ID

22204

Description

Study part: Treatment discontinuation 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. 5/22/17 5/22/17 -
Copyright Holder

Roche

Uploaded on

May 22, 2017

DOI

To request one please log in.

License

Creative Commons BY-NC 3.0
Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Back to model comments
Itemgroup comments for :

Item comments for :

In order to download data models you must be logged in. Please log in or register for free.

TREATMENT DISCONTINUATION REPORT Roche H0650g Breast Cancer

English

TREATMENT DISCONTINUATION REPORT

1 forms  
TREATMENT DISCONTINUATION REPORT
Description

TREATMENT DISCONTINUATION REPORT

Alias
UMLS CUI-1
C0677162
DATE OF DISCONTINUATION:
Description

therapy end date

Data type

date

Alias
UMLS CUI [1]
C1531784
CHECK THE PRIMARY REASON FOR DISCONTINUATION OF THERAPY:
Description

Primary Reason Therapy discontinuation

Data type

text

Alias
UMLS CUI [1]
C1549995
UMLS CUI [2]
C0677162
PROVIDE ADDITIONAL DETAILS FOR THE REASON(S) FOR STUDY DISCONTINUATION:
Description

Reason Therapy discontinuation

Data type

text

Alias
UMLS CUI [1,1]
C0392360
UMLS CUI [1,2]
C0677162
I HAVE PERSONALLY REVIEWED THIS CASE REPORT FORM BOOK FOR COMPLETENESS AND ACCURACY OF ALL DATA RECORDED.
Description

consent

Data type

boolean

Alias
UMLS CUI [1]
C1511481
SIGNATURE OF INVESTIGATOR (M.D.)
Description

SIGNATURE OF INVESTIGATOR

Data type

text

Alias
UMLS CUI [1]
C2346576
DATE:
Description

DATE

Data type

date

Alias
UMLS CUI [1]
C0011008
Back to the top of the page

Similar models

TREATMENT DISCONTINUATION REPORT

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
TREATMENT DISCONTINUATION REPORT
C0677162 (UMLS CUI-1)
therapy end date
Item
DATE OF DISCONTINUATION:
date
C1531784 (UMLS CUI [1])
Item
CHECK THE PRIMARY REASON FOR DISCONTINUATION OF THERAPY:
text
C1549995 (UMLS CUI [1])
C0677162 (UMLS CUI [2])
Primary Reason Therapy discontinuation
Code List
CHECK THE PRIMARY REASON FOR DISCONTINUATION OF THERAPY:
CL Item
ADVERSE EVENT/ INTERCURRENT ILLNESS (PLEASE RECORD ON ADVERSE EVENTS FORM)  (1)
C0877248 (UMLS CUI-1)
CL Item
LABORATORY ABNORMALITY (PLEASE DOCUMENT THE ABNORMALITY ON THE ADVERSE EVENTS PAGE) (2)
C0438215 (UMLS CUI-1)
CL Item
PATIENT REQUESTED REMOVAL FROM STUDY  (3)
CL Item
NON-COMPLIANCE (INCLUDING 3 CONSECUTIVEL Y MISSED rhuMAb HER2 INFUSIONS)  (4)
C0457432 (UMLS CUI-1)
CL Item
PATIENT DIED (COMPLETE DEATH REPORT FORM)  (5)
C0421611 (UMLS CUI-1)
CL Item
DISEASE PROGRESSION (INCLUDING METASTATIC BRAIN DISEASE)  (6)
C0242656 (UMLS CUI-1)
CL Item
LOST TO FOLLOW-UP  (8)
C1302313 (UMLS CUI-1)
CL Item
IMMUNOTHERAPY, CHEMOTHERAPY, HORMONAL THERAPY, OR RADIOTHERAPY DIRECTED AT THE TREATMENT OF EVALUABLE LESIONS=TREATMENT OF EVALUABLE LESIONS (24)
C0021083 (UMLS CUI-1)
C0392920 (UMLS CUI-2)
C0279025 (UMLS CUI-3)
C1522449 (UMLS CUI-4)
Reason Therapy discontinuation
Item
PROVIDE ADDITIONAL DETAILS FOR THE REASON(S) FOR STUDY DISCONTINUATION:
text
C0392360 (UMLS CUI [1,1])
C0677162 (UMLS CUI [1,2])
consent
Item
I HAVE PERSONALLY REVIEWED THIS CASE REPORT FORM BOOK FOR COMPLETENESS AND ACCURACY OF ALL DATA RECORDED.
boolean
C1511481 (UMLS CUI [1])
SIGNATURE OF INVESTIGATOR
Item
SIGNATURE OF INVESTIGATOR (M.D.)
text
C2346576 (UMLS CUI [1])
DATE
Item
DATE:
date
C0011008 (UMLS CUI [1])
Back to the top of the page 

Contact

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

Help

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial