ID

35137

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

Versions (1)
  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

English

Week 36

1 forms  
  1. StudyEvent: ODM
    1. Week 36
Administrative Data
Description

Administrative Data

Site
Description

Study Site

Data type

text

Alias
UMLS CUI [1]
C2825164 (Study Site)
Subject
Description

Clinical trial participant

Data type

text

Alias
UMLS CUI [1]
C1997894 (Clinical trial participant (person))
SNOMED
428024001
Subject No.
Description

Clinical Trial Subject Unique Identifier

Data type

integer

Alias
UMLS CUI [1]
C2348585 (Clinical Trial Subject Unique Identifier)
Candidiasis Examination
Description

Candidiasis Examination

Alias
UMLS CUI-1
C0006840 (Candidiasis)
SNOMED
78048006
UMLS CUI-2
C4321457 (Examination)
Does the subject have clinical evidence of oropharyngeal candidiasis?
Description

Oropharyngeal Candidiasis, Evidence

Data type

boolean

Alias
UMLS CUI [1,1]
C0919659 (Oropharyngeal candidiasis)
UMLS CUI [1,2]
C3887511 (Evidence)
Was a culture swab taken?
Description

Oropharyngeal Candidiasis, Taking of swab

Data type

boolean

Alias
UMLS CUI [1,1]
C0919659 (Oropharyngeal candidiasis)
UMLS CUI [1,2]
C0563454 (Taking of swab)
SNOMED
285570007
Result of culture swab
Description

Oropharyngeal Candidiasis, Taking of swab, Result

Data type

text

Alias
UMLS CUI [1,1]
C0919659 (Oropharyngeal candidiasis)
UMLS CUI [1,2]
C0563454 (Taking of swab)
SNOMED
285570007
UMLS CUI [1,3]
C1274040 (Result)
SNOMED
394617004
Smoking Status
Description

Smoking Status

Alias
UMLS CUI-1
C1519386 (Smoking Status)
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 (Smoking Status)
UMLS CUI [1,2]
C0443172 (Changed status)
SNOMED
263703002
If yes, Smoking Status
Description

Smoking Status, Changed status

Data type

text

Alias
UMLS CUI [1,1]
C1519386 (Smoking Status)
UMLS CUI [1,2]
C0443172 (Changed status)
SNOMED
263703002
Date a change was made
Description

Smoking Status, Changed status, Date in time

Data type

date

Alias
UMLS CUI [1,1]
C1519386 (Smoking Status)
UMLS CUI [1,2]
C0443172 (Changed status)
SNOMED
263703002
UMLS CUI [1,3]
C0011008 (Date in time)
SNOMED
410671006
Date of Visit/Assessment
Description

Date of Visit/Assessment

Alias
UMLS CUI-1
C1320303 (Date of visit)
SNOMED
406543005
UMLS CUI-2
C2985720 (Assessment Date)
Date of Visit/Assessment
Description

Date of Visit, Assessment Date

Data type

date

Alias
UMLS CUI [1,1]
C1320303 (Date of visit)
SNOMED
406543005
UMLS CUI [1,2]
C2985720 (Assessment Date)
Electronically Transferred Lab Data
Description

Electronically Transferred Lab Data

Alias
UMLS CUI-1
C0022885 (Laboratory Procedures)
SNOMED
269814003
Date sample taken
Description

Laboratory Procedures, Sampling, Date in time

Data type

date

Alias
UMLS CUI [1,1]
C0022885 (Laboratory Procedures)
SNOMED
269814003
UMLS CUI [1,2]
C0870078 (Sampling)
UMLS CUI [1,3]
C0011008 (Date in time)
SNOMED
410671006
Not done
Description

Laboratory Procedures, Sampling, Not done

Data type

boolean

Alias
UMLS CUI [1,1]
C0022885 (Laboratory Procedures)
SNOMED
269814003
UMLS CUI [1,2]
C0870078 (Sampling)
UMLS CUI [1,3]
C1272696 (Not Done)
SNOMED
385660001
Liver Events Assessment
Description

Liver Events Assessment

Alias
UMLS CUI-1
C0023884 (Liver)
SNOMED
10200004
LOINC
LP29289-3
UMLS CUI-2
C0877248 (Adverse event)
LOINC
MTHU014542
UMLS CUI-3
C0220825 (Evaluation)
LOINC
LP36377-7
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 (Liver)
SNOMED
10200004
LOINC
LP29289-3
UMLS CUI [1,2]
C0022885 (Laboratory Procedures)
SNOMED
269814003
UMLS CUI [1,3]
C2746065 (Stop (qualifier value))
SNOMED
422117008
UMLS CUI [1,4]
C0243161 (criteria)
Subject Withdrawal Status
Description

Subject Withdrawal Status

Alias
UMLS CUI-1
C0422727 (Patient withdrawn from trial)
SNOMED
185924006
UMLS CUI-2
C0449438 (Status)
SNOMED
263490005
LOINC
LP73412-6
Did the subject withdraw at this visit?
Description

Withdrawal by Subject, Visit

Data type

boolean

Alias
UMLS CUI [1,1]
C1710677 (Withdrawal by Subject)
UMLS CUI [1,2]
C0545082 (Visit)
Pre-Dose Vital Signs
Description

Pre-Dose Vital Signs

Alias
UMLS CUI-1
C0518766 (Vital signs)
LOINC
LP30605-7
UMLS CUI-2
C0439565 (Pre-dose)
SNOMED
255235001
Blood pressure (systolic)
Description

Systolic Pressure

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1]
C0871470 (Systolic Pressure)
SNOMED
271649006
mmHg
Blood Pressure (diastolic)
Description

Diastolic blood pressure

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1]
C0428883 (Diastolic blood pressure)
SNOMED
271650006
mmHg
Heart rate
Description

Heart rate

Data type

integer

Measurement units
  • bpm
Alias
UMLS CUI [1]
C0018810 (heart rate)
SNOMED
364075005
LOINC
LP29713-2
bpm
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Similar models

Week 36

1 forms
  1. StudyEvent: ODM
    1. Week 36
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])
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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