ID

29550

Beschrijving

Study ID: 102932 Clinical Study ID: HZA102932 Study Title:An open-label, randomised, 3-way crossover single dose study to demonstrate dose proportionality of fluticasone furoate (FF) and equivalence of vilanterol (VI) when administered as FF/VI inhalation powder from the novel dry powder inhaler in healthy subjects. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01213849 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: fluticasone furoate Trade Name: Allermist,Veramyst,Avamys; Veramyst,Avamys,Allermist Study Indication: Asthma Documentation part: LOGS and Repeats

Trefwoorden

Versies (2)
  1. 10-03-18 10-03-18 -
  2. 05-04-18 05-04-18 -
Houder van rechten

GlaxoSmithKline

Geüploaded op

5 april 2018

DOI

Voor een aanvraag inloggen.

Licentie

Creative Commons BY-NC 3.0
Model Commentaren :

Hier kunt u commentaar leveren op het model. U kunt de tekstballonnen bij de itemgroepen en items gebruiken om er specifiek commentaar op te geven.

Terug naar het model Commentaren
Itemgroep Commentaren voor :

Item Commentaren voor :

U moet ingelogd zijn om formulieren te downloaden. AUB inloggen of schrijf u gratis in.

GSK Dose proportionality of fluticasone furoate and equivalence of vilanterol in healthy adults NCT01213849

Engels

LOGS and Repeats

1 Formulieren  
  1. StudyEvent: ODM
    1. LOGS and Repeats
ADVERSE EVENT/CONCOMITANT MEDICATION/REPEAT ASSESSMENT CHECK QUESTIONS
Beschrijving

ADVERSE EVENT/CONCOMITANT MEDICATION/REPEAT ASSESSMENT CHECK QUESTIONS

Alias
UMLS CUI-1
C2347852
UMLS CUI-2
C0877248
UMLS CUI-3
C0008976
UMLS CUI-4
C1320722
Date of visit/assessment
Beschrijving

Date of visit/assessment

Datatype

date

Alias
UMLS CUI [1]
C1320303
Were any concomitant medications taken by the subject during the study?
Beschrijving

concomitant medications

Datatype

boolean

Alias
UMLS CUI [1]
C2347852
Did the subject experience any non-serious adverse events during the study?
Beschrijving

non-serious adverse events

Datatype

boolean

Alias
UMLS CUI [1]
C1518404
Did the subject experience any serious adverse events during the study?
Beschrijving

serious adverse events

Datatype

boolean

Alias
UMLS CUI [1]
C1519255
Were any abnormal, clinically significant ECG measurements recorded for this subject during the study?
Beschrijving

abnormal ECG

Datatype

boolean

Alias
UMLS CUI [1]
C0522055
Were any repeat haematology or clinical chemistry samples taken?
Beschrijving

repeat haematology or clinical chemistry samples taken

Datatype

boolean

Alias
UMLS CUI [1,1]
C0008000
UMLS CUI [1,2]
C0018941
UMLS CUI [1,3]
C0200345
Were any repeat urinalysis samples taken?
Beschrijving

urinalysis samples

Datatype

boolean

Alias
UMLS CUI [1,1]
C0042014
UMLS CUI [1,2]
C0200345
Were any repeat ECGs performed?
Beschrijving

ECG

Datatype

boolean

Alias
UMLS CUI [1]
C0013798
Were any repeat vital signs recorded?
Beschrijving

vital signs

Datatype

boolean

Alias
UMLS CUI [1]
C0518766
Were any repeat Pulmonary Function Tests performed?
Beschrijving

Pulmonary Function Tests

Datatype

boolean

Alias
UMLS CUI [1]
C0024119
Were any repeat PK blood samples taken?
Beschrijving

PK blood samples taken

Datatype

boolean

Alias
UMLS CUI [1,1]
C1277698
UMLS CUI [1,2]
C0031327
Any IP device malfunctions?
Beschrijving

IP device malfunctions

Datatype

boolean

Alias
UMLS CUI [1]
C0699733
Have liver chemistry results reached or exceeded protocol-defined investigational product stopping criteria?
Beschrijving

liver chemistry

Datatype

boolean

Alias
UMLS CUI [1,1]
C0232741
UMLS CUI [1,2]
C0008000
UMLS CUI [1,3]
C0587081
Terug naar het begin van de pagina

Similar models

LOGS and Repeats

1 Formulieren
  1. StudyEvent: ODM
    1. LOGS and Repeats
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
ADVERSE EVENT/CONCOMITANT MEDICATION/REPEAT ASSESSMENT CHECK QUESTIONS
C2347852 (UMLS CUI-1)
C0877248 (UMLS CUI-2)
C0008976 (UMLS CUI-3)
C1320722 (UMLS CUI-4)
Date of visit/assessment
Item
Date of visit/assessment
date
C1320303 (UMLS CUI [1])
concomitant medications
Item
Were any concomitant medications taken by the subject during the study?
boolean
C2347852 (UMLS CUI [1])
non-serious adverse events
Item
Did the subject experience any non-serious adverse events during the study?
boolean
C1518404 (UMLS CUI [1])
serious adverse events
Item
Did the subject experience any serious adverse events during the study?
boolean
C1519255 (UMLS CUI [1])
abnormal ECG
Item
Were any abnormal, clinically significant ECG measurements recorded for this subject during the study?
boolean
C0522055 (UMLS CUI [1])
repeat haematology or clinical chemistry samples taken
Item
Were any repeat haematology or clinical chemistry samples taken?
boolean
C0008000 (UMLS CUI [1,1])
C0018941 (UMLS CUI [1,2])
C0200345 (UMLS CUI [1,3])
urinalysis samples
Item
Were any repeat urinalysis samples taken?
boolean
C0042014 (UMLS CUI [1,1])
C0200345 (UMLS CUI [1,2])
ECG
Item
Were any repeat ECGs performed?
boolean
C0013798 (UMLS CUI [1])
vital signs
Item
Were any repeat vital signs recorded?
boolean
C0518766 (UMLS CUI [1])
Pulmonary Function Tests
Item
Were any repeat Pulmonary Function Tests performed?
boolean
C0024119 (UMLS CUI [1])
PK blood samples taken
Item
Were any repeat PK blood samples taken?
boolean
C1277698 (UMLS CUI [1,1])
C0031327 (UMLS CUI [1,2])
IP device malfunctions
Item
Any IP device malfunctions?
boolean
C0699733 (UMLS CUI [1])
liver chemistry
Item
Have liver chemistry results reached or exceeded protocol-defined investigational product stopping criteria?
boolean
C0232741 (UMLS CUI [1,1])
C0008000 (UMLS CUI [1,2])
C0587081 (UMLS CUI [1,3])
Terug naar het begin van de pagina 

Contact

Gebruik dit formulier voor feedback, vragen en verbeteringsvoorstellen.

Velden gemarkeerd met een * zijn verplicht.

Help

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial