ID

34880

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 screening.

Stichworte

Versionen (2)
  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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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

Englisch

Vital signs for screening

1 Formulare  
Administrative data
Beschreibung

Administrative data

Alias
UMLS CUI-1
C1320722
Subject identifier
Beschreibung

Subject identifier

Datentyp

text

Alias
UMLS CUI [1]
C2348585
Vital Signs
Beschreibung

Vital Signs

Alias
UMLS CUI-1
C0518766
Body height
Beschreibung

Body height

Datentyp

integer

Maßeinheiten
  • cm
Alias
UMLS CUI [1]
C0005890
cm
Body weight
Beschreibung

Note: if the Body Weight is < 50 kg, the subject is not eligible for the study.

Datentyp

float

Maßeinheiten
  • kg
Alias
UMLS CUI [1]
C0005910
kg
Body mass index
Beschreibung

Provide the body mass index calculated using the following formula: Body Mass index = (Weight (kg) / (Height (cm))²) x 10.000 Note: if the Body Mass Index is not within range of 19-31 kg/cm2 inclusive, the subject is not eligible for the study.

Datentyp

float

Maßeinheiten
  • kg/m2
Alias
UMLS CUI [1]
C1305855
kg/m2
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

Three measurements, at least 2 minutes apart, will be taken at each specified time -the subject having rested in the supine position for at least 5 minutes before the first measurement. At screening only, the supine measurements will be followed by measurements in the erect position immediately after standing.

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
Subject position
Beschreibung

Subject position

Datentyp

integer

Alias
UMLS CUI [1,1]
C1262869
UMLS CUI [1,2]
C0518766
Heart rate, vital signs
Beschreibung

Ensure that heart rate value is within reasonable limits for beats per minute.

Datentyp

integer

Maßeinheiten
  • beats/min
Alias
UMLS CUI [1,1]
C0018810
UMLS CUI [1,2]
C0518766
beats/min
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Ähnliche Modelle

Vital signs for screening

1 Formulare
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 Group
Vital Signs
C0518766 (UMLS CUI-1)
Body height
Item
Body height
integer
C0005890 (UMLS CUI [1])
Body weight
Item
Body weight
float
C0005910 (UMLS CUI [1])
BMI
Item
Body mass index
float
C1305855 (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
Screening (1)
CL Item
Unscheduled (2)
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])
Item
Subject position
integer
C1262869 (UMLS CUI [1,1])
C0518766 (UMLS CUI [1,2])
Subject position
Code List
Subject position
CL Item
Supine (1)
CL Item
Standing (3)
Heart rate, vital signs
Item
Heart rate, vital signs
integer
C0018810 (UMLS CUI [1,1])
C0518766 (UMLS CUI [1,2])
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