ID

22591

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. 6/8/17 6/8/17 -
  2. 6/8/17 6/8/17 -
Copyright Holder

Genentech, Inc.

Uploaded on

June 8, 2017

DOI

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License

Creative Commons BY-NC 3.0
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STUDY EYE SELECTION (SCREENING) CRFs Roche FVF4168G Macular Edema NCT00473330

English

STUDY EYE SELECTION (SCREENING) 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
Eligibility Criteria
Description

Eligibility Criteria

Eligibility criteria met by:
Description

ELIGIBILITY_CRITERIA

Data type

integer

Alias
UMLS CUI [1,1]
C0681850
UMLS CUI [1,2]
C0015392
If Both Eyes is checked, please answer the following question: Was the eye with worse best corrected visual acuity selected as the study eye?
Description

EYE_PROTOCOL

Data type

boolean

Alias
UMLS CUI [1,1]
C1457868
UMLS CUI [1,2]
C1690532
If No, explain medical reason for selecting the better eye as the study eye:
Description

REASON

Data type

text

Alias
UMLS CUI [1]
C0392360
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Similar models

STUDY EYE SELECTION (SCREENING) 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
Eligibility Criteria
Item
Eligibility criteria met by:
integer
C0681850 (UMLS CUI [1,1])
C0015392 (UMLS CUI [1,2])
COUNT_FINGERS [CTFGR]
Code List
Eligibility criteria met by:
CL Item
Yes (1)
CL Item
No  (2)
CL Item
Not Done (3)
EYE_PROTOCOL
Item
If Both Eyes is checked, please answer the following question: Was the eye with worse best corrected visual acuity selected as the study eye?
boolean
C1457868 (UMLS CUI [1,1])
C1690532 (UMLS CUI [1,2])
REASON
Item
If No, explain medical reason for selecting the better eye as the study eye:
text
C0392360 (UMLS CUI [1])
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