ID

22833

Beschrijving

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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Versies (2)
  1. 12-06-17 12-06-17 -
  2. 25-06-17 25-06-17 -
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12 juni 2017

DOI

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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

Engels

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

1 Formulieren  
Patient administration
Beschrijving

Patient administration

Subject Number
Beschrijving

PT

Datatype

integer

Alias
UMLS CUI [1]
C2348585
Subject Initials:
Beschrijving

PTINIT

Datatype

text

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

VDT

Datatype

date

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

NON-SERIOUS ADVERSE EVENT REPORTING

Were there any events / illnesses?
Beschrijving

If Yes, record below.

Datatype

boolean

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

Adverse Event

PRIMARY ADVERSE EVENT (AE)
Beschrijving

AE_RAW_TERM [AERAW]

Datatype

text

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

AE_LOCATION [AELOC]

Datatype

integer

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

AE_ONSET_DT [AEODT]

Datatype

date

Maateenheden
  • DD/MMM/YY
Alias
UMLS CUI [1]
C2985916
DD/MMM/YY
RESOLUTION
Beschrijving

AE_RESOLVE_DT [AERDT]

Datatype

date

Maateenheden
  • DD/MMM/YY
Alias
UMLS CUI [1]
C2985918
DD/MMM/YY
AE SEVERITY
Beschrijving

AE_INTENSITY [AEINT]

Datatype

integer

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

AE_CAUSE_STUDY_DRUG [AETX]

Datatype

boolean

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

(Investigator’s Assessment; check all that apply)

Datatype

integer

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

AE_ACTION_STUDY_DRUG [AEACTX]

Datatype

integer

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

AE_TX_MEDICATIONS [AETXMD]

Datatype

text

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Similar models

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

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