ID
34830
Descripción
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.
Palabras clave
Versiones (1)
- 30/1/19 30/1/19 -
Titular de derechos de autor
GlaxoSmithKline
Subido en
30 de enero de 2019
DOI
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Licencia
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
Descripción
Concomitant medication
Alias
- UMLS CUI-1
- C2347852
Descripción
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.
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C2347852
- UMLS CUI [1,2]
- C1883727
Descripción
use of Trade Names is preferred.
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C2347852
Descripción
Unit Dose, medication
Tipo de datos
integer
Alias
- UMLS CUI [1]
- C0869039
Descripción
Units, medication
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C1519795
- UMLS CUI [1,2]
- C2347852
Descripción
Frequency, medication
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C3476109
- UMLS CUI [1,2]
- C2347852
Descripción
Route, medication
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0013153
- UMLS CUI [1,2]
- C2347852
Descripción
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
Tipo de datos
text
Alias
- UMLS CUI [1]
- C2826696
Descripción
day month year
Tipo de datos
date
Alias
- UMLS CUI [1]
- C2826734
Descripción
00:00-23:59
Tipo de datos
time
Alias
- UMLS CUI [1,1]
- C1301880
- UMLS CUI [1,2]
- C2347852
Descripción
Taken prior to study
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C2347852
- UMLS CUI [1,2]
- C0332152
- UMLS CUI [1,3]
- C2347804
Descripción
day month year
Tipo de datos
date
Alias
- UMLS CUI [1]
- C2826744
Descripción
00:00-23:59
Tipo de datos
time
Alias
- UMLS CUI [1]
- C2826659
Descripción
Ongoing medication
Tipo de datos
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])