ID

34931

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 12-lead ECG form. It has to be filled in for screening, TP1-4 Day-1 anf for follow-up.

Nyckelord

Versioner (1)
  1. 2019-02-04 2019-02-04 -
Rättsinnehavare

GlaxoSmithKline

Uppladdad den

4 februari 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

Engelsk

12-lead ECG for screening, TP1-4 Day-1 and for follow-up

1 Formulär  
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
12-LEAD ECG
Beskrivning

12-LEAD ECG

Alias
UMLS CUI-1
C0430456
Start Date of ECG
Beskrivning

day month year

Datatyp

date

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0808070
Planned relative time
Beskrivning

Three measurements will be taken at each specified time. screening and unscheduled: for screening visit day-1 and unscheduled: for treatment periods day-1 follow-up and unscheduled: for follow-up

Datatyp

integer

Alias
UMLS CUI [1,1]
C0439564
UMLS CUI [1,2]
C0430456
Start Time of ECG
Beskrivning

00:00-23:59

Datatyp

time

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C1301880
Ventricular Rate
Beskrivning

Ventricular Rate

Datatyp

integer

Måttenheter
  • beats/min
Alias
UMLS CUI [1]
C2189285
beats/min
PR Interval
Beskrivning

PR Interval

Datatyp

integer

Måttenheter
  • msec
Alias
UMLS CUI [1]
C0429087
msec
QRS Duration
Beskrivning

QRS Duration

Datatyp

integer

Måttenheter
  • msec
Alias
UMLS CUI [1]
C0429025
msec
Uncorrected QT Interval
Beskrivning

Uncorrected QT Interval

Datatyp

integer

Måttenheter
  • msec
Alias
UMLS CUI [1]
C1287082
msec
QTc Interval
Beskrivning

QTc Interval

Datatyp

integer

Måttenheter
  • msec
Alias
UMLS CUI [1]
C0855331
msec
QTc (F)
Beskrivning

Not for screening visit.

Datatyp

integer

Måttenheter
  • msec
Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C1882513
msec
Manually read QTc value
Beskrivning

Not for screening visit. If a subject’s QTcF interval extends beyond 500msec or is increased more than 60msec compared to baseline (confirmed on three or more ECG tracings separated by at least 2 minutes), the ECG tracing should be examined by an appropriately trained physician and manual measurements undertaken. If the reading is confirmed, the subject should be closely monitored and followed in the clinical unit until the QT and QTc(F) interval return to within 30msec of their baseline.

Datatyp

integer

Måttenheter
  • msec
Alias
UMLS CUI [1,1]
C0855331
UMLS CUI [1,2]
C2911685
UMLS CUI [1,3]
C0175674
msec
Result of the ECG
Beskrivning

enter code for result from the following list. If you tick 'Abnormal-clinically significant': Complete the Serious Adverse Event (SAE) page(s) if clinically significant abnormalities meet the protocol definition for a SAE. Complete the additional ECG Abnormalities page if clinically significant abnormalities are present.

Datatyp

integer

Alias
UMLS CUI [1]
C0438154
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Similar models

12-lead ECG for screening, TP1-4 Day-1 and for follow-up

1 Formulär
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])
Visit type
Code List
Visit type
CL Item
Screening (1)
CL Item
TP1D-1 (2)
CL Item
TP2D-1 (3)
CL Item
TP3D-1 (4)
CL Item
TP4D-1 (5)
CL Item
Follow-up (6)
Item Group
12-LEAD ECG
C0430456 (UMLS CUI-1)
Start Date of ECG
Item
Start Date of ECG
date
C0430456 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Item
Planned relative time
integer
C0439564 (UMLS CUI [1,1])
C0430456 (UMLS CUI [1,2])
Planned relative time
Code List
Planned relative time
CL Item
Screening (1)
CL Item
Day-1 (2)
CL Item
Follow-up (3)
CL Item
Unscheduled (4)
Start Time of ECG
Item
Start Time of ECG
time
C0430456 (UMLS CUI [1,1])
C1301880 (UMLS CUI [1,2])
Ventricular Rate
Item
Ventricular Rate
integer
C2189285 (UMLS CUI [1])
PR Interval
Item
PR Interval
integer
C0429087 (UMLS CUI [1])
QRS Duration
Item
QRS Duration
integer
C0429025 (UMLS CUI [1])
Uncorrected QT Interval
Item
Uncorrected QT Interval
integer
C1287082 (UMLS CUI [1])
QTc Interval
Item
QTc Interval
integer
C0855331 (UMLS CUI [1])
QTc (F)
Item
QTc (F)
integer
C0430456 (UMLS CUI [1,1])
C1882513 (UMLS CUI [1,2])
Manually read QTc value
Item
Manually read QTc value
integer
C0855331 (UMLS CUI [1,1])
C2911685 (UMLS CUI [1,2])
C0175674 (UMLS CUI [1,3])
Item
Result of the ECG
integer
C0438154 (UMLS CUI [1])
Result of the ECG
Code List
Result of the ECG
CL Item
Normal  (1)
CL Item
Abnormal - not clinically significant  (2)
CL Item
Abnormal-clinically significant  (3)
CL Item
No result (not available) (4)
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