ID

22598

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 (2)
  1. 6/8/17 6/8/17 -
  2. 6/8/17 6/8/17 -
Uploaded on

June 8, 2017

DOI

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License

Creative Commons BY-NC 3.0 Legacy
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CRFs Roche FVF4168G Macular Edema NCT00473330

English

STUDY EYE SELECTION (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
ALCOHOL / TOBACCO USE HISTORY (SCREENING)
Description

ALCOHOL / TOBACCO USE HISTORY (SCREENING)

Smoking cigarettes currently:
Description

Indicate overall tobacco use (check one only).

Data type

boolean

Alias
UMLS CUI [1]
C0543414
Packs / day:
Description

TOBACCO_QUANTITY [TOBQTY1]

Data type

float

Alias
UMLS CUI [1]
C3694145
Year started:
Description

TOBACCO_USE_BEGIN [TOBEG1]

Data type

integer

Alias
UMLS CUI [1]
C0425315
Stopped smoking cigarettes:
Description

TOBACCO_USE_END [TOBEND]

Data type

boolean

Alias
UMLS CUI [1,1]
C0425310
Year started:
Description

TOBACCO_USE_BEGIN [TOBEG2]

Data type

integer

Alias
UMLS CUI [1]
C0425315
Year stopped:
Description

TOBACCO_USE_END [TOBEND]

Data type

integer

Alias
UMLS CUI [1]
C0425310
Packs / day when smoked:
Description

TOBACCO_QUANTITY [TOBQTY2]

Data type

float

Alias
UMLS CUI [1]
C3694145
Smoke pipe or cigars currently
Description

pipe or cigars

Data type

boolean

Alias
UMLS CUI [1,1]
C3241966
UMLS CUI [1,2]
C0240766
UMLS CUI [2,1]
C3241966
UMLS CUI [2,2]
C0337666
Smoked pipe or cigars in the past
Description

pipe or cigars in the past

Data type

boolean

Alias
UMLS CUI [1]
C0240766
UMLS CUI [2]
C0337666
Never smoked
Description

NEVERSMOKED

Data type

boolean

Alias
UMLS CUI [1]
C0425293
Do not drink alcohol currently
Description

Indicate overall alcohol use (check one only).

Data type

boolean

Alias
UMLS CUI [1,1]
C0001948
Currently do drink (even occasionally), how often:
Description

*= A drink is one beer, one glass of wine, one shot of liquor or one mixed drink.

Data type

integer

Alias
UMLS CUI [1]
C0001948
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Similar models

STUDY EYE SELECTION (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
ALCOHOL / TOBACCO USE HISTORY (SCREENING)
TOBACCO_USE_HX
Item
Smoking cigarettes currently:
boolean
C0543414 (UMLS CUI [1])
TOBACCO_QUANTITY [TOBQTY1]
Item
Packs / day:
float
C3694145 (UMLS CUI [1])
TOBACCO_USE_BEGIN [TOBEG1]
Item
Year started:
integer
C0425315 (UMLS CUI [1])
TOBACCO_USE_END [TOBEND]
Item
Stopped smoking cigarettes:
boolean
C0425310 (UMLS CUI [1,1])
TOBACCO_USE_BEGIN [TOBEG2]
Item
Year started:
integer
C0425315 (UMLS CUI [1])
TOBACCO_USE_END [TOBEND]
Item
Year stopped:
integer
C0425310 (UMLS CUI [1])
TOBACCO_QUANTITY [TOBQTY2]
Item
Packs / day when smoked:
float
C3694145 (UMLS CUI [1])
pipe or cigars
Item
Smoke pipe or cigars currently
boolean
C3241966 (UMLS CUI [1,1])
C0240766 (UMLS CUI [1,2])
C3241966 (UMLS CUI [2,1])
C0337666 (UMLS CUI [2,2])
pipe or cigars in the past
Item
Smoked pipe or cigars in the past
boolean
C0240766 (UMLS CUI [1])
C0337666 (UMLS CUI [2])
NEVERSMOKED
Item
Never smoked
boolean
C0425293 (UMLS CUI [1])
ALCOHOL_USE_HX [ALCHX]
Item
Do not drink alcohol currently
boolean
C0001948 (UMLS CUI [1,1])
Item
Currently do drink (even occasionally), how often:
integer
C0001948 (UMLS CUI [1])
COUNT_FINGERS [CTFGR]
Code List
Currently do drink (even occasionally), how often:
CL Item
Yes (1)
CL Item
No  (2)
CL Item
Not Done (3)
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