ID

29537

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: End of Study

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

End of Study

1 forms  
  1. StudyEvent: ODM
    1. End of Study
Status of Treatment Blind
Description

Status of Treatment Blind

Alias
UMLS CUI-1
C0749659
UMLS CUI-2
C2347038
UMLS CUI-3
C0024117
Date of visit/assessment
Description

Date of visit/assessment

Data type

date

Alias
UMLS CUI [1]
C1320303
Was the treatment blind broken during the study?
Description

treatment blind broken

Data type

boolean

Alias
UMLS CUI [1]
C3897431
Date blind broken
Description

Date blind broken

Data type

integer

Alias
UMLS CUI [1,1]
C3897431
UMLS CUI [1,2]
C0011008
Reason blind broken
Description

Reason blind broken

Data type

integer

Alias
UMLS CUI [1,1]
C3897431
UMLS CUI [1,2]
C0392360
Reason blind broken, if other, specify
Description

Reason blind broken

Data type

text

Alias
UMLS CUI [1,1]
C3897431
UMLS CUI [1,2]
C0392360
Pregnancy Information
Description

Pregnancy Information

Alias
UMLS CUI-1
C0032961
Did the subject become pregnant during the study?
Description

pregnant

Data type

boolean

Alias
UMLS CUI [1]
C0032961
Withdrawal of Consent for PGx (DNA)/Sample Destruction
Description

Withdrawal of Consent for PGx (DNA)/Sample Destruction

Alias
UMLS CUI-1
C1707492
UMLS CUI-2
C1948029
UMLS CUI-3
C0178913
Has subject withdrawn consent for PGx research?
Description

withdrawn consent

Data type

boolean

Alias
UMLS CUI [1]
C1707492
Yes, date informed consent withdrawn
Description

Date informed consent withdrawn

Data type

date

Alias
UMLS CUI [1,1]
C1707492
UMLS CUI [1,2]
C0011008
Ha a request been made for sample destruction?
Description

Sample destruction

Data type

boolean

Alias
UMLS CUI [1,1]
C1948029
UMLS CUI [1,2]
C0178913
Yes, check reason for sample destruction
Description

Reason for sample destruction

Data type

integer

Alias
UMLS CUI [1,1]
C1948029
UMLS CUI [1,2]
C0178913
UMLS CUI [1,3]
C0392360
If Other Reason for sample destruction, specify
Description

Reason for sample destruction

Data type

text

Alias
UMLS CUI [1,1]
C1948029
UMLS CUI [1,2]
C0178913
UMLS CUI [1,3]
C0392360
Study Conclusion
Description

Study Conclusion

Alias
UMLS CUI-1
C1707478
UMLS CUI-2
C0008976
Date of subject completion or withdrawal
Description

Date of subject completion or withdrawal

Data type

date

Alias
UMLS CUI [1]
C2983670
Was the subject withdrawn from the study?
Description

subject withdrawn

Data type

boolean

Alias
UMLS CUI [1]
C0422727
Primary reason for withdrawal
Description

Primary reason for withdrawal

Data type

integer

Alias
UMLS CUI [1,1]
C0422727
UMLS CUI [1,2]
C0392360
Subject contacted for follow-up?
Description

follow-up

Data type

boolean

Alias
UMLS CUI [1,1]
C1522577
UMLS CUI [1,2]
C0332158
UMLS CUI [1,3]
C0681850
Investigational Product - Double Blind
Description

Investigational Product - Double Blind

Alias
UMLS CUI-1
C0304229
UMLS CUI-2
C0008976
UMLS CUI-3
C0013072
Double Blind Start Date
Description

Double Blind Start Date

Data type

date

Alias
UMLS CUI [1,1]
C0013072
UMLS CUI [1,2]
C0808070
Double Blind Stop Date
Description

Double Blind Stop Date

Data type

date

Alias
UMLS CUI [1,1]
C0013072
UMLS CUI [1,2]
C0806020
Is this casebook ready to sign? Investigator Signature
Description

Investigator Signature

Data type

boolean

Alias
UMLS CUI [1]
C2346576
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Similar models

End of Study

1 forms
  1. StudyEvent: ODM
    1. End of Study
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Status of Treatment Blind
C0749659 (UMLS CUI-1)
C2347038 (UMLS CUI-2)
C0024117 (UMLS CUI-3)
Date of visit/assessment
Item
Date of visit/assessment
date
C1320303 (UMLS CUI [1])
treatment blind broken
Item
Was the treatment blind broken during the study?
boolean
C3897431 (UMLS CUI [1])
Date blind broken
Item
Date blind broken
integer
C3897431 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item
Reason blind broken
integer
C3897431 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
Reason blind broken
Code List
Reason blind broken
CL Item
Medical emergency requiring identification of investigational product for further treatment (1)
CL Item
Other, specify (2)
Reason blind broken
Item
Reason blind broken, if other, specify
text
C3897431 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
Item Group
Pregnancy Information
C0032961 (UMLS CUI-1)
pregnant
Item
Did the subject become pregnant during the study?
boolean
C0032961 (UMLS CUI [1])
Item Group
Withdrawal of Consent for PGx (DNA)/Sample Destruction
C1707492 (UMLS CUI-1)
C1948029 (UMLS CUI-2)
C0178913 (UMLS CUI-3)
withdrawn consent
Item
Has subject withdrawn consent for PGx research?
boolean
C1707492 (UMLS CUI [1])
Date informed consent withdrawn
Item
Yes, date informed consent withdrawn
date
C1707492 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Sample destruction
Item
Ha a request been made for sample destruction?
boolean
C1948029 (UMLS CUI [1,1])
C0178913 (UMLS CUI [1,2])
Item
Yes, check reason for sample destruction
integer
C1948029 (UMLS CUI [1,1])
C0178913 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,3])
Reason for sample destruction
Code List
Yes, check reason for sample destruction
CL Item
Subject withdrew consent for PGx (1)
CL Item
Screen failure (2)
CL Item
Other, specify (3)
Reason for sample destruction
Item
If Other Reason for sample destruction, specify
text
C1948029 (UMLS CUI [1,1])
C0178913 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,3])
Item Group
Study Conclusion
C1707478 (UMLS CUI-1)
C0008976 (UMLS CUI-2)
Date of subject completion or withdrawal
Item
Date of subject completion or withdrawal
date
C2983670 (UMLS CUI [1])
subject withdrawn
Item
Was the subject withdrawn from the study?
boolean
C0422727 (UMLS CUI [1])
Item
Primary reason for withdrawal
integer
C0422727 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
Primary reason for withdrawal
Code List
Primary reason for withdrawal
CL Item
Adverse Event (1)
CL Item
Lack of efficacy (2)
CL Item
Protocol Deviation (3)
CL Item
Subject reached protocol defined stopping criteria (4)
CL Item
Study closed/terminated (5)
CL Item
Lost to Follow-up (6)
CL Item
Withdrew consent (7)
CL Item
Investigator discretion, specify (8)
follow-up
Item
Subject contacted for follow-up?
boolean
C1522577 (UMLS CUI [1,1])
C0332158 (UMLS CUI [1,2])
C0681850 (UMLS CUI [1,3])
Item Group
Investigational Product - Double Blind
C0304229 (UMLS CUI-1)
C0008976 (UMLS CUI-2)
C0013072 (UMLS CUI-3)
Double Blind Start Date
Item
Double Blind Start Date
date
C0013072 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Double Blind Stop Date
Item
Double Blind Stop Date
date
C0013072 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Investigator Signature
Item
Is this casebook ready to sign? Investigator Signature
boolean
C2346576 (UMLS CUI [1])
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