ID
34830
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 Concomitant medication form. It has to be filled in for the end of study if concomitant medication was taken by subject during study.
Keywords
Versions (1)
- 1/30/19 1/30/19 -
Copyright Holder
GlaxoSmithKline
Uploaded on
January 30, 2019
DOI
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License
Creative Commons BY-NC 3.0
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Effect of inhaled Fluticasone furoate and cellobiose octa-acetate on electrocardiographic parameters in healthy subjects, Study-ID: 101888
Concomitant medication
- StudyEvent: ODM
Description
Concomitant medication
Alias
- UMLS CUI-1
- C2347852
Description
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.
Data type
text
Alias
- UMLS CUI [1,1]
- C2347852
- UMLS CUI [1,2]
- C1883727
Description
use of Trade Names is preferred.
Data type
text
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C2347852
Description
Unit Dose, medication
Data type
integer
Alias
- UMLS CUI [1]
- C0869039
Description
Units, medication
Data type
text
Alias
- UMLS CUI [1,1]
- C1519795
- UMLS CUI [1,2]
- C2347852
Description
Frequency, medication
Data type
text
Alias
- UMLS CUI [1,1]
- C3476109
- UMLS CUI [1,2]
- C2347852
Description
Route, medication
Data type
text
Alias
- UMLS CUI [1,1]
- C0013153
- UMLS CUI [1,2]
- C2347852
Description
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
Data type
text
Alias
- UMLS CUI [1]
- C2826696
Description
day month year
Data type
date
Alias
- UMLS CUI [1]
- C2826734
Description
00:00-23:59
Data type
time
Alias
- UMLS CUI [1,1]
- C1301880
- UMLS CUI [1,2]
- C2347852
Description
Taken prior to study
Data type
text
Alias
- UMLS CUI [1,1]
- C2347852
- UMLS CUI [1,2]
- C0332152
- UMLS CUI [1,3]
- C2347804
Description
day month year
Data type
date
Alias
- UMLS CUI [1]
- C2826744
Description
00:00-23:59
Data type
time
Alias
- UMLS CUI [1]
- C2826659
Description
Ongoing medication
Data type
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])