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ID
22127
Beschrijving
Study part: Study termination physical examination. A phase III multinational, randomized, single-blind study of recombinant humanized anti-p185HER2 monoclonal antibody (rhuMAb HER2) in patients with HER2/neu overexpression who have not received prior cytotoxic chemotherapy for metastatic breast cancer. "Terms of use: You may not use this document or the information contained herein to a regulatory authority in connection with an application for a marketing authorization or any other regulatory submission without the express written consent of Roche"
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- 20-05-17 20-05-17 -
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Roche
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20 mei 2017
DOI
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Creative Commons BY-NC 3.0
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STUDY TERMINATION PHYSICAL EXAMINATION Roche H0650g Breast Cancer
STUDY TERMINATION PHYSICAL EXAMINATION
- StudyEvent: ODM
Similar models
STUDY TERMINATION PHYSICAL EXAMINATION
- StudyEvent: ODM
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Patient initial
Item
PATIENT INT.
text
C2986440 (UMLS CUI [1])
Patient id
Item
PATIENT NUMBER
integer
C2348585 (UMLS CUI [1])
DATE OF EXAMINATION
Item
DATE OF EXAMINATION
date
C2826643 (UMLS CUI [1])
WEIGHT
Item
WEIGHT
float
C0005910 (UMLS CUI [1])
WEIGHT
Item
WEIGHT
float
C0005910 (UMLS CUI [1])
TEMPERATURE
Item
TEMPERATURE
float
C0039476 (UMLS CUI [1])
TEMPERATURE
Item
TEMPERATURE
float
C0039476 (UMLS CUI [1])
SYSTOLIC BLOOD PRESSURE
Item
SYSTOLIC BLOOD PRESSURE
integer
C0871470 (UMLS CUI [1])
Diastolic blood pressure
Item
DIASTOLIC BLOOD PRESSURE
integer
C0428883 (UMLS CUI [1])
Heart rate
Item
HR
integer
C0018810 (UMLS CUI [1])
respiratory rate
Item
RR
integer
C0231832 (UMLS CUI [1])
CL Item
NORMAL (1)
CL Item
ABNORMAL (2)
CL Item
NOT DONE (3)
description
Item
1. IF ABNORMAL, DESCRIBE:
text
C0678257 (UMLS CUI [1])
finding adverse event
Item
1. FINDING IS AN AE?
boolean
C0243095 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C0877248 (UMLS CUI [1,2])
CL Item
NORMAL (1)
CL Item
ABNORMAL (2)
CL Item
NOT DONE (3)
description
Item
2. IF ABNORMAL, DESCRIBE:
text
C0678257 (UMLS CUI [1])
finding adverse event
Item
2. FINDING IS AN AE?
boolean
C0243095 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C0877248 (UMLS CUI [1,2])
CL Item
NORMAL (1)
CL Item
ABNORMAL (2)
CL Item
NOT DONE (3)
description
Item
3. IF ABNORMAL, DESCRIBE:
text
C0678257 (UMLS CUI [1])
finding adverse event
Item
3. FINDING IS AN AE?
boolean
C0243095 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C0877248 (UMLS CUI [1,2])
CL Item
NORMAL (1)
CL Item
ABNORMAL (2)
CL Item
NOT DONE (3)
description
Item
4. IF ABNORMAL, DESCRIBE:
text
C0678257 (UMLS CUI [1])
finding adverse event
Item
4. FINDING IS AN AE?
boolean
C0243095 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C0877248 (UMLS CUI [1,2])
CL Item
NORMAL (1)
CL Item
ABNORMAL (2)
CL Item
NOT DONE (3)
description
Item
5. IF ABNORMAL, DESCRIBE:
text
C0678257 (UMLS CUI [1])
finding adverse event
Item
5. FINDING IS AN AE?
boolean
C0243095 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C0877248 (UMLS CUI [1,2])
CL Item
NORMAL (1)
CL Item
ABNORMAL (2)
CL Item
NOT DONE (3)
description
Item
6. IF ABNORMAL, DESCRIBE:
text
C0678257 (UMLS CUI [1])
finding adverse event
Item
6. FINDING IS AN AE?
boolean
C0243095 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C0877248 (UMLS CUI [1,2])
CL Item
NORMAL (1)
CL Item
ABNORMAL (2)
CL Item
NOT DONE (3)
description
Item
7. IF ABNORMAL, DESCRIBE:
text
C0678257 (UMLS CUI [1])
finding adverse event
Item
7. FINDING IS AN AE?
boolean
C0243095 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C0877248 (UMLS CUI [1,2])
CL Item
NORMAL (1)
CL Item
ABNORMAL (2)
CL Item
NOT DONE (3)
description
Item
8. IF ABNORMAL, DESCRIBE:
text
C0678257 (UMLS CUI [1])
finding adverse event
Item
8. FINDING IS AN AE?
boolean
C0243095 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C0877248 (UMLS CUI [1,2])
CL Item
NORMAL (1)
CL Item
ABNORMAL (2)
CL Item
NOT DONE (3)
description
Item
9. IF ABNORMAL, DESCRIBE:
text
C0678257 (UMLS CUI [1])
finding adverse event
Item
9. FINDING IS AN AE?
boolean
C0243095 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C0877248 (UMLS CUI [1,2])
CL Item
NORMAL (1)
CL Item
ABNORMAL (2)
CL Item
NOT DONE (3)
description
Item
10. IF ABNORMAL, DESCRIBE:
text
C0678257 (UMLS CUI [1])
finding adverse event
Item
10. FINDING IS AN AE?
boolean
C0243095 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C0877248 (UMLS CUI [1,2])
CL Item
NORMAL (1)
CL Item
ABNORMAL (2)
CL Item
NOT DONE (3)
description
Item
11. IF ABNORMAL, DESCRIBE:
text
C0678257 (UMLS CUI [1])
finding adverse event
Item
11. FINDING IS AN AE?
boolean
C0243095 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C0877248 (UMLS CUI [1,2])
CL Item
NORMAL (1)
CL Item
ABNORMAL (2)
CL Item
NOT DONE (3)
description
Item
12. IF ABNORMAL, DESCRIBE:
text
C0678257 (UMLS CUI [1])
finding adverse event
Item
12. FINDING IS AN AE?
boolean
C0243095 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C0877248 (UMLS CUI [1,2])