ID

29536

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: Early Withdrawal

Keywords

Versions (2)
  1. 3/15/18 3/15/18 -
  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

Early Withdrawal

1 forms  
  1. StudyEvent: ODM
    1. Early Withdrawal
Early Withdrawal
Description

Early Withdrawal

Alias
UMLS CUI-1
C1710677
UMLS CUI-2
C0008976
UMLS CUI-3
C0024117
Date of visit/assessment
Description

Date of visit/assessment

Data type

date

Alias
UMLS CUI [1]
C1320303
Pre-Dose Vital Signs
Description

Pre-Dose Vital Signs

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

Blood pressure systolic

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
Blood pressure diastolic
Description

Blood pressure diastolic

Data type

integer

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

Heart rate

Data type

integer

Measurement units
  • beats/min
Alias
UMLS CUI [1]
C0018810
beats/min
Candidiasis examination
Description

Candidiasis examination

Alias
UMLS CUI-1
C0006849
UMLS CUI-2
C0582103
Does the subject have clinical evidence of oropharyngeal candidiasis?
Description

clinical evidence of oropharyngeal candidiasis

Data type

text

Alias
UMLS CUI [1,1]
C0006849
UMLS CUI [1,2]
C3887511
Was a swab taken?
Description

culture swab taken

Data type

boolean

Alias
UMLS CUI [1,1]
C0563454
UMLS CUI [1,2]
C0006849
Yes, result of culture swab
Description

result of culture swab

Data type

integer

Alias
UMLS CUI [1,1]
C0563454
UMLS CUI [1,2]
C1274040
UMLS CUI [1,3]
C0006849
Electronically transferred lab data
Description

Electronically transferred lab data

Alias
UMLS CUI-1
C0200345
UMLS CUI-2
C0022885
UMLS CUI-3
C1320722
Sample taken?
Description

sample taken

Data type

boolean

Alias
UMLS CUI [1]
C0200345
Date sample taken
Description

Date sample taken

Data type

date

Alias
UMLS CUI [1]
C1302413
Liver Events Assessment
Description

Liver Events Assessment

Alias
UMLS CUI-1
C0232741
UMLS CUI-2
C0877248
UMLS CUI-3
C0220825
Have liver chemistry results reached or exceeded protocol-defined investigational product stopping criteria?
Description

liver chemistry results

Data type

boolean

Alias
UMLS CUI [1,1]
C0232741
UMLS CUI [1,2]
C0008000
UMLS CUI [1,3]
C0587081
Smoking Status
Description

Smoking Status

Alias
UMLS CUI-1
C1519386
UMLS CUI-2
C0543414
Has the smoking status changed since the last time it was assessed?
Description

smoking status

Data type

boolean

Alias
UMLS CUI [1]
C1519386
If yes: Specify smoking status
Description

smoking status

Data type

integer

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

date smoking status was changed

Data type

date

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

Early Withdrawal

1 forms
  1. StudyEvent: ODM
    1. Early Withdrawal
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Early Withdrawal
C1710677 (UMLS CUI-1)
C0008976 (UMLS CUI-2)
C0024117 (UMLS CUI-3)
Date of visit/assessment
Item
Date of visit/assessment
date
C1320303 (UMLS CUI [1])
Item Group
Pre-Dose Vital Signs
C0518766 (UMLS CUI-1)
C0439565 (UMLS CUI-2)
Blood pressure systolic
Item
Blood pressure systolic
integer
C0871470 (UMLS CUI [1])
Blood pressure diastolic
Item
Blood pressure diastolic
integer
C0428883 (UMLS CUI [1])
Heart rate
Item
Heart rate
integer
C0018810 (UMLS CUI [1])
Item Group
Candidiasis examination
C0006849 (UMLS CUI-1)
C0582103 (UMLS CUI-2)
Item
Does the subject have clinical evidence of oropharyngeal candidiasis?
text
C0006849 (UMLS CUI [1,1])
C3887511 (UMLS CUI [1,2])
clinical evidence of oropharyngeal candidiasis
Code List
Does the subject have clinical evidence of oropharyngeal candidiasis?
CL Item
Yes (Y)
CL Item
No (N)
culture swab taken
Item
Was a swab taken?
boolean
C0563454 (UMLS CUI [1,1])
C0006849 (UMLS CUI [1,2])
Item
Yes, result of culture swab
integer
C0563454 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
C0006849 (UMLS CUI [1,3])
oropharyngeal candidiasis test result
Code List
Yes, result of culture swab
CL Item
Negative (1)
CL Item
Positive (2)
CL Item
Not available (4)
Item Group
Electronically transferred lab data
C0200345 (UMLS CUI-1)
C0022885 (UMLS CUI-2)
C1320722 (UMLS CUI-3)
sample taken
Item
Sample taken?
boolean
C0200345 (UMLS CUI [1])
Date sample taken
Item
Date sample taken
date
C1302413 (UMLS CUI [1])
Item Group
Liver Events Assessment
C0232741 (UMLS CUI-1)
C0877248 (UMLS CUI-2)
C0220825 (UMLS CUI-3)
liver chemistry results
Item
Have liver chemistry results reached or exceeded protocol-defined investigational product stopping criteria?
boolean
C0232741 (UMLS CUI [1,1])
C0008000 (UMLS CUI [1,2])
C0587081 (UMLS CUI [1,3])
Item Group
Smoking Status
C1519386 (UMLS CUI-1)
C0543414 (UMLS CUI-2)
smoking status
Item
Has the smoking status changed since the last time it was assessed?
boolean
C1519386 (UMLS CUI [1])
Item
If yes: Specify smoking status
integer
C1519386 (UMLS CUI [1])
smoking status
Code List
If yes: Specify smoking status
CL Item
Subject started smoking (1)
CL Item
Subject stopped smoking (2)
date smoking status was changed
Item
Date a change was made
date
C1519386 (UMLS CUI [1,1])
C0443172 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
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