AE_SPORES__FON-Unkown__Form2171260_v3_0_1_ by hedongchenchen

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									Long Name         ADVERSE EVENTS
Definition        ADVERSE EVENTS
Context           SPOREs
Protocol          Iloprost
Workflow          APPRVD FOR TRIAL USE
Type              CRF
Public ID           2171260
Version           3.0

Module                  Question
               Module Instructions CDE                                            CDE       Question Instructions
                                                                         CDE Public ID Version
ADVERSE EVENTS
                        Onset dateAdverse Event Onset Date               2003426     3.0
                                   Resolved Date
                        Resolved date                                    2003713     3.0
                        CTC Term CTC Adverse Event Term Type             323         1.0
                                   Adverse Event
                        Adverse Event DescriptionDescription Text        2003427     3.0
                                   Adverse Event
                        Adverse Event Report filedReport Indicator       2004101     3.0



                              CTC GradeCommon Toxicity Criteria Grade 2003721        3.0




                              Attribution Attribution                    2001691     4.0




                                          Dose Limiting Toxicity Description003895
                              Dose limiting toxicity                       2         3.0


                                        Serious Adverse
                              Adverse Event Seriousness Event            2004102     3.0




                                        Adverse Event Action
                              Adverse Event Action                       2004103     3.0




                                        Adverse Event
                              Adverse Event Therapy Therapy              2004104     3.0
                        Adverse Event
              Adverse Event Outcome Outcome   2004107   1.0




CCRR MODULE
          Value Meaning Value Instructions
Valid Value        Valid




Yes
No
Unkown

0                   NO ADVERSE EVENT OR WITHIN NORMAL LIMITS
1                   MILD ADVERSE EVENT
2                   MODERATE ADVERSE EVENT
3                   SEVERE AND UNDESIRABLE ADVERSE EVENT
4                   LIFE-THREATENING OR DISABLING ADVERSE EVENT
5                   DEATH RELATED TO ADVERSE EVENT

Unrelated
Unlikely
Possible
Probable
Definite

Yes
No

Anomaly
Death      DEATH
Disability DISABILITY
Hospital
Jeopardy
No         NO
Threat

1                   NONE
2                   DOSE REDUCED
3                   REGIMEN INTERRUPTED
4                   THERAPY DISCONTINUED INTERRUPTED/REDUCED
5                   INTERRUPTED/REDUCED
1   NONE   None
2          Symptomatic
    SYMPTOMATIC
3          Supportive
    SUPPORTIVE
4          Vigorous Supportive
    VIGOROUS SUPPORTIVE

1            Recovered
2            Still under treatment/ observation
3            Alive with sequelae
4            Died

								
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