ID

40701

Description

Study ID: 106837 Clinical Study ID: HZA106837 Study Title: A Long-Term, Randomized, Double-Blind, Parallel Group Study of Fluticasone Furoate/GW642444 Inhalation Powder Once-Daily and Fluticasone Furoate Inhalation Powder Once-Daily in Subjects with Asthma Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01086384 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: fluticasone furoate/vilanterol Trade Name: Relvar Study Indication: Asthma

Keywords

Versions (3)
  1. 10/30/18 10/30/18 -
  2. 11/26/18 11/26/18 -
  3. 4/30/20 4/30/20 - Sarah Riepenhausen
Copyright Holder

GSK group of companies

Uploaded on

April 30, 2020

DOI

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License

Creative Commons BY-NC 4.0
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A Parallel Group Study of Fluticasone Furoate/Vilanterol in Subjects with Asthma - 106837

English

Administrative and Demography Form

1 forms  
Inform Screening
Description

Inform Screening

Alias
UMLS CUI-1
C1710477
Subject initials
Description

Subject initials

Data type

text

Alias
UMLS CUI [1,1]
C1997894
UMLS CUI [1,2]
C2986440
Date of Birth
Description

Or Age in years

Data type

date

Alias
UMLS CUI [1]
C0421451
Age in years
Description

Or date of birth. NOTE: Age should be completed for subjects at German sites only. For all other subjects complete Date of Birth.

Data type

integer

Alias
UMLS CUI [1]
C0001779
Are you willing to tell us how you learned about this study?
Description

Are you willing to tell us how you learned about this study?

Data type

boolean

Alias
UMLS CUI [1]
C0242800
If you are willing to tell us how you learned about this study, how did the subject initially hear about the study or how was the subject recruted into the study?
Description

Patient recruitment

Data type

integer

Alias
UMLS CUI [1]
C0242800
If other recruitement, please specify
Description

If other recruitement, please specify

Data type

text

Alias
UMLS CUI [1,1]
C0242800
UMLS CUI [1,2]
C0205394
UMLS CUI [1,3]
C2348235
Inform Enrollment
Description

Inform Enrollment

Alias
UMLS CUI-1
C1552002
UMLS CUI-2
C4041024
Subject number
Description

Subject number

Data type

text

Alias
UMLS CUI [1]
C2348585
Date of Visit/ Assessment
Description

Date of Visit/ Assessment

Alias
UMLS CUI-1
C1320303
UMLS CUI-2
C2985720
Date of Visit/ Assessment
Description

Date of Visit/ Assessment

Data type

date

Alias
UMLS CUI [1,1]
C1320303
UMLS CUI [1,2]
C2985720
Subject Identification
Description

Subject Identification

Alias
UMLS CUI-1
C2348585
Subject Identification
Description

Subject Identification

Data type

text

Alias
UMLS CUI [1]
C2348585
Demography Data
Description

Demography Data

Alias
UMLS CUI-1
C0011298
Date of birth
Description

Or age in years

Data type

date

Alias
UMLS CUI [1]
C0421451
Age in years
Description

Age should be completed for subjects at German sites only. For all other subjects complete Date of Birth.

Data type

integer

Alias
UMLS CUI [1]
C0001779
Sex
Description

Sex

Data type

text

Alias
UMLS CUI [1]
C0079399
Ethnicity
Description

Ethnicity

Data type

integer

Alias
UMLS CUI [1]
C0015031
Geographic Ancestry
Description

check all that apply

Data type

integer

Alias
UMLS CUI [1]
C3841890
Subject Status
Description

Subject Status

Data type

text

Alias
UMLS CUI [1,1]
C0681850
UMLS CUI [1,2]
C0449438
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Similar models

Administrative and Demography Form

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Inform Screening
C1710477 (UMLS CUI-1)
Subject initials
Item
Subject initials
text
C1997894 (UMLS CUI [1,1])
C2986440 (UMLS CUI [1,2])
Date of Birth
Item
Date of Birth
date
C0421451 (UMLS CUI [1])
Age in years
Item
Age in years
integer
C0001779 (UMLS CUI [1])
Are you willing to tell us how you learned about this study?
Item
Are you willing to tell us how you learned about this study?
boolean
C0242800 (UMLS CUI [1])
Item
If you are willing to tell us how you learned about this study, how did the subject initially hear about the study or how was the subject recruted into the study?
integer
C0242800 (UMLS CUI [1])
Patient recruitment
Code List
If you are willing to tell us how you learned about this study, how did the subject initially hear about the study or how was the subject recruted into the study?
CL Item
Prior Clinic Patient (1)
CL Item
Physician or Colleague Referral (2)
CL Item
Word of Mouth (3)
CL Item
Posters, Flyers or Brochures (4)
CL Item
Community Outreach (5)
CL Item
Internet/ Website/ Email (6)
CL Item
Local Advertising (7)
CL Item
Central/ National Media Campaign (8)
CL Item
Call Center (9)
CL Item
Other (10)
If other recruitement, please specify
Item
If other recruitement, please specify
text
C0242800 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
Item Group
Inform Enrollment
C1552002 (UMLS CUI-1)
C4041024 (UMLS CUI-2)
Subject number
Item
Subject number
text
C2348585 (UMLS CUI [1])
Item Group
Date of Visit/ Assessment
C1320303 (UMLS CUI-1)
C2985720 (UMLS CUI-2)
Date of Visit/ Assessment
Item
Date of Visit/ Assessment
date
C1320303 (UMLS CUI [1,1])
C2985720 (UMLS CUI [1,2])
Item Group
Subject Identification
C2348585 (UMLS CUI-1)
Subject Identification
Item
Subject Identification
text
C2348585 (UMLS CUI [1])
Item Group
Demography Data
C0011298 (UMLS CUI-1)
Date of birth
Item
Date of birth
date
C0421451 (UMLS CUI [1])
Age in years
Item
Age in years
integer
C0001779 (UMLS CUI [1])
Item
Sex
text
C0079399 (UMLS CUI [1])
Sex
Code List
Sex
CL Item
Male  (M)
CL Item
Female (F)
Item
Ethnicity
integer
C0015031 (UMLS CUI [1])
Ethnicity
Code List
Ethnicity
CL Item
Hispanic or Latino (1)
CL Item
Not Hispanic or Latino (2)
Item
Geographic Ancestry
integer
C3841890 (UMLS CUI [1])
Geographic Ancestry
Code List
Geographic Ancestry
CL Item
African American/African Heritage (1)
CL Item
American Indian or Alaskan Native (2)
CL Item
Asian - Central/South Asian Heritage (3)
CL Item
Asian - East Asian Heritage (4)
CL Item
Asian - Japanese Heritage (5)
CL Item
Asian - South East Asian Heritage (6)
CL Item
Native Hawaiian or Other Pacific Islander (7)
CL Item
White - Arabic/North African Heritage (8)
CL Item
White - White/Caucsian/European Heritage (9)
Subject Status
Item
Subject Status
text
C0681850 (UMLS CUI [1,1])
C0449438 (UMLS CUI [1,2])
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