ID

28974

Descripción

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.

Palabras clave

Versiones (1)
  1. 18/2/18 18/2/18 -
Titular de derechos de autor

Roche

Subido en

18 de febrero de 2018

DOI

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Licencia

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

Inglés

Non- Serious Adverse Event Reporting Month 1-3

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

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

Alias
UMLS CUI-1
C1518404
Subject Number:
Descripción

Subject Number

Tipo de datos

text

Alias
UMLS CUI [1]
C2348585
Subject Initials:
Descripción

Subject Initials

Tipo de datos

text

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

Visit Date

Tipo de datos

date

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

Non- Serious Adverse Event

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1518404
PRIMARY ADVERSE EVENT
Descripción

Adverse event

Tipo de datos

text

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

eye

Tipo de datos

text

Alias
UMLS CUI [1]
C0015392
ONSET
Descripción

Onset

Tipo de datos

date

Alias
UMLS CUI [1]
C0574845
RESOLUTION
Descripción

end date

Tipo de datos

date

Alias
UMLS CUI [1]
C0806020
AE INTENSITY
Descripción

Adverse Event intensity

Tipo de datos

integer

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

cause of adverse event

Tipo de datos

boolean

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

cause of adverse event

Tipo de datos

integer

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

Action taken

Tipo de datos

integer

Alias
UMLS CUI [1]
C2826626
TREATMENT FOR AE
Descripción

adverse event therapy

Tipo de datos

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 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
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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