ID

34882

Beschrijving

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 Day1 (TP1-4D1).

Trefwoorden

Versies (2)
  1. 31-01-19 31-01-19 -
  2. 01-02-19 01-02-19 -
Houder van rechten

GlaxoSmithKline

Geüploaded op

1 februari 2019

DOI

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Licentie

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

Engels

Vital signs for treatment periods Day1

1 Formulieren  
Administrative data
Beschrijving

Administrative data

Alias
UMLS CUI-1
C1320722
Subject identifier
Beschrijving

Subject identifier

Datatype

text

Alias
UMLS CUI [1]
C2348585
Visit type
Beschrijving

Visit type

Datatype

integer

Alias
UMLS CUI [1,1]
C0332307
UMLS CUI [1,2]
C0545082
Vital Signs
Beschrijving

Vital Signs

Alias
UMLS CUI-1
C0518766
Date of measurement, vital signs
Beschrijving

day month year

Datatype

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0518766
Planned relative time
Beschrijving

Take for each timepoint three measurements. Unscheduled if requiered. Time relative to dosing.

Datatype

integer

Alias
UMLS CUI [1]
C0439564
Actual time, vital signs
Beschrijving

00:00-23:59

Datatype

time

Alias
UMLS CUI [1,1]
C0040223
UMLS CUI [1,2]
C0518766
Blood Pressure: Systolic
Beschrijving

Ensure that blood pressure values are within reasonable limits and systolic blood pressure is greater than diastolic blood pressure.

Datatype

integer

Maateenheden
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
Blood Pressure: Diastolic
Beschrijving

Ensure that blood pressure values are within reasonable limits and systolic blood pressure is greater than diastolic blood pressure.

Datatype

integer

Maateenheden
  • mmHg
Alias
UMLS CUI [1]
C0428883
mmHg
Heart rate supine, vital signs
Beschrijving

Ensure that heart rate value is within reasonable limits for beats per minute. Ensure that the patient is in a supine position.

Datatype

integer

Maateenheden
  • beats/min
Alias
UMLS CUI [1,1]
C0018810
UMLS CUI [1,2]
C0518766
UMLS CUI [1,3]
C0038846
beats/min
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Similar models

Vital signs for treatment periods Day1

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Administrative data
C1320722 (UMLS CUI-1)
Subject identifier
Item
Subject identifier
text
C2348585 (UMLS CUI [1])
Item
Visit type
integer
C0332307 (UMLS CUI [1,1])
C0545082 (UMLS CUI [1,2])
Visit type
Code List
Visit type
CL Item
TP1D1 (1)
CL Item
TP2D1 (2)
CL Item
TP3D1 (3)
CL Item
TP4D1 (4)
Item Group
Vital Signs
C0518766 (UMLS CUI-1)
Date of measurement, vital signs
Item
Date of measurement, vital signs
date
C0011008 (UMLS CUI [1,1])
C0518766 (UMLS CUI [1,2])
Item
Planned relative time
integer
C0439564 (UMLS CUI [1])
Planned relative time
Code List
Planned relative time
CL Item
Pre-dose (1)
CL Item
2h (2)
CL Item
6h (3)
CL Item
12h (4)
CL Item
24h (5)
CL Item
Unscheduled (6)
Actual time, vital signs
Item
Actual time, vital signs
time
C0040223 (UMLS CUI [1,1])
C0518766 (UMLS CUI [1,2])
Blood Pressure: Systolic
Item
Blood Pressure: Systolic
integer
C0871470 (UMLS CUI [1])
Blood Pressure: Diastolic
Item
Blood Pressure: Diastolic
integer
C0428883 (UMLS CUI [1])
Heart rate supine, vital signs
Item
Heart rate supine, vital signs
integer
C0018810 (UMLS CUI [1,1])
C0518766 (UMLS CUI [1,2])
C0038846 (UMLS CUI [1,3])
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