ID

23390

Beschrijving

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

Trefwoorden

  1. 03-07-17 03-07-17 -
Houder van rechten

Genentech, Inc.

Geüploaded op

3 juli 2017

DOI

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Licentie

Creative Commons BY-NC 3.0

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POST-TREATMENT COUNT FINGERS (MONTH 17) CRFs Roche FVF4168G Macular Edema NCT00473330

POST-TREATMENT COUNT FINGERS (MONTH 17) CRFs Roche FVF4168G Macular Edema NCT00473330

Patient administration
Beschrijving

Patient administration

Subject Number
Beschrijving

PT

Datatype

integer

Alias
UMLS CUI [1]
C2348585
Subject Initials:
Beschrijving

PTINIT

Datatype

text

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

VDT

Datatype

date

Alias
UMLS CUI [1,1]
C1302584
POST-TREATMENT COUNT FINGERS (MONTH 17)
Beschrijving

POST-TREATMENT COUNT FINGERS (MONTH 17)

Assessment Not Done
Beschrijving

vision test

Datatype

boolean

Alias
UMLS CUI [1,1]
C0042793
UMLS CUI [1,2]
C3841220
Count fingers?
Beschrijving

COUNT_FINGERS [CTFGR]

Datatype

integer

Alias
UMLS CUI [1,1]
C0042793
UMLS CUI [1,2]
C0449804
If Yes, maximum distance:
Beschrijving

COUNT_FINGERS

Datatype

integer

Alias
UMLS CUI [1,1]
C0442747
UMLS CUI [1,2]
C0042793
Hand movement?
Beschrijving

HAND_MOVEMENT [HDMVT]

Datatype

integer

Alias
UMLS CUI [1,1]
C0042793
UMLS CUI [1,2]
C0575809
If Yes:
Beschrijving

HAND_MOVEMENT_DESC [HDMVTD]

Datatype

integer

Alias
UMLS CUI [1]
C0575809
Light Perception?
Beschrijving

If hand movement is not measurable, please test:

Datatype

integer

Alias
UMLS CUI [1,1]
C0042793
UMLS CUI [1,2]
C1154616
If Yes:
Beschrijving

LIGHT_PERCEPTION_DES [LIPECD]

Datatype

integer

Alias
UMLS CUI [1]
C0442772

Similar models

POST-TREATMENT COUNT FINGERS (MONTH 17) CRFs Roche FVF4168G Macular Edema NCT00473330

Name
Type
Description | Question | Decode (Coded Value)
Datatype
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 (MONTH 17)
vision test
Item
Assessment Not Done
boolean
C0042793 (UMLS CUI [1,1])
C3841220 (UMLS CUI [1,2])
Item
Count fingers?
integer
C0042793 (UMLS CUI [1,1])
C0449804 (UMLS CUI [1,2])
Code List
Count fingers?
CL Item
Yes (1)
CL Item
No  (2)
CL Item
Not Done (3)
Item
If Yes, maximum distance:
integer
C0442747 (UMLS CUI [1,1])
C0042793 (UMLS CUI [1,2])
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])
C0575809 (UMLS CUI [1,2])
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])
CL Item
With Direction (1)
CL Item
Without Direction (2)
Item
Light Perception?
integer
C0042793 (UMLS CUI [1,1])
C1154616 (UMLS CUI [1,2])
Code List
Light Perception?
CL Item
Yes (1)
CL Item
No  (2)
CL Item
Not Done (3)
Item
If Yes:
integer
C0442772 (UMLS CUI [1])
CL Item
With Projection (1)
CL Item
Without Projection (2)

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