ID
33031
Beschrijving
Study ID: 106827 Clinical Study ID: HZA106827 Study Title: HZA106827:A randomised, double-blind, placebo-controlled (with rescue medication), parallel group multicentre study of Fluticasone Furoate/GW642444 Inhalation Powder and Fluticasone Furoate Inhalation Powder alone in the treatment of persistent asthma in adults and adolescents Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01165138 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: fluticasone furoate/vilanterol Trade Name: Allermist,Veramyst,Avamys; Relvar Study Indication: Asthma
Trefwoorden
Versies (1)
- 23-11-18 23-11-18 -
Houder van rechten
GlaxoSmithKline
Geüploaded op
23 november 2018
DOI
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Licentie
Creative Commons BY-NC 3.0
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Fluticasone Furoate GW642444 Inhalation Powder and Fluticasone Furoate Inhalation Powder alone in the treatment of persistent asthma NCT01165138
Date of Visit/ Assessment, Unscheduled Assessments Performed, Vital signs, Candidiasis Examination, Electronically transferred lab data, Liver Events Assessment (Unscheduled); Date of Visit/ Assessment, Status of Treatment Blind, Pregnancy Information, Pharmacogenetic (PGx) Research Withdrawal of Consent, Study Conclusion, Investigator Signature (End of Study)
Beschrijving
Unscheduled Assessments Performed
Alias
- UMLS CUI-1
- C0220825
- UMLS CUI-2
- C3854240
Beschrijving
Vital signs
Alias
- UMLS CUI-1
- C0518766
Beschrijving
Actual date/ time
Datatype
datetime
Alias
- UMLS CUI [1]
- C1264639
Beschrijving
Blood pressure
Datatype
text
Maateenheden
- mmHg
Alias
- UMLS CUI [1]
- C0005823
Beschrijving
Position must be consistent throughout the study.
Datatype
integer
Alias
- UMLS CUI [1]
- C1262869
Beschrijving
Heart rate
Datatype
integer
Maateenheden
- beats/min
Alias
- UMLS CUI [1]
- C0018810
Beschrijving
Temperature
Datatype
float
Maateenheden
- °C
Alias
- UMLS CUI [1]
- C0005903
Beschrijving
Respiration rate
Datatype
integer
Maateenheden
- breaths/min
Alias
- UMLS CUI [1]
- C0231832
Beschrijving
Calculated Subject position
Datatype
text
Alias
- UMLS CUI [1,1]
- C1262869
- UMLS CUI [1,2]
- C0444686
Beschrijving
Candidiasis Examination
Alias
- UMLS CUI-1
- C0006840
- UMLS CUI-2
- C4321457
Beschrijving
Electronically transferred lab data
Alias
- UMLS CUI-1
- C0022885
- UMLS CUI-2
- C1320722
Beschrijving
Date Sample(s) Taken
Datatype
date
Alias
- UMLS CUI [1]
- C1302413
Beschrijving
Haem Lab type code
Datatype
text
Alias
- UMLS CUI [1,1]
- C0018941
- UMLS CUI [1,2]
- C0022877
- UMLS CUI [1,3]
- C0805701
Beschrijving
Chem Lab type code
Datatype
text
Alias
- UMLS CUI [1,1]
- C0005774
- UMLS CUI [1,2]
- C0022877
- UMLS CUI [1,3]
- C0805701
Beschrijving
Urin Lab type code
Datatype
text
Alias
- UMLS CUI [1,1]
- C0042014
- UMLS CUI [1,2]
- C0022877
- UMLS CUI [1,3]
- C0805701
Beschrijving
Liver Events Assessment
Alias
- UMLS CUI-1
- C0023884
- UMLS CUI-2
- C0877248
- UMLS CUI-3
- C0220825
Beschrijving
Liver chemistry event for the lab samples collected at this visit
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0008000
- UMLS CUI [1,2]
- C0023884
- UMLS CUI [1,3]
- C0877248
- UMLS CUI [2,1]
- C0005834
- UMLS CUI [2,2]
- C0545082
Beschrijving
Specify type of liver chemistry event
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0008000
- UMLS CUI [1,2]
- C0023884
- UMLS CUI [1,3]
- C0877248
- UMLS CUI [1,4]
- C2348235
Beschrijving
Date of Visit/ Assessment - End of Study
Alias
- UMLS CUI-1
- C1320303
- UMLS CUI-2
- C2985720
Beschrijving
Status of Treatment Blind
Alias
- UMLS CUI-1
- C0749659
- UMLS CUI-2
- C2347038
Beschrijving
Was the treatment blind broken during the study?
Datatype
boolean
Alias
- UMLS CUI [1]
- C3897431
Beschrijving
Date blind broken
Datatype
date
Alias
- UMLS CUI [1,1]
- C3897431
- UMLS CUI [1,2]
- C0011008
Beschrijving
Reason for treatment blind was broken
Datatype
integer
Alias
- UMLS CUI [1,1]
- C3897431
- UMLS CUI [1,2]
- C0392360
Beschrijving
If other Reason for treatment blind was broken, specify.
Datatype
text
Alias
- UMLS CUI [1,1]
- C3897431
- UMLS CUI [1,2]
- C0392360
- UMLS CUI [1,3]
- C0205394
- UMLS CUI [1,4]
- C2348235
Beschrijving
Pregnancy Information
Alias
- UMLS CUI-1
- C0032961
- UMLS CUI-2
- C1533716
Beschrijving
Pharmacogenetic (PGx) Research Withdrawal of Consent
Alias
- UMLS CUI-1
- C2347500
- UMLS CUI-2
- C0021430
- UMLS CUI-3
- C2349954
Beschrijving
Has the subject withdrawn consent for PGx research?
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C2347500
- UMLS CUI [1,2]
- C0021430
- UMLS CUI [1,3]
- C2349954
Beschrijving
Date informed consent withdrawn
Datatype
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C2349954
- UMLS CUI [1,3]
- C0009797
Beschrijving
Has a request been made for sample destruction?
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C1948029
- UMLS CUI [1,2]
- C0178913
- UMLS CUI [1,3]
- C1272683
Beschrijving
Reason for request for sample destruction
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1948029
- UMLS CUI [1,2]
- C0178913
- UMLS CUI [1,3]
- C1272683
Beschrijving
If other reason for request for sample destruction, specify
Datatype
text
Alias
- UMLS CUI [1,1]
- C1948029
- UMLS CUI [1,2]
- C0178913
- UMLS CUI [1,3]
- C1272683
- UMLS CUI [1,4]
- C0205394
- UMLS CUI [1,5]
- C2348235
Beschrijving
Study Conclusion
Alias
- UMLS CUI-1
- C1707478
- UMLS CUI-2
- C0008976
Beschrijving
Date of subject completion or withdrawal
Datatype
date
Alias
- UMLS CUI [1,1]
- C0422727
- UMLS CUI [1,2]
- C0011008
- UMLS CUI [2]
- C1549507
Beschrijving
Was the subject withdrawn from the study?
Datatype
text
Alias
- UMLS CUI [1]
- C0422727
Beschrijving
Primary reason for withdrawal
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0422727
- UMLS CUI [1,2]
- C0392360
Beschrijving
Specify investigator discretion
Datatype
text
Alias
- UMLS CUI [1,1]
- C0008961
- UMLS CUI [1,2]
- C0022423
- UMLS CUI [1,3]
- C2348235
Beschrijving
Withdrew consent specification
Datatype
text
Alias
- UMLS CUI [1,1]
- C1707492
- UMLS CUI [1,2]
- C2348235
Beschrijving
Investigator Signature
Alias
- UMLS CUI-1
- C2346576
Similar models
Date of Visit/ Assessment, Unscheduled Assessments Performed, Vital signs, Candidiasis Examination, Electronically transferred lab data, Liver Events Assessment (Unscheduled); Date of Visit/ Assessment, Status of Treatment Blind, Pregnancy Information, Pharmacogenetic (PGx) Research Withdrawal of Consent, Study Conclusion, Investigator Signature (End of Study)
C2985720 (UMLS CUI-2)
C2985720 (UMLS CUI [1,2])
C3854240 (UMLS CUI-2)
C3854240 (UMLS CUI [1,2])
C0444686 (UMLS CUI [1,2])
C4321457 (UMLS CUI-2)
C1320722 (UMLS CUI-2)
C0022877 (UMLS CUI [1,2])
C0805701 (UMLS CUI [1,3])
C0022877 (UMLS CUI [1,2])
C0805701 (UMLS CUI [1,3])
C0022877 (UMLS CUI [1,2])
C0805701 (UMLS CUI [1,3])
C0877248 (UMLS CUI-2)
C0220825 (UMLS CUI-3)
C0023884 (UMLS CUI [1,2])
C0877248 (UMLS CUI [1,3])
C0005834 (UMLS CUI [2,1])
C0545082 (UMLS CUI [2,2])
C0023884 (UMLS CUI [1,2])
C0877248 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])
C2985720 (UMLS CUI-2)
C2985720 (UMLS CUI [1,2])
C2347038 (UMLS CUI-2)
C0011008 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])
C0021430 (UMLS CUI-2)
C2349954 (UMLS CUI-3)
C0021430 (UMLS CUI [1,2])
C2349954 (UMLS CUI [1,3])
C2349954 (UMLS CUI [1,2])
C0009797 (UMLS CUI [1,3])
C0178913 (UMLS CUI [1,2])
C1272683 (UMLS CUI [1,3])
C0178913 (UMLS CUI [1,2])
C1272683 (UMLS CUI [1,3])
C0178913 (UMLS CUI [1,2])
C1272683 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,4])
C2348235 (UMLS CUI [1,5])
C0011008 (UMLS CUI [1,2])
C1549507 (UMLS CUI [2])
C0392360 (UMLS CUI [1,2])
C0022423 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,2])