ID
34865
Description
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 24 hours Holter ECG form. It has to be filled in for screening.
Keywords
Versions (1)
- 2/1/19 2/1/19 -
Copyright Holder
GlaxoSmithKline
Uploaded on
February 1, 2019
DOI
To request one please log in.
License
Creative Commons BY-NC 3.0
Model comments :
You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.
Itemgroup comments for :
Item comments for :
In order to download data models you must be logged in. Please log in or register for free.
Effect of inhaled Fluticasone furoate and cellobiose octa-acetate on electrocardiographic parameters in healthy subjects, Study-ID: 101888
24 hours Holter ECG
- StudyEvent: ODM
Description
24 hours Holter ECG
Alias
- UMLS CUI-1
- C0013801
Description
day month year
Data type
date
Alias
- UMLS CUI [1,1]
- C0013801
- UMLS CUI [1,2]
- C0808070
Description
00:00-23:59
Data type
time
Alias
- UMLS CUI [1,1]
- C0013801
- UMLS CUI [1,2]
- C1301880
Description
day month year
Data type
date
Alias
- UMLS CUI [1,1]
- C0013801
- UMLS CUI [1,2]
- C0806020
Description
00:00-23:59
Data type
time
Alias
- UMLS CUI [1,1]
- C0013801
- UMLS CUI [1,2]
- C1522314
Description
Tick one. If you tick 3: Complete the Non-Serious Adverse Events (AE) or Serious Adverse Event (SAE) page(s) if clinically significant abnormalities meet the protocol definition for an AE or SAE. Complete the additional ECG Abnormalities page if clinically significant abnormalities are present.
Data type
integer
Alias
- UMLS CUI [1,1]
- C0013801
- UMLS CUI [1,2]
- C1274040
Similar models
24 hours Holter ECG
- StudyEvent: ODM
C0808070 (UMLS CUI [1,2])
C1301880 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,2])
C1522314 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,2])