ID

22205

Description

Study part: Non- serious adverse events. 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

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22 mai 2017

DOI

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Licence

Creative Commons BY-NC 3.0
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NON-SERIOUS ADVERSE EVENTS Roche H0650g Breast Cancer

Anglais

NON-SERIOUS ADVERSE EVENTS

1 Formulaires  
NON-SERIOUS ADVERSE EVENTS
Description

NON-SERIOUS ADVERSE EVENTS

Alias
UMLS CUI-1
C1518404
PATIENT INT.
Description

Patient initial

Type de données

text

Alias
UMLS CUI [1]
C2986440
PATIENT NUMBER
Description

Patient id

Type de données

integer

Alias
UMLS CUI [1]
C2348585
NON-SERIOUS ADVERSE EVENTS
Description

Non-serious Adverse Event

Type de données

text

Alias
UMLS CUI [1]
C1518404
NON-SERIOUS ADVERSE EVENTS CONTINUING?
Description

Non-serious Adverse Event

Type de données

boolean

Alias
UMLS CUI [1]
C1518404
ONSET DATE
Description

ONSET DATE

Type de données

date

Alias
UMLS CUI [1]
C0574845
ONGOING (FOR ANY EVENTS THAT HAVE NOT RESOLVED BY THE END Of THIS PERIOD)?
Description

Non-serious Adverse Event

Type de données

boolean

Alias
UMLS CUI [1]
C1518404
RESOLUTION DATE
Description

Resolution Date

Type de données

date

Alias
UMLS CUI [1]
C2985858
FREQUENCY
Description

FREQUENCY

Type de données

integer

Alias
UMLS CUI [1]
C0439603
SEVERITY
Description

Severity of adverse event

Type de données

integer

Alias
UMLS CUI [1]
C1710066
RELATIONSHIP TO DISEASE
Description

Disease Non-serious Adverse Event

Type de données

integer

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C1518404
RELATIONSHIP TO STUDY DRUG
Description

study drug Non-serious Adverse Event

Type de données

integer

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C1518404
ACTION TAKEN STUDY DRUG
Description

ACTION TAKEN STUDY DRUG

Type de données

integer

Alias
UMLS CUI [1,1]
C2826626
UMLS CUI [1,2]
C0304229
ACTION TAKEN TREATMENT REQUIRED- NONE
Description

ACTION TAKEN

Type de données

boolean

Alias
UMLS CUI [1]
C2826626
ACTION TAKEN TREATMENT REQUIRED- MEDICATION
Description

ACTION TAKEN MEDICATION

Type de données

boolean

Alias
UMLS CUI [1,1]
C2826626
UMLS CUI [1,2]
C0013227
ACTION TAKEN TREATMENT REQUIRED- PROCEDURE/ SURGERY (COMMENT BELOW)
Description

ACTION TAKEN SURGERY

Type de données

boolean

Alias
UMLS CUI [1,1]
C2826626
UMLS CUI [1,2]
C0543467
ACTION TAKEN TREATMENT REQUIRED- OTHER
Description

ACTION TAKEN OTHER

Type de données

boolean

Alias
UMLS CUI [1,1]
C2826626
UMLS CUI [1,2]
C0205394
OTHER
Description

Other

Type de données

text

Alias
UMLS CUI [1]
C0205394
COMMENT
Description

comment

Type de données

text

Alias
UMLS CUI [1]
C0947611
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Similar models

NON-SERIOUS ADVERSE EVENTS

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
NON-SERIOUS ADVERSE EVENTS
C1518404 (UMLS CUI-1)
Patient initial
Item
PATIENT INT.
text
C2986440 (UMLS CUI [1])
Patient id
Item
PATIENT NUMBER
integer
C2348585 (UMLS CUI [1])
Non-serious Adverse Event
Item
NON-SERIOUS ADVERSE EVENTS
text
C1518404 (UMLS CUI [1])
Non-serious Adverse Event
Item
NON-SERIOUS ADVERSE EVENTS CONTINUING?
boolean
C1518404 (UMLS CUI [1])
ONSET DATE
Item
ONSET DATE
date
C0574845 (UMLS CUI [1])
Non-serious Adverse Event
Item
ONGOING (FOR ANY EVENTS THAT HAVE NOT RESOLVED BY THE END Of THIS PERIOD)?
boolean
C1518404 (UMLS CUI [1])
Resolution Date
Item
RESOLUTION DATE
date
C2985858 (UMLS CUI [1])
Item
FREQUENCY
integer
C0439603 (UMLS CUI [1])
FREQUENCY
Code List
FREQUENCY
CL Item
INTERMITTENT (1)
CL Item
CONTINUOUS (2)
Item
SEVERITY
integer
C1710066 (UMLS CUI [1])
Severity of adverse event
Code List
SEVERITY
CL Item
MILD (1)
CL Item
MODERATE (2)
CL Item
SEVERE (3)
Item
RELATIONSHIP TO DISEASE
integer
C0012634 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Disease Non-serious Adverse Event
Code List
RELATIONSHIP TO DISEASE
CL Item
NOT RELATED (1)
CL Item
POSSIBLE (2)
CL Item
PROBABLE (3)
Item
RELATIONSHIP TO STUDY DRUG
integer
C0304229 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Disease Non-serious Adverse Event
Code List
RELATIONSHIP TO STUDY DRUG
CL Item
NOT RELATED (1)
CL Item
POSSIBLE (2)
CL Item
PROBABLE (3)
Item
ACTION TAKEN STUDY DRUG
integer
C2826626 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
ACTION TAKEN STUDY DRUG
Code List
ACTION TAKEN STUDY DRUG
CL Item
NO CHANGE (1)
CL Item
DOSE MODIFIED (2)
CL Item
HELD (3)
CL Item
DISCONTINUED (4)
ACTION TAKEN
Item
ACTION TAKEN TREATMENT REQUIRED- NONE
boolean
C2826626 (UMLS CUI [1])
ACTION TAKEN MEDICATION
Item
ACTION TAKEN TREATMENT REQUIRED- MEDICATION
boolean
C2826626 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
ACTION TAKEN SURGERY
Item
ACTION TAKEN TREATMENT REQUIRED- PROCEDURE/ SURGERY (COMMENT BELOW)
boolean
C2826626 (UMLS CUI [1,1])
C0543467 (UMLS CUI [1,2])
ACTION TAKEN OTHER
Item
ACTION TAKEN TREATMENT REQUIRED- OTHER
boolean
C2826626 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
Other
Item
OTHER
text
C0205394 (UMLS CUI [1])
comment
Item
COMMENT
text
C0947611 (UMLS CUI [1])
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