ID

22833

Description

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 Study #: FVF4168g Drug: Ranibizumab Study Title: A Phase III, Double-Masked, Multicenter, Randomized, Sham-Controlled Study Of The Efficacy And Safety Of Ranibizumab Injection In Subjects With Clinically Significant Macular Edema With Center Involvement Secondary To Diabetes Mellitus

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Versions (2)
  1. 12/06/2017 12/06/2017 -
  2. 25/06/2017 25/06/2017 -
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12 juin 2017

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Creative Commons BY-NC 3.0 Legacy
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NON-SERIOUS ADVERSE EVENT REPORTING (DAY 0 - MONTH 12) CRFs Roche FVF4168G Macular Edema NCT00473330

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NON-SERIOUS ADVERSE EVENT REPORTING (DAY 0 - MONTH 12) CRFs Roche FVF4168G Macular Edema NCT00473330

1 Formulaires  
Patient administration
Description

Patient administration

Subject Number
Description

PT

Type de données

integer

Alias
UMLS CUI [1]
C2348585
Subject Initials:
Description

PTINIT

Type de données

text

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

VDT

Type de données

date

Alias
UMLS CUI [1,1]
C1302584
NON-SERIOUS ADVERSE EVENT REPORTING
Description

NON-SERIOUS ADVERSE EVENT REPORTING

Were there any events / illnesses?
Description

If Yes, record below.

Type de données

boolean

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0877248
Adverse Event
Description

Adverse Event

PRIMARY ADVERSE EVENT (AE)
Description

AE_RAW_TERM [AERAW]

Type de données

text

Alias
UMLS CUI [1]
C0877248
Ocular AEs only indicate eye affected:
Description

AE_LOCATION [AELOC]

Type de données

integer

Alias
UMLS CUI [1,1]
C2826797
UMLS CUI [1,2]
C0015392
ONSET
Description

AE_ONSET_DT [AEODT]

Type de données

date

Unités de mesure
  • DD/MMM/YY
Alias
UMLS CUI [1]
C2985916
DD/MMM/YY
RESOLUTION
Description

AE_RESOLVE_DT [AERDT]

Type de données

date

Unités de mesure
  • DD/MMM/YY
Alias
UMLS CUI [1]
C2985918
DD/MMM/YY
AE SEVERITY
Description

AE_INTENSITY [AEINT]

Type de données

integer

Alias
UMLS CUI [1]
C2985921
AE SUSPECTED TO BE CAUSED BY STUDY DRUG? (Investigator’s
Description

AE_CAUSE_STUDY_DRUG [AETX]

Type de données

boolean

Alias
UMLS CUI [1,1]
C1706742
UMLS CUI [1,2]
C0304229
OTHER SUSPECTED CAUSES OF AE
Description

(Investigator’s Assessment; check all that apply)

Type de données

integer

Alias
UMLS CUI [1]
C1706742
ACTION TAKEN WITH STUDY DRUG DUE TO AE
Description

AE_ACTION_STUDY_DRUG [AEACTX]

Type de données

integer

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C1608430
TREATMENT FOR AE
Description

AE_TX_MEDICATIONS [AETXMD]

Type de données

text

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Similar models

NON-SERIOUS ADVERSE EVENT REPORTING (DAY 0 - MONTH 12) CRFs Roche FVF4168G Macular Edema NCT00473330

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
Patient administration
PT
Item
Subject Number
integer
C2348585 (UMLS CUI [1])
PTINIT
Item
Subject Initials:
text
C1997894 (UMLS CUI [1,1])
C2986440 (UMLS CUI [1,2])
VDT
Item
Report Date:
date
C1302584 (UMLS CUI [1,1])
Item Group
NON-SERIOUS ADVERSE EVENT REPORTING
AE_RECORDS [AEREC]
Item
Were there any events / illnesses?
boolean
C0262926 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
Item Group
Adverse Event
AE_RAW_TERM [AERAW]
Item
PRIMARY ADVERSE EVENT (AE)
text
C0877248 (UMLS CUI [1])
Item
Ocular AEs only indicate eye affected:
integer
C2826797 (UMLS CUI [1,1])
C0015392 (UMLS CUI [1,2])
LIGHT_PERCEPTION [LIPEC]
Code List
Ocular AEs only indicate eye affected:
CL Item
Right (1)
CL Item
Left (2)
AE_ONSET_DT [AEODT]
Item
ONSET
date
C2985916 (UMLS CUI [1])
AE_RESOLVE_DT [AERDT]
Item
RESOLUTION
date
C2985918 (UMLS CUI [1])
Item
AE SEVERITY
integer
C2985921 (UMLS CUI [1])
AE_INTENSITY [AEINT]
Code List
AE SEVERITY
CL Item
Mild (1 )
CL Item
Moderate (2 )
CL Item
Severe (3 )
AE_CAUSE_STUDY_DRUG [AETX]
Item
AE SUSPECTED TO BE CAUSED BY STUDY DRUG? (Investigator’s
boolean
C1706742 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
Item
OTHER SUSPECTED CAUSES OF AE
integer
C1706742 (UMLS CUI [1])
AE_CAUSE_CONCUR_DX [AECDX]
Code List
OTHER SUSPECTED CAUSES OF AE
CL Item
None (1)
CL Item
Disease Under Study (2)
CL Item
Withdrawal of Study Drug (3)
CL Item
Concurrent Illness (4)
CL Item
Concomitant Medication (5)
CL Item
Non-Drug Intervention (6)
CL Item
Study Drug Injection /(procedure) Sham Procedure (7)
CL Item
Laser Photocoagulation (8)
Item
ACTION TAKEN WITH STUDY DRUG DUE TO AE
integer
C0304229 (UMLS CUI [1,1])
C1608430 (UMLS CUI [1,2])
AE_ACTION_STUDY_DRUG [AEACTX]
Code List
ACTION TAKEN WITH STUDY DRUG DUE TO AE
CL Item
None (1)
CL Item
Drug Permanently (2)
CL Item
Dose Held Discontinued (3)
CL Item
Not Applicable (4)
AE_TX_MEDICATIONS [AETXMD]
Item
TREATMENT FOR AE
text
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