Informações:
Falhas:
ID
33022
Descrição
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
Palavras-chave
Versões (2)
- 22/11/2018 22/11/2018 -
- 23/11/2018 23/11/2018 -
Titular dos direitos
GlaxoSmithKline
Transferido a
23 de novembro de 2018
DOI
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Licença
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, Investigational Product, Vital signs, Candidiasis Examination, PK Sample, Subject Withdrawal Status, Electronically transferred lab data, Liver Events Assessment- Visit 6
Similar models
Date of Visit/ Assessment, Investigational Product, Vital signs, Candidiasis Examination, PK Sample, Subject Withdrawal Status, Electronically transferred lab data, Liver Events Assessment- Visit 6
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
Date of Visit/ Assessment
C1320303 (UMLS CUI-1)
C2985720 (UMLS CUI-2)
C2985720 (UMLS CUI-2)
Date of Visit/ Assessment
Item
Date of Visit/ Assessment
date
C1320303 (UMLS CUI [1,1])
C2985720 (UMLS CUI [1,2])
C2985720 (UMLS CUI [1,2])
Previous Evening Dose Date and Time
Item
Previous Evening Dose Date and Time
datetime
C1986447 (UMLS CUI [1,1])
C0587117 (UMLS CUI [1,2])
C0205156 (UMLS CUI [1,3])
C0587117 (UMLS CUI [1,2])
C0205156 (UMLS CUI [1,3])
Time of PM clinic visit dose
Item
Time of PM clinic visit dose
time
C0008952 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
C1509133 (UMLS CUI [1,4])
C0178602 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
C1509133 (UMLS CUI [1,4])
Actual date/ time
Item
Actual date/ time
datetime
C1264639 (UMLS CUI [1])
Blood pressure
Item
Blood pressure (systolic/ diastolic)
text
C0005823 (UMLS CUI [1])
CL Item
Supine (1)
CL Item
Sitting (2)
CL Item
Standing (3)
CL Item
Semi- supine (4)
Heart rate
Item
Heart rate
integer
C0018810 (UMLS CUI [1])
Temperature
Item
Temperature
float
C0005903 (UMLS CUI [1])
Respiration rate
Item
Respiration rate
integer
C0231832 (UMLS CUI [1])
Calculated Subject position
Item
Calculated Subject position
text
C1262869 (UMLS CUI [1,1])
C0444686 (UMLS CUI [1,2])
C0444686 (UMLS CUI [1,2])
Item Group
Candidiasis Examination
C0006840 (UMLS CUI-1)
C4321457 (UMLS CUI-2)
C4321457 (UMLS CUI-2)
Oropharyngeal candidiasis
Item
Does the subject have clinical visual evidence of oropharyngeal candidiasis?
boolean
C0919659 (UMLS CUI [1])
PK Sample taken?
Item
PK Sample taken?
boolean
C1277698 (UMLS CUI [1,1])
C0031327 (UMLS CUI [1,2])
C0031327 (UMLS CUI [1,2])
If PK sample was taken, complete actual start time
Item
If PK sample was taken, complete actual start time.
datetime
C1277698 (UMLS CUI [1,1])
C0031327 (UMLS CUI [1,2])
C1301880 (UMLS CUI [1,3])
C0031327 (UMLS CUI [1,2])
C1301880 (UMLS CUI [1,3])
Item Group
PK Sample PK Sample - 15 Minutes Post- Dose
C1277698 (UMLS CUI-1)
C0031327 (UMLS CUI-2)
C0031327 (UMLS CUI-2)
PK Sample taken?
Item
PK Sample taken?
boolean
C1277698 (UMLS CUI [1,1])
C0031327 (UMLS CUI [1,2])
C0031327 (UMLS CUI [1,2])
If PK sample was taken, complete actual start time
Item
If PK sample was taken, complete actual start time.
datetime
C1277698 (UMLS CUI [1,1])
C0031327 (UMLS CUI [1,2])
C1301880 (UMLS CUI [1,3])
C0031327 (UMLS CUI [1,2])
C1301880 (UMLS CUI [1,3])
Item Group
PK Sample PK Sample - 1.5 HoursPost- Dose
C1277698 (UMLS CUI-1)
C0031327 (UMLS CUI-2)
C0031327 (UMLS CUI-2)
PK Sample taken?
Item
PK Sample taken?
boolean
C1277698 (UMLS CUI [1,1])
C0031327 (UMLS CUI [1,2])
C0031327 (UMLS CUI [1,2])
If PK sample was taken, complete actual start time
Item
If PK sample was taken, complete actual start time.
datetime
C1277698 (UMLS CUI [1,1])
C0031327 (UMLS CUI [1,2])
C1301880 (UMLS CUI [1,3])
C0031327 (UMLS CUI [1,2])
C1301880 (UMLS CUI [1,3])
Item Group
Subject Withdrawal Status
C0422727 (UMLS CUI-1)
C0449438 (UMLS CUI-2)
C0449438 (UMLS CUI-2)
Did the subject withdraw at this visit?
Item
Did the subject withdraw at this visit?
boolean
C1710677 (UMLS CUI [1])
C0545082 (UMLS CUI [2])
C0545082 (UMLS CUI [2])
Item Group
Electronically transferred lab data
C0022885 (UMLS CUI-1)
C1320722 (UMLS CUI-2)
C1320722 (UMLS CUI-2)
Date Sample(s) Taken
Item
Date Sample(s) Taken
date
C1302413 (UMLS CUI [1])
Haem Lab type code
Item
Haem Lab type code
text
C0018941 (UMLS CUI [1,1])
C0022877 (UMLS CUI [1,2])
C0805701 (UMLS CUI [1,3])
C0022877 (UMLS CUI [1,2])
C0805701 (UMLS CUI [1,3])
Chem Lab type code
Item
Chem Lab type code
text
C0005774 (UMLS CUI [1,1])
C0022877 (UMLS CUI [1,2])
C0805701 (UMLS CUI [1,3])
C0022877 (UMLS CUI [1,2])
C0805701 (UMLS CUI [1,3])
Urin Lab type code
Item
Urin Lab type code
text
C0042014 (UMLS CUI [1,1])
C0022877 (UMLS CUI [1,2])
C0805701 (UMLS CUI [1,3])
C0022877 (UMLS CUI [1,2])
C0805701 (UMLS CUI [1,3])
Item Group
Liver Events Assessment
C0023884 (UMLS CUI-1)
C0877248 (UMLS CUI-2)
C0220825 (UMLS CUI-3)
C0877248 (UMLS CUI-2)
C0220825 (UMLS CUI-3)
Liver chemistry event for the lab samples collected at this visit
Item
Was there a protocol defined liver chemistry event for the lab samples collected at this visit?
boolean
C0008000 (UMLS CUI [1,1])
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])
C0005834 (UMLS CUI [2,1])
C0545082 (UMLS CUI [2,2])
Item
Specify type of liver chemistry event.
integer
C0008000 (UMLS CUI [1,1])
C0023884 (UMLS CUI [1,2])
C0877248 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])
C0023884 (UMLS CUI [1,2])
C0877248 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])
CL Item
Liver Event Monitoring Criteria (subject has met protocol defined liver event monitoring criteria). Obtain tests as per protocol. (1)
CL Item
Liver Event Stopping Criteria (subject has met protocol defined liver event stopping criteria, has been monitored for the protocol specified time period and continues to meet liver chemistry monitoring criteria). Stop investigational product, complete date stopped on Investigational Product Form and contact GSK within 24 hours of occurence of liver event by phone or fax. NOTE: If the liver event meets the definition of an SAE, the SAE form must be completed in InForm. If InForm is unavailable, the SAE form should be faxed to GSK. (2)