ID

22601

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

Versies (2)
  1. 08-06-17 08-06-17 -
  2. 08-06-17 08-06-17 -
Houder van rechten

Genentech, Inc.

Geüploaded op

8 juni 2017

DOI

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Licentie

Creative Commons BY-NC 3.0
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ALCOHOL / TOBACCO USE HISTORY (SCREENING) CRFs Roche FVF4168G Macular Edema NCT00473330

Engels

ALCOHOL / TOBACCO USE HISTORY (SCREENING) CRFs Roche FVF4168G Macular Edema NCT00473330

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
ALCOHOL / TOBACCO USE HISTORY (SCREENING)
Beschrijving

ALCOHOL / TOBACCO USE HISTORY (SCREENING)

Smoking cigarettes currently:
Beschrijving

Indicate overall tobacco use (check one only).

Datatype

boolean

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

TOBACCO_QUANTITY [TOBQTY1]

Datatype

float

Alias
UMLS CUI [1]
C3694145
Year started:
Beschrijving

TOBACCO_USE_BEGIN [TOBEG1]

Datatype

integer

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

TOBACCO_USE_END [TOBEND]

Datatype

boolean

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

TOBACCO_USE_BEGIN [TOBEG2]

Datatype

integer

Alias
UMLS CUI [1]
C0425315
Year stopped:
Beschrijving

TOBACCO_USE_END [TOBEND]

Datatype

integer

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

TOBACCO_QUANTITY [TOBQTY2]

Datatype

float

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

pipe or cigars

Datatype

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
Beschrijving

pipe or cigars in the past

Datatype

boolean

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

NEVERSMOKED

Datatype

boolean

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

Indicate overall alcohol use (check one only).

Datatype

boolean

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

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

Datatype

integer

Alias
UMLS CUI [1]
C0001948
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Similar models

ALCOHOL / TOBACCO USE HISTORY (SCREENING) CRFs Roche FVF4168G Macular Edema NCT00473330

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
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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