ID

35135

Beschreibung

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

Stichworte

Versionen (1)
  1. 19.02.19 19.02.19 -
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GlaxoSmithKline

Hochgeladen am

19. Februar 2019

DOI

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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

Englisch

Week 28

1 Formulare  
  1. StudyEvent: ODM
    1. Week 28
Administrative Data
Beschreibung

Administrative Data

Site
Beschreibung

Study Site

Datentyp

text

Alias
UMLS CUI [1]
C2825164
Subject
Beschreibung

Clinical trial participant

Datentyp

text

Alias
UMLS CUI [1]
C1997894
Subject No.
Beschreibung

Clinical Trial Subject Unique Identifier

Datentyp

integer

Alias
UMLS CUI [1]
C2348585
Candidiasis Examination
Beschreibung

Candidiasis Examination

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

Oropharyngeal Candidiasis, Evidence

Datentyp

boolean

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

Oropharyngeal Candidiasis, Taking of swab

Datentyp

boolean

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

Oropharyngeal Candidiasis, Taking of swab, Result

Datentyp

text

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

Smoking Status

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

Smoking Status, Changed status

Datentyp

boolean

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

Smoking Status, Changed status

Datentyp

text

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

Smoking Status, Changed status, Date in time

Datentyp

date

Alias
UMLS CUI [1,1]
C1519386
UMLS CUI [1,2]
C0443172
UMLS CUI [1,3]
C0011008
Date of Visit/Assessment
Beschreibung

Date of Visit/Assessment

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

Date of Visit, Assessment Date

Datentyp

date

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

Electronically Transferred Lab Data

Alias
UMLS CUI-1
C0022885
Date sample taken
Beschreibung

Laboratory Procedures, Sampling, Date in time

Datentyp

date

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

Laboratory Procedures, Sampling, Not done

Datentyp

boolean

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

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?
Beschreibung

Liver, Laboratory Procedures, Stop, Criteria

Datentyp

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
Beschreibung

Subject Withdrawal Status

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

Withdrawal by Subject, Visit

Datentyp

boolean

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

Pre-Dose Vital Signs

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

Systolic Pressure

Datentyp

integer

Maßeinheiten
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
Blood Pressure (diastolic)
Beschreibung

Diastolic blood pressure

Datentyp

integer

Maßeinheiten
  • mmHg
Alias
UMLS CUI [1]
C0428883
mmHg
Heart rate
Beschreibung

Heart rate

Datentyp

integer

Maßeinheiten
  • bpm
Alias
UMLS CUI [1]
C0018810
bpm
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Ähnliche Modelle

Week 28

1 Formulare
  1. StudyEvent: ODM
    1. Week 28
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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])
Oropharyngeal Candidiasis, Taking of swab, Result
Code List
Result of culture swab
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])
Smoking Status, Changed status
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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