ID

28974

Description

Study part: Non- Serious Adverse Event Reporting Month 1-3. A Phase III, Multicenter, Randomized, Double-Masked, Sham Injection-Controlled Study Of The Efficacy And Safety Of rhuFab V2 (Ranibizumab) In Subjects With Minimally Classic Or Occult Subfoveal Neovascular Age-Related Macular Degeneration.

Keywords

Versions (1)
  1. 2/18/18 2/18/18 -
Copyright Holder

Roche

Uploaded on

February 18, 2018

DOI

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License

Creative Commons BY-NC 3.0
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Non- Serious Adverse Event Reporting Month 1-3 rhuFab V2 Neovascular Age-Related Macular Degeneration FVF2598g

English

Non- Serious Adverse Event Reporting Month 1-3

1 forms  
NON-SERIOUS ADVERSE EVENT REPORTING (MONTH 1 - 3)
Description

NON-SERIOUS ADVERSE EVENT REPORTING (MONTH 1 - 3)

Alias
UMLS CUI-1
C1518404
Subject Number:
Description

Subject Number

Data type

text

Alias
UMLS CUI [1]
C2348585
Subject Initials:
Description

Subject Initials

Data type

text

Alias
UMLS CUI [1,1]
C1997894
UMLS CUI [1,2]
C2986440
Visit Date:
Description

Visit Date

Data type

date

Alias
UMLS CUI [1]
C1320303
Were there any events/illnesses?
Description

Non- Serious Adverse Event

Data type

boolean

Alias
UMLS CUI [1]
C1518404
PRIMARY ADVERSE EVENT
Description

Adverse event

Data type

text

Alias
UMLS CUI [1]
C0877248
Ocular AEs Only Indicate Eye Affected
Description

eye

Data type

text

Alias
UMLS CUI [1]
C0015392
ONSET
Description

Onset

Data type

date

Alias
UMLS CUI [1]
C0574845
RESOLUTION
Description

end date

Data type

date

Alias
UMLS CUI [1]
C0806020
AE INTENSITY
Description

Adverse Event intensity

Data type

integer

Alias
UMLS CUI [1]
C1710066
AE SUSPECTED TO BE CAUSED BY STUDY DRUG?
Description

cause of adverse event

Data type

boolean

Alias
UMLS CUI [1,1]
C0015127
UMLS CUI [1,2]
C0877248
OTHER SUSPECTED CAUSES OF AE
Description

cause of adverse event

Data type

integer

Alias
UMLS CUI [1,1]
C0015127
UMLS CUI [1,2]
C0877248
ACTION TAKEN WITH STUDY DRUG DUE TO AE
Description

Action taken

Data type

integer

Alias
UMLS CUI [1]
C2826626
TREATMENT FOR AE
Description

adverse event therapy

Data type

integer

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0087111
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Similar models

Non- Serious Adverse Event Reporting Month 1-3

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
NON-SERIOUS ADVERSE EVENT REPORTING (MONTH 1 - 3)
C1518404 (UMLS CUI-1)
Subject Number
Item
Subject Number:
text
C2348585 (UMLS CUI [1])
Subject Initials
Item
Subject Initials:
text
C1997894 (UMLS CUI [1,1])
C2986440 (UMLS CUI [1,2])
Visit Date
Item
Visit Date:
date
C1320303 (UMLS CUI [1])
Non- Serious Adverse Event
Item
Were there any events/illnesses?
boolean
C1518404 (UMLS CUI [1])
Adverse event
Item
PRIMARY ADVERSE EVENT
text
C0877248 (UMLS CUI [1])
Item
Ocular AEs Only Indicate Eye Affected
text
C0015392 (UMLS CUI [1])
eye
Code List
Ocular AEs Only Indicate Eye Affected
CL Item
Right (Right)
C0229089 (UMLS CUI-1)
(Comment:en)
CL Item
Left (Left)
C0229090 (UMLS CUI-1)
(Comment:en)
Onset
Item
ONSET
date
C0574845 (UMLS CUI [1])
end date
Item
RESOLUTION
date
C0806020 (UMLS CUI [1])
Item
AE INTENSITY
integer
C1710066 (UMLS CUI [1])
Adverse Event intensity
Code List
AE INTENSITY
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
cause of adverse event
Item
AE SUSPECTED TO BE CAUSED BY STUDY DRUG?
boolean
C0015127 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
Item
OTHER SUSPECTED CAUSES OF AE
integer
C0015127 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
cause of advese event
Code List
OTHER SUSPECTED CAUSES OF AE
CL Item
None  (1)
C0549184 (UMLS CUI-1)
(Comment:en)
CL Item
Disease Under Study (2)
C0012634 (UMLS CUI-1)
(Comment:en)
CL Item
Withdrawal of Study Drug (3)
C2349954 (UMLS CUI-1)
C0304229 (UMLS CUI-2)
(Comment:en)
CL Item
Concurrent Illness (4)
C0009488 (UMLS CUI-1)
(Comment:en)
CL Item
Concurrent Medication (5)
C2347852 (UMLS CUI-1)
(Comment:en)
CL Item
Non-Drug Intervention (6)
C3661844 (UMLS CUI-1)
(Comment:en)
CL Item
Treatment Procedure (7)
C0087111 (UMLS CUI-1)
(Comment:en)
Item
ACTION TAKEN WITH STUDY DRUG DUE TO AE
integer
C2826626 (UMLS CUI [1])
Action taken
Code List
ACTION TAKEN WITH STUDY DRUG DUE TO AE
CL Item
None (1)
CL Item
Drug permanently discontinued (2)
CL Item
Dose held (3)
CL Item
Not applicable (4)
Item
TREATMENT FOR AE
integer
C0877248 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
adverse event therapy
Code List
TREATMENT FOR AE
CL Item
None (1)
CL Item
Medication (2)
CL Item
Procedure/ Surgery (3)
CL Item
Subject DC from study (4)
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