ID

35135

Description

Study ID: 102970 Clinical Study ID: 102970 Study Title: 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: NCT01017952 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: GW642444 Inhalation Powder; FF/GW642444 Inhalation Powder Trade Name: Fluticasone Furoate;Fluticasone Propionate;Fluticasone Propionate/Salmeterol;Salmeterol;Vilanterol Study Indication: Pulmonary Disease, Chronic Obstructive

Keywords

  1. 2/19/19 2/19/19 -
Copyright Holder

GlaxoSmithKline

Uploaded on

February 19, 2019

DOI

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License

Creative Commons BY-NC 3.0

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Effect of Fluticasone Furoate/GW642444 Inhalation Powder With GW642444 on Annual Rate of Exacerbations in Subjects with COPD; 102970

Week 28

  1. StudyEvent: ODM
    1. Week 28
Administrative Data
Description

Administrative Data

Site
Description

Study Site

Data type

text

Alias
UMLS CUI [1]
C2825164
Subject
Description

Clinical trial participant

Data type

text

Alias
UMLS CUI [1]
C1997894
Subject No.
Description

Clinical Trial Subject Unique Identifier

Data type

integer

Alias
UMLS CUI [1]
C2348585
Candidiasis Examination
Description

Candidiasis Examination

Alias
UMLS CUI-1
C0006840
UMLS CUI-2
C4321457
Does the subject have clinical evidence of oropharyngeal candidiasis?
Description

Oropharyngeal Candidiasis, Evidence

Data type

boolean

Alias
UMLS CUI [1,1]
C0919659
UMLS CUI [1,2]
C3887511
Was a culture swab taken?
Description

Oropharyngeal Candidiasis, Taking of swab

Data type

boolean

Alias
UMLS CUI [1,1]
C0919659
UMLS CUI [1,2]
C0563454
Result of culture swab
Description

Oropharyngeal Candidiasis, Taking of swab, Result

Data type

text

Alias
UMLS CUI [1,1]
C0919659
UMLS CUI [1,2]
C0563454
UMLS CUI [1,3]
C1274040
Smoking Status
Description

Smoking Status

Alias
UMLS CUI-1
C1519386
Has the smoking status changed since the last time it was assessed?
Description

Smoking Status, Changed status

Data type

boolean

Alias
UMLS CUI [1,1]
C1519386
UMLS CUI [1,2]
C0443172
If yes, Smoking Status
Description

Smoking Status, Changed status

Data type

text

Alias
UMLS CUI [1,1]
C1519386
UMLS CUI [1,2]
C0443172
Date a change was made
Description

Smoking Status, Changed status, Date in time

Data type

date

Alias
UMLS CUI [1,1]
C1519386
UMLS CUI [1,2]
C0443172
UMLS CUI [1,3]
C0011008
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 Date

Data type

date

Alias
UMLS CUI [1,1]
C1320303
UMLS CUI [1,2]
C2985720
Electronically Transferred Lab Data
Description

Electronically Transferred Lab Data

Alias
UMLS CUI-1
C0022885
Date sample taken
Description

Laboratory Procedures, Sampling, Date in time

Data type

date

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0870078
UMLS CUI [1,3]
C0011008
Not done
Description

Laboratory Procedures, Sampling, Not done

Data type

boolean

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0870078
UMLS CUI [1,3]
C1272696
Liver Events Assessment
Description

Liver Events Assessment

Alias
UMLS CUI-1
C0023884
UMLS CUI-2
C0877248
UMLS CUI-3
C0220825
Have liver chemistry results reached or exceeded protocol-defined investigational product stopping criteria?
Description

Liver, Laboratory Procedures, Stop, Criteria

Data type

boolean

Alias
UMLS CUI [1,1]
C0023884
UMLS CUI [1,2]
C0022885
UMLS CUI [1,3]
C2746065
UMLS CUI [1,4]
C0243161
Subject Withdrawal Status
Description

Subject Withdrawal Status

Alias
UMLS CUI-1
C0422727
UMLS CUI-2
C0449438
Did the subject withdraw at this visit?
Description

Withdrawal by Subject, Visit

Data type

boolean

Alias
UMLS CUI [1,1]
C1710677
UMLS CUI [1,2]
C0545082
Pre-Dose Vital Signs
Description

Pre-Dose Vital Signs

Alias
UMLS CUI-1
C0518766
UMLS CUI-2
C0439565
Blood pressure (systolic)
Description

Systolic Pressure

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
Blood Pressure (diastolic)
Description

Diastolic blood pressure

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1]
C0428883
mmHg
Heart rate
Description

Heart rate

Data type

integer

Measurement units
  • bpm
Alias
UMLS CUI [1]
C0018810
bpm

Similar models

Week 28

  1. StudyEvent: ODM
    1. Week 28
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative Data
Study Site
Item
Site
text
C2825164 (UMLS CUI [1])
Clinical trial participant
Item
Subject
text
C1997894 (UMLS CUI [1])
Clinical Trial Subject Unique Identifier
Item
Subject No.
integer
C2348585 (UMLS CUI [1])
Item Group
Candidiasis Examination
C0006840 (UMLS CUI-1)
C4321457 (UMLS CUI-2)
Oropharyngeal Candidiasis, Evidence
Item
Does the subject have clinical evidence of oropharyngeal candidiasis?
boolean
C0919659 (UMLS CUI [1,1])
C3887511 (UMLS CUI [1,2])
Oropharyngeal Candidiasis, Taking of swab
Item
Was a culture swab taken?
boolean
C0919659 (UMLS CUI [1,1])
C0563454 (UMLS CUI [1,2])
Item
Result of culture swab
text
C0919659 (UMLS CUI [1,1])
C0563454 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,3])
CL Item
Negative (1)
CL Item
Positive (2)
CL Item
Not available (3)
Item Group
Smoking Status
C1519386 (UMLS CUI-1)
Smoking Status, Changed status
Item
Has the smoking status changed since the last time it was assessed?
boolean
C1519386 (UMLS CUI [1,1])
C0443172 (UMLS CUI [1,2])
Item
If yes, Smoking Status
text
C1519386 (UMLS CUI [1,1])
C0443172 (UMLS CUI [1,2])
Code List
If yes, Smoking Status
CL Item
Subject started smoking  (1)
CL Item
Subject stopped smoking (2)
Smoking Status, Changed status, Date in time
Item
Date a change was made
date
C1519386 (UMLS CUI [1,1])
C0443172 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Item Group
Date of Visit/Assessment
C1320303 (UMLS CUI-1)
C2985720 (UMLS CUI-2)
Date of Visit, Assessment Date
Item
Date of Visit/Assessment
date
C1320303 (UMLS CUI [1,1])
C2985720 (UMLS CUI [1,2])
Item Group
Electronically Transferred Lab Data
C0022885 (UMLS CUI-1)
Laboratory Procedures, Sampling, Date in time
Item
Date sample taken
date
C0022885 (UMLS CUI [1,1])
C0870078 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Laboratory Procedures, Sampling, Not done
Item
Not done
boolean
C0022885 (UMLS CUI [1,1])
C0870078 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,3])
Item Group
Liver Events Assessment
C0023884 (UMLS CUI-1)
C0877248 (UMLS CUI-2)
C0220825 (UMLS CUI-3)
Liver, Laboratory Procedures, Stop, Criteria
Item
Have liver chemistry results reached or exceeded protocol-defined investigational product stopping criteria?
boolean
C0023884 (UMLS CUI [1,1])
C0022885 (UMLS CUI [1,2])
C2746065 (UMLS CUI [1,3])
C0243161 (UMLS CUI [1,4])
Item Group
Subject Withdrawal Status
C0422727 (UMLS CUI-1)
C0449438 (UMLS CUI-2)
Withdrawal by Subject, Visit
Item
Did the subject withdraw at this visit?
boolean
C1710677 (UMLS CUI [1,1])
C0545082 (UMLS CUI [1,2])
Item Group
Pre-Dose Vital Signs
C0518766 (UMLS CUI-1)
C0439565 (UMLS CUI-2)
Systolic Pressure
Item
Blood pressure (systolic)
integer
C0871470 (UMLS CUI [1])
Diastolic blood pressure
Item
Blood Pressure (diastolic)
integer
C0428883 (UMLS CUI [1])
Heart rate
Item
Heart rate
integer
C0018810 (UMLS CUI [1])

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