloidal dimension (i.e., typically between 1 nm and 1 micrometer)
                                                                                   are distributed uniformly throughout a liquid. (NCI)

C42906   C66726   Pharmaceutical   GEL, DENTIFRICE      GEL, DENTIFRICE            A combination of a dentifrice (formulation intended to clean and/or polish the teeth, and which
                  Dosage Form                                                      may contain certain additional agents), and a gel. It is used with a toothbrush for the purpose of
                                                                                   cleaning and polishing the teeth. (NCI)




C60930   C66726   Pharmaceutical   GEL, METERED         GEL, METERED               A gel preparation, with metered dose valves, which allow for the delivery of a uniform quantity
                  Dosage Form                                                      of gel upon each activation. (FDA)




C48193   C66726   Pharmaceutical   GENERATOR            GENERATOR                  An apparatus for the formation of vapor or gas from a liquid or solid by heat or chemical action.
                  Dosage Form                                                      The term GENERATOR also applies to radioactive columns from which radionuclides are
                                                                                   provided. (NCI)




C42937   C66726   Pharmaceutical   GLOBULE              GLOBULE                    Also called pellets or pilules, are made of pure sucrose, lactose, or other polysaccharides. They
                  Dosage Form                                                      are formed into small globular masses of various sizes, and are medicated by placing them in a
                                                                                   vial and adding the liquid drug attenuation in the proportion not less than one percent (v/w).
                                                                                   After shaking, the medicated globules are dried at temperatures not to exceed 40 degrees
                                                                                   Centigrade. (NCI)


C45416   C66726   Pharmaceutical   GRAFT                GRAFT                      A slip of skin or of other tissue for implantation. (NCI)
                  Dosage Form




C42938   C66726   Pharmaceutical   GRANULE              GRANULE                    A small particle or grain. (NCI)
                  Dosage Form




C42903   C66726   Pharmaceutical   GRANULE, DELAYED     GRANULE, DELAYED RELEASE   A small medicinal particle or grain to which an enteric or other coating has been applied, thus
                  Dosage Form      RELEASE                                         delaying release of the drug until its passage into the intestines. (NCI)




C42909   C66726   Pharmaceutical   GRANULE,             GRANULE, EFFERVESCENT      A small particle or grain containing a medicinal agent in a dry mixture usually composed of
                  Dosage Form      EFFERVESCENT                                    sodium bicarbonate, citric acid, and tartaric acid which, when in contact with water, has the
                                                                                   capability to release gas, resulting in effervescence. (NCI)




C42939   C66726   Pharmaceutical   GRANULE, FOR         GRANULE, FOR SOLUTION      A small medicinal particle or grain made available in its more stable dry form, to be
                  Dosage Form      SOLUTION                                        reconstituted with solvent just before dispensing; the granules are so prepared to contain not
                                                                                   only the medicinal agent, but the colorants, flavorants, and any other desired pharmaceutic
                                                                                   ingredient. (NCI)



C42940   C66726   Pharmaceutical   GRANULE, FOR         GRANULE, FOR SUSPENSION    A small medicinal particle or grain made available in its more stable dry form, to be
                  Dosage Form      SUSPENSION                                      reconstituted with solvent just before dispensing to form a suspension; the granules are so
                                                                                   prepared to contain not only the medicinal agent, but the colorants, flavorants, and any other
                                                                                   desired pharmaceutic ingredient. (NCI)



C42921   C66726   Pharmaceutical   GRANULE, FOR         GRANULE, FOR SUSPENSION,   A small medicinal particle or grain made available in its more stable dry form, to be
                  Dosage Form      SUSPENSION, EXTENDED EXTENDED RELEASE           reconstituted with solvent just before dispensing to form a suspension; the extended release
                                   RELEASE                                         system achieves slow release of the drug over an extended period of time and maintains
                                                                                   constant drug levels in the blood or target tissue. (NCI)
C42941   C66726   Pharmaceutical   GUM                   GUM                         A mucilaginous excretion from various plants. (NCI)
                  Dosage Form




C42894   C66726   Pharmaceutical   GUM, CHEWING          GUM, CHEWING                A sweetened and flavored insoluble plastic material of various shapes which when chewed,
                  Dosage Form                                                        releases a drug substance into the oral cavity. (NCI)




C42978   C66726   Pharmaceutical   GUM, RESIN            GUM, RESIN                  Natural mixture of gum and resin, usually obtained as exudations from plants. (NCI)
                  Dosage Form




C42942   C66726   Pharmaceutical   IMPLANT               IMPLANT                     A material containing drug intended to be inserted securely and deeply in a living site for
                  Dosage Form                                                        growth, slow release, or formation of an organic union. (NCI)




C42944   C66726   Pharmaceutical   INHALANT              INHALANT                    A special class of inhalations consisting of a drug or combination of drugs, that by virtue of their
                  Dosage Form                                                        high vapor pressure, can be carried by an air current into the nasal passage where they exert
                                                                                     their effect; the container from which the inhalant generally is administered is known as an
                                                                                     inhaler. (NCI)



C60931   C66726   Pharmaceutical   INJECTABLE, LIPOSOMAL INJECTABLE, LIPOSOMAL       An injection, which either consists of or forms liposomes (a lipid bilayer vesicle usually
                  Dosage Form                                                        composed of phospholipids which is used to encapsulate an active drug substance). (FDA)




C42946   C66726   Pharmaceutical   INJECTION             INJECTION                   A sterile preparation intended for parenteral use; five distinct classes of injections exist as
                  Dosage Form                                                        defined by the USP. (NCI)




C42914   C66726   Pharmaceutical   INJECTION, EMULSION   INJECTION, EMULSION         An emulsion consisting of a sterile, pyrogen-free preparation intended to be administered
                  Dosage Form                                                        parenterally.(FDA)




C42950   C66726   Pharmaceutical   INJECTION, LIPID      INJECTION, LIPID COMPLEX    [definition pending](FDA)
                  Dosage Form      COMPLEX




C42974   C66726   Pharmaceutical   INJECTION, POWDER,    INJECTION, POWDER, FOR      A sterile preparation intended for reconstitution to form a solution for parenteral use. (NCI)
                  Dosage Form      FOR SOLUTION          SOLUTION




C42976   C66726   Pharmaceutical   INJECTION, POWDER,    INJECTION, POWDER, FOR      A sterile preparation intended for reconstitution to form a suspension for parenteral use. (NCI)
                  Dosage Form      FOR SUSPENSION        SUSPENSION




C42977   C66726   Pharmaceutical   INJECTION, POWDER,    INJECTION, POWDER, FOR      A dried preparation intended for reconstitution to form a suspension for parenteral use which
                  Dosage Form      FOR SUSPENSION,       SUSPENSION, EXTENDED        has been formulated in a manner to allow at least a reduction in dosing frequency as compared
                                   EXTENDED RELEASE      RELEASE                     to that drug presented as a conventional dosage form (e.g., as a solution).(FDA)




C42959   C66726   Pharmaceutical   INJECTION, POWDER,   INJECTION, POWDER,           A sterile freeze dried preparation intended for reconstitution for parenteral use which has been
                  Dosage Form      LYOPHILIZED, FOR     LYOPHILIZED, FOR             formulated in a manner that would allow liposomes (a lipid bilayer vesicle usually composed of
                                   LIPOSOMAL SUSPENSION LIPOSOMAL SUSPENSION         phospholipids which is used to encapsulate an active drug substance, either within a lipid
                                                                                     bilayer or in an aqueous space) to be formed upon reconstitution. (NCI)



C42957   C66726   Pharmaceutical   INJECTION, POWDER,    INJECTION, POWDER,          A dosage form intended for the solution prepared by lyophilization ('freeze drying'), a process
                  Dosage Form      LYOPHILIZED, FOR      LYOPHILIZED, FOR SOLUTION   which involves the removal of water from products in the frozen state at extremely low
                                   SOLUTION                                          pressures; this is intended for subsequent addition of liquid to create a solution that conforms in
                                                                                     all respects to the requirements for Injections. (NCI)



C42958   C66726   Pharmaceutical   INJECTION, POWDER,    INJECTION, POWDER,          A liquid preparation, intended for parenteral use, that contains solids suspended in a suitable
                  Dosage Form      LYOPHILIZED, FOR      LYOPHILIZED, FOR            fluid medium and conforms in all respects to the requirements for Sterile Suspensions; the
                                   SUSPENSION            SUSPENSION                  medicinal agents intended for the suspension are prepared by lyophilization ("freeze drying"), a
                                                                                     process which involves the removal of water from products in the frozen state at extremely low
                                                                                     pressures. (NCI)


C42956   C66726   Pharmaceutical   INJECTION, POWDER,   INJECTION, POWDER,           A sterile freeze dried preparation intended for reconstitution for parenteral use which has been
                  Dosage Form      LYOPHILIZED, FOR     LYOPHILIZED, FOR             formulated in a manner to allow at least a reduction in dosing frequency as compared to that
                                   SUSPENSION, EXTENDED SUSPENSION                   drug presented as a conventional dosage form (e.g., as a solution). (NCI)
                                   RELEASE
C42945   C66726   Pharmaceutical   INJECTION, SOLUTION    INJECTION, POWDER,         A liquid preparation containing one or more drug substances dissolved in a suitable solvent or
                  Dosage Form                             LYOPHILIZED, FOR           mixture of mutually miscible solvents that is suitable for injection. (NCI)
                                                          SUSPENSION, EXTENDED
                                                          RELEASE



C42899   C66726   Pharmaceutical   INJECTION, SOLUTION,   INJECTION, SOLUTION        A sterile preparation for parenteral use which, upon the addition of suitable solvents, yields a
                  Dosage Form      CONCENTRATE                                       solution conforming in all respects to the requirements for Injections. (NCI)




C42995   C66726   Pharmaceutical   INJECTION, SUSPENSION INJECTION, SOLUTION,        A liquid preparation, suitable for injection, which consists of solid particles dispersed throughout
                  Dosage Form                            CONCENTRATE                 a liquid phase in which the particles are not soluble. It can also consist of an oil phase
                                                                                     dispersed throughout an aqueous phase, or vice-versa. (NCI)




C42926   C66726   Pharmaceutical   INJECTION, SUSPENSION, INJECTION, SUSPENSION      A sterile preparation intended for parenteral use which has been formulated in a manner to
                  Dosage Form      EXTENDED RELEASE                                  allow at least a reduction in dosing frequency as compared to that drug presented as a
                                                                                     conventional dosage form (e.g., as a solution or a prompt drug-releasing, conventional solid
                                                                                     dosage form). (NCI)



C42951   C66726   Pharmaceutical   INJECTION, SUSPENSION, INJECTION, SUSPENSION,     A liquid parenteral pharmaceutical dosage form structured as a multilamellar composition of
                  Dosage Form      LIPOSOMAL              EXTENDED RELEASE           concentric phospholipid spheres that encapsulate the drug (drug delivery systems) separated
                                                                                     by layers of water. Drug release is facilitated and controlled by in vivo erosion of the liposomes.
                                                                                     To further increase the in vivo circulation time, liposomes in some preparations are covalently
                                                                                     derivatized with PEG to produce PEGylated or stealth liposomes. Covalent attachment of drugs
                                                                                     to the outer surface of liposomes can potentially serve as a delayed-release product. (NCI)

C42988   C66726   Pharmaceutical   INJECTION, SUSPENSION, INJECTION, SUSPENSION,     A liquid preparation, suitable for injection, which consists of solid particles dispersed throughout
                  Dosage Form      SONICATED              SONICATED                  a liquid phase in which the particles are not soluble. In addition, the product is sonicated while a
                                                                                     gas is bubbled through the suspension, and this results in the formation of microspheres by the
                                                                                     solid particles. (NCI)



C60933   C66726   Pharmaceutical   INSERT                 INSERT                     A specially formulated and shaped non-encapsulated solid preparation intended to be placed
                  Dosage Form                                                        into a non-rectal orifice of the body, where drug is released, generally for localized effects.
                                                                                     (FDA)




C42922   C66726   Pharmaceutical   INSERT, EXTENDED       INSERT, EXTENDED RELEASE   A specially formulated and shaped solid preparation (e.g., ring, tablet, or stick) intended to be
                  Dosage Form      RELEASE                                           placed in the vagina by special inserters, where the medication is released, generally for
                                                                                     localized effects; the extended release preparation is designed to allow a reduction in dosing
                                                                                     frequency. (NCI)



C47915   C66726   Pharmaceutical   INTRAUTERINE DEVICE    INTRAUTERINE DEVICE        A device inserted and left in the uterus to prevent effective conception. (NCI)
                  Dosage Form




C42947   C66726   Pharmaceutical   IRRIGANT               IRRIGANT                   A sterile solution intended to bathe or flush open wounds or body cavities; they're used
                  Dosage Form                                                        topically, never parenterally. (NCI)




C42948   C66726   Pharmaceutical   JELLY                  JELLY                      A class of gels--semisolid systems which consist of suspensions made up of either small
                  Dosage Form                                                        inorganic particles or large organic molecules interpenetrated by a liquid--in which the structural
                                                                                     coherent matrix contains a high portion of liquid, usually water. (NCI)




C47916   C66726   Pharmaceutical   KIT                    KIT                        A packaged collection of related material. (NCI)
                  Dosage Form




C45413   C66726   Pharmaceutical   LINER, DENTAL          LINER, DENTAL              A material applied to the inside of the dental cavity, for protection or insulation of the
                  Dosage Form                                                        surface.(FDA)




C42949   C66726   Pharmaceutical   LINIMENT               LINIMENT                   A solution or mixture of various substances in oil, alcoholic solutions of soap, or emulsions
                  Dosage Form                                                        intended for external application. (NCI)




C42952   C66726   Pharmaceutical   LIPSTICK               LIPSTICK                   A waxy solid, usually colored cosmetic, in stick form for the lips. (NCI)
                  Dosage Form




C42953   C66726   Pharmaceutical   LIQUID                 LIQUID                     A dosage form consisting of a pure chemical in its liquid state. This dosage form term should
                  Dosage Form                                                        not be applied to solutions. Note: A liquid is pourable; it flows and conforms to its container at
                                                                                     room temperature. It displays Newtonian or pseudoplastic flow behavior.(FDA)
C60934   C66726   Pharmaceutical   LIQUID, EXTENDED      LIQUID, EXTENDED RELEASE   A liquid that delivers a drug in such a manner to allow a reduction in dosing frequency as
                  Dosage Form      RELEASE                                          compared to that drug (or drugs) presented as a conventional dosage form. (FDA)




C29167   C66726   Pharmaceutical   LOTION                LOTION                     An emulsion, liquid (1) dosage form. This dosage form is generally for external application to
                  Dosage Form                                                       the skin (2). Note 1: A liquid is pourable; it flows and conforms to its container at room
                                                                                    temperature. It displays Newtonian or pseudoplastic flow behavior. Note 2: Previously the
                                                                                    definition of a lotion was: The term lotion has been used to categorize many topical
                                                                                    suspensions, solutions, and emulsions intended for application to the skin. The current
                                                                                    definition of a lotion is restricted to an emulsion. (FDA)

C60957   C66726   Pharmaceutical   LOTION. AUGMENTED     LOTION. AUGMENTED          A lotion dosage form that enhances drug delivery. Augmentation does not refer to the strength
                  Dosage Form                                                       of the drug in the dosage form. NOTE: CDER has decided to refrain from expanding the use of
                                                                                    this dosage form due to difficulties in setting specific criteria that must be met to be considered
                                                                                    augmented. (FDA)



C60958   C66726   Pharmaceutical   LOTION/SHAMPOO        LOTION/SHAMPOO             A lotion dosage form which has a soap or detergent that is usually used to clean the hair and
                  Dosage Form                                                       scalp; it is often used as a vehicle for dermatologic agents. (FDA)




C42955   C66726   Pharmaceutical   LOZENGE               LOZENGE                    A solid preparation containing one or more medicaments, usually in a flavored, sweetened
                  Dosage Form                                                       base which is intended to dissolve or disintegrate slowly in the mouth. A lollipop is a lozenge on
                                                                                    a stick.(FDA)




C29269   C66726   Pharmaceutical   MOUTHWASH             MOUTHWASH                  An aqueous solution which is most often used for its deodorant, refreshing, or antiseptic effect.
                  Dosage Form                                                       (NCI)




C48624   C66726   Pharmaceutical   NOT APPLICABLE        NOT APPLICABLE             The use of a dosage form term is not relevant or appropriate. (NCI)
                  Dosage Form




C42965   C66726   Pharmaceutical   OIL                   OIL                        An unctuous, combustible substance which is liquid, or easily liquefiable, on warming, and is
                  Dosage Form                                                       soluble in ether but insoluble in water. Such substances, depending on their origin, are
                                                                                    classified as animal, mineral, or vegetable oils. (NCI)




C42966   C66726   Pharmaceutical   OINTMENT              OINTMENT                   A suspension or emulsion, semisolid (1) dosage form, usually containing < 20% water and
                  Dosage Form                                                       volatiles (2) and > 50% hydrocarbons, waxes, or polyols as the vehicle. This dosage form is
                                                                                    generally for external application to the skin or mucous membranes. Note 1: A semisolid is not
                                                                                    pourable; it does not flow or conform to its container at room temperature. It does not flow at
                                                                                    low shear stress and generally exhibits plastic flow behavior. Note 2: Percent water and
                                                                                    volatiles are measured by a loss on drying test in which the sample is heated at 105 degrees C
                                                                                    until constant weight is achieved. (NCI)
C60984   C66726   Pharmaceutical   OINTMENT, AUGMENTED   OINTMENT, AUGMENTED        An ointment dosage form that enhances drug delivery. Augmentation does not refer to the
                  Dosage Form                                                       strength of the drug in the dosage form. NOTE: CDER has decided to refrain from expanding
                                                                                    the use of this dosage form due to difficulties in setting specific criteria that must be met to be
                                                                                    considered augmented. (FDA)



C47887   C66726   Pharmaceutical   PACKING               PACKING                    A material, usually covered by or impregnated with a drug, that is inserted into a body cavity or
                  Dosage Form                                                       between the tooth enamel and the gingival margin.(FDA)




C42967   C66726   Pharmaceutical   PASTE                 PASTE                      A semisolid dosage form, containing a large proportion (20 - 50%) of solids finely dispersed in a
                  Dosage Form                                                       fatty vehicle. This dosage form is generally for external application to the skin or mucous
                                                                                    membranes. Note: A semisolid is not pourable; it does not flow or conform to its container at
                                                                                    room temperature. It does not flow at low shear stress and generally exhibits plastic flow
                                                                                    behavior. (NCI)


C42907   C66726   Pharmaceutical   PASTE, DENTIFRICE     PASTE, DENTIFRICE          A paste formulation intended to clean and/or polish the teeth, and which may contain certain
                  Dosage Form                                                       additional agents. (NCI)




C60985   C66726   Pharmaceutical   PASTILLE              PASTILLE                   An aromatic preparation, often with a pleasing flavor, usually intended to dissolve in the mouth.
                  Dosage Form                                                       (FDA)




C42968   C66726   Pharmaceutical   PATCH                 PATCH                      A drug delivery system that often contains an adhesive backing that is usually applied to an
                  Dosage Form                                                       external site on the body. Its ingredients either passively diffuse from, or are actively
                                                                                    transported from, some portion of the patch. Depending upon the patch, the ingredients are
                                                                                    either delivered to the outer surface of the body or into the body. A patch is sometimes
                                                                                    synonymous with the terms Extended Release Film and System. (NCI)


C42923   C66726   Pharmaceutical   PATCH, EXTENDED       PATCH, EXTENDED RELEASE    A drug delivery system in the form of a patch that releases the drug in such a manner that a
                  Dosage Form      RELEASE                                          reduction in dosing frequency compared to that drug presented as a conventional dosage form
                                                                                    (e.g., a solution or a prompt drug-releasing, conventional solid dosage form). (NCI)
C42911   C66726   Pharmaceutical   PATCH, EXTENDED       PATCH, EXTENDED RELEASE,   A drug delivery system in the form of a patch which is controlled by an electric current that
                  Dosage Form      RELEASE, ELECTRICALLY ELECTRICALLY CONTROLLED    releases the drug in such a manner that a reduction in dosing frequency compared to that drug
                                   CONTROLLED                                       presented as a conventional dosage form (e.g., a solution or a prompt drug-releasing,
                                                                                    conventional solid dosage form). (NCI)



C42969   C66726   Pharmaceutical   PELLET                PELLET                     A small sterile solid mass consisting of a highly purified drug (with or without excipients) made
                  Dosage Form                                                       by the formation of granules, or by compression and molding. (NCI)




C42943   C66726   Pharmaceutical   PELLET, IMPLANTABLE   PELLET, IMPLANTABLE        A small sterile solid mass consisting of a highly purified drug (with or without excipients) made
                  Dosage Form                                                       by the formation of granules, or by compression and molding; they are intended for
                                                                                    implantation in the body (usually subcutaneously) for the purpose of providing continuous
                                                                                    release of the drug over long periods of time. (NCI)



C42918   C66726   Pharmaceutical   PELLETS, COATED,      PELLETS, COATED,           A solid dosage form in which the drug itself is in the form of granules to which varying amounts
                  Dosage Form      EXTENDED RELEASE      EXTENDED RELEASE           of coating have been applied, and which releases a drug (or drugs) in such a manner to allow a
                                                                                    reduction in dosing frequency as compared to that drug (or drugs) presented as a conventional
                                                                                    dosage form. (NCI)



C25394   C66726   Pharmaceutical   PILL                  PILL                       A dose of medicine in the form of a small pellet. (NCI)
                  Dosage Form




C42970   C66726   Pharmaceutical   PLASTER               PLASTER                    Substance intended for external application made of such materials and of such consistency as
                  Dosage Form                                                       to adhere to the skin and attach to a dressing; plasters are intended to afford protection and
                                                                                    support and/or to furnish an occlusion and macerating action and to bring medication into close
                                                                                    contact with the skin. (NCI)



C47913   C66726   Pharmaceutical   POULTICE              POULTICE                   A soft, moist mass of meal, herbs, seed, etc., usually applied hot in cloth that consists of gruel-
                  Dosage Form                                                       like consistency. (NCI)




C42972   C66726   Pharmaceutical   POWDER                POWDER                     An intimate mixture of dry, finely divided drugs and/or chemicals that may be intended for
                  Dosage Form                                                       internal or external use. (NCI)




C42908   C66726   Pharmaceutical   POWDER, DENTIFRICE    POWDER, DENTIFRICE         A powder formulation intended to clean and/or polish the teeth, and which may contain certain
                  Dosage Form                                                       additional agents. (NCI)




C42973   C66726   Pharmaceutical   POWDER, FOR SOLUTION POWDER, FOR SOLUTION        An intimate mixture of dry, finely divided drugs and/or chemicals, which, upon the addition of
                  Dosage Form                                                       suitable vehicles, yields a solution. (NCI)




C42975   C66726   Pharmaceutical   POWDER, FOR           POWDER, FOR SUSPENSION     An intimate mixture of dry, finely divided drugs and/or chemicals, which, upon the addition of
                  Dosage Form      SUSPENSION                                       suitable vehicles, yields a suspension (a liquid preparation containing the solid particles
                                                                                    dispersed in the liquid vehicle). (NCI)




C42961   C66726   Pharmaceutical   POWDER, METERED       POWDER, METERED            A powder dosage form that is situated inside a container that has a mechanism to deliver a
                  Dosage Form                                                       specified quantity. (NCI)




C60988   C66726   Pharmaceutical   RING                  RING                       A small circular object with a vacant circular center that is usually intended to be placed in the
                  Dosage Form                                                       body by special inserters, where the medication is released, generally for localized effects.
                                                                                    (FDA)




C42979   C66726   Pharmaceutical   RINSE                 RINSE                      A liquid used to cleanse by flushing. (NCI)
                  Dosage Form




C42980   C66726   Pharmaceutical   SALVE                 SALVE                      A thick ointment or cerate (a fat or wax based preparation with a consistency between an
                  Dosage Form                                                       ointment and a plaster). (NCI)




C42981   C66726   Pharmaceutical   SHAMPOO               SHAMPOO                    A liquid soap or detergent used to clean the hair and scalp and is often used as a vehicle for
                  Dosage Form                                                       dermatologic agents. (NCI)
C42982   C66726   Pharmaceutical   SHAMPOO, SUSPENSION   SHAMPOO, SUSPENSION       A liquid soap or detergent containing one or more solid, insoluble substances dispersed in a
                  Dosage Form                                                      liquid vehicle that is used to clean the hair and scalp and is often used as a vehicle for
                                                                                   dermatologic agents. (NCI)




C42983   C66726   Pharmaceutical   SOAP                  SOAP                      Any compound of one or more fatty acids, or their equivalents, with an alkali; soap is detergent
                  Dosage Form                                                      and is much employed in liniments, enemas, and in making pills. It is also a mild aperient,
                                                                                   antacid and antiseptic. (NCI)




C42986   C66726   Pharmaceutical   SOLUTION              SOLUTION                  A clear, homogeneous liquid dosage form that contains one or more chemical substances
                  Dosage Form                                                      dissolved in a solvent or mixture of mutually miscible solvents. Note: A liquid is pourable; it
                                                                                   flows and conforms to its container at room temperature. It displays Newtonian or pseudoplastic
                                                                                   flow behavior. (NCI)



C42898   C66726   Pharmaceutical   SOLUTION,             SOLUTION, CONCENTRATE     A liquid preparation (i.e., a substance that flows readily in its natural state) that contains a drug
                  Dosage Form      CONCENTRATE                                     dissolved in a suitable solvent or mixture of mutually miscible solvents; the drug has been
                                                                                   strengthened by the evaporation of its non-active parts. (NCI)




C42987   C66726   Pharmaceutical   SOLUTION, FOR SLUSH   SOLUTION, FOR SLUSH       A solution for the preparation of an iced saline slush, which is administered by irrigation and
                  Dosage Form                                                      used to induce regional hypothermia (in conditions such as certain open heart and kidney
                                                                                   surgical procedures) by its direct application. (NCI)




C60994   C66726   Pharmaceutical   SOLUTION, GEL FORMING SOLUTION, GEL FORMING /   A solution, which after usually being administered in a drop-wise fashion, forms a gel. (FDA)
                  Dosage Form      / DROPS               DROPS




C42935   C66726   Pharmaceutical   SOLUTION, GEL         SOLUTION, GEL FORMING,    A solution that forms a gel when it comes in contact with ocular fluid, and which allows at least
                  Dosage Form      FORMING, EXTENDED     EXTENDED RELEASE          a reduction in dosing frequency
                                   RELEASE




C60992   C66726   Pharmaceutical   SOLUTION/ DROPS       SOLUTION/ DROPS           A solution which is usually administered in a drop-wise fashion. (FDA)
                  Dosage Form




C47912   C66726   Pharmaceutical   SPONGE                SPONGE                    A porous, interlacing, absorbent material that contains a drug. It is typically used for applying
                  Dosage Form                                                      or introducing medication, or for cleansing. A sponge usually retains its shape.(FDA)




C42989   C66726   Pharmaceutical   SPRAY                 SPRAY                     A liquid minutely divided as by a jet of air or steam. (NCI)
                  Dosage Form




C42962   C66726   Pharmaceutical   SPRAY, METERED        SPRAY, METERED            A non-pressurized dosage form consisting of valves which allow the dispensing of a specified
                  Dosage Form                                                      quantity of spray upon each activation. (NCI)




C42990   C66726   Pharmaceutical   SPRAY, SUSPENSION     SPRAY, SUSPENSION         A liquid preparation containing solid particles dispersed in a liquid vehicle and in the form of
                  Dosage Form                                                      coarse droplets or as finely divided solids to be applied locally, most usually to the nasal-
                                                                                   pharyngeal tract, or topically to the skin. (NCI)




C42991   C66726   Pharmaceutical   STICK                 STICK                     A dosage form prepared in a relatively long and slender often cylindrical form. (NCI)
                  Dosage Form




C47914   C66726   Pharmaceutical   STRIP                 STRIP                     A long narrow piece of material.
                  Dosage Form




C42993   C66726   Pharmaceutical   SUPPOSITORY           SUPPOSITORY               A solid body of various weights and shapes, adapted for introduction into the rectal, vaginal, or
                  Dosage Form                                                      urethral orifice of the human body; they usually melt, soften, or dissolve at body temperature.
                                                                                   (NCI)




C42924   C66726   Pharmaceutical   SUPPOSITORY,          SUPPOSITORY, EXTENDED     A drug delivery system in the form of a suppository that allows at least a reduction in dosing
                  Dosage Form      EXTENDED RELEASE      RELEASE                   frequency. (NCI)
C42994   C66726   Pharmaceutical   SUSPENSION             SUSPENSION                 A liquid dosage form that contains solid particles dispersed in a liquid vehicle. Note: A liquid is
                  Dosage Form                                                        pourable; it flows and conforms to its container at room temperature. It displays Newtonian or
                                                                                     pseudoplastic flow behavior.(FDA)




C42925   C66726   Pharmaceutical   SUSPENSION, EXTENDED SUSPENSION, EXTENDED         A liquid preparation consisting of solid particles dispersed throughout a liquid phase in which
                  Dosage Form      RELEASE              RELEASE                      the particles are not soluble; the suspension has been formulated in a manner to allow at least
                                                                                     a reduction in dosing frequency as compared to that drug presented as a conventional dosage
                                                                                     form (e.g., as a solution or a prompt drug-releasing, conventional solid dosage form). (NCI)



C60995   C66726   Pharmaceutical   SUSPENSION/DROPS       SUSPENSION/DROPS           A suspension which is usually administered in a dropwise fashion. (FDA)
                  Dosage Form




C47889   C66726   Pharmaceutical   SUTURE                 SUTURE                     A strand or fiber used to hold wound edges in apposition during healing. (NCI)
                  Dosage Form




C47898   C66726   Pharmaceutical   SWAB                   SWAB                       A small piece of relatively flat absorbent material that contains a drug. A swab may also be
                  Dosage Form                                                        attached to one end of a small stick. A swab is typically used for applying medication or for
                                                                                     cleansing. (NCI)




C42996   C66726   Pharmaceutical   SYRUP                  SYRUP                      An oral solution containing high concentrations of sucrose or other sugars; the term has also
                  Dosage Form                                                        been used to include any other liquid dosage form prepared in a sweet and viscid vehicle,
                                                                                     including oral suspensions. (NCI)




C42998   C66726   Pharmaceutical   TABLET                 TABLET                     A solid dosage form containing medicinal substances with or without suitable diluents. (NCI)
                  Dosage Form




C42893   C66726   Pharmaceutical   TABLET, CHEWABLE       TABLET, CHEWABLE           A solid dosage form containing medicinal substances with or without suitable diluents that is
                  Dosage Form                                                        intended to be chewed, producing a pleasant tasting residue in the oral cavity that is easily
                                                                                     swallowed and does not leave a bitter or unpleasant after-taste. (NCI)




C42897   C66726   Pharmaceutical   TABLET, COATED         TABLET, COATED             A solid dosage form that contains medicinal substances with or without suitable diluents and is
                  Dosage Form                                                        covered with a designated coating. (NCI)




C60997   C66726   Pharmaceutical   TABLET, COATED         TABLET, COATED PARTICLES   A solid dosage form containing a conglomerate of medicinal particles that have each been
                  Dosage Form      PARTICLES                                         covered with a coating. (FDA)




C42905   C66726   Pharmaceutical   TABLET, DELAYED        TABLET, DELAYED RELEASE    A solid dosage form which releases a drug (or drugs) at a time other than promptly after
                  Dosage Form      RELEASE                                           administration. Enteric-coated articles are delayed release dosage forms. (NCI)




C42997   C66726   Pharmaceutical   TABLET, DELAYED        TABLET, DELAYED RELEASE    A solid dosage form containing a conglomerate of medicinal particles that have been covered
                  Dosage Form      RELEASE PARTICLES      PARTICLES                  with a coating which releases a drug (or drugs) at a time other than promptly after
                                                                                     administration. Enteric-coated articles are delayed release dosage forms. (NCI)




C42910   C66726   Pharmaceutical   TABLET, EFFERVESCENT TABLET, EFFERVESCENT         A solid dosage form containing mixtures of acids (e.g., citric acid, tartaric acid) and sodium
                  Dosage Form                                                        bicarbonate, which release carbon dioxide when dissolved in water; it is intended to be
                                                                                     dissolved or dispersed in water before administration.(FDA)




C42927   C66726   Pharmaceutical   TABLET, EXTENDED       TABLET, EXTENDED RELEASE   A solid dosage form containing a drug which allows at least a reduction in dosing frequency as
                  Dosage Form      RELEASE                                           compared to that drug presented in conventional dosage form. (NCI)




C42931   C66726   Pharmaceutical   TABLET, FILM COATED    TABLET, FILM COATED        A solid dosage form that contains medicinal substances with or without suitable diluents and is
                  Dosage Form                                                        coated with a thin layer of a water-insoluble or water-soluble polymer. (NCI)




C42930   C66726   Pharmaceutical   TABLET, FILM COATED,   TABLET, FILM COATED,       A solid dosage form that contains medicinal substances with or without suitable diluents and is
                  Dosage Form      EXTENDED RELEASE       EXTENDED RELEASE           coated with a thin layer of a water-insoluble or water-soluble polymer; the tablet is formulated in
                                                                                     such manner as to make the contained medicament available over an extended period of time
                                                                                     following ingestion. (NCI)
C61004   C66726         Pharmaceutical       TABLET, FOR SOLUTION   TABLET, FOR SOLUTION                                   A tablet that forms a solution when placed in a liquid. (FDA)
                        Dosage Form




C61005   C66726         Pharmaceutical       TABLET, FOR            TABLET, FOR SUSPENSION;                                A tablet that forms a suspension when placed in a liquid (formerly referred to as a Dispersible
                        Dosage Form          SUSPENSION             TABLET, DISPERSIBLE                                    Tablet).

C42964   C66726         Pharmaceutical       TABLET, MULTILAYER     TABLET, MULTILAYER                                     A solid dosage form containing medicinal substances that have been compressed to form a
                        Dosage Form                                                                                        multiple-layered tablet or a tablet-within-a-tablet, the inner tablet being the core and the outer
                                                                                                                           portion being the shell. (NCI)



C42963   C66726         Pharmaceutical       TABLET, MULTILAYER,    TABLET, MULTILAYER,                                    A solid dosage form containing medicinal substances that have been compressed to form a
                        Dosage Form          EXTENDED RELEASE       EXTENDED RELEASE                                       multiple-layered tablet or a tablet-within-a-tablet, the inner tablet being the core and the outer
                                                                                                                           portion being the shell, which, additionally, is covered in a designated coating; the tablet is
                                                                                                                           formulated in such manner as to allow at least a reduction in dosing frequency as compared to
                                                                                                                           that drug presented as a conventional dosage form. (NCI)


C42999   C66726         Pharmaceutical       TABLET, ORALLY         TABLET, ORALLY                                         A solid dosage form containing medicinal substances which disintegrates rapidly, usually within
                        Dosage Form          DISINTEGRATING         DISINTEGRATING                                         a matter of seconds, when placed upon the tongue. (NCI)



C61006   C66726         Pharmaceutical       TABLET, ORALLY         TABLET, ORALLY                                         A solid dosage form containing medicinal substances which disintegrates rapidly, usually within
                        Dosage Form          DISINTEGRATING,        DISINTEGRATING, DELAYED                                a matter of seconds, when placed upon the tongue, but which releases a drug (or drugs) at a
                                             DELAYED RELEASE        RELEASE                                                time other than promptly after administration. (FDA)




C42985   C66726         Pharmaceutical       TABLET, SOLUBLE        TABLET, SOLUBLE                                        A solid dosage form that contains medicinal substances with or without suitable diluents and
                        Dosage Form                                                                                        possesses the ability to dissolve in fluids. (NCI)


C42992   C66726         Pharmaceutical       TABLET, SUGAR COATED TABLET, SUGAR COATED                                     A solid dosage form that contains medicinal substances with or without suitable diluents and is
                        Dosage Form                                                                                        coated with a colored or an uncolored water-soluble sugar. (NCI)



C47892   C66726         Pharmaceutical       TAMPON                 TAMPON                                                 A plug made of cotton, sponge, or oakum variously used in surgery to plug the nose, vagina,
                        Dosage Form                                                                                        etc., for the control of hemorrhage or the absorption of secretions. (NCI)



C47897   C66726         Pharmaceutical       TAPE                   TAPE                                                   A narrow woven fabric, or a narrow extruded synthetic (such as plastic), usually with an
                        Dosage Form                                                                                        adhesive on one or both sides. (NCI)

C43000   C66726         Pharmaceutical       TINCTURE               TINCTURE                                               An alcoholic or hydroalcoholic solution prepared from vegetable materials or from chemical
                        Dosage Form                                                                                        substances. (NCI)


C43001   C66726         Pharmaceutical       TROCHE                 TROCHE                                                 A discoid-shaped solid containing the medicinal agent in a suitably flavored base; troches are
                        Dosage Form                                                                                        placed in the mouth where they slowly dissolve, liberating the active ingredients. (NCI)




C43002   C66726         Pharmaceutical       UNASSIGNED             UNASSIGNED                                             A dosage form has yet to be assigned. (NCI)
                        Dosage Form




C43003   C66726         Pharmaceutical       WAFER                  WAFER                                                  A thin slice of material containing a medicinal agent. (NCI)
                        Dosage Form




C66727            Yes   Completion/Reason    NCOMPLT                NCOMPLT                   Completion/Reason for Non- The reason that a subject was discontinued from a clinical trial.
                        for Non-Completion                                                    Completion

C41331   C66727         Completion/Reason    ADVERSE EVENT          ADVERSE EVENT                                          Any untoward medical occurrence in a patient or clinical investigation subject administered a
                        for Non-Completion                                                                                 pharmaceutical product and which does not necessarily have a causal relationship with this
                                                                                                                           treatment. An adverse event (AE) can therefore be any unintended sign (including an abnormal
                                                                                                                           laboratory finding), symptom,or disease temporally associated with the use of a medicinal
                                                                                                                           (investigational) product, whether or not related to the medicinal (investigational) product.
                                                                                                                           NOTE: For further information, see the ICH Guideline for Clinical Safety Data Management:
                                                                                                                           Definitions and Standards for Expedited Reporting. [Modified from ICH E2A] Synonyms: side
                                                                                                                           effect, adverse experience. See also serious adverse event, serious adverse experience.
                                                                                                                           (CDISC glossary)
C25250   C66727         Completion/Reason    COMPLETED              COMPLETED                                              To possess every necessary or normal part or component or step; having come or been
                        for Non-Completion                                                                                 brought to a conclusion. (NCI)
C28554   C66727         Completion/Reason    DEATH                  DEATH                                                  The absence of life or state of being dead. (NCI)
                        for Non-Completion
C48226   C66727         Completion/Reason    LACK OF EFFICACY       LACK OF EFFICACY                                       The lack of expected or desired effect related to a therapy. (NCI)
                        for Non-Completion
C48227   C66727         Completion/Reason    LOST TO FOLLOW-UP      LOST TO FOLLOW-UP                                      The loss or lack of continuation of follow-up after a study has officially closed. See Follow-up.
                        for Non-Completion                                                                                 (NCI)
C49631   C66727         Completion/Reason    NON-COMPLIANCE WITH    NON-COMPLIANCE WITH                                    An indication that a subject has not agreed with or followed the instructions related to the study
                        for Non-Completion   STUDY DRUG             STUDY DRUG                                             medication. (NCI)
C17649   C66727         Completion/Reason    OTHER                  OTHER                     Other                        Different than the one(s) previously specified or mentioned. (NCI)
                        for Non-Completion
C48250   C66727         Completion/Reason    PHYSICIAN DECISION     PHYSICIAN DECISION                                     A position, opinion or judgment reached after consideration by a physician with reference to
                        for Non-Completion                                                                                 subject. (NCI)
C25742   C66727         Completion/Reason    PREGNANCY              PREGNANCY                                              Pregnancy is the state or condition of having a developing embryo or fetus in the body (uterus),
                        for Non-Completion                                                                                 after union of an ovum and spermatozoon, during the period from conception to birth. (NCI)




C35571   C66727         Completion/Reason    PROGRESSIVE DISEASE    PROGRESSIVE DISEASE                                    A disease process that is increasing in scope or severity. (NCI)
                        for Non-Completion
C48251   C66727         Completion/Reason    PROTOCOL VIOLATION     PROTOCOL VIOLATION                                     An event or decision that stands in contrast to the guidelines set out by the protocol. (NCI)
                        for Non-Completion

C25746   C66727         Completion/Reason    RECOVERY               RECOVERY                                               A healing process and/or an outcome implying relative health. The term is typically used in the
                        for Non-Completion                                                                                 context of direct and indirect effects of sickness or injury. (NCI)
C49628   C66727         Completion/Reason    SCREEN FAILURE         SCREEN FAILURE                                         The potential subject who does not meet one or more criteria required for participation in a trial.
                        for Non-Completion
C49632   C66727         Completion/Reason    STUDY TERMINATED BY    STUDY TERMINATED BY                                    An indication that a clinical study was stopped by its sponsor. (NCI)
                        for Non-Completion   SPONSOR                SPONSOR
C49633   C66727         Completion/Reason    TECHNICAL PROBLEMS   TECHNICAL PROBLEMS                                A problem with some technical aspect of a clinical study, usually related to an instrument.
                        for Non-Completion                                                                          (NCI)
C49634   C66727         Completion/Reason    WITHDRAWAL BY        WITHDRAWAL BY SUBJECT                             An indication that a study participant has removed itself from the study. (NCI)
                        for Non-Completion   SUBJECT

C66728            No    Relation to Reference STENRF              STENRF                  Relation to Reference     The name of a code list that contains terms that reference timepoints within and without a
                        Period                                                            Period                    defined time period.

C38008   C66728         Relation to Reference AFTER               AFTER                                             The time period following a point or another period of time. (NCI)
                        Period




C25629   C66728         Relation to Reference BEFORE              BEFORE                                            Earlier in time or order. (NCI)
                        Period




C25490   C66728         Relation to Reference DURING              DURING                                            At some point in a given period of time. (NCI)
                        Period




C49640   C66728         Relation to Reference DURING/AFTER        DURING/AFTER                                      Within a certain period of time or after a certain point or period in time. (NCI)
                        Period




C17998   C66728         Relation to Reference U                   UNKNOWN                 U; Unknown                Not known, not observed, not recorded, or refused. (NCI)
                        Period




C66729            Yes   Route of             ROUTE                ROUTE                   Route of Administration   The course by which a substance was administered in order to reach the site of action in the
                        Administration                                                                              body.

C38192   C66729         Route of             AURICULAR (OTIC)     AURICULAR (OTIC)                                  Administration to or by way of the ear.(FDA)
                        Administration




C38193   C66729         Route of             BUCCAL               BUCCAL                                            Administration directed toward the cheek, generally from within the mouth.(FDA)
                        Administration




C38194   C66729         Route of             CONJUNCTIVAL         CONJUNCTIVAL                                      Administration to the conjunctiva, the delicate membrane that lines the eyelids and covers the
                        Administration                                                                              exposed surface of the eyeball.(FDA)




C38675   C66729         Route of             CUTANEOUS            CUTANEOUS                                         Administration to the skin.(FDA)
                        Administration




C38197   C66729         Route of             DENTAL               DENTAL                                            Administration to a tooth or teeth.(FDA)
                        Administration




C38633   C66729         Route of             ELECTRO-OSMOSIS      ELECTRO-OSMOSIS                                   Administration of through the diffusion of substance through a membrane in an electric
                        Administration                                                                              field.(FDA)




C38205   C66729         Route of             ENDOCERVICAL         ENDOCERVICAL                                      Administration within the canal of the cervix uteri. Synonymous with the term
                        Administration                                                                              intracervical.(FDA)




C38206   C66729         Route of             ENDOSINUSIAL         ENDOSINUSIAL                                      Administration within the nasal sinuses of the head.(FDA)
                        Administration




C38208   C66729         Route of             ENDOTRACHEAL         ENDOTRACHEAL                                      Administration directly into the trachea. Synonymous with the term intratracheal.(FDA)
                        Administration




C38209   C66729         Route of             ENTERAL              ENTERAL                                           Administration directly into the intestines.(FDA)
                        Administration
C38210   C66729   Route of         EPIDURAL             EPIDURAL             Administration upon or over the dura mater.(FDA)
                  Administration




C38211   C66729   Route of         EXTRA-AMNIOTIC       EXTRA-AMNIOTIC       Administration to the outside of the membrane enveloping the fetus.(FDA)
                  Administration




C38212   C66729   Route of         EXTRACORPOREAL       EXTRACORPOREAL       Administration outside of the body.(FDA)
                  Administration




C38200   C66729   Route of         HEMODIALYSIS         HEMODIALYSIS         Administration through hemodialysate fluid.(FDA)
                  Administration




C38215   C66729   Route of         INFILTRATION         INFILTRATION         Administration that results in substances passing into tissue spaces or into cells.(FDA)
                  Administration




C38219   C66729   Route of         INTERSTITIAL         INTERSTITIAL         Administration to or in the interstices of a tissue.(FDA)
                  Administration




C38220   C66729   Route of         INTRA-ABDOMINAL      INTRA-ABDOMINAL      Administration within the abdomen.(FDA)
                  Administration




C38221   C66729   Route of         INTRA-AMNIOTIC       INTRA-AMNIOTIC       Administration within the amnion.(FDA)
                  Administration




C38222   C66729   Route of         INTRA-ARTERIAL       INTRA-ARTERIAL       Administration within an artery or arteries.(FDA)
                  Administration




C38223   C66729   Route of         INTRA-ARTICULAR      INTRA-ARTICULAR      Administration within a joint.(FDA)
                  Administration




C38224   C66729   Route of         INTRABILIARY         INTRABILIARY         Administration within the bile, bile ducts or gallbladder.(FDA)
                  Administration




C38225   C66729   Route of         INTRABRONCHIAL       INTRABRONCHIAL       Administration within a bronchus.(FDA)
                  Administration




C38226   C66729   Route of         INTRABURSAL          INTRABURSAL          Administration within a bursa.(FDA)
                  Administration




C38227   C66729   Route of         INTRACARDIAC         INTRACARDIAC         Administration within the heart.(FDA)
                  Administration




C38228   C66729   Route of         INTRACARTILAGINOUS   INTRACARTILAGINOUS   Administration within a cartilage; endochondral.(FDA)
                  Administration




C38229   C66729   Route of         INTRACAUDAL          INTRACAUDAL          Administration within the cauda equina.(FDA)
                  Administration
C38230   C66729   Route of         INTRACAVERNOUS       INTRACAVERNOUS         Administration within a pathologic cavity, such as occurs in the lung in tuberculosis.(FDA)
                  Administration




C38231   C66729   Route of         INTRACAVITARY        INTRACAVITARY          Administration within a non-pathologic cavity, such as that of the cervix, uterus, or penis, or
                  Administration                                               such as that is formed as the result of a wound.(FDA)




C38232   C66729   Route of         INTRACEREBRAL        INTRACEREBRAL          Administration within the cerebrum.(FDA)
                  Administration




C38233   C66729   Route of         INTRACISTERNAL       INTRACISTERNAL         Administration within the cisterna magna cerebellomedularis.(FDA)
                  Administration




C38234   C66729   Route of         INTRACORNEAL         INTRACORNEAL           Administration within the cornea (the transparent structure forming the anterior part of the
                  Administration                                               fibrous tunic of the eye).(FDA)




C38217   C66729   Route of         INTRACORONAL, DENTAL INTRACORONAL, DENTAL   Administration of a drug within a portion of a tooth which is covered by enamel and which is
                  Administration                                               separated from the roots by a slightly constricted region known as the neck.(FDA)




C38218   C66729   Route of         INTRACORONARY        INTRACORONARY          Administration within the coronary arteries.(FDA)
                  Administration




C38235   C66729   Route of         INTRACORPORUS        INTRACORPORUS          Administration within the dilatable spaces of the corporus cavernosa of the penis.(FDA)
                  Administration   CAVERNOSUM           CAVERNOSUM




C38238   C66729   Route of         INTRADERMAL          INTRADERMAL            Administration within the dermis.(FDA)
                  Administration




C38239   C66729   Route of         INTRADISCAL          INTRADISCAL            Administration within a disc.(FDA)
                  Administration




C38240   C66729   Route of         INTRADUCTAL          INTRADUCTAL            Administration within the duct of a gland.(FDA)
                  Administration




C38241   C66729   Route of         INTRADUODENAL        INTRADUODENAL          Administration within the duodenum.(FDA)
                  Administration




C38242   C66729   Route of         INTRADURAL           INTRADURAL             Administration within or beneath the dura.(FDA)
                  Administration




C38243   C66729   Route of         INTRAEPIDERMAL       INTRAEPIDERMAL         Administration within the epidermis.(FDA)
                  Administration




C38245   C66729   Route of         INTRAESOPHAGEAL      INTRAESOPHAGEAL        Administration within the esophagus.(FDA)
                  Administration




C38246   C66729   Route of         INTRAGASTRIC         INTRAGASTRIC           Administration within the stomach.(FDA)
                  Administration
C38247   C66729   Route of         INTRAGINGIVAL      INTRAGINGIVAL      Administration within the gingivae.(FDA)
                  Administration




C38249   C66729   Route of         INTRAILEAL         INTRAILEAL         Administration within the distal portion of the small intestine, from the jejunum to the
                  Administration                                         cecum.(FDA)




C38250   C66729   Route of         INTRALESIONAL      INTRALESIONAL      Administration within or introduced directly into a localized lesion.(FDA)
                  Administration




C38251   C66729   Route of         INTRALUMINAL       INTRALUMINAL       Administration within the lumen of a tube.(FDA)
                  Administration




C38252   C66729   Route of         INTRALYMPHATIC     INTRALYMPHATIC     Administration within the lymph.(FDA)
                  Administration




C38253   C66729   Route of         INTRAMEDULLARY     INTRAMEDULLARY     Administration within the marrow cavity of a bone.(FDA)
                  Administration




C38254   C66729   Route of         INTRAMENINGEAL     INTRAMENINGEAL     Administration within the meninges (the three membranes that envelope the brain and spinal
                  Administration                                         cord).(FDA)




C28161   C66729   Route of         INTRAMUSCULAR      INTRAMUSCULAR      Administration within a muscle. (FDA)
                  Administration




C38255   C66729   Route of         INTRAOCULAR        INTRAOCULAR        Administration within the eye.(FDA)
                  Administration




C38256   C66729   Route of         INTRAOVARIAN       INTRAOVARIAN       Administration within the ovary.(FDA)
                  Administration




C38257   C66729   Route of         INTRAPERICARDIAL   INTRAPERICARDIAL   Administration within the pericardium.(FDA)
                  Administration




C38258   C66729   Route of         INTRAPERITONEAL    INTRAPERITONEAL    Administration within the peritoneal cavity.(FDA)
                  Administration




C38259   C66729   Route of         INTRAPLEURAL       INTRAPLEURAL       Administration within the pleura.(FDA)
                  Administration




C38260   C66729   Route of         INTRAPROSTATIC     INTRAPROSTATIC     Administration within the prostate gland.(FDA)
                  Administration




C38261   C66729   Route of         INTRAPULMONARY     INTRAPULMONARY     Administration within the lungs or its bronchi.(FDA)
                  Administration




C38262   C66729   Route of         INTRASINAL         INTRASINAL         Administration within the nasal or periorbital sinuses.(FDA)
                  Administration
C38263   C66729   Route of         INTRASPINAL         INTRASPINAL                               Administration within the vertebral column.(FDA)
                  Administration




C38264   C66729   Route of         INTRASYNOVIAL       INTRASYNOVIAL                             Administration within the synovial cavity of a joint.(FDA)
                  Administration




C38265   C66729   Route of         INTRATENDINOUS      INTRATENDINOUS                            Administration within a tendon.(FDA)
                  Administration




C38266   C66729   Route of         INTRATESTICULAR     INTRATESTICULAR                           Administration within the testicle.(FDA)
                  Administration




C38267   C66729   Route of         INTRATHECAL         INTRATHECAL                               Administration within the cerebrospinal fluid at any level of the cerebrospinal axis, including
                  Administration                                                                 injection into the cerebral ventricles.(FDA)




C38207   C66729   Route of         INTRATHORACIC       INTRATHORACIC                             Administration within the thorax (internal to the ribs); synonymous with the term
                  Administration                                                                 endothoracic.(FDA)




C38268   C66729   Route of         INTRATUBULAR        INTRATUBULAR                              Administration within the tubules of an organ.(FDA)
                  Administration




C38269   C66729   Route of         INTRATUMOR          INTRATUMOR          Intratumor Route of   Administration within a tumor.(FDA)
                  Administration                                           Administration

C38270   C66729   Route of         INTRATYMPANIC       INTRATYMPANIC                             Administration within the auris media.(FDA)
                  Administration




C38272   C66729   Route of         INTRAUTERINE        INTRAUTERINE                              Administration within the uterus.(FDA)
                  Administration




C38273   C66729   Route of         INTRAVASCULAR       INTRAVASCULAR                             Administration within a vessel or vessels.(FDA)
                  Administration




C38276   C66729   Route of         INTRAVENOUS         INTRAVENOUS                               Administration within or into a vein or veins.(FDA)
                  Administration




C38274   C66729   Route of         INTRAVENOUS BOLUS   INTRAVENOUS BOLUS                         Administration within or into a vein or veins all at once.(FDA)
                  Administration




C38279   C66729   Route of         INTRAVENOUS DRIP    INTRAVENOUS DRIP                          Administration within or into a vein or veins over a sustained period of time.(FDA)
                  Administration




C38277   C66729   Route of         INTRAVENTRICULAR    INTRAVENTRICULAR                          Administration within a ventricle.(FDA)
                  Administration




C38278   C66729   Route of         INTRAVESICAL        INTRAVESICAL                              Administration within the bladder.(FDA)
                  Administration




C38280   C66729   Route of         INTRAVITREAL        INTRAVITREAL                              Administration within the vitreous body of the eye.(FDA)
                  Administration
C38203   C66729   Route of         IONTOPHORESIS        IONTOPHORESIS        Administration by means of an electric current where ions of soluble salts migrate into the
                  Administration                                             tissues of the body.(FDA)




C38281   C66729   Route of         IRRIGATION           IRRIGATION           Administration to bathe or flush open wounds or body cavities.(FDA)
                  Administration




C38282   C66729   Route of         LARYNGEAL            LARYNGEAL            Administration directly upon the larynx.(FDA)
                  Administration




C38284   C66729   Route of         NASAL                NASAL                Administration to the nose; administered by way of the nose.(FDA)
                  Administration




C38285   C66729   Route of         NASOGASTRIC          NASOGASTRIC          Administration through the nose and into the stomach, usually by means of a tube.(FDA)
                  Administration




C48623   C66729   Route of         NOT APPLICABLE       NOT APPLICABLE       Routes of administration are not applicable.(FDA)
                  Administration




C38286   C66729   Route of         OCCLUSIVE DRESSING   OCCLUSIVE DRESSING   Administration by the topical route which is then covered by a dressing which occludes the
                  Administration   TECHNIQUE            TECHNIQUE            area.(FDA)

C38287   C66729   Route of         OPHTHALMIC           OPHTHALMIC           Administration to the external eye.(FDA)
                  Administration




C38288   C66729   Route of         ORAL                 ORAL                 Administration to or by way of the mouth.(FDA)
                  Administration




C38289   C66729   Route of         OROPHARYNGEAL        OROPHARYNGEAL        Administration directly to the mouth and pharynx.(FDA)
                  Administration




C38290   C66729   Route of         OTHER                OTHER                Administration is different from others on this list.(FDA)
                  Administration




C38291   C66729   Route of         PARENTERAL           PARENTERAL           Administration by injection, infusion, or implantation.(FDA)
                  Administration




C38676   C66729   Route of         PERCUTANEOUS         PERCUTANEOUS         Administration through the skin.(FDA)
                  Administration




C38292   C66729   Route of         PERIARTICULAR        PERIARTICULAR        Administration around a joint.(FDA)
                  Administration




C38677   C66729   Route of         PERIDURAL            PERIDURAL            Administration to the outside of the dura mater of the spinal cord.(FDA)
                  Administration




C38293   C66729   Route of         PERINEURAL           PERINEURAL           Administration surrounding a nerve or nerves.(FDA)
                  Administration




C38294   C66729   Route of         PERIODONTAL          PERIODONTAL          Administration around a tooth.(FDA)
                  Administration
C38295   C66729   Route of         RECTAL            RECTAL                     Administration to the rectum.(FDA)
                  Administration




C38216   C66729   Route of         RESPIRATORY       RESPIRATORY (INHALATION)   Administration within the respiratory tract by inhaling orally or nasally for local or systemic
                  Administration   (INHALATION)                                 effect.(FDA)




C38296   C66729   Route of         RETROBULBAR       RETROBULBAR                Administration behind the pons or behind the eyeball.(FDA)
                  Administration




C38198   C66729   Route of         SOFT TISSUE       SOFT TISSUE                Administration into any soft tissue.(FDA)
                  Administration




C38297   C66729   Route of         SUBARACHNOID      SUBARACHNOID               Administration beneath the arachnoid.(FDA)
                  Administration




C38298   C66729   Route of         SUBCONJUNCTIVAL   SUBCONJUNCTIVAL            Administration beneath the conjunctiva.(FDA)
                  Administration




C38299   C66729   Route of         SUBCUTANEOUS      SUBCUTANEOUS               Administration beneath the skin; hypodermic. Synonymous with the term SUBDERMAL.(FDA)
                  Administration




C38300   C66729   Route of         SUBLINGUAL        SUBLINGUAL                 Administration beneath the tongue.(FDA)
                  Administration




C38301   C66729   Route of         SUBMUCOSAL        SUBMUCOSAL                 Administration beneath the mucous membrane.(FDA)
                  Administration




C38304   C66729   Route of         TOPICAL           TOPICAL                    Administration to a particular spot on the outer surface of the body. The E2B term
                  Administration                                                TRANSMAMMARY is a subset of the term TOPICAL.(FDA)



C38305   C66729   Route of         TRANSDERMAL       TRANSDERMAL                Administration through the dermal layer of the skin to the systemic circulation by
                  Administration                                                diffusion.(FDA)




C38283   C66729   Route of         TRANSMUCOSAL      TRANSMUCOSAL               Administration across the mucosa.(FDA)
                  Administration




C38307   C66729   Route of         TRANSPLACENTAL    TRANSPLACENTAL             Administration through or across the placenta.(FDA)
                  Administration




C38308   C66729   Route of         TRANSTRACHEAL     TRANSTRACHEAL              Administration through the wall of the trachea.(FDA)
                  Administration




C38309   C66729   Route of         TRANSTYMPANIC     TRANSTYMPANIC              Administration across or through the tympanic cavity.(FDA)
                  Administration




C38310   C66729   Route of         UNASSIGNED        UNASSIGNED                 Route of administration has not yet been assigned.(FDA)
                  Administration
C38311   C66729         Route of              UNKNOWN    UNKNOWN                                  Route of administration is unknown.(FDA)
                        Administration




C38312   C66729         Route of              URETERAL   URETERAL                                 Administration into the ureter.(FDA)
                        Administration




C38271   C66729         Route of              URETHRAL   URETHRAL                                 Administration into the urethra.(FDA)
                        Administration




C38313   C66729         Route of              VAGINAL    VAGINAL                                  Administration into the vagina.(FDA)
                        Administration




C66769            No    Severity/Intensity    AESEV      AESEV      Severity/Intensity Scale for A scale that defines the degree or state of disease existing in a patient as a result of the
                        Scale for Adverse                           Adverse Events               occurrence of an adverse event. (NCI)
                        Events

C41338   C66769         Severity/Intensity    MILD       MILD       Grade 1; 1                    A type of adverse event that is usually transient and may require only minimal treatment or
                        Scale for Adverse                                                         therapeutic intervention. The event does not generally interfere with usual activities of daily
                        Events                                                                    living.




C41339   C66769         Severity/Intensity    MODERATE   MODERATE   Grade 2; 2                    A type of adverse event that is usually alleviated with additional specific therapeutic
                        Scale for Adverse                                                         intervention. The event interferes with usual activities of daily living, causing discomfort but
                        Events                                                                    poses no significant or permanent risk of harm to the research participant.




C41340   C66769         Severity/Intensity    SEVERE     SEVERE     Grade 3; 3                    A type of adverse event that requires intensive therapeutic intervention. The event interrupts
                        Scale for Adverse                                                         usual activities of daily living, or significantly affects clinical status. The event possesses a
                        Events                                                                    significant risk of harm to the research participant and hospitalization may be required.




C66731            No    Sex                   SEX        SEX        Sex                           The assemblage of physical properties or qualities by which male is distinguished from female;
                                                                                                  the physical difference between male and female; the distinguishing peculiarity of male or
                                                                                                  female. (NCI)
C16576   C66731         Sex                   F          F          Female                        A person who belongs to the sex that normally produces ova. The term is used to indicate
                                                                                                  biological sex distinctions, or cultural gender role distinctions, or both. (NCI)




C20197   C66731         Sex                   M          M          Male                          A person who belongs to the sex that normally produces sperm. The term is used to indicate
                                                                                                  biological sex distinctions, cultural gender role distinctions, or both. (NCI)




C17998   C66731         Sex                   U          UNKNOWN    U; Unknown                    Not known, not observed, not recorded, or refused. (NCI)




C45908   C66731         Sex                   UN         UN         Undifferentiated              A person (one of unisexual specimens) who is born with genitalia and/or secondary sexual
                                                                                                  characteristics of indeterminate sex, or which combine features of both sexes. (NCI)
C66732            No    Sex of Participants   SEXPOP     SEXPOP     Sex of Participants           The specific sex, either male, female, or mixed of the subject group being studied. (NCI)


C49636   C66732         Sex of Participants   BOTH       BOTH                                     One and the other; relating to or being two in conjunction. (NCI)




C16576   C66732         Sex of Participants   F          F          Female                        A person who belongs to the sex that normally produces ova. The term is used to indicate
                                                                                                  biological sex distinctions, or cultural gender role distinctions, or both. (NCI)




C20197   C66732         Sex of Participants   M          M          Male                          A person who belongs to the sex that normally produces sperm. The term is used to indicate
                                                                                                  biological sex distinctions, cultural gender role distinctions, or both. (NCI)




C66733            Yes   Size                  SIZE       SIZE       Size                          The physical magnitude of something. (NCI)

C49508   C66733         Size                  LARGE      LARGE                                    Of considerable or relatively great size, extent, or capacity. (NCI)
C49507   C66733         Size                  MEDIUM     MEDIUM                                   Mid-way between small and large in number, quantity, magnitude or extent. (NCI)
C25376   C66733         Size                  SMALL      SMALL                                    Limited in number, quantity, magnitude or extent. (NCI)
C66734            Yes   Domain Abbreviation   DOMAIN     DOMAIN     Domain Abbreviation           A unique, 2-character domain code used in the regulatory submission process. The domain
                                                                                                  abbreviation is used consistently throughout the submission, i.e. in the dataset name, as the
                                                                                                  value of the domain variable within the dataset, and as a prefix for most variable names in the
                                                                                                  dataset. (CDISC Glossary)
C49563   C66734   Domain Abbreviation AD   AD   Analysis Dataset          Datasets used for statistical analysis and reporting by the sponsor. These are submitted in
                                                                          addition to the data tabulation datasets.




C49562   C66734   Domain Abbreviation AE   AE   Adverse Events            Adverse events may be captured either as free text or a pre-specified list of terms.




C49565   C66734   Domain Abbreviation AU   AU   Autopsy                   Additional data about deaths, specific to findings from autopsies.




C49566   C66734   Domain Abbreviation BM   BM   Bone Mineral Density      Findings resulting from evaluations of bone mineral density.
                                                (BMD) Data




C49567   C66734   Domain Abbreviation BR   BR   Biopsy                    Findings resulting from biopsies.




C49568   C66734   Domain Abbreviation CM   CM   Concomitant Meds          Case report form (CRF) data that captures the Concomitant and Prior Medications/Therapies
                                                                          used by the subject. Examples are the Concomitant Medications/Therapies given on an as
                                                                          needed basis and the usual Background Medications/Therapies given for a condition.




C49569   C66734   Domain Abbreviation CO   CO   Comments                  The Comments dataset accommodates two sources of comments: 1) those collected alongside
                                                                          other data on topical case report form (CRF) pages such as Adverse Events and 2) those
                                                                          collected on a separate page specifically dedicated to comments.




C49578   C66734   Domain Abbreviation DA   DA   Drug Accountability       Data regarding the accountability of study drug, such as information on the receipt, dispensing,
                                                                          return, and packaging.




C49570   C66734   Domain Abbreviation DC   DC   Disease Characteristics   Data related to the characteristics of a specific disease state under study for a subject.




C49572   C66734   Domain Abbreviation DM   DM   Demographics              The Demographics domain includes a set of essential standard variables that describe each
                                                                          subject in a clinical study. It is the parent domain for all other observations for human clinical
                                                                          subjects




C49576   C66734   Domain Abbreviation DS   DS   Disposition               A subject domain utilized for the submission of information encompassing and representing
                                                                          data, vocabulary or records related to disposition. (NCI)




C49585   C66734   Domain Abbreviation DV   DV   Protocol Deviations       The intent of the domain is to capture protocol violations and deviations during the course of
                                                                          the study and will store only those criteria violation by or deviated from by the subject and not a
                                                                          response to each violation or deviation.




C49625   C66734   Domain Abbreviation EE   EE   Electroencephalogram      Findings resulting from electroencephalogram (EEG) tests.




C49626   C66734   Domain Abbreviation EG   EG   Electrocardiogram         Findings related to the collection of ECG data, including position of the subject, method of
                                                                          evaluation, all cycle measurements and all findings from the ECG including an overall
                                                                          interpretation if collected or derived.




C49587   C66734   Domain Abbreviation EX   EX   Exposure                  The Exposure domain model records the details of a subject's exposure to protocol-specified
                                                                          study treatment. Study treatment may be any intervention that is prospectively defined as a test
                                                                          material within a study, and is typically but not always supplied to the subject.




C49588   C66734   Domain Abbreviation FH   FH   Family History            A subject domain utilized for the submission of information encompassing and representing
                                                                          data, vocabulary or records related to family history. (NCI)
C49589   C66734   Domain Abbreviation HU   HU   Healthcare Resource           Healthcare resource utilization data such as subject visits to physicians, hospitalizations, and
                                                Utilization                   nursing home stays.




C61536   C66734   Domain Abbreviation IE   IE   Inclusion/Exclusion           The intent of the domain model is to only collect those criteria that cause the subject to be in
                                                                              violation of the inclusion/exclusion criteria not a response to each criterion.




C49592   C66734   Domain Abbreviation LB   LB   Laboratory Data               Laboratory test findings including, but is not limited to hematology, clinical chemistry and
                                                                              urinalysis data. This domain does not include microbiology or pharmacokinetic data, which are
                                                                              stored in separate domains.




C49602   C66734   Domain Abbreviation MB   MB   Microbiology                  Microbiology specimen findings, including gram stain results, and organisms found.




C49603   C66734   Domain Abbreviation MH   MH   Medical History               The medical history dataset includes the subject's prior history at the start of the trial. Examples
                                                                              of subject medical history information could include general medical history, gynecological
                                                                              history, and primary diagnosis.



C49604   C66734   Domain Abbreviation ML   ML   Meal Data                     Information regarding the subject's meal consumption, such as fluid intake, amounts, form
                                                                              (solid or liquid state), frequency, etc., typically used for pharmacokinetic analysis.




C61531   C66734   Domain Abbreviation MS   MS   Microbiology Susceptibility   This includes microbiology susceptibility test results, plus results of any other organism-related
                                                                              tests.




C49605   C66734   Domain Abbreviation OM   OM   Organ Measurements            Findings from organ measurement evaluations.




C49606   C66734   Domain Abbreviation PC   PC   Pharmacokinetic               Concentrations of drugs/metabolites in fluids or tissues as a function of time.
                                                Concentration




C49608   C66734   Domain Abbreviation PE   PE   Physical Exam                 Findings collected during a physical examination of the subject. It has findings that are
                                                                              discovered that are related to body systems. Does not include vital signs measurements, which
                                                                              are stored in the vital signs domain.




C61529   C66734   Domain Abbreviation PG   PG   Pharmacogenomics              Pharmacogenomics findings that initially focus on genotype and gene expression data.




C49607   C66734   Domain Abbreviation PP   PP   Pharmacokinetic               Pharmacokinetic parameters derived from pharmacokinetic concentration-time (PC) data.
                                                Parameters




C49609   C66734   Domain Abbreviation QS   QS   Questionnaires                Questionnaire data may include, but are not limited to the following: subject reported outcomes,
                                                                              validated or non-validated questionnaires, and validated or non-validated diaries (i.e. data with
                                                                              a common topicality).




C49610   C66734   Domain Abbreviation SC   SC   Subject Characteristics       The subject characteristics domain is for data not collected in other domains that is subject-
                                                                              related. Examples: subject initials, other race details, eye color, childbearing status, etc.




C49616   C66734   Domain Abbreviation SE   SE   Subject Element               The subject element table describes the actual order of elements followed by the subject,
                                                                              together with the start date/time and end date/time for each element.




C49611   C66734   Domain Abbreviation SG   SG   Surgery                       Surgical information.
C49612   C66734         Domain Abbreviation SK               SK             Skin Test                   Findings from diagnostic skin tests.




C49613   C66734         Domain Abbreviation SL               SL             Sleep Polysomnography       Findings from diagnostic sleep tests (polysomnography).
                                                                            Data




C49614   C66734         Domain Abbreviation ST               ST             Stress (Exercise) Test Data Findings from exercise stress tests.




C49615   C66734         Domain Abbreviation SU               SU             Substance Use               The intent of the domain is to capture substance use information that may be used to assess
                                                                                                        the efficacy and/or safety of therapies that look to mitigate the effects of chronic substance use.




C49617   C66734         Domain Abbreviation SV               SV             Subject Visits              The subject visits table describes the actual start and end data/time for each visit of each
                                                                                                        individual subject.




C49618   C66734         Domain Abbreviation TA               TA             Trial Arms                  The trial arms table describes each planned arm in the trial. An arm is described as an ordered
                                                                                                        sequence of elements.




C49619   C66734         Domain Abbreviation TE               TE             TE; Trial Elements          The trial elements table describes the element code that is unique for each element, the
                                                                                                        element description, and the rules for starting and ending an element.




C49620   C66734         Domain Abbreviation TI               TI             Trial Inclusion/Exclusion   The trial summary information domain is not subject oriented. It contains one record for each of
                                                                            Criteria                    the inclusion and exclusion criteria for the trial.




C53483   C66734         Domain Abbreviation TS               TS             Trial Summary               The trial summary information domain is not subject oriented. It contains one record for each
                                                                                                        trial summary characteristic.




C49621   C66734         Domain Abbreviation TV               TV             Trial Visits                The trial visits table describes the planned order and number of visits in the study within each
                                                                                                        arm.




C49622   C66734         Domain Abbreviation VS               VS             Vital Signs                 Measurements including but not limited to blood pressure, temperature, respiration, body
                                                                                                        surface area, BMI, height and weight.




C66735            Yes   Trial Blinding Schema TBLIND         TBLIND         Trial Blinding Schema       The name of a code list that contains terms to define the type of blinding for the trial. (NCI)


C15228   C66735         Trial Blinding Schema DOUBLE BLIND   DOUBLE BLIND                               A study in which neither the subject nor the investigator nor the research team interacting with
                                                                                                        the subject or data during the trial knows what treatment a subject is receiving. (CDISC
                                                                                                        glossary)
C49659   C66735         Trial Blinding Schema OPEN LABEL     OPEN LABEL                                 A trial in which subjects and investigators know which product each subject is receiving;
                                                                                                        opposite of a blinded or double-blind study. (CDISC glossary)
C28233   C66735         Trial Blinding Schema SINGLE BLIND   SINGLE BLIND                               A study in which one party, either the investigator or the subject, does not know which
                                                                                                        medication or placebo is administered to the subject; also called singlemasked study. (CDISC
                                                                                                        glossary)
C66736            Yes   Trial Indication Type   TINDTP       TINDTP         Trial Indication Type       The name of a code list that contains terms to define the type of trial, e.g. cure or prevention.
                                                                                                        (NCI)

C49654   C66736         Trial Indication Type   CURE         CURE                                       A type of study protocol designed to evaluate intervention(s) aimed to cure a disease or
                                                                                                        condition. (NCI)
C49653   C66736         Trial Indication Type   DIAGNOSIS    DIAGNOSIS                                  A type of study protocol designed to evaluate intervention(s) aimed at identifying a disease or
                                                                                                        condition. (NCI)
C49655   C66736         Trial Indication Type   MITIGATION   MITIGATION                                 A type of study designed to identify actions necessary to eliminate or reduce the risk to human
                                                                                                        life or well-being as a result of a particular medication or treatment regimen. (NCI)
C49657   C66736         Trial Indication Type   PREVENTION   PREVENTION                                 A type of study designed to identify actions necessary to permanently eliminate or reduce the
                                                                                                        long-term risk to human life as a result of a particular medication or treatment regimen.
C49656   C66736         Trial Indication Type   TREATMENT    TREATMENT                                  A type of study protocol designed to evaluate intervention(s) for treatment of disease,
                                                                                                        syndrome or condition.
C66737            Yes   Trial Phase             TPHASE       TPHASE         Trial Phase                 Clinical trials are broken into three or four phases: Phase I tests a new drug or treatment for
                                                                                                        safety in a small group; Phase II expands the study to a larger group of people; Phase III
                                                                                                        expands the study to an even larger group of people to measure whether the treatment actually
                                                                                                        benefits patients, and whether its benefits exceed its risks; and Phase IV takes place after the
                                                                                                        drug or treatment has been licensed and marketed. (NCI)
C15600   C66737         Trial Phase           Phase I Trial        Phase I Trial        Trial Phase 1; 1             The initial introduction of an investigational new drug into humans. Phase 1 studies are typically
                                                                                                                     closely monitored and may be conducted in patients or normal volunteer subjects. NOTE:
                                                                                                                     These studies are designed to determine the metabolism and pharmacologic actions of the
                                                                                                                     drug in humans, the side effects associated with increasing doses, and, if possible, to gain early
                                                                                                                     evidence on effectiveness. During Phase 1, sufficient information about the drug's
                                                                                                                     pharmacokinetics and pharmacological effects should be obtained to permit the design of well-
                                                                                                                     controlled, scientifically valid, Phase 2 studies. The total number of subjects and patients
                                                                                                                     included in Phase I studies varies with the drug, but is generally in the range of 20 to 80. Phase
                                                                                                                     1 studies also include studies of drug metabolism, structure-activity relationships, and
                                                                                                                     mechanism of action in humans, as well as studies in which investigational drugs are used as
                                                                                                                     research tools to explore biological phenomena or disease processes. [After FDA CDER
                                                                                                                     Handbook, ICH E8] (CDISC glossary)




C15693   C66737         Trial Phase           Phase I/II Trial     Phase I/II Trial     Trial Phase 1-2; 1-2         A class of clinical study that combines elements characteristic of traditional Phase I and Phase
                                                                                                                     II trials. See also Phase I, Phase II.
C15601   C66737         Trial Phase           Phase II Trial       Phase II Trial       Trial Phase 2; 2             Phase 2. Controlled clinical studies conducted to evaluate the effectiveness of the drug for a
                                                                                                                     particular indication or indications in patients with the disease or condition under study and to
                                                                                                                     determine the common short-term side effects and risks associated with the drug. NOTE:
                                                                                                                     Phase 2 studies are typically well controlled, closely monitored, and conducted in a relatively
                                                                                                                     small number of patients, usually involving no more than several hundred subjects. [After FDA
                                                                                                                     CDER Handbook, ICH E8] (CDISC glossary)
C15694   C66737         Trial Phase           Phase II/III Trial   Phase II/III Trial   Trial Phase 2-3; 2-3         A class of clinical study that combines elements characteristic of traditional Phase II and Phase
                                                                                                                     III trials.
C49686   C66737         Trial Phase           Phase IIa Trial      Phase IIa Trial      Trial Phase 2A; 2A           A clinical research protocol generally refered to as a pilot or feasibility trial that aims to prove
                                                                                                                     the concept of the new intervention in question. (NCI)
C49688   C66737         Trial Phase           Phase IIb Trial      Phase IIb Trial      Trial Phase 2B; 2B           A clinical research protocol generally refered to as a well-controlled and pivotal trial that aims
                                                                                                                     to prove the mechanism of action of the new intervention in question. A pivotal study will
                                                                                                                     generally be well-controlled, randomized, of adequate size, and whenever possible, double-
                                                                                                                     blind. (NCI)
C15602   C66737         Trial Phase           Phase III Trial      Phase III Trial      Trial Phase 3; 3             Phase 3. Studies are expanded controlled and uncontrolled trials. They are performed after
                                                                                                                     preliminary evidence suggesting effectiveness of the drug has been obtained, and are intended
                                                                                                                     to gather the additional information about effectiveness and safety that is needed to confirm
                                                                                                                     efficacy and evaluate the overall benefit-risk relationship of the drug and to provide an
                                                                                                                     adequate basis for physician labeling. NOTE: Phase 3 studies usually include from several
                                                                                                                     hundred to several thousand subjects. [After FDA CDER Handbook, ICH E8] (CDISC glossary)

C49687   C66737         Trial Phase           Phase IIIaTrial      Phase IIIaTrial      Trial Phase 3A; 3A           A classification typically assigned retrospectively to a Phase III trial upon determination by
                                                                                                                     regulatory authorities of a need for a Phase III B trial.
C49689   C66737         Trial Phase           Phase IIIb Trial     Phase IIIb Trial     Trial Phase 3B; 3B           A subcategory of Phase III trials done near the time of approval to elicit additional findings.
                                                                                                                     NOTE: Dossier review may continue while associated Phase IIIB trials are conducted. These
                                                                                                                     trials may be required as a condition of regulatory authority approval.
C15603   C66737         Trial Phase           Phase IV Trial       Phase IV Trial       Trial Phase 4; 4             Phase 4. Postmarketing (Phase 4) studies to delineate additional information about the drug's
                                                                                                                     risks, benefits, and optimal use that may be requested by regulatory authorities in conjunction
                                                                                                                     with marketing approval. NOTE: These studies could include, but would not be limited to,
                                                                                                                     studying different doses or schedules of administration than were used in Phase 2 studies, use
                                                                                                                     of the drug in other patient populations or other stages of the disease, or use of the drug over a
                                                                                                                     longer period of time. [After FDA CDER Handbook, ICH E8] (CDISC glossary)

C47865   C66737         Trial Phase         Phase V Trial          Phase V Trial        Trial Phase 5; 5             Postmarketing surveillance is sometimes referred to as Phase V.
C48660   C66737         Trial Phase         NA                     NOT APPLICABLE       NA                           Determination of a value is not relevant in the current context. (NCI)
C66738            Yes   Trial Summary       TSPARMCD               TSPARMCD             Trial Summary Parameter      Individual characteristics of a clinical trial, e.g. description of trial design, trial blinding schema,
                        Parameter Test Code                                             Test Code                    and primary objective of trial. (NCI)

C49703   C66738         Trial Summary       ADDON                  ADDON                Added on to Existing         The addition of a therapeutic product to the existing regimen in a clinical trial, where both
                        Parameter Test Code                                             Treatments                   entities remain as discrete products.
C49700   C66738         Trial Summary       AEDICT                 AEDICT               Adverse Event Dictionary     A reference source that provides meanings of words related to adverse events. (NCI)
                        Parameter Test Code
C49694   C66738         Trial Summary       AGEMAX                 AGEMAX               Planned Maximum Age of       The anticipated maximum age of the subjects to be entered in a clinical trial. (NCI)
                        Parameter Test Code                                             Subjects
C49693   C66738         Trial Summary       AGEMIN                 AGEMIN               Planned Minimum Age of       The anticipated minimum age of the subjects to be entered in a clinical trial. (NCI)
                        Parameter Test Code                                             Subjects
C20587   C66738         Trial Summary       AGESPAN                AGESPAN              Age Span                     Subgroups of populations based on age. (NCI)
                        Parameter Test Code

C50400   C66738         Trial Summary         AGEU                 AGEU                 Age Unit                     Those units of time that are routinely used to express the age of a person. (NCI)
                        Parameter Test Code
C25488   C66738         Trial Summary         DOSE                 DOSE                 Dose per Administration      The amount of drug administered to a patient or test subject at one time or the total quantity
                        Parameter Test Code                                                                          administered. [AMA Manual of Style] (CDISC Glossary)
C49701   C66738         Trial Summary         DRUGDICT             DRUGDICT             Drug Dictionary              A reference source that provides meanings of words related to drugs. (NCI)
                        Parameter Test Code
C49697   C66738         Trial Summary         LENGTH               LENGTH               Trial Length                 The anticipated length of a clinical trial measured as a unit of time. (NCI)
                        Parameter Test Code
C49702   C66738         Trial Summary         MHDICT               MHDICT               Medical History Dictionary   A reference source that provides meanings of words related to medical history. (NCI)
                        Parameter Test Code
C49692   C66738         Trial Summary         PLANSUB              PLANSUB              Planned Number of            The number of subjects entered in a clinical trial. (NCI)
                        Parameter Test Code                                             Subjects
C25196   C66738         Trial Summary         RANDOM               RANDOM               Trial is Randomized          The process of assigning trial subjects to treatment or control groups using an element of
                        Parameter Test Code                                                                          chance to determine the assignments in order to reduce bias. NOTE: Unequal randomization is
                                                                                                                     used to allocate subjects into groups at a differential rate; for example, three subjects may be
                                                                                                                     assigned to a treatment group for every one assigned to the control group. [ICH E6 1.48] See
                                                                                                                     also balanced study. (CDISC glossary)
C38114   C66738         Trial Summary         ROUTE                ROUTE                Route of Administration      The course by which a substance was administered in order to reach the site of action in the
                        Parameter Test Code                                                                          body.
C49696   C66738         Trial Summary         SEXPOP               SEXPOP               Sex of Participants          The specific sex, either male, female, or mixed of the subject group being studied. (NCI)
                        Parameter Test Code
C49698   C66738         Trial Summary         STOPRULE             STOPRULE             Study Stop Rules             The rule, regulation and/or condition that determines the point in time when a clinical trial will
                        Parameter Test Code                                                                          be terminated. (NCI)
C49658   C66738         Trial Summary         TBLIND               TBLIND               Trial Blinding Schema        The name of a code list that contains terms to define the type of blinding for the trial. (NCI)
                        Parameter Test Code
C49647   C66738         Trial Summary         TCNTRL               TCNTRL               Control Type                 Comparator against which the study treatment is evaluated (e.g., concurrent (placebo, no
                        Parameter Test Code                                                                          treatment, dose-response, active), external (historical, published literature).
C49650   C66738         Trial Summary         TDIGRP               TDIGRP               Diagnosis Group              A grouping of individuals on the basis of a shared procedure or disease, or lack thereof (e.g.
                        Parameter Test Code                                                                          healthy volunteers, type 2 diabetic subjects, subjects with renal cell cancer). Standardized
                                                                                                                     naming systems are available that define the groups within which a subject should be placed.
                                                                                                                     (NCI)
C49652   C66738         Trial Summary       TINDTP                 TINDTP               Trial Indication Type        The name of a code list that contains terms to define the type of trial, e.g. cure or prevention.
                        Parameter Test Code                                                                          (NCI)
C49802   C66738         Trial Summary       TITLE                  TITLE                Trial Title                  The name of a clinical trial. (NCI)
                        Parameter Test Code
C48281   C66738         Trial Summary       TPHASE                 TPHASE               Trial Phase Classification   Clinical trials are broken into three or four phases: Phase I tests a new drug or treatment for
                        Parameter Test Code                                                                          safety in a small group; Phase II expands the study to a larger group of people; Phase III
                                                                                                                     expands the study to an even larger group of people to measure whether the treatment actually
                                                                                                                     benefits patients, and whether its benefits exceed its risks; and Phase IV takes place after the
                                                                                                                     drug or treatment has been licensed and marketed. (NCI)
C49660   C66738         Trial Summary       TTYPE                        TTYPE              Trial Type                   The type of clinical trial performed e.g. efficacy, safety. (NCI)
                        Parameter Test Code
C67152            Yes   Trial Summary       TSPARM                       TSPARM             Trial Summary Parameter      Individual characteristics of a clinical trial, e.g. description of trial design, trial blinding schema,
                        Parameter Test Name                                                 Test Name                    and primary objective of trial. (NCI)

C49703   C67152         Trial Summary       Added on to Existing         ADDON              Added on to Existing         The addition of a therapeutic product to the existing regimen in a clinical trial, where both
                        Parameter Test Name Treatments                                      Treatments                   entities remain as discrete products.

C49700   C67152         Trial Summary       Adverse Event Dictionary     AEDICT             Adverse Event Dictionary     A reference source that provides meanings of words related to adverse events. (NCI)
                        Parameter Test Name

C49694   C67152         Trial Summary       Planned Maximum Age of       AGEMAX             Planned Maximum Age of       The anticipated maximum age of the subjects to be entered in a clinical trial. (NCI)
                        Parameter Test Name Subjects                                        Subjects

C49693   C67152         Trial Summary       Planned Minimum Age of       AGEMIN             Planned Minimum Age of       The anticipated minimum age of the subjects to be entered in a clinical trial. (NCI)
                        Parameter Test Name Subjects                                        Subjects

C20587   C67152         Trial Summary       Age Group                    AGESPAN            Age Group                    Subgroups of populations based on age. (NCI)
                        Parameter Test Name

C50400   C67152         Trial Summary       Age Unit                     AGEU               Age Unit                     Those units of time that are routinely used to express the age of a person. (NCI)
                        Parameter Test Name

C25488   C67152         Trial Summary       Dose per Administration      DOSE               Dose per Administration      The amount of drug administered to a patient or test subject at one time or the total quantity
                        Parameter Test Name                                                                              administered. [AMA Manual of Style] (CDISC Glossary)

C49701   C67152         Trial Summary       Drug Dictionary              DRUGDICT           Drug Dictionary              A reference source that provides meanings of words related to drugs. (NCI)
                        Parameter Test Name

C49697   C67152         Trial Summary       Trial Length                 LENGTH             Trial Length                 The anticipated length of a clinical trial measured as a unit of time. (NCI)
                        Parameter Test Name

C49702   C67152         Trial Summary       Medical History Dictionary   MHDICT             Medical History Dictionary   A reference source that provides meanings of words related to medical history. (NCI)
                        Parameter Test Name

C49692   C67152         Trial Summary       Planned Number of Subjects PLANSUB              Planned Number of            The number of subjects entered in a clinical trial. (NCI)
                        Parameter Test Name                                                 Subjects
C25196   C67152         Trial Summary       Trial is Randomized          RANDOM             Trial is Randomized          The process of assigning trial subjects to treatment or control groups using an element of
                        Parameter Test Name                                                                              chance to determine the assignments in order to reduce bias. NOTE: Unequal randomization is
                                                                                                                         used to allocate subjects into groups at a differential rate; for example, three subjects may be
                                                                                                                         assigned to a treatment group for every one assigned to the control group. [ICH E6 1.48] See
C38114   C67152         Trial Summary       Route of Administration      ROUTE              Route of Administration      also balanced which a substance was
                                                                                                                         The course by study. (CDISC glossary)administered in order to reach the site of action in the
                        Parameter Test Name                                                                              body.



C49696   C67152         Trial Summary       Sex of Participants          SEXPOP             Sex of Participants          The specific sex, either male, female, or mixed of the subject group being studied. (NCI)
                        Parameter Test Name

C49698   C67152         Trial Summary       Study Stop Rules             STOPRULE           Study Stop Rules             The rule, regulation and/or condition that determines the point in time when a clinical trial will
                        Parameter Test Name                                                                              be terminated. (NCI)

C49658   C67152         Trial Summary       Trial Blinding Schema        TBLIND             Trial Blinding Schema        The name of a code list that contains terms to define the type of blinding for the trial. (NCI)
                        Parameter Test Name

C49647   C67152         Trial Summary       Control Type                 TCNTRL             Control Type                 Comparator against which the study treatment is evaluated (e.g., concurrent (placebo, no
                        Parameter Test Name                                                                              treatment, dose-response, active), external (historical, published literature).

C49650   C67152         Trial Summary       Diagnosis Group              TDIGRP             Diagnosis Group              A grouping of individuals on the basis of a shared procedure or disease, or lack thereof (e.g.
                        Parameter Test Name                                                                              healthy volunteers, type 2 diabetic subjects, subjects with renal cell cancer). Standardized
                                                                                                                         naming systems are available that define the groups within which a subject should be placed.
                                                                                                                         (NCI)
C49652   C67152         Trial Summary       Trial Indication Type        TINDTP             Trial Indication Type        The name of a code list that contains terms to define the type of trial, e.g. cure or prevention.
                        Parameter Test Name                                                                              (NCI)

C49802   C67152         Trial Summary       Trial Title                  TITLE              Trial Title                  The name of a clinical trial. (NCI)
                        Parameter Test Name

C48281   C67152         Trial Summary       Trial Phase Classification   TPHASE             Trial Phase Classification   Clinical trials are broken into three or four phases: Phase I tests a new drug or treatment for
                        Parameter Test Name                                                                              safety in a small group; Phase II expands the study to a larger group of people; Phase III
                                                                                                                         expands the study to an even larger group of people to measure whether the treatment actually
                                                                                                                         benefits patients, and whether its benefits exceed its risks; and Phase IV takes place after the
                                                                                                                         drug or treatment has been licensed and marketed. (NCI)




C49660   C67152         Trial Summary       Trial Type                   TTYPE              Trial Type                   The type of clinical trial performed e.g. efficacy, safety. (NCI)
                        Parameter Test Name


C66739            Yes   Trial Type            TTYPE                      TTYPE              Trial Type                   The type of clinical trial performed e.g. efficacy, safety. (NCI)

C49664   C66739         Trial Type            BIO-AVAILABILITY           BIO-AVAILABILITY                                A study of the degree to which or rate at which a drug or other substance is absorbed or
                                                                                                                         becomes available at the site of physiological activity after administration. (NCI)


C49665   C66739         Trial Type            BIO-EQUIVALENCE            BIO-EQUIVALENCE                                 A study most often used to compare the efficacy of different formulations to treat a given
                                                                                                                         disease. It is the testing of an old versus a new formulation in healthy volunteers or subjects
                                                                                                                         with the disease under study and usually in one dose. (NCI)



C49666   C66739         Trial Type            EFFICACY                   EFFICACY                                        A study of the relative therapeutic efficacy of treatment of a disease. Usually this is a Phase II
                                                                                                                         or III study. (NCI)

C49662   C66739         Trial Type            PHARMACODYNAMIC            PHARMACODYNAMIC                                 A study of the biochemical and physiological effect of a drug and the mechanism of drug action
                                                                                                                         and the relationship between drug concentration and effect. (NCI)



C39493   C66739         Trial Type            PHARMACOECONOMIC           PHARMACOECONOMIC                                A study that assesses the value associated with a given drug in therapeutic and economic
                                                                                                                         terms. This type of study is multidisciplinary in nature and takes into consideration the social
                                                                                                                         and economic costs (resource utilization costs including direct, indirect, and intangible costs) of
                                                                                                                         drug therapy in addition to its direct therapeutic benefits. Analyses relate the difference in
                                                                                                                         therapeutic benefits to the difference in costs between treatment alternatives. (NCI)

C49661   C66739         Trial Type            PHARMACOGENOMIC            PHARMACOGENOMIC                                 A study of identification and analysis of genomic variations that affect the efficacy of a drug.
                                                                                                                         Pharmacogenomic studies can potentially be predictive of an individual's drug-response or
                                                                                                                         adverse reactions or susceptibility to iatrogenic disorders, and may also reveal new targets that
                                                                                                                         can help in the design of new drugs. (NCI)
C49663   C66739         Trial Type            PHARMACOKINETIC            PHARMACOKINETIC                                 A study of the process by which a drug is absorbed, distributed, metabolized, and eliminated by
                                                                                                                         the body. (NCI)
C49667   C66739         Trial Type            SAFETY                     SAFETY                                          A study of the relative safety of treatment of a disease. Usually this is a Phase I or II trial. (NCI)
C66770            Yes   Units for Vital Signs   VSRESU        VSRESU        Units for Vital Signs Results The unit used to record and describe the result of a test investigating a vital sign. (NCI)
                        Results

C25613   C66770         Units for Vital Signs   %             %             Percentage                    A fraction or ratio with 100 understood as the denominator. (NCI)
                        Results
C49673   C66770         Units for Vital Signs   BEATS/MIN     BEATS/MIN     Beats per Minute              The number of heartbeats measured per minute time. (NCI)
                        Results



C49674   C66770         Units for Vital Signs   BREATHS/MIN   BREATHS/MIN   Breaths per Minute            The number of breaths (inhalation and exhalation) taken per minute time. (NCI)
                        Results



C42559   C66770         Units for Vital Signs   C             C             Degree Celsius                A unit of temperature of the temperature scale designed so that the freezing point of water is 0
                        Results                                                                           degrees and the boiling point is 100 degrees at standard atmospheric pressure. The current
                                                                                                          official definition of the Celsius sets 0.01 C to be at the triple point of water and a degree to be
                                                                                                          1/273.16 of the difference in temperature between the triple point of water and absolute zero.
                                                                                                          One degree Celsius represents the same temperature difference as one Kelvin. (NCI)

C49668   C66770         Units for Vital Signs   cm            cm            Centimeter                    A basic unit of length in the former CGS version of metric system, equal to one hundredth of a
                        Results                                                                           meter or approximately 0.393 700 787 inch. (NCI)
C44277   C66770         Units for Vital Signs   F             F             Degree Fahrenheit             The Fahrenheit temperature scale is named after the German physicist Gabriel Fahrenheit
                        Results                                                                           (1686-1736), who proposed it in 1724. In this scale, the freezing point of water is 32 degrees
                                                                                                          Fahrenheit and the boiling point is 212 degrees, placing the boiling and melting points of water
                                                                                                          180 degrees apart. In this scale a degree Fahrenheit is 5/9ths of a kelvin (or of a degree
                                                                                                          Celsius), and minus 40 degrees Fahrenheit is equal to minus 40 degrees Celsius. (NCI)




C48155   C66770         Units for Vital Signs   g             g             Gram                          A metric unit of mass equal to one one thousandth of a kilogram. (NCI)
                        Results
C48500   C66770         Units for Vital Signs   IN            IN            Inch                          A traditional unit of length equal to 2.54 centimeters. (NCI)
                        Results


C28252   C66770         Units for Vital Signs   kg            kg            Kilogram                  The basic SI unit of mass. It is defined as the mass of an international prototype in the form of
                        Results                                                                       a platinum-iridium cylinder kept at Sevres in France. It is the only basic unit still defined in
                                                                                                      terms of a material object, and also the only one with a prefix [kilo] already in place. A kilogram
                                                                                                      is equal to 1,000 grams and 2.204 622 6 pounds. (NCI)
C49671   C66770         Units for Vital Signs   kg/m2         kg/m2         Kilogram Per Square Meter The SI derived unit of spread rate of a substance by mass, used also as a measure of area
                        Results                                                                       density. (NCI)
C48531   C66770         Units for Vital Signs   LB            LB            Pound                     A traditional unit of mass. By international agreement, one avoirdupois pound is equal to
                        Results                                                                       exactly 0.453 592 37 kilogram, 16 ounces, or 1.215 28 troy pounds. (NCI)
C42569   C66770         Units for Vital Signs   m2            m2            Square Meter              The SI unit of area measurement equal to a square whose sides are one meter long. Square
                        Results                                                                       meter is equal to 10,000 square centimeters; 0.01 ares; 1.196 square yards; 10.76 square feet;
                                                                                                      1550 square inches. (NCI)
C49670   C66770         Units for Vital Signs   mmHg          mmHg          Millimeter of Mercury     A unit of pressure equal to 0.001316 atmosphere and equal to the pressure indicated by one
                        Results                                                                       millimeter rise of mercury in a barometer at the Earth's surface. (NCI)
C42554   C66770         Units for Vital Signs   ohm           ohm           ohm                       A unit of electrical resistance equal to the resistance between two points on a conductor when a
                        Results                                                                       potential difference of one volt between them produces a current of one ampere. Ohm is also
                                                                                                      used to measure impedance and reactance for complex resistance. A measurement in ohms is
                                                                                                      the reciprocal of a measurement in siemens. (NCI)
C66741            Yes   Vital Signs Test Code VSTESTCD        VSTESTCD      Vital Signs Test Code     The name given to the test that analyzes a particular set of vital signs including temperature,
                                                                                                      respiratory rate, heart beat (pulse), and blood pressure. (NCI)

C16358   C66741         Vital Signs Test Code BMI             BMI           Body Mass Index               A general indicator of the body fat an individual is carrying based upon the ratio of weight to
                                                                                                          height. (NCI)




C12472   C66741         Vital Signs Test Code BODYFAT         BODYFAT       Adipose Tissue                A specialized form of connective tissue consisting primarily of adipocytes (fat cells), surrounded
                                                                                                          by a meshwork of collagen fibers.




C25157   C66741         Vital Signs Test Code BSA             BSA           Body Surface Area             A measure of the 2-dimensional extent of the body surface (i.e., the skin). Body surface area
                                                                                                          (BSA) can be calculated by mathematical formula or from a chart that relates height to weight.
                                                                                                          BSA is often an important factor in dosing. (NCI)




C25299   C66741         Vital Signs Test Code DIABP           DIABP         Diastolic Blood Pressure      The blood pressure after the contraction of the heart while the chambers of the heart refill with
                                                                                                          blood. (NCI)




C49680   C66741         Vital Signs Test Code FRMSIZE         FRMSIZE       Body Frame Size               The categorization of a person's body frame into small, medium and large based on the
                                                                                                          measurement of wrist circumference or the breadth of the elbow. (NCI)




C25347   C66741         Vital Signs Test Code HEIGHT          HEIGHT        Height                        The vertical measurement or distance from the base to the top of an object; the vertical
                                                                                                          dimension of extension. (NCI)




C49677   C66741         Vital Signs Test Code HR              HR            Heart Rate                    The number of heartbeats per unit of time, usually expressed as beats per minute. (NCI)




C49679   C66741         Vital Signs Test Code MAP             MAP           Mean Arterial Pressure        The mean pressure of the blood within the arterial circulation. The arterial pressure may be
                                                                                                          directly measured by insertion of an intra-arterial catheter connected to a transducer. The mean
                                                                                                          arterial pressure (MAP) can be calculated by subsequent analysis of the waveform. MAP can
                                                                                                          be approximated without an invasive procedure using the following formula: diastolic pressure
                                                                                                          plus 1/3 of the pulse pressure, where pulse pressure is systolic pressure - diastolic pressure.
                                                                                                          (NCI)
C49676   C66741         Vital Signs Test Code PULSE                     PULSE     Pulse Rate                 The rate of the pulse as observed in an artery, expressed as beats per minute. It can be
                                                                                                             measured at several anatomical sites, including the wrist, neck, temple, groin, behind the
                                                                                                             knees, or on top of the foot. (NCI)




C49678   C66741         Vital Signs Test Code RESP                      RESP      Respiratory Rate           The rate of breathing (inhalation and exhalation) measured within in a unit time, usually
                                                                                                             expressed as breaths per minute. (NCI)




C25298   C66741         Vital Signs Test Code SYSBP                     SYSBP     Systolic Blood             The blood pressure during the contraction of the left ventricle of the heart.




C25206   C66741         Vital Signs Test Code TEMP                      TEMP      Temperature                The property of a body or region of space that determines whether or not there will be a net
                                                                                                             flow of heat into it or out of it from a neighboring body or region and in which direction (if any)
                                                                                                             the heat will flow, perceptible by living organism as a somatic sensation of cold or heat. It is a
                                                                                                             measure of the average translational kinetic energy associated with the disordered microscopic
                                                                                                             motion of atoms and molecules. Temperature is measured in one of the three standard
                                                                                                             temperature scales: Celsius, Kelvin, and Fahrenheit. (NCI)

C25208   C66741         Vital Signs Test Code WEIGHT                    WEIGHT    Weight                     The vertical force exerted by a mass as a result of gravity. (NCI)




C67153            Yes   Vital Signs Test Name VSTEST                    VSTEST    Vital Signs Test Name      The name given to the test that analyzes a particular set of vital signs including temperature,
                                                                                                             respiratory rate, heart beat (pulse), and blood pressure. (NCI)


C16358   C67153         Vital SignsTest Name Body Mass Index            BMI       Body Mass Index            A general indicator of the body fat an individual is carrying based upon the ratio of weight to
                                                                                                             height. (NCI)

C12472   C67153         Vital SignsTest Name Adipose Tissue             BODYFAT   Adipose Tissue             A specialized form of connective tissue consisting primarily of adipocytes (fat cells), surrounded
                                                                                                             by a meshwork of collagen fibers.




C25157   C67153         Vital SignsTest Name Body Surface Area          BSA       Body Surface Area          A measure of the 2-dimensional extent of the body surface (i.e., the skin). Body surface area
                                                                                                             (BSA) can be calculated by mathematical formula or from a chart that relates height to weight.
                                                                                                             BSA is often an important factor in dosing. (NCI)




C25299   C67153         Vital SignsTest Name Diastolic Blood Pressure   DIABP     Diastolic Blood Pressure   The blood pressure after the contraction of the heart while the chambers of the heart refill with
                                                                                                             blood. (NCI)




C49680   C67153         Vital SignsTest Name Body Frame Size            FRMSIZE   Body Frame Size            The categorization of a person's body frame into small, medium and large based on the
                                                                                                             measurement of wrist circumference or the breadth of the elbow. (NCI)

				
DOCUMENT INFO
Shared By:
Categories:
Tags:
Stats:
views:29
posted:9/24/2011
language:English
pages:46