ID

23136

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

Keywords

Versions (2)
  1. 6/25/17 6/25/17 -
  2. 6/25/17 6/25/17 -
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June 25, 2017

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NON-SERIOUS ADVERSE EVENT REPORTING (MONTH 13 - MONTH 24) CRFs Roche FVF4168G Macular Edema NCT00473330

English

NON-SERIOUS ADVERSE EVENT REPORTING (MONTH 13 - MONTH 24) CRFs Roche FVF4168G Macular Edema NCT00473330

1 forms  
Patient administration
Description

Patient administration

Subject Number
Description

PT

Data type

integer

Alias
UMLS CUI [1]
C2348585
Subject Initials:
Description

PTINIT

Data type

text

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

VDT

Data type

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.

Data type

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]

Data type

text

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

AE_LOCATION [AELOC]

Data type

integer

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

AE_ONSET_DT [AEODT]

Data type

date

Measurement units
  • DD/MMM/YY
Alias
UMLS CUI [1]
C2985916
DD/MMM/YY
RESOLUTION
Description

AE_RESOLVE_DT [AERDT]

Data type

date

Measurement units
  • DD/MMM/YY
Alias
UMLS CUI [1]
C2985918
DD/MMM/YY
AE SEVERITY
Description

AE_INTENSITY [AEINT]

Data type

integer

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

AE_CAUSE_STUDY_DRUG [AETX]

Data type

boolean

Alias
UMLS CUI [1,1]
C1706742
UMLS CUI [1,2]
C0304229
OTHER SUSPECTED CAUSES OF AE None
Description

AE_CAUSE_CONCUR_DX [AECDX1]

Data type

boolean

Alias
UMLS CUI [1]
C1706742
OTHER SUSPECTED CAUSES OF AE Disease Under Study
Description

AE_CAUSE_CONCUR_DX [AECDX2]

Data type

boolean

Alias
UMLS CUI [1]
C1706742
OTHER SUSPECTED CAUSES OF AE Withdrawal of Study Drug
Description

AE_CAUSE_CONCUR_DX [AECDX3]

Data type

boolean

Alias
UMLS CUI [1]
C1706742
OTHER SUSPECTED CAUSES OF AE Concurrent Illness
Description

AE_CAUSE_CONCUR_DX [AECDX4]

Data type

boolean

Alias
UMLS CUI [1]
C1706742
OTHER SUSPECTED CAUSES OF AE Concomitant Medication
Description

AE_CAUSE_CONCUR_DX [AECDX5]

Data type

boolean

Alias
UMLS CUI [1]
C1706742
OTHER SUSPECTED CAUSES OF AE Non-Drug Intervention (procedure)
Description

AE_CAUSE_CONCUR_DX [AECDX6]

Data type

boolean

Alias
UMLS CUI [1]
C1706742
OTHER SUSPECTED CAUSES OF AE Study Drug Injection / Sham Procedure
Description

AE_CAUSE_CONCUR_DX [AECDX7]

Data type

boolean

Alias
UMLS CUI [1]
C1706742
OTHER SUSPECTED CAUSES OF AE Laser Photocoagulation
Description

AE_CAUSE_CONCUR_DX [AECDX8]

Data type

boolean

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

AE_ACTION_STUDY_DRUG [AEACTX]

Data type

integer

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C1608430
TREATMENT FOR AE 1. None
Description

AE_TX_MEDICATIONS [AETXMD1]

Data type

boolean

Alias
UMLS CUI [1]
C2981656
TREATMENT FOR AE 2. Medications (record on meds CRF)
Description

AE_TX_MEDICATIONS [AETXMD2]

Data type

boolean

Alias
UMLS CUI [1]
C2981656
TREATMENT FOR AE 3. Procedure / Surgery (record on protocol specific Concurrent Ocular Procedures CRF)
Description

AE_TX_MEDICATIONS [AETXMD3]

Data type

boolean

Alias
UMLS CUI [1]
C2981656
TREATMENT FOR AE 4. Subject Discontinued from Study
Description

AE_TX_MEDICATIONS [AETXMD4]

Data type

boolean

Alias
UMLS CUI [1]
C2981656
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Similar models

NON-SERIOUS ADVERSE EVENT REPORTING (MONTH 13 - MONTH 24) CRFs Roche FVF4168G Macular Edema NCT00473330

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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])
AE_CAUSE_CONCUR_DX [AECDX1]
Item
OTHER SUSPECTED CAUSES OF AE None
boolean
C1706742 (UMLS CUI [1])
AE_CAUSE_CONCUR_DX [AECDX2]
Item
OTHER SUSPECTED CAUSES OF AE Disease Under Study
boolean
C1706742 (UMLS CUI [1])
AE_CAUSE_CONCUR_DX [AECDX3]
Item
OTHER SUSPECTED CAUSES OF AE Withdrawal of Study Drug
boolean
C1706742 (UMLS CUI [1])
AE_CAUSE_CONCUR_DX [AECDX4]
Item
OTHER SUSPECTED CAUSES OF AE Concurrent Illness
boolean
C1706742 (UMLS CUI [1])
AE_CAUSE_CONCUR_DX [AECDX5]
Item
OTHER SUSPECTED CAUSES OF AE Concomitant Medication
boolean
C1706742 (UMLS CUI [1])
AE_CAUSE_CONCUR_DX [AECDX6]
Item
OTHER SUSPECTED CAUSES OF AE Non-Drug Intervention (procedure)
boolean
C1706742 (UMLS CUI [1])
AE_CAUSE_CONCUR_DX [AECDX7]
Item
OTHER SUSPECTED CAUSES OF AE Study Drug Injection / Sham Procedure
boolean
C1706742 (UMLS CUI [1])
AE_CAUSE_CONCUR_DX [AECDX8]
Item
OTHER SUSPECTED CAUSES OF AE Laser Photocoagulation
boolean
C1706742 (UMLS CUI [1])
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 [AETXMD1]
Item
TREATMENT FOR AE 1. None
boolean
C2981656 (UMLS CUI [1])
AE_TX_MEDICATIONS [AETXMD2]
Item
TREATMENT FOR AE 2. Medications (record on meds CRF)
boolean
C2981656 (UMLS CUI [1])
AE_TX_MEDICATIONS [AETXMD3]
Item
TREATMENT FOR AE 3. Procedure / Surgery (record on protocol specific Concurrent Ocular Procedures CRF)
boolean
C2981656 (UMLS CUI [1])
AE_TX_MEDICATIONS [AETXMD4]
Item
TREATMENT FOR AE 4. Subject Discontinued from Study
boolean
C2981656 (UMLS CUI [1])
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