ID

22599

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

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License

Creative Commons BY-NC 3.0
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PRIOR OCULAR THERAPIES AND PROCEDURES (SCREENING) CRFs Roche FVF4168G Macular Edema NCT00473330

English

PRIOR OCULAR THERAPIES AND PROCEDURES (SCREENING) 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
PRIOR OCULAR THERAPIES AND PROCEDURES (SCREENING)
Description

PRIOR OCULAR THERAPIES AND PROCEDURES (SCREENING)

Any prior ocular therapies?
Description

If Yes, complete below.

Data type

boolean

Alias
UMLS CUI [1,1]
C0695410
UMLS CUI [1,2]
C1514463
Name of Therapy
Description

Name of Therapy

Line Number
Description

LINE_NUMBER [LN]

Data type

integer

Alias
UMLS CUI [1,1]
C0449788
UMLS CUI [1,2]
C0087111
Name of Therapy
Description

THERAPY_NAME [THPNM]

Data type

text

Alias
UMLS CUI [1]
C0087111
Therapy Code
Description

THERAPY_TYPE [THPTYP]

Data type

integer

Alias
UMLS CUI [1,1]
C0237753
UMLS CUI [1,2]
C0087111
Eye
Description

EYE [EYE]

Data type

integer

Alias
UMLS CUI [1]
C0015392
Procedure / Start Date
Description

START_DT [STRDT]

Data type

date

Measurement units
  • DD/MMM/YY
Alias
UMLS CUI [1]
C0808070
DD/MMM/YY
Procedure / Stop Date
Description

STOP_DT [STPDT]

Data type

date

Measurement units
  • DD/MMM/YY
Alias
UMLS CUI [1]
C0806020
DD/MMM/YY
Check if ongoing
Description

ONGOING [ONGO]

Data type

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0549178
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Similar models

PRIOR OCULAR THERAPIES AND PROCEDURES (SCREENING) 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
PRIOR OCULAR THERAPIES AND PROCEDURES (SCREENING)
ANY_RECORDS [ANYREC]
Item
Any prior ocular therapies?
boolean
C0695410 (UMLS CUI [1,1])
C1514463 (UMLS CUI [1,2])
Item Group
Name of Therapy
LINE_NUMBER [LN]
Item
Line Number
integer
C0449788 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
THERAPY_NAME [THPNM]
Item
Name of Therapy
text
C0087111 (UMLS CUI [1])
Item
Therapy Code
integer
C0237753 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
HAND_MOVEMENT_DESC [HDMVTD]
Code List
Therapy Code
CL Item
With Direction (1)
CL Item
Without Direction (2)
Item
Eye
integer
C0015392 (UMLS CUI [1])
LIGHT_PERCEPTION [LIPEC]
Code List
Eye
CL Item
With Projection (1)
CL Item
Without Projection (2)
START_DT [STRDT]
Item
Procedure / Start Date
date
C0808070 (UMLS CUI [1])
STOP_DT [STPDT]
Item
Procedure / Stop Date
date
C0806020 (UMLS CUI [1])
ONGOING [ONGO]
Item
Check if ongoing
boolean
C0087111 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
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