ID

22135

Description

Study part: Patient death report. 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. 5/20/17 5/20/17 -
Copyright Holder

Roche

Uploaded on

May 20, 2017

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License

Creative Commons BY-NC 3.0
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PATIENT DEATH REPORT Roche H0650g Breast Cancer

English

PATIENT DEATH REPORT

1 forms  
  1. StudyEvent: ODM
    1. PATIENT DEATH REPORT
PATIENT DEATH REPORT
Description

PATIENT DEATH REPORT

Alias
UMLS CUI-1
C0011065
UMLS CUI-2
C1516308
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]
C1269815
DATE OF DEATH:
Description

DATE OF DEATH

Data type

date

Alias
UMLS CUI [1]
C1148348
PRIMARY CAUSE OF DEATH:
Description

cause of death

Data type

text

Alias
UMLS CUI [1]
C0007465
PROVIDE DETAILS:
Description

cause of death

Data type

text

Alias
UMLS CUI [1]
C0007465
RELATIONSHIP OF DEATH TO STUDY DRUG
Description

cause of death study drug

Data type

integer

Alias
UMLS CUI [1,1]
C0007465
UMLS CUI [1,2]
C0304229
RELATIONSHIP OF DEATH TO DISEASE
Description

Cause of Death disease

Data type

integer

Alias
UMLS CUI [1,1]
C0007465
UMLS CUI [1,2]
C0012634
AUTOPSY PERFORMED?
Description

AUTOPSY

Data type

boolean

Alias
UMLS CUI [1]
C0004398
IF YES
Description

AUTOPSY

Data type

integer

Alias
UMLS CUI [1]
C0004398
I HAVE REVIEWED ALL RELEVANT DATA AND AGREE WITH THE ASSESSMENTS PROVIDED.
Description

consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
SIGNATURE OF PRINCIPAL INVESTIGATOR
Description

SIGNATURE OF INVESTIGATOR

Data type

text

Alias
UMLS CUI [1]
C2826892
DATE
Description

DATE

Data type

date

Alias
UMLS CUI [1]
C0011008
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Similar models

PATIENT DEATH REPORT

1 forms
  1. StudyEvent: ODM
    1. PATIENT DEATH REPORT
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
PATIENT DEATH REPORT
C0011065 (UMLS CUI-1)
C1516308 (UMLS CUI-2)
Patient initial
Item
PATIENT INT.
text
C2986440 (UMLS CUI [1])
Patient id
Item
PATIENT NUMBER
integer
C1269815 (UMLS CUI [1])
DATE OF DEATH
Item
DATE OF DEATH:
date
C1148348 (UMLS CUI [1])
cause of death
Item
PRIMARY CAUSE OF DEATH:
text
C0007465 (UMLS CUI [1])
cause of death
Item
PROVIDE DETAILS:
text
C0007465 (UMLS CUI [1])
Item
RELATIONSHIP OF DEATH TO STUDY DRUG
integer
C0007465 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
study drug
Code List
RELATIONSHIP OF DEATH TO STUDY DRUG
CL Item
NOT RELATED  (1)
CL Item
POSSIBLE (2)
CL Item
PROBABLE (3)
Item
RELATIONSHIP OF DEATH TO DISEASE
integer
C0007465 (UMLS CUI [1,1])
C0012634 (UMLS CUI [1,2])
study drug
Code List
RELATIONSHIP OF DEATH TO DISEASE
CL Item
NOT RELATED  (1)
CL Item
POSSIBLE (2)
CL Item
PROBABLE (3)
AUTOPSY
Item
AUTOPSY PERFORMED?
boolean
C0004398 (UMLS CUI [1])
Item
IF YES
integer
C0004398 (UMLS CUI [1])
AUTOPSY
Code List
IF YES
CL Item
A COPY OF THE REPORT IS ATTACHED (1)
CL Item
A COPY OF THE REPORT IS NOT ATTACHED OR UNAVAILABLE (2)
consent
Item
I HAVE REVIEWED ALL RELEVANT DATA AND AGREE WITH THE ASSESSMENTS PROVIDED.
boolean
C0021430 (UMLS CUI [1])
SIGNATURE OF INVESTIGATOR
Item
SIGNATURE OF PRINCIPAL INVESTIGATOR
text
C2826892 (UMLS CUI [1])
DATE
Item
DATE
date
C0011008 (UMLS CUI [1])
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