ID

22737

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. 6/11/17 6/11/17 -
  2. 6/11/17 6/11/17 -
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June 11, 2017

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INDIRECT OPHTHALMOSCOPY (DAY 7) CRFs Roche FVF4168G Macular Edema NCT00473330

English

INDIRECT OPHTHALMOSCOPY (DAY 7) 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
INDIRECT OPHTHALMOSCOPY (DAY 7) Right Eye
Description

INDIRECT OPHTHALMOSCOPY (DAY 7) Right Eye

Have any new or worsened abnormalities been identified since last ophthalmoscopy?
Description

ANY_CHANGE [ANYCHG]

Data type

integer

Alias
UMLS CUI [1,1]
C1444582
UMLS CUI [1,2]
C1704258
Date of Exam:
Description

EXAM_DT [EXMDT]

Data type

date

Measurement units
  • DD/MMM/YY
Alias
UMLS CUI [1,1]
C1444582
UMLS CUI [1,2]
C0011008
DD/MMM/YY
Clinically Significant Macular Edema (CSME) Present?
Description

MACULAR_EDEMA [MACEDM]

Data type

boolean

Alias
UMLS CUI [1,1]
C0271051
UMLS CUI [1,2]
C0229089
Neovascularization of the Disc (NVD)?
Description

OPHTHALMO_NEOV_DISC [OPHNVD]

Data type

boolean

Alias
UMLS CUI [1,1]
C1112634
UMLS CUI [1,2]
C0229089
Neovascularization (NVE) of the Retina elsewhere?
Description

OPHTHALMO_NVE [OPHNVE]

Data type

boolean

Alias
UMLS CUI [1,1]
C0035320
UMLS CUI [1,2]
C0229089
Neovascularization of the Iris?
Description

OPHTHALMO_NV_IRIS [OPHIRIS]

Data type

boolean

Alias
UMLS CUI [1,1]
C0271110
UMLS CUI [1,2]
C0229089
Posterior Vitreal Detachment (PVD)?
Description

IND_OPHT_VIT_DETACH [IODET]

Data type

boolean

Alias
UMLS CUI [1,1]
C0423361
UMLS CUI [1,2]
C0229089
Retinal Hemorrhages
Description

OPHTHALMO_RET_HEM [OPHEM]

Data type

integer

Alias
UMLS CUI [1,1]
C0035317
UMLS CUI [1,2]
C0229089
Cotton Wool Spots
Description

OPHTHALMO_COTTON [OPHCOT]

Data type

integer

Alias
UMLS CUI [1,1]
C0271053
UMLS CUI [1,2]
C0229089
Is there a new or worsened retinal break or detachment?
Description

OPHTHALMO_RET_BRK_DH [OPHBD]

Data type

boolean

Alias
UMLS CUI [1,1]
C0035321
UMLS CUI [1,2]
C0035305
UMLS CUI [1,3]
C0229089
INDIRECT OPHTHALMOSCOPY (DAY 7) Left Eye
Description

INDIRECT OPHTHALMOSCOPY (DAY 7) Left Eye

Date of Exam:
Description

EXAM_DT [EXMDT]

Data type

date

Measurement units
  • DD/MMM/YY
Alias
UMLS CUI [1,1]
C1444582
UMLS CUI [1,2]
C0011008
DD/MMM/YY
Clinically Significant Macular Edema (CSME) Present?
Description

MACULAR_EDEMA [MACEDM]

Data type

boolean

Alias
UMLS CUI [1,1]
C0271051
UMLS CUI [1,2]
C0229090
Neovascularization of the Disc (NVD)?
Description

OPHTHALMO_NEOV_DISC [OPHNVD]

Data type

boolean

Alias
UMLS CUI [1,1]
C1112634
UMLS CUI [1,2]
C0229090
Neovascularization (NVE) of the Retina elsewhere?
Description

OPHTHALMO_NVE [OPHNVE]

Data type

boolean

Alias
UMLS CUI [1,1]
C0035320
UMLS CUI [1,2]
C0229090
Neovascularization of the Iris?
Description

OPHTHALMO_NV_IRIS [OPHIRIS]

Data type

boolean

Alias
UMLS CUI [1,1]
C0271110
UMLS CUI [1,2]
C0229090
Posterior Vitreal Detachment (PVD)?
Description

IND_OPHT_VIT_DETACH [IODET]

Data type

boolean

Alias
UMLS CUI [1,1]
C0423361
UMLS CUI [1,2]
C0229090
Retinal Hemorrhages
Description

OPHTHALMO_RET_HEM [OPHEM]

Data type

integer

Alias
UMLS CUI [1,1]
C0035317
UMLS CUI [1,2]
C0229090
Cotton Wool Spots
Description

OPHTHALMO_COTTON [OPHCOT]

Data type

integer

Alias
UMLS CUI [1,1]
C0271053
UMLS CUI [1,2]
C0229090
Is there a new or worsened retinal break or detachment?
Description

OPHTHALMO_RET_BRK_DH [OPHBD]

Data type

boolean

Alias
UMLS CUI [1,1]
C0035321
UMLS CUI [1,2]
C0035305
UMLS CUI [1,3]
C0229090
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Similar models

INDIRECT OPHTHALMOSCOPY (DAY 7) 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
INDIRECT OPHTHALMOSCOPY (DAY 7) Right Eye
Item
Have any new or worsened abnormalities been identified since last ophthalmoscopy?
integer
C1444582 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
ANY_CHANGE [ANYCHG]
Code List
Have any new or worsened abnormalities been identified since last ophthalmoscopy?
CL Item
Yes  (1)
CL Item
No  (2)
CL Item
Ophthalmoscopy Not Done (3)
EXAM_DT [EXMDT]
Item
Date of Exam:
date
C1444582 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
MACULAR_EDEMA [MACEDM]
Item
Clinically Significant Macular Edema (CSME) Present?
boolean
C0271051 (UMLS CUI [1,1])
C0229089 (UMLS CUI [1,2])
OPHTHALMO_NEOV_DISC [OPHNVD]
Item
Neovascularization of the Disc (NVD)?
boolean
C1112634 (UMLS CUI [1,1])
C0229089 (UMLS CUI [1,2])
OPHTHALMO_NVE [OPHNVE]
Item
Neovascularization (NVE) of the Retina elsewhere?
boolean
C0035320 (UMLS CUI [1,1])
C0229089 (UMLS CUI [1,2])
OPHTHALMO_NV_IRIS [OPHIRIS]
Item
Neovascularization of the Iris?
boolean
C0271110 (UMLS CUI [1,1])
C0229089 (UMLS CUI [1,2])
IND_OPHT_VIT_DETACH [IODET]
Item
Posterior Vitreal Detachment (PVD)?
boolean
C0423361 (UMLS CUI [1,1])
C0229089 (UMLS CUI [1,2])
OPHTHALMO_RET_HEM [OPHEM]
Item
Retinal Hemorrhages
integer
C0035317 (UMLS CUI [1,1])
C0229089 (UMLS CUI [1,2])
Item
Cotton Wool Spots
integer
C0271053 (UMLS CUI [1,1])
C0229089 (UMLS CUI [1,2])
OPHTHALMO_COTTON [OPHCOT]
Code List
Cotton Wool Spots
CL Item
0 (1)
CL Item
1-10 (2)
CL Item
>10 (3)
OPHTHALMO_RET_BRK_DH [OPHBD]
Item
Is there a new or worsened retinal break or detachment?
boolean
C0035321 (UMLS CUI [1,1])
C0035305 (UMLS CUI [1,2])
C0229089 (UMLS CUI [1,3])
Item Group
INDIRECT OPHTHALMOSCOPY (DAY 7) Left Eye
EXAM_DT [EXMDT]
Item
Date of Exam:
date
C1444582 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
MACULAR_EDEMA [MACEDM]
Item
Clinically Significant Macular Edema (CSME) Present?
boolean
C0271051 (UMLS CUI [1,1])
C0229090 (UMLS CUI [1,2])
OPHTHALMO_NEOV_DISC [OPHNVD]
Item
Neovascularization of the Disc (NVD)?
boolean
C1112634 (UMLS CUI [1,1])
C0229090 (UMLS CUI [1,2])
OPHTHALMO_NVE [OPHNVE]
Item
Neovascularization (NVE) of the Retina elsewhere?
boolean
C0035320 (UMLS CUI [1,1])
C0229090 (UMLS CUI [1,2])
OPHTHALMO_NV_IRIS [OPHIRIS]
Item
Neovascularization of the Iris?
boolean
C0271110 (UMLS CUI [1,1])
C0229090 (UMLS CUI [1,2])
IND_OPHT_VIT_DETACH [IODET]
Item
Posterior Vitreal Detachment (PVD)?
boolean
C0423361 (UMLS CUI [1,1])
C0229090 (UMLS CUI [1,2])
OPHTHALMO_RET_HEM [OPHEM]
Item
Retinal Hemorrhages
integer
C0035317 (UMLS CUI [1,1])
C0229090 (UMLS CUI [1,2])
Item
Cotton Wool Spots
integer
C0271053 (UMLS CUI [1,1])
C0229090 (UMLS CUI [1,2])
OPHTHALMO_COTTON [OPHCOT]
Code List
Cotton Wool Spots
CL Item
0 (1)
CL Item
1-10 (2)
CL Item
>10 (3)
OPHTHALMO_RET_BRK_DH [OPHBD]
Item
Is there a new or worsened retinal break or detachment?
boolean
C0035321 (UMLS CUI [1,1])
C0035305 (UMLS CUI [1,2])
C0229090 (UMLS CUI [1,3])
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