ID
33031
Descripción
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
Palabras clave
Versiones (1)
- 23/11/18 23/11/18 -
Titular de derechos de autor
GlaxoSmithKline
Subido en
23 de noviembre de 2018
DOI
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Licencia
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)
Descripción
Unscheduled Assessments Performed
Alias
- UMLS CUI-1
- C0220825
- UMLS CUI-2
- C3854240
Descripción
Vital signs
Alias
- UMLS CUI-1
- C0518766
Descripción
Actual date/ time
Tipo de datos
datetime
Alias
- UMLS CUI [1]
- C1264639
Descripción
Blood pressure
Tipo de datos
text
Unidades de medida
- mmHg
Alias
- UMLS CUI [1]
- C0005823
Descripción
Position must be consistent throughout the study.
Tipo de datos
integer
Alias
- UMLS CUI [1]
- C1262869
Descripción
Heart rate
Tipo de datos
integer
Unidades de medida
- beats/min
Alias
- UMLS CUI [1]
- C0018810
Descripción
Temperature
Tipo de datos
float
Unidades de medida
- °C
Alias
- UMLS CUI [1]
- C0005903
Descripción
Respiration rate
Tipo de datos
integer
Unidades de medida
- breaths/min
Alias
- UMLS CUI [1]
- C0231832
Descripción
Calculated Subject position
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C1262869
- UMLS CUI [1,2]
- C0444686
Descripción
Candidiasis Examination
Alias
- UMLS CUI-1
- C0006840
- UMLS CUI-2
- C4321457
Descripción
Electronically transferred lab data
Alias
- UMLS CUI-1
- C0022885
- UMLS CUI-2
- C1320722
Descripción
Date Sample(s) Taken
Tipo de datos
date
Alias
- UMLS CUI [1]
- C1302413
Descripción
Haem Lab type code
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0018941
- UMLS CUI [1,2]
- C0022877
- UMLS CUI [1,3]
- C0805701
Descripción
Chem Lab type code
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0005774
- UMLS CUI [1,2]
- C0022877
- UMLS CUI [1,3]
- C0805701
Descripción
Urin Lab type code
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0042014
- UMLS CUI [1,2]
- C0022877
- UMLS CUI [1,3]
- C0805701
Descripción
Liver Events Assessment
Alias
- UMLS CUI-1
- C0023884
- UMLS CUI-2
- C0877248
- UMLS CUI-3
- C0220825
Descripción
Liver chemistry event for the lab samples collected at this visit
Tipo de datos
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
Descripción
Specify type of liver chemistry event
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C0008000
- UMLS CUI [1,2]
- C0023884
- UMLS CUI [1,3]
- C0877248
- UMLS CUI [1,4]
- C2348235
Descripción
Date of Visit/ Assessment - End of Study
Alias
- UMLS CUI-1
- C1320303
- UMLS CUI-2
- C2985720
Descripción
Status of Treatment Blind
Alias
- UMLS CUI-1
- C0749659
- UMLS CUI-2
- C2347038
Descripción
Was the treatment blind broken during the study?
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C3897431
Descripción
Date blind broken
Tipo de datos
date
Alias
- UMLS CUI [1,1]
- C3897431
- UMLS CUI [1,2]
- C0011008
Descripción
Reason for treatment blind was broken
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C3897431
- UMLS CUI [1,2]
- C0392360
Descripción
If other Reason for treatment blind was broken, specify.
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C3897431
- UMLS CUI [1,2]
- C0392360
- UMLS CUI [1,3]
- C0205394
- UMLS CUI [1,4]
- C2348235
Descripción
Pregnancy Information
Alias
- UMLS CUI-1
- C0032961
- UMLS CUI-2
- C1533716
Descripción
Pharmacogenetic (PGx) Research Withdrawal of Consent
Alias
- UMLS CUI-1
- C2347500
- UMLS CUI-2
- C0021430
- UMLS CUI-3
- C2349954
Descripción
Has the subject withdrawn consent for PGx research?
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C2347500
- UMLS CUI [1,2]
- C0021430
- UMLS CUI [1,3]
- C2349954
Descripción
Date informed consent withdrawn
Tipo de datos
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C2349954
- UMLS CUI [1,3]
- C0009797
Descripción
Has a request been made for sample destruction?
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C1948029
- UMLS CUI [1,2]
- C0178913
- UMLS CUI [1,3]
- C1272683
Descripción
Reason for request for sample destruction
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C1948029
- UMLS CUI [1,2]
- C0178913
- UMLS CUI [1,3]
- C1272683
Descripción
If other reason for request for sample destruction, specify
Tipo de datos
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
Descripción
Study Conclusion
Alias
- UMLS CUI-1
- C1707478
- UMLS CUI-2
- C0008976
Descripción
Date of subject completion or withdrawal
Tipo de datos
date
Alias
- UMLS CUI [1,1]
- C0422727
- UMLS CUI [1,2]
- C0011008
- UMLS CUI [2]
- C1549507
Descripción
Was the subject withdrawn from the study?
Tipo de datos
text
Alias
- UMLS CUI [1]
- C0422727
Descripción
Primary reason for withdrawal
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C0422727
- UMLS CUI [1,2]
- C0392360
Descripción
Specify investigator discretion
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0008961
- UMLS CUI [1,2]
- C0022423
- UMLS CUI [1,3]
- C2348235
Descripción
Withdrew consent specification
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C1707492
- UMLS CUI [1,2]
- C2348235
Descripción
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])