Informations:
Erreur:
ID
33031
Description
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
Mots-clés
Versions (1)
- 23/11/18 23/11/18 -
Détendeur de droits
GlaxoSmithKline
Téléchargé le
23 de noviembre de 2018
DOI
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Licence
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)
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)
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
Date of Visit/ Assessment - Unscheduled
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])
Item Group
Unscheduled Assessments Performed
C0220825 (UMLS CUI-1)
C3854240 (UMLS CUI-2)
C3854240 (UMLS CUI-2)
Item
Select any unscheduled assessments that were performed at this visit.
integer
C0220825 (UMLS CUI [1,1])
C3854240 (UMLS CUI [1,2])
C3854240 (UMLS CUI [1,2])
Code List
Select any unscheduled assessments that were performed at this visit.
CL Item
Vitals (1)
CL Item
Lab (2)
CL Item
Candidiasis (3)
CL Item
Liver events assessment as a result of unscheduled chemistry lab results (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])
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)
Item Group
Date of Visit/ Assessment - End of Study
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])
Item Group
Status of Treatment Blind
C0749659 (UMLS CUI-1)
C2347038 (UMLS CUI-2)
C2347038 (UMLS CUI-2)
Was the treatment blind broken during the study?
Item
Was the treatment blind broken during the study?
boolean
C3897431 (UMLS CUI [1])
Date blind broken
Item
If the treatment blind was broken during the study, complete Date blind broken.
date
C3897431 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
Item
Reason for treatment blind was broken
integer
C3897431 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,2])
CL Item
Medical emergency requiring identification of investigational product for further treatment (1)
CL Item
Other, specify (2)
If other Reason for treatment blind was broken, specify.
Item
If other Reason for treatment blind was broken, specify.
text
C3897431 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])
C0392360 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])
Did the subject become pregnant during the study?
Item
Did the subject become pregnant during the study?
boolean
C3828490 (UMLS CUI [1])
Item Group
Pharmacogenetic (PGx) Research Withdrawal of Consent
C2347500 (UMLS CUI-1)
C0021430 (UMLS CUI-2)
C2349954 (UMLS CUI-3)
C0021430 (UMLS CUI-2)
C2349954 (UMLS CUI-3)
Has the subject withdrawn consent for PGx research?
Item
Has the subject withdrawn consent for PGx research?
boolean
C2347500 (UMLS CUI [1,1])
C0021430 (UMLS CUI [1,2])
C2349954 (UMLS CUI [1,3])
C0021430 (UMLS CUI [1,2])
C2349954 (UMLS CUI [1,3])
Date informed consent withdrawn
Item
Date informed consent withdrawn
date
C0011008 (UMLS CUI [1,1])
C2349954 (UMLS CUI [1,2])
C0009797 (UMLS CUI [1,3])
C2349954 (UMLS CUI [1,2])
C0009797 (UMLS CUI [1,3])
Has a request been made for sample destruction?
Item
Has a request been made for sample destruction?
boolean
C1948029 (UMLS CUI [1,1])
C0178913 (UMLS CUI [1,2])
C1272683 (UMLS CUI [1,3])
C0178913 (UMLS CUI [1,2])
C1272683 (UMLS CUI [1,3])
Item
If a request has been made for sample destruction, check reason.
integer
C1948029 (UMLS CUI [1,1])
C0178913 (UMLS CUI [1,2])
C1272683 (UMLS CUI [1,3])
C0178913 (UMLS CUI [1,2])
C1272683 (UMLS CUI [1,3])
Code List
If a request has been made for sample destruction, check reason.
CL Item
Subject withdrew consent for PGx (3)
CL Item
Screen failure (2)
CL Item
Other, speciy (1)
If other reason for request for sample destruction, specify
Item
If other reason for request for sample destruction, specify.
text
C1948029 (UMLS CUI [1,1])
C0178913 (UMLS CUI [1,2])
C1272683 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,4])
C2348235 (UMLS CUI [1,5])
C0178913 (UMLS CUI [1,2])
C1272683 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,4])
C2348235 (UMLS CUI [1,5])
Date of subject completion or withdrawal
Item
Date of subject completion or withdrawal
date
C0422727 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C1549507 (UMLS CUI [2])
C0011008 (UMLS CUI [1,2])
C1549507 (UMLS CUI [2])
Item
Was the subject withdrawn from the study?
text
C0422727 (UMLS CUI [1])
CL Item
No (N)
CL Item
Yes, complete the primary reason for withdrawal (Y)
Item
Primary reason for withdrawal
integer
C0422727 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,2])
CL Item
Adverse Event (Record all details on the Non- Serious Adverse Events or Serious Adverse Events forms as approprioate) (1)
CL Item
Lack of efficacy (check all that apply. If none, select "No Subreasons") (2)
CL Item
No subreasons (99)
CL Item
Exacerbation (019)
CL Item
Exceeded rescue medication use (as defined in the protocol) (071)
CL Item
Below PEF stability limit (073)
CL Item
Below FEV1 stability limit (074)
CL Item
Asthma worsening requiring additional asthma medication (148)
CL Item
Protocol Deviation (check all that apply. If none, select "No Subreasons") (3)
CL Item
No subreasons (99)
CL Item
Pregnancy (024)
CL Item
Prohibited medication use (029)
CL Item
Subject reached protocol defined stopping criteria (4)
CL Item
Liver function test abnormality (017)
CL Item
ECG abnormality (007)
CL Item
Study closed/ terminated (5)
CL Item
Lost to Follow- up (6)
CL Item
Investigator discretion, specify (Select this reason if none of the other primary reasons are appropriate.) (7)
CL Item
Withdrew consent, specify: Select this reason if none of the other primary reasons are appropriate (8)
Specify investigator discretion
Item
Specify investigator discretion
text
C0008961 (UMLS CUI [1,1])
C0022423 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
C0022423 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
Withdrew consent specification
Item
Withdrew consent specification
text
C1707492 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,2])
Investigator Siganture
Item
Investigator Signature
text
C2346576 (UMLS CUI [1])
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