ID

22019

Description

Study part: Medical History. 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"

Keywords

Versions (1)
  1. 5/14/17 5/14/17 -
Copyright Holder

Roche

Uploaded on

May 14, 2017

DOI

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License

Creative Commons BY-NC 3.0
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MEDICAL HISTORY Roche H0650g Breast Cancer

English

MEDICAL HISTORY

1 forms  
  1. StudyEvent: ODM
    1. MEDICAL HISTORY
MEDICAL HISTORY (OTHER THAN BREAST CANCER)
Description

MEDICAL HISTORY (OTHER THAN BREAST CANCER)

Alias
UMLS CUI-1
C0262926
PATIENT INT.
Description

Patient initial

Data type

text

Alias
UMLS CUI [1]
C2986440
PATIENT NUMBER
Description

Patient id

Data type

integer

Alias
UMLS CUI [1]
C2348585
IS PATIENT ALLERGIC TO ANY MEDICATION?
Description

Hypersensitivity drugs

Data type

text

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0013227
IF YES, LIST MEDICATION(S).
Description

Medication name

Data type

text

Alias
UMLS CUI [1]
C2360065
ACTIVE INTERCURRENT ILLNESSES (other than breast cancer)
Description

ACTIVE INTERCURRENT ILLNESSES (other than breast cancer)

Alias
UMLS CUI-1
C0012634
ACTIVE INTERCURRENT ILLNESSES (other than breast cancer) -NONE
Description

disease present

Data type

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0150312
ACTIVE INTERCURRENT ILLNESSES (other than breast cancer)
Description

disease present

Data type

text

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0150312
DATE OF DIAGNOSIS
Description

date of diagnosis

Data type

date

Alias
UMLS CUI [1]
C2316983
PAST MAJOR SURGERIES AND PAST MAJOR ILLNESSES
Description

PAST MAJOR SURGERIES AND PAST MAJOR ILLNESSES

Alias
UMLS CUI-1
C0744961
UMLS CUI-2
C0012634
UMLS CUI-3
C0205156
PAST MAJOR SURGERIES AND PAST MAJOR ILLNESSES
Description

history of prior surgery; disease Previous

Data type

text

Alias
UMLS CUI [1,1]
C0744961
UMLS CUI [1,2]
C0012634
UMLS CUI [1,3]
C0205156
PAST MAJOR SURGERIES AND PAST MAJOR ILLNESSES
Description

history of prior surgery; disease Previous

Data type

text

Alias
UMLS CUI [1,1]
C0744961
UMLS CUI [1,2]
C0012634
UMLS CUI [1,3]
C0205156
DATE OF SURGERY/ILLNESS
Description

date surgery; date of diagnosis

Data type

date

Alias
UMLS CUI [1]
C1628561
UMLS CUI [2]
C2316983
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Similar models

MEDICAL HISTORY

1 forms
  1. StudyEvent: ODM
    1. MEDICAL HISTORY
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
MEDICAL HISTORY (OTHER THAN BREAST CANCER)
C0262926 (UMLS CUI-1)
Patient initial
Item
PATIENT INT.
text
C2986440 (UMLS CUI [1])
Patient id
Item
PATIENT NUMBER
integer
C2348585 (UMLS CUI [1])
Item
IS PATIENT ALLERGIC TO ANY MEDICATION?
text
C0020517 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
Hypersensitivity drugs
Code List
IS PATIENT ALLERGIC TO ANY MEDICATION?
CL Item
YES (YES)
CL Item
NO (NO)
CL Item
UNKNOWN (UNKNOWN)
Medication name
Item
IF YES, LIST MEDICATION(S).
text
C2360065 (UMLS CUI [1])
Item Group
ACTIVE INTERCURRENT ILLNESSES (other than breast cancer)
C0012634 (UMLS CUI-1)
disease present
Item
ACTIVE INTERCURRENT ILLNESSES (other than breast cancer) -NONE
boolean
C0012634 (UMLS CUI [1,1])
C0150312 (UMLS CUI [1,2])
disease present
Item
ACTIVE INTERCURRENT ILLNESSES (other than breast cancer)
text
C0012634 (UMLS CUI [1,1])
C0150312 (UMLS CUI [1,2])
date of diagnosis
Item
DATE OF DIAGNOSIS
date
C2316983 (UMLS CUI [1])
Item Group
PAST MAJOR SURGERIES AND PAST MAJOR ILLNESSES
C0744961 (UMLS CUI-1)
C0012634 (UMLS CUI-2)
C0205156 (UMLS CUI-3)
Item
PAST MAJOR SURGERIES AND PAST MAJOR ILLNESSES
text
C0744961 (UMLS CUI [1,1])
C0012634 (UMLS CUI [1,2])
C0205156 (UMLS CUI [1,3])
history of prior surgery; disease Previous
Code List
PAST MAJOR SURGERIES AND PAST MAJOR ILLNESSES
CL Item
NONE  (NONE )
CL Item
UNKNOWN (UNKNOWN)
history of prior surgery; disease Previous
Item
PAST MAJOR SURGERIES AND PAST MAJOR ILLNESSES
text
C0744961 (UMLS CUI [1,1])
C0012634 (UMLS CUI [1,2])
C0205156 (UMLS CUI [1,3])
date surgery; date of diagnosis
Item
DATE OF SURGERY/ILLNESS
date
C1628561 (UMLS CUI [1])
C2316983 (UMLS CUI [2])
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