ID

29525

Description

Study ID: 102871 Clinical Study ID: HZC102871 Study Title:HZC102871: A 52-week efficacy and safety study to compare the effect of three dosage strengths of Fluticasone Furoate/GW642444 Inhalation Powder with GW642444 on the Annual Rate of Exacerbations in Subjects with Chronic Obstructive Pulmonary Disease (COPD) Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01009463 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: fluticasone furoate Trade Name: Veramyst,Avamys,Allermist Study Indication: Pulmonary Disease, Chronic Obstructive Documentation part: LOG Status

Keywords

Versions (2)
  1. 3/4/18 3/4/18 -
  2. 4/5/18 4/5/18 -
Copyright Holder

GlaxoSmithKline

Uploaded on

April 5, 2018

DOI

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License

Creative Commons BY-NC 3.0
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GSK Efficacy and safety of Fluticasone on the Annual Rate of Exacerbations in Subjects with Chronic Obstructive Pulmonary Disease (COPD) NCT01009463

English

LOG Status

1 forms  
  1. StudyEvent: ODM
    1. LOG Status
LOG Status
Description

LOG Status

Alias
UMLS CUI-1
C1708728
UMLS CUI-2
C0449438
Were any concomitant medications taken by the subject during the study?
Description

Concomitant medications

Data type

boolean

Alias
UMLS CUI [1]
C2347852
Did the subject experience any non-serious adverse events during the study?
Description

non-serious adverse event

Data type

boolean

Alias
UMLS CUI [1]
C1518404
Did the subject experience any COPD exacerbations?
Description

COPD exacerbations

Data type

boolean

Alias
UMLS CUI [1]
C0740304
Has subject been diagnosed with pneumonia?
Description

pneumonia

Data type

boolean

Alias
UMLS CUI [1]
C0032285
Did the subject have a fracture during the course of the study?
Description

fracture

Data type

boolean

Alias
UMLS CUI [1]
C0016658
Did any Novel Dry Powder Inhaler device(s) supplied to the subject malfunction during the course of the study?
Description

device malfunction

Data type

boolean

Alias
UMLS CUI [1]
C0025080
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Similar models

LOG Status

1 forms
  1. StudyEvent: ODM
    1. LOG Status
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
LOG Status
C1708728 (UMLS CUI-1)
C0449438 (UMLS CUI-2)
Concomitant medications
Item
Were any concomitant medications taken by the subject during the study?
boolean
C2347852 (UMLS CUI [1])
non-serious adverse event
Item
Did the subject experience any non-serious adverse events during the study?
boolean
C1518404 (UMLS CUI [1])
COPD exacerbations
Item
Did the subject experience any COPD exacerbations?
boolean
C0740304 (UMLS CUI [1])
pneumonia
Item
Has subject been diagnosed with pneumonia?
boolean
C0032285 (UMLS CUI [1])
fracture
Item
Did the subject have a fracture during the course of the study?
boolean
C0016658 (UMLS CUI [1])
device malfunction
Item
Did any Novel Dry Powder Inhaler device(s) supplied to the subject malfunction during the course of the study?
boolean
C0025080 (UMLS CUI [1])
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