ID

29536

Beschrijving

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

Trefwoorden

Versies (2)
  1. 15-03-18 15-03-18 -
  2. 05-04-18 05-04-18 -
Houder van rechten

GlaxoSmithKline

Geüploaded op

5 april 2018

DOI

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Licentie

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

Engels

Early Withdrawal

1 Formulieren  
  1. StudyEvent: ODM
    1. Early Withdrawal
Early Withdrawal
Beschrijving

Early Withdrawal

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

Date of visit/assessment

Datatype

date

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

Pre-Dose Vital Signs

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

Blood pressure systolic

Datatype

integer

Maateenheden
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
Blood pressure diastolic
Beschrijving

Blood pressure diastolic

Datatype

integer

Maateenheden
  • mmHg
Alias
UMLS CUI [1]
C0428883
mmHg
Heart rate
Beschrijving

Heart rate

Datatype

integer

Maateenheden
  • beats/min
Alias
UMLS CUI [1]
C0018810
beats/min
Candidiasis examination
Beschrijving

Candidiasis examination

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

clinical evidence of oropharyngeal candidiasis

Datatype

text

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

culture swab taken

Datatype

boolean

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

result of culture swab

Datatype

integer

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

Electronically transferred lab data

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

sample taken

Datatype

boolean

Alias
UMLS CUI [1]
C0200345
Date sample taken
Beschrijving

Date sample taken

Datatype

date

Alias
UMLS CUI [1]
C1302413
Liver Events Assessment
Beschrijving

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?
Beschrijving

liver chemistry results

Datatype

boolean

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

Smoking Status

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

smoking status

Datatype

boolean

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

smoking status

Datatype

integer

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

date smoking status was changed

Datatype

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 Formulieren
  1. StudyEvent: ODM
    1. Early Withdrawal
Name
Type
Description | Question | Decode (Coded Value)
Datatype
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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