ID

29177

Descripción

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: Randomisation

Palabras clave

Versiones (2)
  1. 4/3/18 4/3/18 -
  2. 5/4/18 5/4/18 -
Titular de derechos de autor

GlaxoSmithKline

Subido en

4 de marzo de 2018

DOI

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Licencia

Creative Commons BY-NC 3.0
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Efficacy and safety of Fluticasone on the Annual Rate of Exacerbations in Subjects with Chronic Obstructive Pulmonary Disease (COPD) GSK102871

Inglés

Randomisation

1 formularios  
  1. StudyEvent: ODM
    1. Randomisation
Randomisation
Descripción

Randomisation

Alias
UMLS CUI-1
C0034656
Did the subject meet all of the Randomisation criteria?
Descripción

Randomisation criteria

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0034656
UMLS CUI [1,2]
C0243161
Was this subject a run-in failure?
Descripción

run-in failure

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1710476
Yes, complete run-in failure reason
Descripción

run-in failure reason

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C1710476
UMLS CUI [1,2]
C0392360
Run-in failure date
Descripción

Run-in failure date

Tipo de datos

date

Alias
UMLS CUI [1,1]
C1710476
UMLS CUI [1,2]
C0011008
Investigator signature
Descripción

Investigator signature

Tipo de datos

text

Alias
UMLS CUI [1]
C2346576
Randomisation number
Descripción

Randomisation number

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0034656
UMLS CUI [1,2]
C0237753
Date of randomisation
Descripción

Date of randomisation

Tipo de datos

date

Alias
UMLS CUI [1,1]
C0034656
UMLS CUI [1,2]
C0011008
Pre-Dose Vital Signs
Descripción

Pre-Dose Vital Signs

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

Blood pressure systolic

Tipo de datos

integer

Unidades de medida
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
Blood pressure diastolic
Descripción

Blood pressure diastolic

Tipo de datos

integer

Unidades de medida
  • mmHg
Alias
UMLS CUI [1]
C0428883
mmHg
Heart rate
Descripción

Heart rate

Tipo de datos

integer

Unidades de medida
  • beats/min
Alias
UMLS CUI [1]
C0018810
beats/min
Candidiasis examination
Descripción

Candidiasis examination

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

clinical evidence of oropharyngeal candidiasis

Tipo de datos

text

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

culture swab taken

Tipo de datos

boolean

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

result of culture swab

Tipo de datos

integer

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

Electronically transferred lab data

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

sample taken

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0200345
Date sample taken
Descripción

Date sample taken

Tipo de datos

date

Alias
UMLS CUI [1]
C1302413
Liver Events Assessment
Descripción

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?
Descripción

liver chemistry results

Tipo de datos

boolean

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

Smoking Status

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

smoking status

Tipo de datos

boolean

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

smoking status

Tipo de datos

integer

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

date smoking status was changed

Tipo de datos

date

Alias
UMLS CUI [1,1]
C1519386
UMLS CUI [1,2]
C0443172
UMLS CUI [1,3]
C0011008
Subject withdrawal
Descripción

Subject withdrawal

Alias
UMLS CUI-1
C1710677
UMLS CUI-2
C0008976
UMLS CUI-3
C0024117
Did the subject withdraw at this visit?
Descripción

withdraw

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1710677
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Similar models

Randomisation

1 formularios
  1. StudyEvent: ODM
    1. Randomisation
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
Randomisation
C0034656 (UMLS CUI-1)
Randomisation criteria
Item
Did the subject meet all of the Randomisation criteria?
boolean
C0034656 (UMLS CUI [1,1])
C0243161 (UMLS CUI [1,2])
run-in failure
Item
Was this subject a run-in failure?
boolean
C1710476 (UMLS CUI [1])
Item
Yes, complete run-in failure reason
integer
C1710476 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
run-in failure reason
Code List
Yes, complete run-in failure reason
CL Item
Did not meet continuation criteria (1)
CL Item
Adverse Event (2)
CL Item
Study closed/terminated (3)
CL Item
Lost to Follow-up (4)
CL Item
Investigator discretion, specify (5)
CL Item
Withdrew consent, specify (6)
Run-in failure date
Item
Run-in failure date
date
C1710476 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Investigator signature
Item
Investigator signature
text
C2346576 (UMLS CUI [1])
Randomisation number
Item
Randomisation number
integer
C0034656 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Date of randomisation
Item
Date of randomisation
date
C0034656 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
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])
Item Group
Subject withdrawal
C1710677 (UMLS CUI-1)
C0008976 (UMLS CUI-2)
C0024117 (UMLS CUI-3)
withdraw
Item
Did the subject withdraw at this visit?
boolean
C1710677 (UMLS CUI [1])
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