ID

22617

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 (1)
  1. 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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CONTRAST SENSITIVITY (DAY 0) CRFs Roche FVF4168G Macular Edema NCT00473330

English

CONTRAST SENSITIVITY (DAY 0) 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
CONTRAST SENSITIVITY (DAY 0)
Description

CONTRAST SENSITIVITY (DAY 0)

Testing Distance: 1 meter
Description

DISTANCE_CHAR [DSTCHR]

Data type

text

Alias
UMLS CUI [1]
C0429925
Test Date:
Description

EXAM_DT [EXMDT]

Data type

date

Measurement units
  • DD/MMM/YY
Alias
UMLS CUI [1,1]
C0200150
UMLS CUI [1,2]
C0011008
DD/MMM/YY
Right Eye: Not Done
Description

NOT_DONE [NOTDN]

Data type

boolean

Alias
UMLS CUI [1,1]
C0430888
UMLS CUI [1,2]
C0229089
Total number correct =
Description

CORRECT_READING [COTRD]

Data type

integer

Alias
UMLS CUI [1,1]
C0846621
UMLS CUI [1,2]
C0229089
Total CS Score =
Description

[(Total number correct - 3) X 0.05]

Data type

float

Alias
UMLS CUI [1,1]
C0430888
UMLS CUI [1,2]
C0449820
UMLS CUI [1,3]
C0229089
Left Eye: Not Done
Description

NOT_DONE [NOTDN]

Data type

boolean

Alias
UMLS CUI [1,1]
C0430888
UMLS CUI [1,2]
C0229090
Total number correct =
Description

CORRECT_READING [COTRD]

Data type

integer

Alias
UMLS CUI [1,1]
C0846621
UMLS CUI [1,2]
C0229090
Total CS Score =
Description

[(Total number correct - 3) X 0.05]

Data type

float

Alias
UMLS CUI [1,1]
C0430888
UMLS CUI [1,2]
C0449820
UMLS CUI [1,3]
C0229090
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Similar models

CONTRAST SENSITIVITY (DAY 0) 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
CONTRAST SENSITIVITY (DAY 0)
DISTANCE_CHAR [DSTCHR]
Item
Testing Distance: 1 meter
text
C0429925 (UMLS CUI [1])
EXAM_DT [EXMDT]
Item
Test Date:
date
C0200150 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
NOT_DONE [NOTDN]
Item
Right Eye: Not Done
boolean
C0430888 (UMLS CUI [1,1])
C0229089 (UMLS CUI [1,2])
CORRECT_READING [COTRD]
Item
Total number correct =
integer
C0846621 (UMLS CUI [1,1])
C0229089 (UMLS CUI [1,2])
CONTRAST_SENS_SCORE [TCSS]
Item
Total CS Score =
float
C0430888 (UMLS CUI [1,1])
C0449820 (UMLS CUI [1,2])
C0229089 (UMLS CUI [1,3])
NOT_DONE [NOTDN]
Item
Left Eye: Not Done
boolean
C0430888 (UMLS CUI [1,1])
C0229090 (UMLS CUI [1,2])
CORRECT_READING [COTRD]
Item
Total number correct =
integer
C0846621 (UMLS CUI [1,1])
C0229090 (UMLS CUI [1,2])
CONTRAST_SENS_SCORE [TCSS]
Item
Total CS Score =
float
C0430888 (UMLS CUI [1,1])
C0449820 (UMLS CUI [1,2])
C0229090 (UMLS CUI [1,3])
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