ID

28974

Beschreibung

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.

Stichworte

Versionen (1)
  1. 18.02.18 18.02.18 -
Rechteinhaber

Roche

Hochgeladen am

18. Februar 2018

DOI

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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

Englisch

Non- Serious Adverse Event Reporting Month 1-3

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

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

Alias
UMLS CUI-1
C1518404
Subject Number:
Beschreibung

Subject Number

Datentyp

text

Alias
UMLS CUI [1]
C2348585
Subject Initials:
Beschreibung

Subject Initials

Datentyp

text

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

Visit Date

Datentyp

date

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

Non- Serious Adverse Event

Datentyp

boolean

Alias
UMLS CUI [1]
C1518404
PRIMARY ADVERSE EVENT
Beschreibung

Adverse event

Datentyp

text

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

eye

Datentyp

text

Alias
UMLS CUI [1]
C0015392
ONSET
Beschreibung

Onset

Datentyp

date

Alias
UMLS CUI [1]
C0574845
RESOLUTION
Beschreibung

end date

Datentyp

date

Alias
UMLS CUI [1]
C0806020
AE INTENSITY
Beschreibung

Adverse Event intensity

Datentyp

integer

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

cause of adverse event

Datentyp

boolean

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

cause of adverse event

Datentyp

integer

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

Action taken

Datentyp

integer

Alias
UMLS CUI [1]
C2826626
TREATMENT FOR AE
Beschreibung

adverse event therapy

Datentyp

integer

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0087111
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Ähnliche Modelle

Non- Serious Adverse Event Reporting Month 1-3

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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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