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.
Mots-clés
Versions (1)
- 30/01/2019 30/01/2019 -
Détendeur de droits
GlaxoSmithKline
Téléchargé le
30 janvier 2019
DOI
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Licence
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.
Type de données
text
Alias
- UMLS CUI [1,1]
- C2347852
- UMLS CUI [1,2]
- C1883727
Description
use of Trade Names is preferred.
Type de données
text
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C2347852
Description
Unit Dose, medication
Type de données
integer
Alias
- UMLS CUI [1]
- C0869039
Description
Units, medication
Type de données
text
Alias
- UMLS CUI [1,1]
- C1519795
- UMLS CUI [1,2]
- C2347852
Description
Frequency, medication
Type de données
text
Alias
- UMLS CUI [1,1]
- C3476109
- UMLS CUI [1,2]
- C2347852
Description
Route, medication
Type de données
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
Type de données
text
Alias
- UMLS CUI [1]
- C2826696
Description
day month year
Type de données
date
Alias
- UMLS CUI [1]
- C2826734
Description
00:00-23:59
Type de données
time
Alias
- UMLS CUI [1,1]
- C1301880
- UMLS CUI [1,2]
- C2347852
Description
Taken prior to study
Type de données
text
Alias
- UMLS CUI [1,1]
- C2347852
- UMLS CUI [1,2]
- C0332152
- UMLS CUI [1,3]
- C2347804
Description
day month year
Type de données
date
Alias
- UMLS CUI [1]
- C2826744
Description
00:00-23:59
Type de données
time
Alias
- UMLS CUI [1]
- C2826659
Description
Ongoing medication
Type de données
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])