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"

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Versions (1)
  1. 22/05/2017 22/05/2017 -
Détendeur de droits

Roche

Téléchargé le

22 mai 2017

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Creative Commons BY-NC 3.0
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TREATMENT DISCONTINUATION REPORT Roche H0650g Breast Cancer

Anglais

TREATMENT DISCONTINUATION REPORT

1 Formulaires  
TREATMENT DISCONTINUATION REPORT
Description

TREATMENT DISCONTINUATION REPORT

Alias
UMLS CUI-1
C0677162
DATE OF DISCONTINUATION:
Description

therapy end date

Type de données

date

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

Primary Reason Therapy discontinuation

Type de données

text

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

Reason Therapy discontinuation

Type de données

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

Type de données

boolean

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

SIGNATURE OF INVESTIGATOR

Type de données

text

Alias
UMLS CUI [1]
C2346576
DATE:
Description

DATE

Type de données

date

Alias
UMLS CUI [1]
C0011008
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Similar models

TREATMENT DISCONTINUATION REPORT

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
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])
Retour au début de la page 

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