ID

34852

Beskrivning

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).

Nyckelord

  1. 2019-01-31 2019-01-31 -
  2. 2019-02-01 2019-02-01 -
Rättsinnehavare

GlaxoSmithKline

Uppladdad den

31 januari 2019

DOI

För en begäran logga in.

Licens

Creative Commons BY-NC 3.0

Modellkommentarer :

Här kan du kommentera modellen. Med hjälp av pratbubblor i Item-grupperna och Item kan du lägga in specifika kommentarer.

Itemgroup-kommentar för :

Item-kommentar för :

Du måste vara inloggad för att kunna ladda ner formulär. Var vänlig logga in eller registrera dig utan kostnad.

Effect of inhaled Fluticasone furoate and cellobiose octa-acetate on electrocardiographic parameters in healthy subjects, Study-ID: 101888

Vital signs for treatment periods Day1

Administrative data
Beskrivning

Administrative data

Alias
UMLS CUI-1
C1320722
Subject identifier
Beskrivning

Subject identifier

Datatyp

text

Alias
UMLS CUI [1]
C2348585
Visit type
Beskrivning

Visit type

Datatyp

integer

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

Vital Signs

Alias
UMLS CUI-1
C0518766
Date of measurement
Beskrivning

day month year

Datatyp

date

Alias
UMLS CUI [1]
C0011008
Planned relative time
Beskrivning

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

Datatyp

integer

Alias
UMLS CUI [1]
C0439564
Actual time
Beskrivning

00:00-23:59

Datatyp

time

Alias
UMLS CUI [1]
C0040223
Blood Pressure: Systolic
Beskrivning

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

Datatyp

integer

Måttenheter
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
Blood Pressure: Diastolic
Beskrivning

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

Datatyp

integer

Måttenheter
  • mmHg
Alias
UMLS CUI [1]
C0428883
mmHg
Heart rate
Beskrivning

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

Datatyp

integer

Måttenheter
  • beats/min
Alias
UMLS CUI [1,1]
C0018810
UMLS CUI [1,2]
C0038846
beats/min

Similar models

Vital signs for treatment periods Day1

Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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
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
Item
Date of measurement
date
C0011008 (UMLS CUI [1])
Item
Planned relative time
integer
C0439564 (UMLS CUI [1])
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
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])
Heart rate supine
Item
Heart rate
integer
C0018810 (UMLS CUI [1,1])
C0038846 (UMLS CUI [1,2])

Använd detta formulär för feedback, frågor och förslag på förbättringar.

Fält markerade med * är obligatoriska.

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