ID

34850

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 screening.

Keywords

Versions (2)
  1. 1/31/19 1/31/19 -
  2. 2/1/19 2/1/19 -
Copyright Holder

GlaxoSmithKline

Uploaded on

January 31, 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.

Back to model comments
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

English

Vital signs for screening

1 forms  
Administrative data
Description

Administrative data

Alias
UMLS CUI-1
C1320722
Subject identifier
Description

Subject identifier

Data type

text

Alias
UMLS CUI [1]
C2348585
Vital Signs
Description

Vital Signs

Alias
UMLS CUI-1
C0518766
Body height
Description

Body height

Data type

integer

Measurement units
  • cm
Alias
UMLS CUI [1]
C0005890
cm
Body weight
Description

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

Data type

float

Measurement units
  • kg
Alias
UMLS CUI [1]
C0005910
kg
Body mass index
Description

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 19-31kgfm2 inclusive, the subject is not efigibfe for the study.

Data type

float

Measurement units
  • kg/m2
Alias
UMLS CUI [1]
C1305855
kg/m2
Date of measurement
Description

day month year

Data type

date

Alias
UMLS CUI [1]
C0011008
Planned relative time
Description

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.

Data type

integer

Alias
UMLS CUI [1]
C0439564
Actual time
Description

00:00-23:59

Data type

time

Alias
UMLS CUI [1]
C0040223
Blood Pressure: Systolic
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
mmHg
Blood Pressure: Diastolic
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
mmHg
Subject position
Description

Subject position

Data type

integer

Alias
UMLS CUI [1,1]
C1262869
UMLS CUI [1,2]
C0518766
Heart rate
Description

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

Data type

integer

Measurement units
  • beats/min
Alias
UMLS CUI [1]
C0018810
beats/min
Back to the top of the page

Similar models

Vital signs for screening

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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
Item
Date of measurement
date
C0011008 (UMLS CUI [1])
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
Item
Actual time
time
C0040223 (UMLS CUI [1])
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
Item
Heart rate
integer
C0018810 (UMLS CUI [1])
Back to the top of the page 

Contact

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

Help

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial