ID

33361

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 (2)
  1. 11/6/18 11/6/18 -
  2. 12/6/18 12/6/18 -
Copyright Holder

GSK group of companies

Uploaded on

December 6, 2018

DOI

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License

Creative Commons BY-NC 3.0
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A Parallel Group Study of Fluticasone Furoate/Vilanterol in Subjects with Asthma - 106837

English

Run-In Failure Report

1 forms  
  1. StudyEvent: ODM
    1. Run-In Failure Report
Run-In Failure
Description

Run-In Failure

Alias
UMLS CUI-1
C1710476
Was this subject a run-in failure?
Description

Was this subject a run-in failure?

Data type

boolean

Alias
UMLS CUI [1,1]
C1710476
UMLS CUI [1,2]
C0681850
If YES, complete run-in reason
Description

If YES, complete run-in reason

Data type

text

Alias
UMLS CUI [1,1]
C1710476
UMLS CUI [1,2]
C0392360
If INVESTIGATOR DISCRETION, specify
Description

Select this reason if none of the other primary reasons are appropriate

Data type

text

Alias
UMLS CUI [1,1]
C0008961
UMLS CUI [1,2]
C0022423
UMLS CUI [1,3]
C2348235
If WITHDREW CONSENT, specify
Description

Select this reason if none of the other primary reasons are appropriate

Data type

text

Alias
UMLS CUI [1,1]
C1707492
UMLS CUI [1,2]
C2348235
Run-In Failure Date
Description

Run-In Failure Date

Data type

date

Alias
UMLS CUI [1,1]
C1710476
UMLS CUI [1,2]
C0011008
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Similar models

Run-In Failure Report

1 forms
  1. StudyEvent: ODM
    1. Run-In Failure Report
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Run-In Failure
C1710476 (UMLS CUI-1)
Was this subject a run-in failure?
Item
Was this subject a run-in failure?
boolean
C1710476 (UMLS CUI [1,1])
C0681850 (UMLS CUI [1,2])
Item
If YES, complete run-in reason
text
C1710476 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
If YES, complete run-in reason
Code List
If YES, complete run-in reason
CL Item
Adverse event (record details on the Non-Serious Adverse Events or Serious Adverse Events forms as appropriate) (1)
CL Item
Protocol Deviation (2)
CL Item
Study closed/terminated (3)
CL Item
Lost to Follow-up (4)
CL Item
Investigator discretion (5)
CL Item
Withdrew consent (6)
CL Item
Did not meet continuation criteria (7)
If INVESTIGATOR DISCRETION, specify
Item
If INVESTIGATOR DISCRETION, specify
text
C0008961 (UMLS CUI [1,1])
C0022423 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
If WITHDREW CONSENT, specify
Item
If WITHDREW CONSENT, specify
text
C1707492 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
Run-In Failure Date
Item
Run-In Failure Date
date
C1710476 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
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