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

Mots-clés

  1. 08/06/2017 08/06/2017 -
Détendeur de droits

Genentech, Inc.

Téléchargé le

8 juin 2017

DOI

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Licence

Creative Commons BY-NC 3.0

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

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

Patient administration
Description

Patient administration

Subject Number
Description

PT

Type de données

integer

Alias
UMLS CUI [1]
C2348585
Subject Initials:
Description

PTINIT

Type de données

text

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

VDT

Type de données

date

Alias
UMLS CUI [1,1]
C1302584
CONTRAST SENSITIVITY (DAY 0)
Description

CONTRAST SENSITIVITY (DAY 0)

Testing Distance: 1 meter
Description

DISTANCE_CHAR [DSTCHR]

Type de données

text

Alias
UMLS CUI [1]
C0429925
Test Date:
Description

EXAM_DT [EXMDT]

Type de données

date

Unités de mesure
  • 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]

Type de données

boolean

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

CORRECT_READING [COTRD]

Type de données

integer

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

[(Total number correct - 3) X 0.05]

Type de données

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]

Type de données

boolean

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

CORRECT_READING [COTRD]

Type de données

integer

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

[(Total number correct - 3) X 0.05]

Type de données

float

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

Similar models

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

Name
Type
Description | Question | Decode (Coded Value)
Type de données
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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