ID

34881

Beschreibung

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.

Stichworte

  1. 31.01.19 31.01.19 -
  2. 01.02.19 01.02.19 -
Rechteinhaber

GlaxoSmithKline

Hochgeladen am

1. Februar 2019

DOI

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Lizenz

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

Vital signs for treatment periods Day-1 and for follow-up

Administrative data
Beschreibung

Administrative data

Alias
UMLS CUI-1
C1320722
Subject identifier
Beschreibung

Subject identifier

Datentyp

text

Alias
UMLS CUI [1]
C2348585
Visit type
Beschreibung

Visit type

Datentyp

integer

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

Vital Signs

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

day month year

Datentyp

date

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

Planned relative time

Datentyp

integer

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

00:00-23:59

Datentyp

time

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

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

Datentyp

integer

Maßeinheiten
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
Blood Pressure: Diastolic
Beschreibung

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

Datentyp

integer

Maßeinheiten
  • mmHg
Alias
UMLS CUI [1]
C0428883
mmHg
Heart rate supine, vital signs
Beschreibung

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

Datentyp

integer

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

Ähnliche Modelle

Vital signs for treatment periods Day-1 and for follow-up

Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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])
Code List
Visit type
CL Item
TP1D-1 (1)
CL Item
TP2D-1 (2)
CL Item
TP3D-1 (3)
CL Item
TP4D-1 (4)
CL Item
Follow-up (5)
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])
Code List
Planned relative time
CL Item
Day-1 (1)
CL Item
Follow-up (2)
CL Item
Unscheduled (3)
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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