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ID
22735
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)
- 6/11/17 6/11/17 -
- 6/11/17 6/11/17 -
Copyright Holder
Genentech, Inc.
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June 11, 2017
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Creative Commons BY-NC 3.0
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INDIRECT OPHTHALMOSCOPY (DAY 0) CRFs Roche FVF4168G Macular Edema NCT00473330
INDIRECT OPHTHALMOSCOPY (DAY 0) CRFs Roche FVF4168G Macular Edema NCT00473330
Similar models
INDIRECT OPHTHALMOSCOPY (DAY 0) CRFs Roche FVF4168G Macular Edema NCT00473330
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
PT
Item
Subject Number
integer
C2348585 (UMLS CUI [1])
PTINIT
Item
Subject Initials:
text
C1997894 (UMLS CUI [1,1])
C2986440 (UMLS CUI [1,2])
C2986440 (UMLS CUI [1,2])
VDT
Item
Report Date:
date
C1302584 (UMLS CUI [1,1])
Item
Have any new or worsened abnormalities been identified since last ophthalmoscopy?
integer
C1444582 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
C1704258 (UMLS CUI [1,2])
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])
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])
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])
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])
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])
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])
C0229089 (UMLS CUI [1,2])
OPHTHALMO_RET_HEM [OPHEM]
Item
Retinal Hemorrhages
integer
C0035317 (UMLS CUI [1,1])
C0229089 (UMLS CUI [1,2])
C0229089 (UMLS CUI [1,2])
Item
Cotton Wool Spots
integer
C0271053 (UMLS CUI [1,1])
C0229089 (UMLS CUI [1,2])
C0229089 (UMLS CUI [1,2])
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])
C0035305 (UMLS CUI [1,2])
C0229089 (UMLS CUI [1,3])
EXAM_DT [EXMDT]
Item
Date of Exam:
date
C1444582 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
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])
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])
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])
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])
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])
C0229090 (UMLS CUI [1,2])
OPHTHALMO_RET_HEM [OPHEM]
Item
Retinal Hemorrhages
integer
C0035317 (UMLS CUI [1,1])
C0229090 (UMLS CUI [1,2])
C0229090 (UMLS CUI [1,2])
Item
Cotton Wool Spots
integer
C0271053 (UMLS CUI [1,1])
C0229090 (UMLS CUI [1,2])
C0229090 (UMLS CUI [1,2])
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])
C0035305 (UMLS CUI [1,2])
C0229090 (UMLS CUI [1,3])