ID

22205

Beschrijving

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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  1. 22-05-17 22-05-17 -
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Roche

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22 mei 2017

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

Engels

NON-SERIOUS ADVERSE EVENTS

1 Formulieren  
NON-SERIOUS ADVERSE EVENTS
Beschrijving

NON-SERIOUS ADVERSE EVENTS

Alias
UMLS CUI-1
C1518404
PATIENT INT.
Beschrijving

Patient initial

Datatype

text

Alias
UMLS CUI [1]
C2986440
PATIENT NUMBER
Beschrijving

Patient id

Datatype

integer

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

Non-serious Adverse Event

Datatype

text

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

Non-serious Adverse Event

Datatype

boolean

Alias
UMLS CUI [1]
C1518404
ONSET DATE
Beschrijving

ONSET DATE

Datatype

date

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

Non-serious Adverse Event

Datatype

boolean

Alias
UMLS CUI [1]
C1518404
RESOLUTION DATE
Beschrijving

Resolution Date

Datatype

date

Alias
UMLS CUI [1]
C2985858
FREQUENCY
Beschrijving

FREQUENCY

Datatype

integer

Alias
UMLS CUI [1]
C0439603
SEVERITY
Beschrijving

Severity of adverse event

Datatype

integer

Alias
UMLS CUI [1]
C1710066
RELATIONSHIP TO DISEASE
Beschrijving

Disease Non-serious Adverse Event

Datatype

integer

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

study drug Non-serious Adverse Event

Datatype

integer

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

ACTION TAKEN STUDY DRUG

Datatype

integer

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

ACTION TAKEN

Datatype

boolean

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

ACTION TAKEN MEDICATION

Datatype

boolean

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

ACTION TAKEN SURGERY

Datatype

boolean

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

ACTION TAKEN OTHER

Datatype

boolean

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

Other

Datatype

text

Alias
UMLS CUI [1]
C0205394
COMMENT
Beschrijving

comment

Datatype

text

Alias
UMLS CUI [1]
C0947611
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Similar models

NON-SERIOUS ADVERSE EVENTS

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
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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