ID

35257

Beschreibung

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

Stichworte

Versionen (1)
  1. 25.02.19 25.02.19 -
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GlaxoSmithKline

Hochgeladen am

25. Februar 2019

DOI

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Lizenz

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

Englisch

End of Study

1 Formulare  
  1. StudyEvent: ODM
    1. End of Study
Administrative Data
Beschreibung

Administrative Data

Site
Beschreibung

Study Site

Datentyp

text

Alias
UMLS CUI [1]
C2825164
Subject
Beschreibung

Clinical trial participant

Datentyp

text

Alias
UMLS CUI [1]
C1997894
Subject No.
Beschreibung

Clinical Trial Subject Unique Identifier

Datentyp

integer

Alias
UMLS CUI [1]
C2348585
Status of Treatment Blind
Beschreibung

Status of Treatment Blind

Alias
UMLS CUI-1
C2347038
UMLS CUI-2
C0449438
Was the treatment blind broken during the study?
Beschreibung

If yes, complete Non-Serious Adverse Events, Serious Adverse Event and/or Investigational Product forms as appropriate

Datentyp

boolean

Alias
UMLS CUI [1]
C3897431
Date blind broken
Beschreibung

Subject Unblinding Event Record, Date in time

Datentyp

date

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

Subject Unblinding Event Record, Indication

Datentyp

text

Alias
UMLS CUI [1,1]
C3897431
UMLS CUI [1,2]
C0392360
Follow-Up Contact
Beschreibung

Follow-Up Contact

Alias
UMLS CUI-1
C1522577
Subject contacted for follow-up?
Beschreibung

Follow-up, Contact with, Study subject

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1522577
UMLS CUI [1,2]
C0332158
UMLS CUI [1,3]
C0681850
Date of Visit/Assessment
Beschreibung

Date of Visit/Assessment

Alias
UMLS CUI-1
C1320303
UMLS CUI-2
C2985720
Date of visit/assessment
Beschreibung

Date of visit, Assessment Date

Datentyp

date

Alias
UMLS CUI [1,1]
C1320303
UMLS CUI [1,2]
C2985720
Study Conclusion
Beschreibung

Study Conclusion

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

Study End Date, Patient withdrawn from trial, Date in time

Datentyp

date

Alias
UMLS CUI [1,1]
C2983670
UMLS CUI [1,2]
C0422727
UMLS CUI [1,3]
C0011008
Was the subject withdrawn from the study?
Beschreibung

Patient withdrawn from trial

Datentyp

boolean

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

Patient withdrawn from trial, Indication

Datentyp

text

Alias
UMLS CUI [1,1]
C0422727
UMLS CUI [1,2]
C3146298
Investigational Product - Double Blind
Beschreibung

Investigational Product - Double Blind

Alias
UMLS CUI-1
C0304229
UMLS CUI-2
C0013072
Start Date
Beschreibung

Experimental drug, Double-Blind Method, Start Date

Datentyp

date

Alias
UMLS CUI [1,1]
C0013072
UMLS CUI [1,2]
C0808070
UMLS CUI [1,3]
C0808070
Stop Date
Beschreibung

Experimental drug, Double-Blind Method, End Date

Datentyp

date

Alias
UMLS CUI [1,1]
C0013072
UMLS CUI [1,2]
C0808070
UMLS CUI [1,3]
C0806020
Pharmacogenetic (PGx) Research Withdrawal of Consent
Beschreibung

Pharmacogenetic (PGx) Research Withdrawal of Consent

Alias
UMLS CUI-1
C0031325
UMLS CUI-2
C1707492
Has subject withdrawn consent for PGx research?
Beschreibung

Pharmacogenetics, Consent Withdrawn

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0031325
UMLS CUI [1,2]
C1707492
Yes, date informed consent withdrawn
Beschreibung

Pharmacogenetics, Consent Withdrawn, Date in time

Datentyp

date

Alias
UMLS CUI [1,1]
C2347500
UMLS CUI [1,2]
C1707492
UMLS CUI [1,3]
C0011008
Has a request been made for sample destruction?
Beschreibung

Pharmacogenetics, Blood Specimen, Destruction, Request

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0031325
UMLS CUI [1,2]
C0178913
UMLS CUI [1,3]
C1948029
UMLS CUI [1,4]
C1272683
Yes, check reason
Beschreibung

Pharmacogenetics, Blood Specimen, Destruction, Request, Indication

Datentyp

text

Alias
UMLS CUI [1,1]
C0031325
UMLS CUI [1,2]
C0178913
UMLS CUI [1,3]
C1948029
UMLS CUI [1,4]
C1272683
UMLS CUI [1,5]
C3146298
Investigator Signature
Beschreibung

Investigator Signature

Alias
UMLS CUI-1
C2346576
Is this casebook ready to sign?
Beschreibung

Investigator Signature

Datentyp

boolean

Alias
UMLS CUI [1]
C2346576
Pregnancy Information
Beschreibung

Pregnancy Information

Alias
UMLS CUI-1
C0032961
UMLS CUI-2
C1533716
Did the subject become pregnant during the study?
Beschreibung

Pregnant during the study

Datentyp

boolean

Alias
UMLS CUI [1]
C3828490
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Ähnliche Modelle

End of Study

1 Formulare
  1. StudyEvent: ODM
    1. End of Study
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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
Status of Treatment Blind
C2347038 (UMLS CUI-1)
C0449438 (UMLS CUI-2)
Subject Unblinding Event Record
Item
Was the treatment blind broken during the study?
boolean
C3897431 (UMLS CUI [1])
Subject Unblinding Event Record, Date in time
Item
Date blind broken
date
C3897431 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item
Reason blind broken
text
C3897431 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
Subject Unblinding Event Record, Indication
Code List
Reason blind broken
CL Item
Medical emergency requiring identification of investigational product for further treatment (1)
CL Item
Other, specify (2)
Item Group
Follow-Up Contact
C1522577 (UMLS CUI-1)
Follow-up, Contact with, Study subject
Item
Subject contacted for follow-up?
boolean
C1522577 (UMLS CUI [1,1])
C0332158 (UMLS CUI [1,2])
C0681850 (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
Study Conclusion
C0008976 (UMLS CUI-1)
C1707478 (UMLS CUI-2)
Study End Date, Patient withdrawn from trial, Date in time
Item
Date of subject completion or withdrawal
date
C2983670 (UMLS CUI [1,1])
C0422727 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Patient withdrawn from trial
Item
Was the subject withdrawn from the study?
boolean
C0422727 (UMLS CUI [1])
Item
Primary reason for withdrawal
text
C0422727 (UMLS CUI [1,1])
C3146298 (UMLS CUI [1,2])
Patient withdrawn from trial, Indication
Code List
Primary reason for withdrawal
CL Item
Adverse Event (1)
CL Item
Lack of efficacy  (2)
CL Item
Exacerbation (3)
CL Item
Protocol Deviation (4)
CL Item
Subject reached protocol defined stopping criteria  (5)
CL Item
Study closed/terminated (6)
CL Item
Lost to Follow-up (7)
CL Item
Withdrew consent (8)
CL Item
Investigator discretion, specify (9)
Item Group
Investigational Product - Double Blind
C0304229 (UMLS CUI-1)
C0013072 (UMLS CUI-2)
Experimental drug, Double-Blind Method, Start Date
Item
Start Date
date
C0013072 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,3])
Experimental drug, Double-Blind Method, End Date
Item
Stop Date
date
C0013072 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,3])
Item Group
Pharmacogenetic (PGx) Research Withdrawal of Consent
C0031325 (UMLS CUI-1)
C1707492 (UMLS CUI-2)
Pharmacogenetics, Consent Withdrawn
Item
Has subject withdrawn consent for PGx research?
boolean
C0031325 (UMLS CUI [1,1])
C1707492 (UMLS CUI [1,2])
Pharmacogenetics, Consent Withdrawn, Date in time
Item
Yes, date informed consent withdrawn
date
C2347500 (UMLS CUI [1,1])
C1707492 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Pharmacogenetics, Blood Specimen, Destruction, Request
Item
Has a request been made for sample destruction?
boolean
C0031325 (UMLS CUI [1,1])
C0178913 (UMLS CUI [1,2])
C1948029 (UMLS CUI [1,3])
C1272683 (UMLS CUI [1,4])
Item
Yes, check reason
text
C0031325 (UMLS CUI [1,1])
C0178913 (UMLS CUI [1,2])
C1948029 (UMLS CUI [1,3])
C1272683 (UMLS CUI [1,4])
C3146298 (UMLS CUI [1,5])
Pharmacogenetics, Blood Specimen, Destruction, Request, Indication
Code List
Yes, check reason
CL Item
Subject withdrew consent for PGx  (1)
CL Item
Screen failure (2)
CL Item
Other, specify (3)
Item Group
Investigator Signature
C2346576 (UMLS CUI-1)
Investigator Signature
Item
Is this casebook ready to sign?
boolean
C2346576 (UMLS CUI [1])
Item Group
Pregnancy Information
C0032961 (UMLS CUI-1)
C1533716 (UMLS CUI-2)
Pregnant during the study
Item
Did the subject become pregnant during the study?
boolean
C3828490 (UMLS CUI [1])
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