ID
34881
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 vital signs form. It has to be filled in for treatment periods Day-1 (TP1-4 D-1)and for follow-up.
Keywords
Versions (2)
- 1/31/19 1/31/19 -
- 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
Vital signs for treatment periods Day-1 and for follow-up
- StudyEvent: ODM
Description
Vital Signs
Alias
- UMLS CUI-1
- C0518766
Description
day month year
Data type
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0518766
Description
Planned relative time
Data type
integer
Alias
- UMLS CUI [1]
- C0439564
Description
00:00-23:59
Data type
time
Alias
- UMLS CUI [1,1]
- C0040223
- UMLS CUI [1,2]
- C0518766
Description
Ensure that blood pressure values are within reasonable limits and systolic blood pressure is greater than diastolic blood pressure.
Data type
integer
Measurement units
- mmHg
Alias
- UMLS CUI [1]
- C0871470
Description
Ensure that blood pressure values are within reasonable limits and systolic blood pressure is greater than diastolic blood pressure.
Data type
integer
Measurement units
- mmHg
Alias
- UMLS CUI [1]
- C0428883
Description
Ensure that heart rate value is within reasonable limits for beats per minute. Ensure that the patient is in a supine position.
Data type
integer
Measurement units
- beats/min
Alias
- UMLS CUI [1,1]
- C0018810
- UMLS CUI [1,2]
- C0518766
- UMLS CUI [1,3]
- C0038846
Similar models
Vital signs for treatment periods Day-1 and for follow-up
- StudyEvent: ODM
C0518766 (UMLS CUI [1,2])
C0518766 (UMLS CUI [1,2])
C0518766 (UMLS CUI [1,2])
C0038846 (UMLS CUI [1,3])