ID
34830
Beschrijving
Study ID: 101888 Clinical Study ID: FFR101888 Study Title: A randomised, placebo-controlled, four way crossover study to evaluate the effect of double-blind 4000 mcg of orally inhaled GW685698X and of 6.25 mg cellobiose octa-acetate on electrocardiographic parameters, with single-blind 400 mg of oral moxifloxacin as a positive control, in 40 healthy male and female subjects. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: fluticasone furoate Trade Name: Veramyst,Avamys,Allermist Study Indication: Rhinitis, Allergic, Perennial The study consists of a screening, 4 treatment periods (TP) and a follow-up visit. For each TP there is a Day-1 (D-1) and a Day1 (D1). This document contains the Concomitant medication form. It has to be filled in for the end of study if concomitant medication was taken by subject during study.
Trefwoorden
Versies (1)
- 30-01-19 30-01-19 -
Houder van rechten
GlaxoSmithKline
Geüploaded op
30 januari 2019
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.
Itemgroep Commentaren voor :
Item Commentaren voor :
U moet ingelogd zijn om formulieren te downloaden. AUB inloggen of schrijf u gratis in.
Effect of inhaled Fluticasone furoate and cellobiose octa-acetate on electrocardiographic parameters in healthy subjects, Study-ID: 101888
Concomitant medication
- StudyEvent: ODM
Beschrijving
Concomitant medication
Alias
- UMLS CUI-1
- C2347852
Beschrijving
If Yes, record each medication on a separate line using Trade Names where possible. If the medication is related to a Non-Serious Adverse Event or Serious Adverse Event, details should be expressed using the same terminology.
Datatype
text
Alias
- UMLS CUI [1,1]
- C2347852
- UMLS CUI [1,2]
- C1883727
Beschrijving
use of Trade Names is preferred.
Datatype
text
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C2347852
Beschrijving
Unit Dose, medication
Datatype
integer
Alias
- UMLS CUI [1]
- C0869039
Beschrijving
Units, medication
Datatype
text
Alias
- UMLS CUI [1,1]
- C1519795
- UMLS CUI [1,2]
- C2347852
Beschrijving
Frequency, medication
Datatype
text
Alias
- UMLS CUI [1,1]
- C3476109
- UMLS CUI [1,2]
- C2347852
Beschrijving
Route, medication
Datatype
text
Alias
- UMLS CUI [1,1]
- C0013153
- UMLS CUI [1,2]
- C2347852
Beschrijving
Ensure that the 'Reason for Medication' is recorded on one of the following forms using the same terms: Current Medical Conditions, Non-Serious Adverse Events, Serious Adverse Events Form
Datatype
text
Alias
- UMLS CUI [1]
- C2826696
Beschrijving
day month year
Datatype
date
Alias
- UMLS CUI [1]
- C2826734
Beschrijving
00:00-23:59
Datatype
time
Alias
- UMLS CUI [1,1]
- C1301880
- UMLS CUI [1,2]
- C2347852
Beschrijving
Taken prior to study
Datatype
text
Alias
- UMLS CUI [1,1]
- C2347852
- UMLS CUI [1,2]
- C0332152
- UMLS CUI [1,3]
- C2347804
Beschrijving
day month year
Datatype
date
Alias
- UMLS CUI [1]
- C2826744
Beschrijving
00:00-23:59
Datatype
time
Alias
- UMLS CUI [1]
- C2826659
Beschrijving
Ongoing medication
Datatype
text
Alias
- UMLS CUI [1]
- C2826666
Similar models
Concomitant medication
- StudyEvent: ODM
C1883727 (UMLS CUI [1,2])
C2347852 (UMLS CUI [1,2])
C2347852 (UMLS CUI [1,2])
C2347852 (UMLS CUI [1,2])
C0332152 (UMLS CUI [1,2])
C2347804 (UMLS CUI [1,3])