Baseline Randomization

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					                                   Patient Initials     |__|__|__|               Patient Number   |__|__|__|__|__|
    ITP 001
                                   Center Number        |__|__|              Centre name


Baseline                                                                                                                            Page 1

                                                         Day      Month   Year
Date of visit:                                         |__|__|.|__|__|.|__|__|


Inclusion criteria:                                                                                                 yes        no
   ITP with platelet count <30 x 109/L OR platelet count 30-50 x 109/L if a higher platelet
    count is considered necessary because of any of the following:
         1. Concomitant medical illness predisposing to bleeding (gastric ulcer, bleeding diathesis,
                 previous history of bleeding)
         2. Concomitant medical condition requiring aspirin and/or clopidogrel intake or
                 anticoagulation
                                                                                                                              
         3.      Persistent bleeding manifestation despite platelets > 30 x 109/L
         4.      Other patient related factors necessitating higher platelet count as occupation, hobby,
                 psychological intolerability
         5.      Age > 75 years

   Previous treatment with corticosteroids for a minimum duration of 2 weeks as
    recommended by the protocol (prednisone or prednisolone 1-2 mg/kg/day) with either no                                     
    response (i.e. failed to achieve an initial increase in platelet count >30 x 109/L) or relapse
    (platelet count falls to <30 x 109/L) during the dose tapering period or after
    discontinuation of corticosteroids.

   Age ≥ 18 years                                                                                                            
   Subject has signed and dated written informed consent.                                                                    
   Subject is able to understand and comply with protocol requirements and instructions,                                     
    and intends to complete the study as planned
   Females in child-bearing age willing to use contraceptive means during the study and for                                  
    6 months following the administration of study drugs
                                                                                             If any box is marked “NO”         
                                                                                             the patient is not eligible for
                                                                                             enrollment




Case Report Form date 04.12.2008
                             Patient Initials   |__|__|__|          Patient Number   |__|__|__|__|__|
    ITP 001
                             Center Number      |__|__|            Centre name


Baseline                                                                                                                 Page 2-a



Exclusion criteria:                                                                       yes                   no
 Previous splenectomy, chemotherapy, treatment with anti-D Ig, rituximab or                                   
  immune.suppressive treatment other than corticosteroids, Dapsone or Danazole
 Underlying malignancy or previous history of malignancy in the past 5 years                                  
  (except skin carcinoma)
 Pregnancy and lactation                                                                                      
 Not willing to participate in the study                                                                      
   Expected survival of < 2 years                                                                             
 Known intolerance to murine antibodies                                                                       
   Females in child-bearing age not willing to use contraception for 6months                                  
 HIV/AIDS-, Hepatitis-B virus antigen positive or Hepatitis-C virus antibodies                                
  positive patients
 Patients with Systemic Lupus Erythematosus (SLE) (≥ 4 of the American College                                
  of Rheumatology Criteria) (Tan et al, 1982;Hochberg, 1997)
 Patients currently involved in another clinical trial with evaluation of drug                                
  treatment
 Bacterial infections, viral infections, fungal infections, myco-bacterial infections                         
  (excluding ungeal fungal infections) or other evolutive infections or any other
  infections episode requiring hospitalisation or treatment with an antibiotics 4
  weeks before selection for IV route or within 2 weeks before selection for oral
  route
 History of soft tissue, bone or joint infections (fascitis, abscess, osteomyelitis,                          
  septic arthritis) during the last year prior to inclusion in the study.
 Medical history of relapsing or chronic severe infectious diseases or any other                              
  underlying pathology predisposing to serious infections.
 Known Primary or secondary immune deficiency syndromes.                                                      
 Administration of a living vaccine within 4 weeks preceding the inclusion in the                             
  study.
 Previous treatment with inhibitors of leucocytes transmigration (e.g. Tysabri®)                              
 Known intolerance to human monoclonal antibodies                                                             
 Known severe chronic pulmonary obstructive disease (FEV < 50% or functional                                  
  dyspnoea grade 3).
 Known congestive heart failure NYHA (New York Heart Association classification                               
  of heart failure) class III and IV.
 Recent episode (< 6 months) of acute coronary syndrome.                                                      
                                                                                          If any box is marked “YES”
                                                                                            the patient is not eligible for
                                                                                            enrollment




Case Report Form date 04.12.2008
                             Patient Initials     |__|__|__|               Patient Number   |__|__|__|__|__|
    ITP 001
                             Center Number        |__|__|                 Centre name


Baseline                                                                                                           Page 2-b


If platelet count is 30-50 x 109/L, please specify reason for why the patient may be
eligible for the study:

    1. Concomitant medical illness predisposing to bleeding (gastric ulcer, bleeding diathesis,                
       previous history of bleeding)
    2. Concomitant medical condition requiring aspirin and/or clopidogrel intake or                            
       anticoagulation

    3. Persistent bleeding manifestation despite platelets > 30 x 109/L                                        

    4. Other patient related factors necessitating higher platelet count as occupation, hobby,                 
       psychological intolerability
    5. Age > 75 years                                                                                          
    6. Other                                                                                                   
       If “Other”, please specify:_________________________________________________




Informed consent
                                                  Day   Month    Year
Date of written informed consent:               |__|__|.|__|__|.|__|__|




Case Report Form date 04.12.2008
                                Patient Initials       |__|__|__|             Patient Number   |__|__|__|__|__|
    ITP 001
                                Center Number          |__|__|              Centre name


Baseline                                                                                                          Page 3



                                            Day    Month    Year
Date of birth:                            |__|__|.|__|__|.|__|__|

Sex                                    Female          Male 

Family History

Family history of ITP                         No          Yes            If yes, specify relationship:



Current ITP Episode
                                                                   Day   Month    Year
Date of ITP diagnosis:                                           |__|__|.|__|__|.|__|__|


Platelet count at baseline: _________ x 109/L                      Day   Month    Year
                                                                 |__|__|.|__|__|.|__|__|



Bleeding (Clinical features of current ITP episode)

Grade 0     (no bleeding)                                                   
Grade I     (Petechiae)                                                     
Grade II    (Mild blood loss)                                               
Grade III   (Gross blood loss)                                              
Grade IV    (Debilitating blood loss)                                       




Case Report Form date 04.12.2008
                                Patient Initials   |__|__|__|     Patient Number   |__|__|__|__|__|
   ITP 001
                                Center Number      |__|__|       Centre name


Baseline Bleeding score                                                                               Page 4




                                     Age                            Points
          > 65 years                                                   2
          >75 years                                                    5
                         Cutaneous bleeding
          Localized petechial purpura (legs)                           1
          Localized ecchymotic purpura                                 2
          2 locations of petechial purpura                             2
          Generalized petechial purpura                                3
          Generalized ecchymotic purpura                               4
                          Mucosal bleeding
          Unilateral epistaxis                                         2
          Bilateral epistaxis                                          3
          Hemorrhagic oral bullae, spontaneous gingival                5
          bleeding or both
                       Gastrointestinal bleeding
          GI hemorrhage without anemia                                 4
          GI hemorrhage with acute anemia (>2 g Hb fall               15
          in 24 hours) and/or shock
                           Urinary bleeding
          Macroscopic hematuria without anemia                         4
          Macroscopic hematuria with acute anemia                     10
                   Genitourinary tract bleeding
          Major meno/metrorrhagia without anemia                       4
          Major meno/metrorrhagia with acute anemia                   10
                 Central nervous system bleeding
          CNS bleeding and /or life threatening bleeding              15
                                                   Total score




Case Report Form date 04.12.2008
                                    Patient Initials       |__|__|__|              Patient Number   |__|__|__|__|__|
     ITP 001
                                    Center Number          |__|__|                Centre name


Baseline                                                                                                                        Page 5



Medical History

Relevant medical history incl. previous ITP episodes (An ITP episode is considered “previous” if the patient had sustained
platelet count >150 x 109/L for >3 months without platelet elevating treatment)
please record both previous and ongoing conditions
                  Disease                          Start date                                     End date             active

                                                              Day     Month Year            Day     Month    Year

1.                                                          |__|__|.|__|__|.|__|__|       |__|__|.|__|__|.|__|__|       
2.                                                          |__|__|.|__|__|.|__|__|       |__|__|.|__|__|.|__|__|       
3.                                                          |__|__|.|__|__|.|__|__|       |__|__|.|__|__|.|__|__|       
4.                                                          |__|__|.|__|__|.|__|__|       |__|__|.|__|__|.|__|__|       
5.                                                          |__|__|.|__|__|.|__|__|       |__|__|.|__|__|.|__|__|       
6.                                                          |__|__|.|__|__|.|__|__|       |__|__|.|__|__|.|__|__|       




Case Report Form date 04.12.2008
                               Patient Initials     |__|__|__|             Patient Number        |__|__|__|__|__|
     ITP 001
                               Center Number        |__|__|               Centre name


Baseline (* to be performed within 2 weeks prior to randomization)                                                               Page 6



ITP treatment

Current Treatment with Prednisolone
                                                                 Day     Month    Year
Date of start                                                  |__|__|.|__|__|.|__|__|

Dose at start:                                                 ____________ mg/day


Prednisolone dose at baseline:                                 ____________ mg/day



Previous Treatment courses with Prednisolone / other corticosteroids

                 Treatment                                Start Date                         End date
                                                        Day      Month    Year         Day    Month Year

1.                                                  |__|__|.|__|__|.|__|__|       |__|__|.|__|__|.|__|__|
2.                                                  |__|__|.|__|__|.|__|__|       |__|__|.|__|__|.|__|__|
3.                                                  |__|__|.|__|__|.|__|__|       |__|__|.|__|__|.|__|__|
4.                                                  |__|__|.|__|__|.|__|__|       |__|__|.|__|__|.|__|__|
5.                                                  |__|__|.|__|__|.|__|__|       |__|__|.|__|__|.|__|__|


Other treatments for ITP (including IVIG, Dapson or Danazole)

                 Treatment                             Dose*                      Start Date                       End date
                                                                                 Day     Month     Year      Day    Month Year

1.                                                                         |__|__|.|__|__|.|__|__|         |__|__|.|__|__|.|__|__|
2.                                                                         |__|__|.|__|__|.|__|__|         |__|__|.|__|__|.|__|__|
3.                                                                         |__|__|.|__|__|.|__|__|         |__|__|.|__|__|.|__|__|
4.                                                                         |__|__|.|__|__|.|__|__|         |__|__|.|__|__|.|__|__|
5.                                                                         |__|__|.|__|__|.|__|__|         |__|__|.|__|__|.|__|__|

*If possible




Please record ongoing medications for other indications on the Concomitant Medication page




Case Report Form date 04.12.2008
                                Patient Initials     |__|__|__|            Patient Number   |__|__|__|__|__|
    ITP 001
                                Center Number        |__|__|             Centre name


Baseline (* to be performed within 2 weeks prior to randomization)                                             Page 7




General physical examination

Perform a standard physical examination. Specify only abnormalities

     normal

  abnormal           specify:
                      s



     Height                                                    |__|__|__| (cm)
     Weight                                                    |__|__|__| (kg)



Vital signs

     Pulse                                |__|__|__| (bpm)

                                              systolic / diastolic
     Blood pressure                       |__|__|__|/|__|__|__| (mmHg)



Spleen (palpation): __________ cm below the costal margin




Case Report Form date 04.12.2008
                               Patient Initials      |__|__|__|        Patient Number    |__|__|__|__|__|
    ITP 001
                               Center Number         |__|__|          Centre name


Baseline ( * to be performed within 2 weeks prior to randomization)                                         Page 8




Laboratory Analysis

Heamatology
                                  Day   Month     Year
Sample collection date:        |__|__|.|__|__|.|__|__|

                                                  Results                         Unit

Hemoglobin                                                              g/L

Platelets                                                               x 109/L

WBC                                                                     x 109/L

Neutrophils                                                             x 109/L

Lymphocytes                                                             x 109/L

Monocytes                                                               x 109/L

Eosinophils                                                             x 109/L

Basophils                                                               x 109/L

Haptoglobin                                                             g/L


Blood chemistry

Creatinine                                                              Umol/L

ALT                                                                     U/L

AST                                                                     U/L

LDH                                                                     U/L

ALP                                                                     U/L

CRP                                                                     mg/L




Case Report Form date 04.12.2008
                               Patient Initials           |__|__|__|              Patient Number   |__|__|__|__|__|
      ITP 001
                               Center Number              |__|__|              Centre name


Baseline                                                                                                                     Page 9




Blood smear
Platelet aggregates                           Present                   Absent   



Bone marrow aspirate

                            Day    Month      Year
Date performed            |__|__|.|__|__|.|__|__|

If not performed, specify reason: ______________________________________________________


Megacaryocytes > 10                        Yes                     No   



Immunoglobuline Quantification

Has the patient received            Yes             No            If yes, please specify the       Day   Month      Year
IVIG treatment?                                                     last administration date       |__|__|.|__|__|.|__|__|

                                    Day    Month      Year
Sample collection date:           |__|__|.|__|__|.|__|__|

                                                     Results                       Unit

IgG                                                                                g/L

IgM                                                                                g/L

IgA                                                                                g/L




Case Report Form date 04.12.2008
                               Patient Initials      |__|__|__|                Patient Number   |__|__|__|__|__|
      ITP 001
                               Center Number         |__|__|                  Centre name


Baseline                                                                                                           Page 10



Serological Tests

HBV                                          Positive             Negative   
HCV                                          Positive             Negative   
HIV                                          Positive             Negative   
ANA                                          Positive             Negative   
Antilupus antibodies                         Positive             Negative   
Anticardiolilipin antibodies                 Positive             Negative   
DAT                                          Positive             Negative   

H. Pylori serology test *                    Positive             Negative          if positive IgG titre



OR Helicobacter Pylori C13 urea              Positive             Negative   
breath test

OR Helicobacter faecal Ag test               Positive             Negative   
*prefered test




Randomization

Is the patient eligible for the study?            No                Yes

Is the patient randomized?                        No                Yes

                                           Day    Month     Year
Date of reception of fax of              |__|__|.|__|__|.|__|__|
randomization

Investigators signature:                                                                         Date:

Please complete the Randomization Form and fax it to fax no. +47 69 38 50 01

Note: Study medicine should be administered within 4 days after randomization




Case Report Form date 04.12.2008
                            Patient Initials    |__|__|__|             Patient Number   |__|__|__|__|__|
    ITP 001
                            Center Number       |__|__|               Centre name


STUDY MEDICATION                                                                                                Page 11


Dose 1          (OBS! Please schedule next infusion after 1 week)

Has the patient experienced any Adverse Event(s)               No           Yes           Complete AE Form

Are there any changes in concomitant medications               No           Yes           Complete Concomitant medication Form

Are there any changes in ITP treatment                         No           Yes           Complete Prednisolon form and/or IVIG Form if
                                                                                             relevant


Date                      Start time           Stop time               Total dose            Was treatment infusion rate modified ? if yes : because of AE (complete AE
(day, month, year)        (24 hr clock)        (24 hr clock)           (mg)                 form) or because of Other
                                                                                            Adverse event 
                                   :                  :                                     Other 



Dose 2          (OBS! Please schedule next infusion after 1 week)


Has the patient experienced any Adverse Event(s)               No           Yes           Complete AE Form

Are there any changes in concomitant medications               No           Yes           Complete Concomitant medication Form

Are there any changes in ITP treatment                         No           Yes           Complete Prednisolon form and/or IVIG Form if
                                                                                             relevant


Date                      Start time           Stop time               Total dose            Was treatment infusion rate modified ? if yes : because of AE (complete AE
(day, month, year)        (24 hr clock)        (24 hr clock)           (mg)                 form) or because of Other
                                                                                            Adverse event 
                                   :                  :                                     Other 




Case Report Form date 04.12.2008
                            Patient Initials    |__|__|__|             Patient Number   |__|__|__|__|__|
    ITP 001
                            Center Number       |__|__|               Centre name


STUDY MEDICATION                                                                                                Page 12


Dose 3          (OBS! Please schedule next infusion after 1 week)


Has the patient experienced any Adverse Event(s)               No           Yes           Complete AE Form

Are there any changes in concomitant medications               No           Yes           Complete Concomitant medication Form

Are there any changes in ITP treatment                         No           Yes           Complete Prednisolon form and/or IVIG Form if
                                                                                             relevant


Date                      Start time           Stop time               Total dose            Was treatment infusion rate modified ? if yes : because of AE (complete AE
(day, month, year)        (24 hr clock)        (24 hr clock)           (mg)                 form) or because of Other

                                                                                            Adverse event 
                                   :                  :                                     Other 


Dose 4          (OBS! Please schedule first Follow-up visit 6 weeks after RANDOMIZATION)

Has the patient experienced any Adverse Event(s)               No           Yes           Complete AE Form

Are there any changes in concomitant medications               No           Yes           Complete Concomitant medication Form

Are there any changes in ITP treatment                         No           Yes           Complete Prednisolon form and/or IVIG Form if
                                                                                             relevant

Date                      Start time           Stop time               Total dose            Was treatment infusion rate modified ? if yes : because of AE (complete AE
(day, month, year)        (24 hr clock)        (24 hr clock)           (mg)                 form) or because of Other
                                                                                            Adverse event 
                                   :                  :                                     Other 




Case Report Form date 04.12.2008
                              Patient Initials      |__|__|__|             Patient Number      |__|__|__|__|__|
    ITP 001
                              Center Number         |__|__|              Centre name



Follow-up week 6 after date of randomization (± 4 days)                                                                   Page 13


                                Day    Month     Year
Date of visit:                |__|__|.|__|__|.|__|__|


Haematology
                        Day    Month     Year                                          Results
Assessment date:      |__|__|.|__|__|.|__|__|            Platelet count                            x 109/L



Response evaluation

Has the patient met the criteria       No                       Yes 
for splenectomy
Was splenectomy performed?             No                       Yes                                If yes, complete the Splenectomy Form
                                                                                                     If No, please specify reason:

Splenectomy planned                   Patient refusal          Patient not fit for surgery        Other   
                                                                                                     If “Other”, please specify:


Has the patient received any           No                       Yes                                If yes, please update the Concomitant
treatments for ITP other than                                                                        treatment form and/or IVIG Form
Prednisolone after the
administration of study medicine?

Has the prednisolone treatment         No                       Yes                                If yes, please update the Prednisolone
been modified since last visit?                                                                      Form


Bleeding

Has the patient experienced bleeding        No                          Yes  
including mucocutaneous bleeding

Petechiae                                  Mild blood loss             Gross blood loss            Debilitating blood loss      
If yes, please also complete the Bleeding score,                            Total bleeding score
page?


Adverse Event
Has the patient experienced any Adverse Event(s)                  No             Yes             Complete AE Form

Has the patient experienced infection                             No             Yes             Complete AE Form

Has the patient experienced thrombosis?                           No             Yes             Complete AE Form




Case Report Form date 04.12.2008
                              Patient Initials   |__|__|__|           Patient Number   |__|__|__|__|__|
    ITP 001
                              Center Number      |__|__|             Centre name


Follow-up week 6 after date of randomization (± 4 days) cont.                                                  Page 14




Concomitant Medication

Has there been any changes in the patients concomitant        No             Yes         Complete Concomitant
medication?                                                                                 Medication Form




Total dose of Prednisolone since last visit                               g




Visits to health care professional since randomization

Type of visit                                         Number of visits

Nurse (out-patient)

Physicians (out-patient) including this visit

                                                      Number of day(s)

Hospitalizations related to ITP

Hospitalizations not related to ITP



Days of sick leave since randomization:




Investigators signature:                                                                Date:




Case Report Form date 04.12.2008
                              Patient Initials      |__|__|__|             Patient Number      |__|__|__|__|__|
    ITP 001
                              Center Number         |__|__|              Centre name


Follow-up week 12 after date of randomization (± 4 days)                                                                   Page 15


                                Day    Month     Year
Date of visit:                |__|__|.|__|__|.|__|__|



Haematology
                        Day    Month     Year                                          Results
Assessment date:      |__|__|.|__|__|.|__|__|            Platelet count                            x 109/L



Response evaluation

Has the patient met the criteria       No                       Yes 
for splenectomy
Was splenectomy performed?             No                       Yes                                If yes, complete the Splenectomy Form
                                                                                                     If No, please specify reason:

Splenectomy planned                   Patient refusal          Patient not fit for surgery        Other   
                                                                                                     If “Other”, please specify:


Has the patient received any           No                       Yes                                If yes, please update the Concomitant
treatments for ITP other than                                                                        treatment form and/or IVIG Form
Prednisolone after the
administration of study medicine?

Has the prednisolone treatment         No                       Yes                                If yes, please update the Prednisolone
been modified since last visit?                                                                      Form



Bleeding

Has the patient experienced bleeding        No                          Yes  
including mucocutaneous bleeding

Petechiae                                  Mild blood loss             Gross blood loss            Debilitating blood loss      
If yes, please also complete the Bleeding score,                            Total bleeding score
page?


Adverse Event
Has the patient experienced any Adverse Event(s)                  No             Yes             Complete AE Form

Has the patient experienced infection                             No             Yes             Complete AE Form

Has the patient experienced thrombosis?                           No             Yes             Complete AE Form




Case Report Form date 04.12.2008
                              Patient Initials   |__|__|__|           Patient Number   |__|__|__|__|__|
    ITP 001
                              Center Number      |__|__|             Centre name


Follow-up week 12 after date of randomization (± 4 days) cont.                                                 Page 16




Concomitant Medication

Has there been any changes in the patients concomitant        No             Yes         Complete Concomitant
medication?                                                                                 Medication Form




Total dose of Prednisolone since last visit                               g




Visits to health care professional since randomization

Type of visit                                         Number of visits

Nurse (out-patient)

Physicians (out-patient) including this visit

                                                      Number of days)

Hospitalizations related to ITP

Hospitalizations not related to ITP



Days of sick leave since randomization:




Investigators signature:                                                                Date:




Case Report Form date 04.12.2008
                              Patient Initials      |__|__|__|             Patient Number      |__|__|__|__|__|
    ITP 001
                              Center Number         |__|__|              Centre name


Follow-up week 18 after date of randomization (± 4 days)                                                                   Page 17


                                Day    Month     Year
Date of visit:                |__|__|.|__|__|.|__|__|



Haematology
                        Day    Month     Year                                          Results
Assessment date:      |__|__|.|__|__|.|__|__|            Platelet count                            x 109/L




Response evaluation

Has the patient met the criteria       No                       Yes 
for splenectomy
Was splenectomy performed?             No                       Yes                                If yes, complete the Splenectomy Form
                                                                                                     If No, please specify reason:

Splenectomy planned                   Patient refusal          Patient not fit for surgery        Other   
                                                                                                     If “Other”, please specify:


Has the patient received any           No                       Yes                                If yes, please update the Concomitant
treatments for ITP other than                                                                        treatment form and/or IVIG Form
Prednisolone after the
administration of study medicine?

Has the prednisolone treatment         No                       Yes                                If yes, please update the Prednisolone
been modified since last visit?                                                                      Form


Bleeding

Has the patient experienced bleeding        No                          Yes  
including mucocutaneous bleeding

Petechiae                                  Mild blood loss             Gross blood loss            Debilitating blood loss      
If yes, please also complete the Bleeding score,                            Total bleeding score
page?


Adverse Event
Has the patient experienced any Adverse Event(s)                  No             Yes             Complete AE Form

Has the patient experienced infection                             No             Yes             Complete AE Form

Has the patient experienced thrombosis?                           No             Yes             Complete AE Form




Case Report Form date 04.12.2008
                              Patient Initials   |__|__|__|           Patient Number   |__|__|__|__|__|
    ITP 001
                              Center Number      |__|__|             Centre name


Follow-up week 18 after date of randomization (± 4 days) cont.                                                 Page 18




Concomitant Medication

Has there been any changes in the patients concomitant        No             Yes         Complete Concomitant
medication?                                                                                 Medication Form




Total dose of Prednisolone since last visit                               g




Visits to health care professional since randomization

Type of visit                                         Number of visits

Nurse (out-patient)

Physicians (out-patient) including this visit

                                                      Number of days)

Hospitalizations related to ITP

Hospitalizations not related to ITP



Days of sick leave since randomization:




Investigators signature:                                                                Date:




Case Report Form date 04.12.2008
                                Patient Initials      |__|__|__|           Patient Number   |__|__|__|__|__|
      ITP 001
                                Center Number         |__|__|            Centre name


Follow-up week 24 after date of randomization (± 4 days)                                                              Page 19



                                  Day     Month    Year
Date of visit:                  |__|__|.|__|__|.|__|__|


Haematology (Two blood samples to be taken at least one week apart)
                          Day    Month     Year                                   Results
Assessment date:     |__|__|.|__|__|.|__|__|          Platelet count                     x 109/L

                          Day    Month     Year                                   Results
Assessment date:     |__|__|.|__|__|.|__|__|          Platelet count                     x 109/L


Immunoglobuline Quantification

Has the patient received            Yes           No          If yes, please specify        Day    Month     Year
IVIG during the last 4                                          the last date               |__|__|.|__|__|.|__|__|
weeks?

                                    Day    Month    Year
Sample collection date:          |__|__|.|__|__|.|__|__|

                                                   Results                  Unit

IgG                                                                         g/L

IgM                                                                         g/L

IgA                                                                         g/L




Case Report Form date 04.12.2008
                              Patient Initials      |__|__|__|              Patient Number      |__|__|__|__|__|
    ITP 001
                              Center Number         |__|__|               Centre name


Follow-up week 24 after date of randomization (± 4 days) cont.                                                              Page 20



Response evaluation

Has the patient had response to        No                         Yes         If yes:   CR         PR      MR   
study
medication?
                                          Day    Month   Year
If Yes, date of response                |__|__|.|__|__|.|__|__|

Has the patient met the criteria       No                        Yes 
for splenectomy
Was splenectomy performed?             No                        Yes                                If yes, complete the Splenectomy Form
                                                                                                      If No, please specify reason:
Splenectomy planned                   Patient refusal           Patient not fit for surgery        Other 

                                                                                                      If “Other”, please specify:


Has the patient received any           No                        Yes                                If yes, please update the Concomitant
treatments for ITP other than                                                                         treatment form and/or IVIG Form
Prednisoloneafter the
administration of study medicine?

Has the prednisolone treatment         No                        Yes                                If yes, please update the Prednisolone
been modified since last visit?                                                                       Form




Bleeding

Has the patient experienced bleeding        No                           Yes  
including mucocutaneous bleeding

Petechiae                                  Mild blood loss              Gross blood loss            Debilitating blood loss      
If yes, please also complete the Bleeding score,                             Total bleeding score
page?



Adverse Event
Has the patient experienced any Adverse Event(s)                   No             Yes             Complete AE Form

Has the patient experienced infection                              No             Yes             Complete AE Form

Has the patient experienced thrombosis?                            No             Yes             Complete AE Form




Case Report Form date 04.12.2008
                              Patient Initials   |__|__|__|           Patient Number   |__|__|__|__|__|
    ITP 001
                              Center Number      |__|__|             Centre name


Follow-up week 24 after date of randomization (± 4 days) cont.                                               Page 21




Concomitant Medication

Has there been any changes in the patients concomitant        No             Yes         Complete Concomitant
medication?                                                                                 Medication Form



Total dose of Prednisolone since last visit                               g



Visits to health care professional since randomization

Type of visit                                         Number of visits

Nurse (out-patient)

Physicians (out-patient) including this visit

                                                      Number of days)

Hospitalizations related to ITP

Hospitalizations not related to ITP



Days of sick leave since randomization:


Investigators signature:                                                                Date:




Case Report Form date 04.12.2008
                              Patient Initials      |__|__|__|             Patient Number      |__|__|__|__|__|
    ITP 001
                              Center Number         |__|__|              Centre name


Follow-up week 30 after date of randomization (± 4 days)                                                                  Page 22


                                Day    Month     Year
Date of visit:                |__|__|.|__|__|.|__|__|



Haematology
                        Day    Month     Year                                          Results
Assessment date:      |__|__|.|__|__|.|__|__|            Platelet count                            x 109/L



Response evaluation

Has the patient met the criteria       No                       Yes 
for splenectomy
Was splenectomy performed?             No                       Yes                                If yes, complete the Splenectomy Form
                                                                                                     If No, please specify reason:

Splenectomy planned                   Patient refusal          Patient not fit for surgery        Other   
                                                                                                     If “Other”, please specify:


Has the patient received any           No                       Yes                                If yes, please update the Concomitant
treatments for ITP other than                                                                        treatment form and/or IVIG Form
Prednisolone after the
administration of study medicine?

Has the prednisolone treatment         No                       Yes                                If yes, please update the Prednisolone
been modified since last visit?                                                                      Form



Bleeding

Has the patient experienced bleeding        No                          Yes  
including mucocutaneous bleeding

Petechiae                                  Mild blood loss             Gross blood loss            Debilitating blood loss      
If yes, please also complete the Bleeding score,                            Total bleeding score
page?


Adverse Event
Has the patient experienced any Adverse Event(s)                  No             Yes             Complete AE Form

Has the patient experienced infection                             No             Yes             Complete AE Form

Has the patient experienced thrombosis?                           No             Yes             Complete AE Form




Case Report Form date 04.12.2008
                              Patient Initials   |__|__|__|           Patient Number   |__|__|__|__|__|
    ITP 001
                              Center Number      |__|__|             Centre name


Follow-up week 30 after date of randomization (± 4 days) cont.                                                 Page 23




Concomitant Medication

Has there been any changes in the patients concomitant        No             Yes         Complete Concomitant
medication?                                                                                 Medication Form




Total dose of Prednisolone since last visit                               g




Visits to health care professional since randomization

Type of visit                                         Number of visits

Nurse (out-patient)

Physicians (out-patient) including this visit

                                                      Number of days)

Hospitalizations related to ITP

Hospitalizations not related to ITP



Days of sick leave since randomization:




Investigators signature:                                                                Date:




Case Report Form date 04.12.2008
                              Patient Initials      |__|__|__|             Patient Number      |__|__|__|__|__|
    ITP 001
                              Center Number         |__|__|              Centre name


Follow-up week 36 after date of randomization (± 4 days)                                                                     Page 24


                                Day    Month     Year
Date of visit:                |__|__|.|__|__|.|__|__|


Haematology
                        Day    Month     Year                                          Results
Assessment date:      |__|__|.|__|__|.|__|__|            Platelet count                            x 109/L




Response evaluation

Has the patient met the criteria       No                       Yes 
for splenectomy
Was splenectomy performed?             No                       Yes                                If yes, complete the Splenectomy Form
                                                                                                     If No, please specify reason:

Splenectomy planned                   Patient refusal          Patient not fit for surgery        Other   
                                                                                                     If “Other”, please specify:


Has the patient received any           No                       Yes                                If yes, please update the Concomitant
treatments for ITP other than                                                                        treatment form and/or IVIG Form
Prednisolone after the
administration of study medicine?

Has the prednisolone treatment         No                       Yes                                If yes, please update the Prednisolone
been modified since last visit?                                                                      Form



Bleeding

Has the patient experienced bleeding        No                          Yes  
including mucocutaneous bleeding

Petechiae                                  Mild blood loss             Gross blood loss            Debilitating blood loss      
If yes, please also complete the Bleeding score,                            Total bleeding score
page?


Adverse Event
Has the patient experienced any Adverse Event(s)                  No             Yes             Complete AE Form

Has the patient experienced infection                             No             Yes             Complete AE Form

Has the patient experienced thrombosis?                           No             Yes             Complete AE Form




Case Report Form date 04.12.2008
                              Patient Initials   |__|__|__|           Patient Number   |__|__|__|__|__|
    ITP 001
                              Center Number      |__|__|             Centre name


Follow-up week 36 after date of randomization (± 4 days) cont.                                                     Page 25




Concomitant Medication

Has there been any changes in the patients concomitant        No             Yes         Complete Concomitant
medication?                                                                                 Medication Form




Total dose of Prednisolone since last visit                               g




Visits to health care professional since randomization

Type of visit                                         Number of visits

Nurse (out-patient)

Physicians (out-patient) including this visit

                                                      Number of days)

Hospitalizations related to ITP

Hospitalizations not related to ITP



Days of sick leave since randomization:




Investigators signature:                                                                Date:




Case Report Form date 04.12.2008
                              Patient Initials      |__|__|__|             Patient Number      |__|__|__|__|__|
    ITP 001
                              Center Number         |__|__|              Centre name


Follow-up week 42 after date of randomization (± 4 days)                                                                     Page 26


                                Day    Month     Year
Date of visit:                |__|__|.|__|__|.|__|__|



Haematology
                        Day    Month     Year                                          Results
Assessment date:      |__|__|.|__|__|.|__|__|            Platelet count                            x 109/L




Response evaluation

Has the patient met the criteria       No                       Yes 
for splenectomy
Was splenectomy performed?             No                       Yes                                If yes, complete the Splenectomy Form
                                                                                                     If No, please specify reason:

Splenectomy planned                   Patient refusal          Patient not fit for surgery        Other   
                                                                                                     If “Other”, please specify:


Has the patient received any           No                       Yes                                If yes, please update the Concomitant
treatments for ITP other than                                                                        treatment form and/or IVIG Form
Prednisolone after the
administration of study medicine?

Has the prednisolone treatment         No                       Yes                                If yes, please update the Prednisolone
been modified since last visit?                                                                      Form



Bleeding

Has the patient experienced bleeding        No                          Yes  
including mucocutaneous bleeding

Petechiae                                  Mild blood loss             Gross blood loss            Debilitating blood loss      
If yes, please also complete the Bleeding score,                            Total bleeding score
page?


Adverse Event
Has the patient experienced any Adverse Event(s)                  No             Yes             Complete AE Form

Has the patient experienced infection                             No             Yes             Complete AE Form

Has the patient experienced thrombosis?                           No             Yes             Complete AE Form




Case Report Form date 04.12.2008
                              Patient Initials   |__|__|__|           Patient Number   |__|__|__|__|__|
    ITP 001
                              Center Number      |__|__|             Centre name


Follow-up week 42 after date of randomization (± 4 days) cont.                                                     Page 27




Concomitant Medication

Has there been any changes in the patients concomitant        No             Yes         Complete Concomitant
medication?                                                                                 Medication Form




Total dose of Prednisolone since last visit                               g




Visits to health care professional since randomization

Type of visit                                         Number of visits

Nurse (out-patient)

Physicians (out-patient) including this visit

                                                      Number of days)

Hospitalizations related to ITP

Hospitalizations not related to ITP



Days of sick leave since randomization:




Investigators signature:                                                                Date:




Case Report Form date 04.12.2008
                              Patient Initials      |__|__|__|             Patient Number      |__|__|__|__|__|
    ITP 001
                              Center Number         |__|__|              Centre name


Follow-up week 48 after date of randomization (± 4 days)                                                                     Page 28


                                Day    Month     Year
Date of visit:                |__|__|.|__|__|.|__|__|



Haematology
                        Day    Month     Year                                          Results
Assessment date:      |__|__|.|__|__|.|__|__|            Platelet count                            x 109/L



Response evaluation

Has the patient met the criteria       No                       Yes 
for splenectomy
Was splenectomy performed?             No                       Yes                                If yes, complete the Splenectomy Form
                                                                                                     If No, please specify reason:

Splenectomy planned                   Patient refusal          Patient not fit for surgery        Other   
                                                                                                     If “Other”, please specify:


Has the patient received any           No                       Yes                                If yes, please update the Concomitant
treatments for ITP other than                                                                        treatment form and/or IVIG Form
Prednisolone after the
administration of study medicine?

Has the prednisolone treatment         No                       Yes                                If yes, please update the Prednisolone
been modified since last visit?                                                                      Form



Bleeding

Has the patient experienced bleeding        No                          Yes  
including mucocutaneous bleeding

Petechiae                                  Mild blood loss             Gross blood loss            Debilitating blood loss      
If yes, please also complete the Bleeding score,                            Total bleeding score
page?


Adverse Event
Has the patient experienced any Adverse Event(s)                  No             Yes             Complete AE Form

Has the patient experienced infection                             No             Yes             Complete AE Form

Has the patient experienced thrombosis?                           No             Yes             Complete AE Form




Case Report Form date 04.12.2008
                              Patient Initials   |__|__|__|           Patient Number   |__|__|__|__|__|
    ITP 001
                              Center Number      |__|__|             Centre name


Follow-up week 48 after date of randomization (± 4 days) cont.                                                 Page 29




Concomitant Medication

Has there been any changes in the patients concomitant        No             Yes         Complete Concomitant
medication?                                                                                 Medication Form




Total dose of Prednisolone since last visit                               g




Visits to health care professional since randomization

Type of visit                                         Number of visits

Nurse (out-patient)

Physicians (out-patient) including this visit

                                                      Number of days)

Hospitalizations related to ITP

Hospitalizations not related to ITP



Days of sick leave since randomization:




Investigators signature:                                                                Date:




Case Report Form date 04.12.2008
                              Patient Initials      |__|__|__|             Patient Number      |__|__|__|__|__|
    ITP 001
                              Center Number         |__|__|              Centre name


Follow-up week 54 after date of randomization (± 4 days)                                                                    Page 30


                                Day    Month     Year
Date of visit:                |__|__|.|__|__|.|__|__|



Haematology
                        Day    Month     Year                                          Results
Assessment date:      |__|__|.|__|__|.|__|__|            Platelet count                            x 109/L




Response evaluation

Has the patient met the criteria       No                       Yes 
for splenectomy
Was splenectomy performed?             No                       Yes                                If yes, complete the Splenectomy Form
                                                                                                     If No, please specify reason:

Splenectomy planned                   Patient refusal          Patient not fit for surgery        Other   
                                                                                                     If “Other”, please specify:


Has the patient received any           No                       Yes                                If yes, please update the Concomitant
treatments for ITP other than                                                                        treatment form and/or IVIG Form
Prednisolone after the
administration of study medicine?

Has the prednisolone treatment         No                       Yes                                If yes, please update the Prednisolone
been modified since last visit?                                                                      Form


Bleeding

Has the patient experienced bleeding        No                          Yes  
including mucocutaneous bleeding

Petechiae                                  Mild blood loss             Gross blood loss            Debilitating blood loss      
If yes, please also complete the Bleeding score,                            Total bleeding score
page?


Adverse Event
Has the patient experienced any Adverse Event(s)                  No             Yes             Complete AE Form

Has the patient experienced infection                             No             Yes             Complete AE Form

Has the patient experienced thrombosis?                           No             Yes             Complete AE Form




Case Report Form date 04.12.2008
                              Patient Initials   |__|__|__|           Patient Number   |__|__|__|__|__|
    ITP 001
                              Center Number      |__|__|             Centre name


Follow-up week 54 after date of randomization (± 4 days) cont.                                                     Page 31




Concomitant Medication

Has there been any changes in the patients concomitant        No             Yes         Complete Concomitant
medication?                                                                                 Medication Form




Total dose of Prednisolone since last visit                               g




Visits to health care professional since randomization

Type of visit                                         Number of visits

Nurse (out-patient)

Physicians (out-patient) including this visit

                                                      Number of days)

Hospitalizations related to ITP

Hospitalizations not related to ITP



Days of sick leave since randomization:




Investigators signature:                                                                Date:




Case Report Form date 04.12.2008
                              Patient Initials      |__|__|__|             Patient Number      |__|__|__|__|__|
    ITP 001
                              Center Number         |__|__|              Centre name


Follow-up week 60 after date of randomization (± 4 days)                                                                    Page 32


                                Day    Month     Year
Date of visit:                |__|__|.|__|__|.|__|__|



Haematology
                        Day    Month     Year                                          Results
Assessment date:      |__|__|.|__|__|.|__|__|            Platelet count                            x 109/L




Response evaluation

Has the patient met the criteria       No                       Yes 
for splenectomy
Was splenectomy performed?             No                       Yes                                If yes, complete the Splenectomy Form
                                                                                                     If No, please specify reason:

Splenectomy planned                   Patient refusal          Patient not fit for surgery        Other   
                                                                                                     If “Other”, please specify:


Has the patient received any           No                       Yes                                If yes, please update the Concomitant
treatments for ITP other than                                                                        treatment form and/or IVIG Form
Prednisolone after the
administration of study medicine?

Has the prednisolone treatment         No                       Yes                                If yes, please update the Prednisolone
been modified since last visit?                                                                      Form


Bleeding

Has the patient experienced bleeding        No                          Yes  
including mucocutaneous bleeding

Petechiae                                  Mild blood loss             Gross blood loss            Debilitating blood loss      
If yes, please also complete the Bleeding score,                            Total bleeding score
page?


Adverse Event
Has the patient experienced any Adverse Event(s)                  No             Yes             Complete AE Form

Has the patient experienced infection                             No             Yes             Complete AE Form

Has the patient experienced thrombosis?                           No             Yes             Complete AE Form




Case Report Form date 04.12.2008
                              Patient Initials   |__|__|__|           Patient Number   |__|__|__|__|__|
    ITP 001
                              Center Number      |__|__|             Centre name


Follow-up week 60 after date of randomization (± 4 days) cont.                                                     Page 33




Concomitant Medication

Has there been any changes in the patients concomitant        No             Yes         Complete Concomitant
medication?                                                                                 Medication Form




Total dose of Prednisolone since last visit                               g




Visits to health care professional since randomization

Type of visit                                         Number of visits

Nurse (out-patient)

Physicians (out-patient) including this visit

                                                      Number of days)

Hospitalizations related to ITP

Hospitalizations not related to ITP



Days of sick leave since randomization:




Investigators signature:                                                                Date:




Case Report Form date 04.12.2008
                              Patient Initials      |__|__|__|             Patient Number      |__|__|__|__|__|
    ITP 001
                              Center Number         |__|__|              Centre name


Follow-up week 66 after date of randomization (± 4 days)                                                                     Page 34


                                Day    Month     Year
Date of visit:                |__|__|.|__|__|.|__|__|



Haematology
                        Day    Month     Year                                          Results
Assessment date:      |__|__|.|__|__|.|__|__|            Platelet count                            x 109/L



Response evaluation

Has the patient met the criteria       No                       Yes 
for splenectomy
Was splenectomy performed?             No                       Yes                                If yes, complete the Splenectomy Form
                                                                                                     If No, please specify reason:

Splenectomy planned                   Patient refusal          Patient not fit for surgery        Other   
                                                                                                     If “Other”, please specify:


Has the patient received any           No                       Yes                                If yes, please update the Concomitant
treatments for ITP other than                                                                        treatment form and/or IVIG Form
Prednisolone after the
administration of study medicine?

Has the prednisolone treatment         No                       Yes                                If yes, please update the Prednisolone
been modified since last visit?                                                                      Form




Bleeding

Has the patient experienced bleeding        No                          Yes  
including mucocutaneous bleeding

Petechiae                                  Mild blood loss             Gross blood loss            Debilitating blood loss      
If yes, please also complete the Bleeding score,                            Total bleeding score
page?


Adverse Event
Has the patient experienced any Adverse Event(s)                  No             Yes             Complete AE Form

Has the patient experienced infection                             No             Yes             Complete AE Form

Has the patient experienced thrombosis?                           No             Yes             Complete AE Form




Case Report Form date 04.12.2008
                              Patient Initials   |__|__|__|           Patient Number   |__|__|__|__|__|
    ITP 001
                              Center Number      |__|__|             Centre name


Follow-up week 66 after date of randomization (± 4 days) cont.                                                 Page 35




Concomitant Medication

Has there been any changes in the patients concomitant        No             Yes         Complete Concomitant
medication?                                                                                 Medication Form




Total dose of Prednisolone since last visit                               g




Visits to health care professional since randomization

Type of visit                                         Number of visits

Nurse (out-patient)

Physicians (out-patient) including this visit

                                                      Number of days)

Hospitalizations related to ITP

Hospitalizations not related to ITP



Days of sick leave since randomization:




Investigators signature:                                                                Date:




Case Report Form date 04.12.2008
                              Patient Initials      |__|__|__|             Patient Number      |__|__|__|__|__|
    ITP 001
                              Center Number         |__|__|              Centre name


Follow-up week 72 after date of randomization (± 4 days)                                                                    Page 36


                                Day    Month     Year
Date of visit:                |__|__|.|__|__|.|__|__|



Haematology
                        Day    Month     Year                                          Results
Assessment date:      |__|__|.|__|__|.|__|__|            Platelet count                            x 109/L



Response evaluation

Has the patient met the criteria       No                       Yes 
for splenectomy
Was splenectomy performed?             No                       Yes                                If yes, complete the Splenectomy Form
                                                                                                     If No, please specify reason:

Splenectomy planned                   Patient refusal          Patient not fit for surgery        Other   
                                                                                                     If “Other”, please specify:


Has the patient received any           No                       Yes                                If yes, please update the Concomitant
treatments for ITP other than                                                                        treatment form and/or IVIG Form
Prednisolone after the
administration of study medicine?

Has the prednisolone treatment         No                       Yes                                If yes, please update the Prednisolone
been modified since last visit?                                                                      Form




Bleeding

Has the patient experienced bleeding        No                          Yes  
including mucocutaneous bleeding

Petechiae                                  Mild blood loss             Gross blood loss            Debilitating blood loss      
If yes, please also complete the Bleeding score,                            Total bleeding score
page?


Adverse Event
Has the patient experienced any Adverse Event(s)                  No             Yes             Complete AE Form

Has the patient experienced infection                             No             Yes             Complete AE Form

Has the patient experienced thrombosis?                           No             Yes             Complete AE Form




Case Report Form date 04.12.2008
                              Patient Initials   |__|__|__|           Patient Number   |__|__|__|__|__|
    ITP 001
                              Center Number      |__|__|             Centre name


Follow-up week 72 after date of randomization (± 4 days) cont.                                                 Page 37




Concomitant Medication

Has there been any changes in the patients concomitant        No             Yes         Complete Concomitant
medication?                                                                                 Medication Form




Total dose of Prednisolone since last visit                               g




Visits to health care professional since randomization

Type of visit                                         Number of visits

Nurse (out-patient)

Physicians (out-patient) including this visit

                                                      Number of days)

Hospitalizations related to ITP

Hospitalizations not related to ITP



Days of sick leave since randomization:




Investigators signature:                                                                Date:




Case Report Form date 04.12.2008
                              Patient Initials      |__|__|__|             Patient Number      |__|__|__|__|__|
    ITP 001
                              Center Number         |__|__|              Centre name


Follow-up week 78 after date of randomization (± 4 days)                                                                     Page 38


                                Day    Month     Year
Date of visit:                |__|__|.|__|__|.|__|__|



Haematology
                        Day    Month     Year                                          Results
Assessment date:      |__|__|.|__|__|.|__|__|            Platelet count                            x 109/L




Response evaluation

Has the patient met the criteria       No                       Yes 
for splenectomy
Was splenectomy performed?             No                       Yes                                If yes, complete the Splenectomy Form
                                                                                                     If No, please specify reason:

Splenectomy planned                   Patient refusal          Patient not fit for surgery        Other   
                                                                                                     If “Other”, please specify:


Has the patient received any           No                       Yes                                If yes, please update the Concomitant
treatments for ITP other than                                                                        treatment form and/or IVIG Form
Prednisolone after the
administration of study medicine?

Has the prednisolone treatment         No                       Yes                                If yes, please update the Prednisolone
been modified since last visit?                                                                      Form


Bleeding

Has the patient experienced bleeding        No                          Yes  
including mucocutaneous bleeding

Petechiae                                  Mild blood loss             Gross blood loss            Debilitating blood loss      
If yes, please also complete the Bleeding score,                            Total bleeding score
page?


Adverse Event
Has the patient experienced any Adverse Event(s)                  No             Yes             Complete AE Form

Has the patient experienced infection                             No             Yes             Complete AE Form

Has the patient experienced thrombosis?                           No             Yes             Complete AE Form




Case Report Form date 04.12.2008
                              Patient Initials   |__|__|__|           Patient Number   |__|__|__|__|__|
    ITP 001
                              Center Number      |__|__|             Centre name


Follow-up week 78 after date of randomization (± 4 days) cont.                                                 Page 39




Concomitant Medication

Has there been any changes in the patients concomitant        No             Yes         Complete Concomitant
medication?                                                                                 Medication Form




Total dose of Prednisolone since last visit                               g




Visits to health care professional since randomization

Type of visit                                         Number of visits

Nurse (out-patient)

Physicians (out-patient) including this visit

                                                      Number of days)

Hospitalizations related to ITP

Hospitalizations not related to ITP



Days of sick leave since randomization:




Investigators signature:                                                                Date:




Case Report Form date 04.12.2008
                              Patient Initials      |__|__|__|             Patient Number      |__|__|__|__|__|
    ITP 001
                              Center Number         |__|__|              Centre name


Follow-up week 84 after date of randomization (± 4 days)                                                                     Page 40


                                Day    Month     Year
Date of visit:                |__|__|.|__|__|.|__|__|



Haematology
                        Day    Month     Year                                          Results
Assessment date:      |__|__|.|__|__|.|__|__|            Platelet count                            x 109/L



Response evaluation

Has the patient met the criteria       No                       Yes 
for splenectomy
Was splenectomy performed?             No                       Yes                                If yes, complete the Splenectomy Form
                                                                                                     If No, please specify reason:

Splenectomy planned                   Patient refusal          Patient not fit for surgery        Other   
                                                                                                     If “Other”, please specify:


Has the patient received any           No                       Yes                                If yes, please update the Concomitant
treatments for ITP other than                                                                        treatment form and/or IVIG Form
Prednisolone after the
administration of study medicine?

Has the prednisolone treatment         No                       Yes                                If yes, please update the Prednisolone
been modified since last visit?                                                                      Form



Bleeding

Has the patient experienced bleeding        No                          Yes  
including mucocutaneous bleeding

Petechiae                                  Mild blood loss             Gross blood loss            Debilitating blood loss      
If yes, please also complete the Bleeding score,                            Total bleeding score
page?


Adverse Event
Has the patient experienced any Adverse Event(s)                  No             Yes             Complete AE Form

Has the patient experienced infection                             No             Yes             Complete AE Form

Has the patient experienced thrombosis?                           No             Yes             Complete AE Form




Case Report Form date 04.12.2008
                              Patient Initials   |__|__|__|           Patient Number   |__|__|__|__|__|
    ITP 001
                              Center Number      |__|__|             Centre name


Follow-up week 84 after date of randomization (± 4 days) cont.                                                 Page 41




Concomitant Medication

Has there been any changes in the patients concomitant        No             Yes         Complete Concomitant
medication?                                                                                 Medication Form




Total dose of Prednisolone since last visit                               g




Visits to health care professional since randomization

Type of visit                                         Number of visits

Nurse (out-patient)

Physicians (out-patient) including this visit

                                                      Number of days)

Hospitalizations related to ITP

Hospitalizations not related to ITP



Days of sick leave since randomization:




Investigators signature:                                                                Date:




Case Report Form date 04.12.2008
                                Patient Initials      |__|__|__|           Patient Number   |__|__|__|__|__|
      ITP 001
                                Center Number         |__|__|            Centre name


Follow-up week 90 after date of randomization (± 4 days)                                                              Page 42



                                  Day     Month    Year
Date of visit:                  |__|__|.|__|__|.|__|__|



Haematology (Two blood samples to be taken at least one week apart)
                          Day    Month     Year                                   Results
Assessment date:     |__|__|.|__|__|.|__|__|          Platelet count                     x 109/L

                          Day    Month     Year                                   Results
Assessment date:     |__|__|.|__|__|.|__|__|          Platelet count                     x 109/L



Immunoglobuline Quantification

Has the patient received            Yes           No          If yes, please specify        Day    Month     Year
IVIG during the last 4                                          the last date               |__|__|.|__|__|.|__|__|
weeks?

                                    Day    Month    Year
Sample collection date:          |__|__|.|__|__|.|__|__|

                                                   Results                  Unit

IgG                                                                         g/L

IgM                                                                         g/L

IgA                                                                         g/L




Case Report Form date 04.12.2008
                              Patient Initials     |__|__|__|             Patient Number      |__|__|__|__|__|
    ITP 001
                              Center Number        |__|__|               Centre name


Follow-up week 90 after date of randomization (± 4 days) cont.                                                                Page 43


Response evaluation

Has the patient had response to study                No         Yes            If yes:   CR      PR        MR   
medication?
                                                         Day    Month   Year
If Yes, date of response                              |__|__|.|__|__|.|__|__|

Has the patient relapsed following an initial         No        Yes 
response?
                                                         Day    Month   Year
If Yes, date of relapse                               |__|__|.|__|__|.|__|__|

Has the patient met the criteria       No                      Yes 
for splenectomy
Was splenectomy performed?             No                      Yes                                  If yes, complete the Splenectomy Form
                                                                                                      If No, please specify reason:
Splenectomy planned                   Patient refusal         Patient not fit for surgery          Other 

                                                                                                      If “Other”, please specify:


Has the patient received any           No                      Yes                                  If yes, please update the Concomitant
treatments for ITP other than                                                                         treatment form and/or IVIG Form
Prednisoloneafter the
administration of study medicine?

Has the prednisolone treatment         No                      Yes                                  If yes, please update the Prednisolone
been modified since last visit?                                                                       Form



Bleeding

Has the patient experienced bleeding        No                         Yes  
including mucocutaneous bleeding

Petechiae                                  Mild blood loss            Gross blood loss              Debilitating blood loss      
If yes, please also complete the Bleeding score,                               Total bleeding score
page?


Adverse Event
Has the patient experienced any Adverse Event(s)                 No                Yes           Complete AE Form

Has the patient experienced infection                            No                Yes           Complete AE Form

Has the patient experienced thrombosis?                          No                Yes           Complete AE Form




Case Report Form date 04.12.2008
                              Patient Initials   |__|__|__|           Patient Number   |__|__|__|__|__|
    ITP 001
                              Center Number      |__|__|             Centre name


Follow-up week 90 after date of randomization (± 4 days) cont.                                                     Page 44




Concomitant Medication

Has there been any changes in the patients concomitant        No             Yes         Complete Concomitant
medication?                                                                                 Medication Form



Total dose of Prednisolone since last visit                               g



Visits to health care professional since randomization

Type of visit                                         Number of visits

Nurse (out-patient)

Physicians (out-patient) including this visit

                                                      Number of days)

Hospitalizations related to ITP

Hospitalizations not related to ITP



Days of sick leave since randomization:




Investigators signature:                                                                Date:




Case Report Form date 04.12.2008
                               Patient Initials    |__|__|__|      Patient Number   |__|__|__|__|__|
        ITP 001
                               Center Number       |__|__|        Centre name


   Follow-up (to be performed every 3 months after 18 months following randomization)                  Page 45


     Date of visit         Platelet                        Response                  Splenectomy
                            count                     (CR/PR/MR/Relapse)              perfomed?


  Day   Month    Year
|__|__|.|__|__|.|__|__|                  X109/L   CR  PR  MR  Relapse            Yes     No 

  Day   Month    Year
|__|__|.|__|__|.|__|__|                  X109/L   CR  PR  MR  Relapse            Yes     No 

  Day   Month    Year
|__|__|.|__|__|.|__|__|                  X109/L   CR  PR  MR  Relapse            Yes     No 

  Day   Month    Year
|__|__|.|__|__|.|__|__|                  X109/L   CR  PR  MR  Relapse            Yes     No 

  Day   Month    Year
|__|__|.|__|__|.|__|__|                  X109/L   CR  PR  MR  Relapse            Yes     No 

  Day   Month    Year
|__|__|.|__|__|.|__|__|                  X109/L   CR  PR  MR  Relapse            Yes     No 

  Day   Month    Year
|__|__|.|__|__|.|__|__|                  X109/L   CR  PR  MR  Relapse            Yes     No 

  Day   Month    Year
|__|__|.|__|__|.|__|__|                  X109/L   CR  PR  MR  Relapse            Yes     No 

  Day   Month    Year
|__|__|.|__|__|.|__|__|                  X109/L   CR  PR  MR  Relapse            Yes     No 

  Day   Month    Year
|__|__|.|__|__|.|__|__|                  X109/L   CR  PR  MR  Relapse            Yes     No 

  Day   Month    Year
|__|__|.|__|__|.|__|__|                  X109/L   CR  PR  MR  Relapse            Yes     No 

  Day   Month    Year
|__|__|.|__|__|.|__|__|                  X109/L   CR  PR  MR  Relapse            Yes     No 

  Day   Month    Year
|__|__|.|__|__|.|__|__|                  X109/L   CR  PR  MR  Relapse            Yes     No 

  Day   Month    Year
|__|__|.|__|__|.|__|__|                  X109/L   CR  PR  MR  Relapse            Yes     No 




   Case Report Form date 04.12.2008
                                  Patient Initials      |__|__|__|            Patient Number   |__|__|__|__|__|
    ITP 001
                                  Center Number         |__|__|            Centre name


END OF TRIAL                                                                                                        Page 46

                                                                                    Day    Month   Year
Date of last visit in the trial                                                   |__|__|.|__|__|.|__|__|

                                                                                    Day    Month   Year
If the patient received less than 4 infusions of study drug, please               |__|__|.|__|__|.|__|__|
specify date of last infusion of study drug


Why did the patient stopped the trial ?
                                                        Premature termination     
                                                     Splenectomy / End of trial   

In case of premature termination
     Please specify reason(s) (Please tick box):

1    Adverse event(s)        Please complete Adverse Event Form                   
2    Death                                                                        
3    Insufficient therapeutic response                                            
4    Refused treatment/did not cooperate                                          
5     Withdrawal of Informed consent                                              
6     Lost to follow up                                                           
7    Sponsor decision                                                             
8    Other reasons                                                                

     If other or Sponsor
     decision, Please specify:




Remission status at the End of Trial                    CR          PR          MR           No response     

Death

                                                                                    Day    Month   Year
If patient is dead, please specify date of death                                  |__|__|.|__|__|.|__|__|

Reason of death                                                                   ITP              
                                                                                  Other            
                                                                                  If “Other”, please specify:




Case Report Form date 04.12.2008
                             Patient Initials    |__|__|__|      Patient Number   |__|__|__|__|__|
    ITP 001
                             Center Number       |__|__|        Centre name


Bleeding score                                                                                       Page 47


                                                       Date
                       Age                           Points
> 65 years                                                 2
>75 years                                                  5
               Cutaneous bleeding
Localized petechial purpura (legs)                         1
Localized ecchymotic purpura                               2
2 locations of petechial purpura                           2
Generalized petechial purpura                              3
Generalized ecchymotic purpura                             4
                Mucosal bleeding
Unilateral epistaxis                                       2
Bilateral epistaxis                                        3
Hemorrhagic oral bullae, spontaneous gingival              5
bleeding or both
             Gastrointestinal bleeding
GI hemorrhage without anemia                               4
GI hemorrhage with acute anemia (>2 g Hb fall              15
in 24 hours) and/or shock
                 Urinary bleeding
Macroscopic hematuria without anemia                       4
Macroscopic hematuria with acute anemia                    10
         Genitourinary tract bleeding
Major meno/metrorrhagia without anemia                     4
Major meno/metrorrhagia with acute anemia                  10
      Central nervous system bleeding
CNS bleeding and /or life threatening bleeding             15
                                       Total score




Case Report Form date 04.12.2008
                            Patient Initials          |__|__|__|          Patient Number    |__|__|__|__|__|
    ITP 001
                            Center Number             |__|__|            Centre name


Platelet count and Prednisolon dose changes *                                                                             Page 48


*If you think that it can help the patient, please give the copy of this form to the patient. Please update
this form at each visit and at each time the prednisolon dose is modified


Sample collection date        Result           Unit        Prednisolon           Start date                Stop date
                                                           dose

  Day   Month    Year                                                         Day   Month     Year      Day    Month   Year
|__|__|.|__|__|.|__|__|                        x   109/L                    |__|__|.|__|__|.|__|__| |__|__|.|__|__|.|__|__|
  Day   Month    Year                                                         Day   Month     Year      Day    Month   Year
|__|__|.|__|__|.|__|__|                        x 109/L                      |__|__|.|__|__|.|__|__| |__|__|.|__|__|.|__|__|
  Day   Month    Year                                                         Day   Month     Year      Day    Month   Year
|__|__|.|__|__|.|__|__|                        x   109/L                    |__|__|.|__|__|.|__|__| |__|__|.|__|__|.|__|__|
  Day   Month    Year                                                         Day   Month     Year      Day    Month   Year
|__|__|.|__|__|.|__|__|                        x   109/L                    |__|__|.|__|__|.|__|__| |__|__|.|__|__|.|__|__|

  Day   Month    Year                                                         Day   Month     Year      Day    Month   Year
|__|__|.|__|__|.|__|__|                        x 109/L                      |__|__|.|__|__|.|__|__| |__|__|.|__|__|.|__|__|
  Day   Month    Year                                                         Day   Month     Year      Day    Month   Year
|__|__|.|__|__|.|__|__|                        x   109/L                    |__|__|.|__|__|.|__|__| |__|__|.|__|__|.|__|__|
  Day   Month    Year                                                         Day   Month     Year      Day    Month   Year
|__|__|.|__|__|.|__|__|                        x   109/L                    |__|__|.|__|__|.|__|__| |__|__|.|__|__|.|__|__|
  Day   Month    Year                                                         Day   Month     Year      Day    Month   Year
|__|__|.|__|__|.|__|__|                        x 109/L                      |__|__|.|__|__|.|__|__| |__|__|.|__|__|.|__|__|
  Day   Month    Year                                                         Day   Month     Year      Day    Month   Year
|__|__|.|__|__|.|__|__|                        x   109/L                    |__|__|.|__|__|.|__|__| |__|__|.|__|__|.|__|__|
  Day   Month    Year                                                         Day   Month     Year      Day    Month   Year
|__|__|.|__|__|.|__|__|                        x   109/L                    |__|__|.|__|__|.|__|__| |__|__|.|__|__|.|__|__|
  Day   Month    Year                                                         Day   Month     Year      Day    Month   Year
|__|__|.|__|__|.|__|__|                        x 109/L                      |__|__|.|__|__|.|__|__| |__|__|.|__|__|.|__|__|

  Day   Month    Year                                                         Day   Month     Year      Day    Month   Year
|__|__|.|__|__|.|__|__|                        x   109/L                    |__|__|.|__|__|.|__|__| |__|__|.|__|__|.|__|__|
  Day   Month    Year                                                         Day   Month     Year      Day    Month   Year
|__|__|.|__|__|.|__|__|                        x   109/L                    |__|__|.|__|__|.|__|__| |__|__|.|__|__|.|__|__|
  Day   Month    Year                                                         Day   Month     Year      Day    Month   Year
|__|__|.|__|__|.|__|__|                        x 109/L                      |__|__|.|__|__|.|__|__| |__|__|.|__|__|.|__|__|




Case Report Form date 04.12.2008
                            Patient Initials          |__|__|__|          Patient Number    |__|__|__|__|__|
    ITP 001
                            Center Number             |__|__|            Centre name




Platelet count and Prednisolon dose changes *                                                                            Page 49


*If you think that it can help the patient, please give the copy of this form to the patient. Please update
this form at each visit and at each time the prednisolon dose is modified


Sample collection date        Result           Unit        Prednisolon           Start date                Stop date
                                                           dose

  Day   Month    Year                                                         Day   Month     Year      Day    Month   Year
|__|__|.|__|__|.|__|__|                        x   109/L                    |__|__|.|__|__|.|__|__| |__|__|.|__|__|.|__|__|

  Day   Month    Year                                                         Day   Month     Year      Day    Month   Year
|__|__|.|__|__|.|__|__|                        x 109/L                      |__|__|.|__|__|.|__|__| |__|__|.|__|__|.|__|__|

  Day   Month    Year                                                         Day   Month     Year      Day    Month   Year
|__|__|.|__|__|.|__|__|                        x   109/L                    |__|__|.|__|__|.|__|__| |__|__|.|__|__|.|__|__|
  Day   Month    Year                                                         Day   Month     Year      Day    Month   Year
|__|__|.|__|__|.|__|__|                        x   109/L                    |__|__|.|__|__|.|__|__| |__|__|.|__|__|.|__|__|
  Day   Month    Year                                                         Day   Month     Year      Day    Month   Year
|__|__|.|__|__|.|__|__|                        x 109/L                      |__|__|.|__|__|.|__|__| |__|__|.|__|__|.|__|__|
  Day   Month    Year                                                         Day   Month     Year      Day    Month   Year
|__|__|.|__|__|.|__|__|                        x   109/L                    |__|__|.|__|__|.|__|__| |__|__|.|__|__|.|__|__|

  Day   Month    Year                                                         Day   Month     Year      Day    Month   Year
|__|__|.|__|__|.|__|__|                        x   109/L                    |__|__|.|__|__|.|__|__| |__|__|.|__|__|.|__|__|

  Day   Month    Year                                                         Day   Month     Year      Day    Month   Year
|__|__|.|__|__|.|__|__|                        x 109/L                      |__|__|.|__|__|.|__|__| |__|__|.|__|__|.|__|__|
  Day   Month    Year                                                         Day   Month     Year      Day    Month   Year
|__|__|.|__|__|.|__|__|                        x   109/L                    |__|__|.|__|__|.|__|__| |__|__|.|__|__|.|__|__|
  Day   Month    Year                                                         Day   Month     Year      Day    Month   Year
|__|__|.|__|__|.|__|__|                        x   109/L                    |__|__|.|__|__|.|__|__| |__|__|.|__|__|.|__|__|
  Day   Month    Year                                                         Day   Month     Year      Day    Month   Year
|__|__|.|__|__|.|__|__|                        x 109/L                      |__|__|.|__|__|.|__|__| |__|__|.|__|__|.|__|__|
  Day   Month    Year                                                         Day   Month     Year      Day    Month   Year
|__|__|.|__|__|.|__|__|                        x   109/L                    |__|__|.|__|__|.|__|__| |__|__|.|__|__|.|__|__|

  Day   Month    Year                                                         Day   Month     Year      Day    Month   Year
|__|__|.|__|__|.|__|__|                        x   109/L                    |__|__|.|__|__|.|__|__| |__|__|.|__|__|.|__|__|

  Day   Month    Year                                                         Day   Month     Year      Day    Month   Year
|__|__|.|__|__|.|__|__|                        x 109/L                      |__|__|.|__|__|.|__|__| |__|__|.|__|__|.|__|__|




Case Report Form date 04.12.2008
                            Patient Initials   |__|__|__|                Patient Number   |__|__|__|__|__|
   ITP 001
                            Center Number      |__|__|                  Centre name



CONCOMITANT MEDICATION                                                                                           Page 50


Medication given for an adverse event should be recorded on the appropriate “Adverse Event” page.
Prednisolon treatment and IVIG treatment should be recorded on separate forms

        Drug                           Dose              Start (Date)          Stop (Date)            Ongoing    Indication

  1.                                                                                                         

  2.                                                                                                         

  3.                                                                                                         

  4.                                                                                                         

  5.                                                                                                         

  6.                                                                                                         

  7.                                                                                                         

  8.                                                                                                         

  9.                                                                                                         

  10.                                                                                                        

  11.                                                                                                        

  12.                                                                                                        




Case Report Form date 04.12.2008
                            Patient Initials   |__|__|__|                Patient Number   |__|__|__|__|__|
   ITP 001
                            Center Number      |__|__|                  Centre name



IVIG Dosage Form                                                                                                 Page 51



Please report all IVIG treatment

        Drug                           Dose              Start (Date)          Stop (Date)            Ongoing

  1.    IVIG                                                                                                 

  2.    IVIG                                                                                                 

  3.    IVIG                                                                                                 

  4.    IVIG                                                                                                 

  5.    IVIG                                                                                                 

  6.    IVIG                                                                                                 

  7.    IVIG                                                                                                 

  8.    IVIG                                                                                                 

  9.    IVIG                                                                                                 

  10.   IVIG                                                                                                 

  11.   IVIG                                                                                                 

  12.   IVIG                                                                                                 

  13.   IVIG                                                                                                 

  14.   IVIG                                                                                                 

  15.   IVIG                                                                                                 

  16.   IVIG                                                                                                 

  17.   IVIG                                                                                                 
  18.   IVIG                                                                                                 
  19.   IVIG                                                                                                 
  20.   IVIG                                                                                                 




Case Report Form date 04.12.2008
                               Patient Initials           |__|__|__|            Patient Number     |__|__|__|__|__|
    ITP 001
                               Center Number              |__|__|              Centre name


Splenectomy Form                                                                                                          Page 52


NB! Bleeding score should be performed between the date of decision of doing splenectomy and the
date of surgery

                                     Day    Month         Year
Date of splenectomy:               |__|__|.|__|__|.|__|__|

Reason for Splenectomy                                      Platelet count ≤ 20 x 109/L                               
                                                            Daily dose of prednisone/prednisolone ≥ 7,5 mg            
                                                            Other                                                     
                                                            If “Other”, please specify:




Haematology
Platelet count when the patient met criteria for splenectomy

                                           Day      Month        Year          Results

Assessment date:                        |__|__|.|__|__|.|__|__|                                   x 109/L

Platelet count at day of                                                                          x 109/L
splenectomy


                                                                                   Day    Month     Year
Date of administration of pneumococcal vaccine                                  |__|__|.|__|__|.|__|__|


Type of procedure

Laparascopic                                      Laparatomy                  

Hospital admission for splenectomy
                                                    Day     Month       Year
Date of admission in hospital:                    |__|__|.|__|__|.|__|__|
                                                    Day     Month       Year
Date of discharge from hospital:                  |__|__|.|__|__|.|__|__|


Intensive Care Unit (ICU)
                                                    Day     Month       Year
Date of admission in ICU:                         |__|__|.|__|__|.|__|__|
                                                    Day     Month       Year
Date of discharge from ICU:                       |__|__|.|__|__|.|__|__|




Case Report Form date 04.12.2008
                              Patient Initials         |__|__|__|                 Patient Number   |__|__|__|__|__|
    ITP 001
                              Center Number            |__|__|                Centre name


Splenectomy Form (cont.)                                                                                                     Page 53


Transfusion requirement

Number of transfusions during admission

SAG (Blood units):                ___________

Platelet consentrates:            ____________



Complications related to splenectomy during hospitalization

Reoperation          No        Yes             if yes please complete AE form




Bleeding             No        Yes             if yes please complete AE form




Infection            No        Yes             if yes please complete AE form




Other                No        Yes             if yes please complete AE form




Bleeding

Has the patient experienced bleeding        No                              Yes  
including mucocutaneous bleeding

Petechiae                                  Mild blood loss                 Gross blood loss            Debilitating blood loss   
If yes, please also complete the Bleeding score,                                   Total bleeding score
page?




     Investigators signature:                                                            Date:




Case Report Form date 04.12.2008
                                Patient Initials          |__|__|__|                Patient Number   |__|__|__|__|__|
    ITP 001
                                Center Number             |__|__|                  Centre name


Day 90 after Splenectomy                                                                                                         Page 54

                                        Day   Month       Year
Date of visit:                      |__|__|.|__|__|.|__|__|



Haematology
                                  Day     Month       Year
Assessment date:                |__|__|.|__|__|.|__|__|

                                                     Results                                Unit

Platelet count                                                                       x 109/L


Response evaluation

Has the patient had response to splenectomy?                            No          Yes           If yes:   CR      PR      MR   
Has the patient relapsed following an initial response?
                                                                        No          Yes           If yes, duration of response: _________weeks



Pneumococcal vaccine titre
                            Day    Month      Year
Assessment date:          |__|__|.|__|__|.|__|__|
Titre                     _____ Unit/mL
Low                       
Intermediate              
High                      


Complications related to splenectomy during 90 days after surgery (not previously reported)

Reoperation          No          Yes             If yes, please cmplete AE form




Bleeding             No          Yes             If yes, please cmplete AE form




Infection            No          Yes             If yes, please cmplete AE form




Other                No          Yes             If yes please cmplete AE form




     Investigators signature:                                                               Date:




Case Report Form date 04.12.2008
                                Patient Initials         |__|__|__|          Patient Number   |__|__|__|__|__|
    ITP 001
                                Center Number            |__|__|            Centre name


ADVERSE EVENT (including intercurrent illnesses)                                                                          Page 55

Please record only one event on this page
Is this a serious adverse event?        Yes           If yes, please complete Serious Adverse Event (SAE) reporting form
                                        No    
Adverse event or intercurrent illness

INITIAL ASSESSMENT
Date of onset:       ____/____/____                Initial intensity:        Mild                          Severe    
                                                                         Moderate                 Life threatening   
FINAL ASSESSMENT (please complete when event ceased or at study end)

AE ongoing?               Yes                No           Date ceased:    ____/____/____
Most Severe Intensity:
                     Mild       
                Moderate        
                  Severe        
         Life threatening       
Action(s) taken for event (tick all that apply):
                      None     
             Dose reduced       enter details in study medication section
        Drug discontinued       enter details in study medication section
           Drug interrupted     enter details in study medication section
           Treatment given      please see below
                      Other     please specify:
Outcome:
    Resolved - no sequela       
   Resolved - with sequela      
               Unresolved       
                     Death      
Relation to trial drug:
                Unrelated       
                  Remote        
                 Possible       
                 Probable       
           Not assessable       
Comments on AE: ___________________________________________________________________________

__________________________________________________________________________________________
TREATMENT FOR THIS EVENT*
Treatment                                                      Start date       End date
(generic name for drugs)                                    Day Month Year   Day Month Year
                                                                              ____/____/____       ____/____/____

                                                                              ____/____/____       ____/____/____

                                                                              ____/____/____       ____/____/____




Case Report Form date 04.12.2008
                                Patient Initials         |__|__|__|          Patient Number   |__|__|__|__|__|
    ITP 001
                                Center Number            |__|__|            Centre name


ADVERSE EVENT (including intercurrent illnesses)                                                                          Page 56

Please record only one event on this page
Is this a serious adverse event?        Yes           If yes, please complete Serious Adverse Event (SAE) reporting form
                                        No    
Adverse event or intercurrent illness

INITIAL ASSESSMENT
Date of onset:       ____/____/____                Initial intensity:        Mild                          Severe    
                                                                         Moderate                 Life threatening   
FINAL ASSESSMENT (please complete when event ceased or at study end)

AE ongoing?               Yes                No           Date ceased:    ____/____/____
Most Severe Intensity:
                     Mild       
                Moderate        
                  Severe        
         Life threatening       
Action(s) taken for event (tick all that apply):
                      None     
             Dose reduced       enter details in study medication section
        Drug discontinued       enter details in study medication section
           Drug interrupted     enter details in study medication section
           Treatment given      please see below
                      Other     please specify:
Outcome:
    Resolved - no sequela       
   Resolved - with sequela      
               Unresolved       
                     Death      
Relation to trial drug:
                Unrelated       
                  Remote        
                 Possible       
                 Probable       
           Not assessable       
Comments on AE: ___________________________________________________________________________

__________________________________________________________________________________________
TREATMENT FOR THIS EVENT*
Treatment                                                      Start date       End date
(generic name for drugs)                                    Day Month Year   Day Month Year
                                                                              ____/____/____       ____/____/____

                                                                              ____/____/____       ____/____/____

                                                                              ____/____/____       ____/____/____




Case Report Form date 04.12.2008
                                Patient Initials         |__|__|__|          Patient Number   |__|__|__|__|__|
    ITP 001
                                Center Number            |__|__|            Centre name


ADVERSE EVENT (including intercurrent illnesses)                                                                          Page 57

Please record only one event on this page
Is this a serious adverse event?        Yes           If yes, please complete Serious Adverse Event (SAE) reporting form
                                        No    
Adverse event or intercurrent illness

INITIAL ASSESSMENT
Date of onset:       ____/____/____                Initial intensity:        Mild                          Severe    
                                                                         Moderate                 Life threatening   
FINAL ASSESSMENT (please complete when event ceased or at study end)

AE ongoing?               Yes                No           Date ceased:    ____/____/____
Most Severe Intensity:
                     Mild       
                Moderate        
                  Severe        
         Life threatening       
Action(s) taken for event (tick all that apply):
                      None     
             Dose reduced       enter details in study medication section
        Drug discontinued       enter details in study medication section
           Drug interrupted     enter details in study medication section
           Treatment given      please see below
                      Other     please specify:
Outcome:
    Resolved - no sequela       
   Resolved - with sequela      
               Unresolved       
                     Death      
Relation to trial drug:
                Unrelated       
                  Remote        
                 Possible       
                 Probable       
           Not assessable       
Comments on AE: ___________________________________________________________________________

__________________________________________________________________________________________
TREATMENT FOR THIS EVENT*
Treatment                                                      Start date       End date
(generic name for drugs)                                    Day Month Year   Day Month Year
                                                                              ____/____/____       ____/____/____

                                                                              ____/____/____       ____/____/____

                                                                              ____/____/____       ____/____/____




Case Report Form date 04.12.2008
                                Patient Initials         |__|__|__|          Patient Number   |__|__|__|__|__|
    ITP 001
                                Center Number            |__|__|            Centre name


ADVERSE EVENT (including intercurrent illnesses)                                                                          Page 58

Please record only one event on this page
Is this a serious adverse event?        Yes           If yes, please complete Serious Adverse Event (SAE) reporting form
                                        No    
Adverse event or intercurrent illness

INITIAL ASSESSMENT
Date of onset:       ____/____/____                Initial intensity:        Mild                          Severe    
                                                                         Moderate                 Life threatening   
FINAL ASSESSMENT (please complete when event ceased or at study end)

AE ongoing?               Yes                No           Date ceased:    ____/____/____
Most Severe Intensity:
                     Mild       
                Moderate        
                  Severe        
         Life threatening       
Action(s) taken for event (tick all that apply):
                      None     
             Dose reduced       enter details in study medication section
        Drug discontinued       enter details in study medication section
           Drug interrupted     enter details in study medication section
           Treatment given      please see below
                      Other     please specify:
Outcome:
    Resolved - no sequela       
   Resolved - with sequela      
               Unresolved       
                     Death      
Relation to trial drug:
                Unrelated       
                  Remote        
                 Possible       
                 Probable       
           Not assessable       
Comments on AE: ___________________________________________________________________________

__________________________________________________________________________________________
TREATMENT FOR THIS EVENT*
Treatment                                                      Start date       End date
(generic name for drugs)                                    Day Month Year   Day Month Year
                                                                              ____/____/____       ____/____/____

                                                                              ____/____/____       ____/____/____

                                                                              ____/____/____       ____/____/____




Case Report Form date 04.12.2008
                                Patient Initials         |__|__|__|          Patient Number   |__|__|__|__|__|
    ITP 001
                                Center Number            |__|__|            Centre name


ADVERSE EVENT (including intercurrent illnesses)                                                                          Page 59

Please record only one event on this page
Is this a serious adverse event?        Yes           If yes, please complete Serious Adverse Event (SAE) reporting form
                                        No    
Adverse event or intercurrent illness

INITIAL ASSESSMENT
Date of onset:       ____/____/____                Initial intensity:        Mild                          Severe    
                                                                         Moderate                 Life threatening   
FINAL ASSESSMENT (please complete when event ceased or at study end)

AE ongoing?               Yes                No           Date ceased:    ____/____/____
Most Severe Intensity:
                     Mild       
                Moderate        
                  Severe        
         Life threatening       
Action(s) taken for event (tick all that apply):
                      None     
             Dose reduced       enter details in study medication section
        Drug discontinued       enter details in study medication section
           Drug interrupted     enter details in study medication section
           Treatment given      please see below
                      Other     please specify:
Outcome:
    Resolved - no sequela       
   Resolved - with sequela      
               Unresolved       
                     Death      
Relation to trial drug:
                Unrelated       
                  Remote        
                 Possible       
                 Probable       
           Not assessable       
Comments on AE: ___________________________________________________________________________

__________________________________________________________________________________________
TREATMENT FOR THIS EVENT*
Treatment                                                      Start date       End date
(generic name for drugs)                                    Day Month Year   Day Month Year
                                                                              ____/____/____       ____/____/____

                                                                              ____/____/____       ____/____/____

                                                                              ____/____/____       ____/____/____




Case Report Form date 04.12.2008
                                Patient Initials         |__|__|__|          Patient Number   |__|__|__|__|__|
    ITP 001
                                Center Number            |__|__|            Centre name


ADVERSE EVENT (including intercurrent illnesses)                                                                          Page 60

Please record only one event on this page
Is this a serious adverse event?        Yes           If yes, please complete Serious Adverse Event (SAE) reporting form
                                        No    
Adverse event or intercurrent illness

INITIAL ASSESSMENT
Date of onset:       ____/____/____                Initial intensity:        Mild                          Severe    
                                                                         Moderate                 Life threatening   
FINAL ASSESSMENT (please complete when event ceased or at study end)

AE ongoing?               Yes                No           Date ceased:    ____/____/____
Most Severe Intensity:
                     Mild       
                Moderate        
                  Severe        
         Life threatening       
Action(s) taken for event (tick all that apply):
                      None     
             Dose reduced       enter details in study medication section
        Drug discontinued       enter details in study medication section
           Drug interrupted     enter details in study medication section
           Treatment given      please see below
                      Other     please specify:
Outcome:
    Resolved - no sequela       
   Resolved - with sequela      
               Unresolved       
                     Death      
Relation to trial drug:
                Unrelated       
                  Remote        
                 Possible       
                 Probable       
           Not assessable       
Comments on AE: ___________________________________________________________________________

__________________________________________________________________________________________
TREATMENT FOR THIS EVENT*
Treatment                                                      Start date       End date
(generic name for drugs)                                    Day Month Year   Day Month Year
                                                                              ____/____/____       ____/____/____

                                                                              ____/____/____       ____/____/____

                                                                              ____/____/____       ____/____/____




Case Report Form date 04.12.2008
                                Patient Initials         |__|__|__|          Patient Number   |__|__|__|__|__|
    ITP 001
                                Center Number            |__|__|            Centre name


ADVERSE EVENT (including intercurrent illnesses)                                                                          Page 61

Please record only one event on this page
Is this a serious adverse event?        Yes           If yes, please complete Serious Adverse Event (SAE) reporting form
                                        No    
Adverse event or intercurrent illness

INITIAL ASSESSMENT
Date of onset:       ____/____/____                Initial intensity:        Mild                          Severe    
                                                                         Moderate                 Life threatening   
FINAL ASSESSMENT (please complete when event ceased or at study end)

AE ongoing?               Yes                No           Date ceased:    ____/____/____
Most Severe Intensity:
                     Mild       
                Moderate        
                  Severe        
         Life threatening       
Action(s) taken for event (tick all that apply):
                      None     
             Dose reduced       enter details in study medication section
        Drug discontinued       enter details in study medication section
           Drug interrupted     enter details in study medication section
           Treatment given      please see below
                      Other     please specify:
Outcome:
    Resolved - no sequela       
   Resolved - with sequela      
               Unresolved       
                     Death      
Relation to trial drug:
                Unrelated       
                  Remote        
                 Possible       
                 Probable       
           Not assessable       
Comments on AE: ___________________________________________________________________________

__________________________________________________________________________________________
TREATMENT FOR THIS EVENT*
Treatment                                                      Start date       End date
(generic name for drugs)                                    Day Month Year   Day Month Year
                                                                              ____/____/____       ____/____/____

                                                                              ____/____/____       ____/____/____

                                                                              ____/____/____       ____/____/____




Case Report Form date 04.12.2008
                                Patient Initials         |__|__|__|          Patient Number   |__|__|__|__|__|
    ITP 001
                                Center Number            |__|__|            Centre name


ADVERSE EVENT (including intercurrent illnesses)                                                                          Page 62

Please record only one event on this page
Is this a serious adverse event?        Yes           If yes, please complete Serious Adverse Event (SAE) reporting form
                                        No    
Adverse event or intercurrent illness

INITIAL ASSESSMENT
Date of onset:       ____/____/____                Initial intensity:        Mild                          Severe    
                                                                         Moderate                 Life threatening   
FINAL ASSESSMENT (please complete when event ceased or at study end)

AE ongoing?               Yes                No           Date ceased:    ____/____/____
Most Severe Intensity:
                     Mild       
                Moderate        
                  Severe        
         Life threatening       
Action(s) taken for event (tick all that apply):
                      None     
             Dose reduced       enter details in study medication section
        Drug discontinued       enter details in study medication section
           Drug interrupted     enter details in study medication section
           Treatment given      please see below
                      Other     please specify:
Outcome:
    Resolved - no sequela       
   Resolved - with sequela      
               Unresolved       
                     Death      
Relation to trial drug:
                Unrelated       
                  Remote        
                 Possible       
                 Probable       
           Not assessable       
Comments on AE: ___________________________________________________________________________

__________________________________________________________________________________________
TREATMENT FOR THIS EVENT*
Treatment                                                      Start date       End date
(generic name for drugs)                                    Day Month Year   Day Month Year
                                                                              ____/____/____       ____/____/____

                                                                              ____/____/____       ____/____/____

                                                                              ____/____/____       ____/____/____




Case Report Form date 04.12.2008
                                Patient Initials         |__|__|__|          Patient Number   |__|__|__|__|__|
    ITP 001
                                Center Number            |__|__|            Centre name


ADVERSE EVENT (including intercurrent illnesses)                                                                          Page 63

Please record only one event on this page
Is this a serious adverse event?        Yes           If yes, please complete Serious Adverse Event (SAE) reporting form
                                        No    
Adverse event or intercurrent illness

INITIAL ASSESSMENT
Date of onset:       ____/____/____                Initial intensity:        Mild                          Severe    
                                                                         Moderate                 Life threatening   
FINAL ASSESSMENT (please complete when event ceased or at study end)

AE ongoing?               Yes                No           Date ceased:    ____/____/____
Most Severe Intensity:
                     Mild       
                Moderate        
                  Severe        
         Life threatening       
Action(s) taken for event (tick all that apply):
                      None     
             Dose reduced       enter details in study medication section
        Drug discontinued       enter details in study medication section
           Drug interrupted     enter details in study medication section
           Treatment given      please see below
                      Other     please specify:
Outcome:
    Resolved - no sequela       
   Resolved - with sequela      
               Unresolved       
                     Death      
Relation to trial drug:
                Unrelated       
                  Remote        
                 Possible       
                 Probable       
           Not assessable       
Comments on AE: ___________________________________________________________________________

__________________________________________________________________________________________
TREATMENT FOR THIS EVENT*
Treatment                                                      Start date       End date
(generic name for drugs)                                    Day Month Year   Day Month Year
                                                                              ____/____/____       ____/____/____

                                                                              ____/____/____       ____/____/____

                                                                              ____/____/____       ____/____/____




Case Report Form date 04.12.2008
                                Patient Initials         |__|__|__|          Patient Number   |__|__|__|__|__|
    ITP 001
                                Center Number            |__|__|            Centre name


ADVERSE EVENT (including intercurrent illnesses)                                                                          Page 64

Please record only one event on this page
Is this a serious adverse event?        Yes           If yes, please complete Serious Adverse Event (SAE) reporting form
                                        No    
Adverse event or intercurrent illness

INITIAL ASSESSMENT
Date of onset:       ____/____/____                Initial intensity:        Mild                          Severe    
                                                                         Moderate                 Life threatening   
FINAL ASSESSMENT (please complete when event ceased or at study end)

AE ongoing?               Yes                No           Date ceased:    ____/____/____
Most Severe Intensity:
                     Mild       
                Moderate        
                  Severe        
         Life threatening       
Action(s) taken for event (tick all that apply):
                      None     
             Dose reduced       enter details in study medication section
        Drug discontinued       enter details in study medication section
           Drug interrupted     enter details in study medication section
           Treatment given      please see below
                      Other     please specify:
Outcome:
    Resolved - no sequela       
   Resolved - with sequela      
               Unresolved       
                     Death      
Relation to trial drug:
                Unrelated       
                  Remote        
                 Possible       
                 Probable       
           Not assessable       
Comments on AE: ___________________________________________________________________________

__________________________________________________________________________________________
TREATMENT FOR THIS EVENT*
Treatment                                                      Start date       End date
(generic name for drugs)                                    Day Month Year   Day Month Year
                                                                              ____/____/____       ____/____/____

                                                                              ____/____/____       ____/____/____

                                                                              ____/____/____       ____/____/____




Case Report Form date 04.12.2008