ID

22744

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 #: FVF4170g 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

Versies (1)
  1. 11-06-17 11-06-17 -
Houder van rechten

Genentech, Inc.

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11 juni 2017

DOI

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Licentie

Creative Commons BY-NC 3.0
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CONCURRENT OCULAR PROCEDURES (DAY 0 - MONTH 12) CRFs Roche FVF4170G Macular Edema NCT00473382

Engels

CONCURRENT OCULAR PROCEDURES (DAY 0 - MONTH 12) CRFs Roche FVF4170G Macular Edema NCT00473382

1 Formulieren  
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
CONCURRENT OCULAR PROCEDURES (DAY 0 - MONTH 12)
Beschrijving

CONCURRENT OCULAR PROCEDURES (DAY 0 - MONTH 12)

Any concurrent ocular procedures performed other than FOCAL, GRID, and Pan Retinal Photocoagulation (PRP) Laser?
Beschrijving

If Yes, complete below.

Datatype

boolean

Alias
UMLS CUI [1]
C0196950
Procedure
Beschrijving

Procedure

Line Number
Beschrijving

LINE_NUMBER [LN]

Datatype

integer

Alias
UMLS CUI [1,1]
C0449788
UMLS CUI [1,2]
C0087111
Name of Ocular Procedure
Beschrijving

THERAPY_NAME [THPNM]

Datatype

text

Alias
UMLS CUI [1]
C0196950
Procedure Date
Beschrijving

PROCEDURE_DT [PRDT]

Datatype

date

Maateenheden
  • DD/MMM/YY
Alias
UMLS CUI [1]
C2584899
DD/MMM/YY
Right Eye
Beschrijving

EYE [EYE]

Datatype

boolean

Alias
UMLS CUI [1]
C0229089
Left Eye
Beschrijving

EYE [EYE]

Datatype

boolean

Alias
UMLS CUI [1]
C0229090
Disease Category Code
Beschrijving

THERAPY_TYPE [THPTYP]

Datatype

integer

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0805701
Underlying Diagnosis / Indication
Beschrijving

DIAGNOSIS [DIAG]

Datatype

text

Alias
UMLS CUI [1]
C0011900
Procedure Outcome Stable?
Beschrijving

CLINICAL_ASSESSMENT [CLNAS]

Datatype

boolean

Alias
UMLS CUI [1]
C0205360
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Similar models

CONCURRENT OCULAR PROCEDURES (DAY 0 - MONTH 12) CRFs Roche FVF4170G Macular Edema NCT00473382

1 Formulieren
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
CONCURRENT OCULAR PROCEDURES (DAY 0 - MONTH 12)
ANY_RECORDS [ANYREC]
Item
Any concurrent ocular procedures performed other than FOCAL, GRID, and Pan Retinal Photocoagulation (PRP) Laser?
boolean
C0196950 (UMLS CUI [1])
Item Group
Procedure
LINE_NUMBER [LN]
Item
Line Number
integer
C0449788 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
THERAPY_NAME [THPNM]
Item
Name of Ocular Procedure
text
C0196950 (UMLS CUI [1])
PROCEDURE_DT [PRDT]
Item
Procedure Date
date
C2584899 (UMLS CUI [1])
EYE [EYE]
Item
Right Eye
boolean
C0229089 (UMLS CUI [1])
EYE [EYE]
Item
Left Eye
boolean
C0229090 (UMLS CUI [1])
Item
Disease Category Code
integer
C0012634 (UMLS CUI [1,1])
C0805701 (UMLS CUI [1,2])
EYE_CODE [EYECD]
Code List
Disease Category Code
CL Item
DME Related (1 )
CL Item
Cataract (including post cataract surgery) (2 )
CL Item
Glaucoma (3 )
CL Item
Vitreoretinal Disease (non-AMD) (4 )
CL Item
Diabetic Retinopathy Related (5 )
CL Item
Other (99 )
DIAGNOSIS [DIAG]
Item
Underlying Diagnosis / Indication
text
C0011900 (UMLS CUI [1])
CLINICAL_ASSESSMENT [CLNAS]
Item
Procedure Outcome Stable?
boolean
C0205360 (UMLS CUI [1])
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