ID

22689

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 (1)
  1. 09/06/2017 09/06/2017 -
Détendeur de droits

Genentech, Inc.

Téléchargé le

9 juin 2017

DOI

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Creative Commons BY-NC 3.0
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POST-TREATMENT COUNT FINGERS DAY 0 CRFs Roche FVF4168G Macular Edema NCT00473330

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POST-TREATMENT COUNT FINGERS DAY 0 CRFs Roche FVF4168G Macular Edema NCT00473330

1 Formulaires  
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
POST-TREATMENT COUNT FINGERS (DAY 0)
Description

POST-TREATMENT COUNT FINGERS (DAY 0)

Assessment Not Done
Description

NOT_DONE [NOTDN]

Type de données

boolean

Alias
UMLS CUI [1,1]
C0042793
UMLS CUI [1,2]
C1272696
Test Date:
Description

EXAM_DT [EXMDT]

Type de données

date

Alias
UMLS CUI [1,1]
C0042793
UMLS CUI [1,2]
C0011008
Test Time:
Description

EXAM_TIME [EXMTM]

Type de données

time

Unités de mesure
  • 24 hr clock
Alias
UMLS CUI [1,1]
C0042793
UMLS CUI [1,2]
C0040223
24 hr clock
Count fingers?
Description

COUNT_FINGERS [CTFGR]

Type de données

integer

Alias
UMLS CUI [1,1]
C0042793
UMLS CUI [1,2]
C0229090
UMLS CUI [1,3]
C0449804
If Yes, maximum distance:
Description

MAXIMUM_DISTANCE [MAXDST]

Type de données

integer

Alias
UMLS CUI [1,1]
C0442747
UMLS CUI [1,2]
C0042793
UMLS CUI [1,3]
C0229090
Hand movement?
Description

HAND_MOVEMENT [HDMVT]

Type de données

integer

Alias
UMLS CUI [1,1]
C0042793
UMLS CUI [1,2]
C0229090
UMLS CUI [1,3]
C0575809
If Yes:
Description

HAND_MOVEMENT_DESC [HDMVTD]

Type de données

integer

Alias
UMLS CUI [1,1]
C0575809
UMLS CUI [1,2]
C0229090
Light Perception?
Description

If hand movement is not measurable, please test:

Type de données

integer

Alias
UMLS CUI [1,1]
C0042793
UMLS CUI [1,2]
C0229090
UMLS CUI [1,3]
C1154616
If Yes:
Description

LIGHT_PERCEPTION_DES [LIPECD]

Type de données

integer

Alias
UMLS CUI [1,1]
C0442772
UMLS CUI [1,2]
C0229090
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Similar models

POST-TREATMENT COUNT FINGERS DAY 0 CRFs Roche FVF4168G Macular Edema NCT00473330

1 Formulaires
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
POST-TREATMENT COUNT FINGERS (DAY 0)
NOT_DONE [NOTDN]
Item
Assessment Not Done
boolean
C0042793 (UMLS CUI [1,1])
C1272696 (UMLS CUI [1,2])
EXAM_DT [EXMDT]
Item
Test Date:
date
C0042793 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
EXAM_TIME [EXMTM]
Item
Test Time:
time
C0042793 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Item
Count fingers?
integer
C0042793 (UMLS CUI [1,1])
C0229090 (UMLS CUI [1,2])
C0449804 (UMLS CUI [1,3])
MAXIMUM_DISTANCE [MAXDST]
Code List
Count fingers?
CL Item
4 ft (1)
CL Item
2 ft (2)
CL Item
1 ft (3)
Item
If Yes, maximum distance:
integer
C0442747 (UMLS CUI [1,1])
C0042793 (UMLS CUI [1,2])
C0229090 (UMLS CUI [1,3])
MAXIMUM_DISTANCE [MAXDST]
Code List
If Yes, maximum distance:
CL Item
4 ft (1)
CL Item
2 ft (2)
CL Item
1 ft (3)
Item
Hand movement?
integer
C0042793 (UMLS CUI [1,1])
C0229090 (UMLS CUI [1,2])
C0575809 (UMLS CUI [1,3])
COUNT_FINGERS [CTFGR]
Code List
Hand movement?
CL Item
Yes (1)
CL Item
No  (2)
CL Item
Not Done (3)
Item
If Yes:
integer
C0575809 (UMLS CUI [1,1])
C0229090 (UMLS CUI [1,2])
HAND_MOVEMENT_DESC [HDMVTD]
Code List
If Yes:
CL Item
With Direction (1)
CL Item
Without Direction (2)
Item
Light Perception?
integer
C0042793 (UMLS CUI [1,1])
C0229090 (UMLS CUI [1,2])
C1154616 (UMLS CUI [1,3])
MAXIMUM_DISTANCE [MAXDST]
Code List
Light Perception?
CL Item
4 ft (1)
CL Item
2 ft (2)
CL Item
1 ft (3)
Item
If Yes:
integer
C0442772 (UMLS CUI [1,1])
C0229090 (UMLS CUI [1,2])
LIGHT_PERCEPTION [LIPEC]
Code List
If Yes:
CL Item
With Projection (1)
CL Item
Without Projection (2)
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