ID

33365

Description

Study ID: 106837 Clinical Study ID: HZA106837 Study Title: A Long-Term, Randomized, Double-Blind, Parallel Group Study of Fluticasone Furoate/GW642444 Inhalation Powder Once-Daily and Fluticasone Furoate Inhalation Powder Once-Daily in Subjects with Asthma Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01086384 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: fluticasone furoate/vilanterol Trade Name: Relvar Study Indication: Asthma

Mots-clés

Versions (2)
  1. 06/11/2018 06/11/2018 -
  2. 06/12/2018 06/12/2018 -
Détendeur de droits

GSK group of companies

Téléchargé le

6 décembre 2018

DOI

Pour une demande vous connecter.

Licence

Creative Commons BY-NC 3.0
Modèle Commentaires :

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A Parallel Group Study of Fluticasone Furoate/Vilanterol in Subjects with Asthma - 106837

Anglais

Liver Events Assessment Report

1 Formulaires  
Liver Events
Description

Liver Events

Alias
UMLS CUI-1
C0023884
UMLS CUI-2
C0877248
Was there a protocol defined liver chemistry event for the lab samples collected at this visit?
Description

Was there a protocol defined liver chemistry event for the lab samples collected at this visit?

Type de données

boolean

Alias
UMLS CUI [1,1]
C0023884
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C0008000
UMLS CUI [2]
C0005834
If YES, specify type of liver chemistry event
Description

If YES and type of liver chemistry event is Liver Monitoring, obtain tests as per protocol. If YES and type of liver chemistry event is Liver Event, stop investigational product, complete date stopped on Investigational Product Form and contact GSK within 24 hours of occurrence of liver by phone or fax. NOTE: If the liver event mets the definition of an SAE form must be completed inForm. If InForm is unavailable, the SAE form should be faxed to GSK. *Obtain tests as per protocol *Obtain blood samples for pharmacokinetic (PK) analysis within 72 hours of last dose *Complete Liver Events Forms (completed Liver Event Forms do not need to be supplied to GSK within 24 hours)

Type de données

text

Alias
UMLS CUI [1,1]
C0023884
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C0008000
UMLS CUI [1,4]
C2348235
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Similar models

Liver Events Assessment Report

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
Liver Events
C0023884 (UMLS CUI-1)
C0877248 (UMLS CUI-2)
Was there a protocol defined 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
C0023884 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C0008000 (UMLS CUI [1,3])
C0005834 (UMLS CUI [2])
Item
If YES, specify type of liver chemistry event
text
C0023884 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C0008000 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])
If YES, specify type of liver chemistry event
Code List
If YES, specify type of liver chemistry event
CL Item
Liver Event Monitoring Criteria (subject has met protocol defined liver event monitoring criteria) (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) (2)
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