ID

34865

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 24 hours Holter ECG form. It has to be filled in for screening.

Keywords

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

GlaxoSmithKline

Uploaded on

February 1, 2019

DOI

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License

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

English

24 hours Holter ECG

1 forms  
  1. StudyEvent: ODM
    1. 24 hours Holter ECG
Administrative data
Description

Administrative data

Alias
UMLS CUI-1
C1320722
Subject identifier
Description

Subject identifier

Data type

text

Alias
UMLS CUI [1]
C2348585
24 hours Holter ECG
Description

24 hours Holter ECG

Alias
UMLS CUI-1
C0013801
Start Date of Holter
Description

day month year

Data type

date

Alias
UMLS CUI [1,1]
C0013801
UMLS CUI [1,2]
C0808070
Start Time of Holter
Description

00:00-23:59

Data type

time

Alias
UMLS CUI [1,1]
C0013801
UMLS CUI [1,2]
C1301880
End Date of Holter
Description

day month year

Data type

date

Alias
UMLS CUI [1,1]
C0013801
UMLS CUI [1,2]
C0806020
End Time of Holter
Description

00:00-23:59

Data type

time

Alias
UMLS CUI [1,1]
C0013801
UMLS CUI [1,2]
C1522314
Result of the Holter
Description

Tick one. If you tick 3: Complete the Non-Serious Adverse Events (AE) or Serious Adverse Event (SAE) page(s) if clinically significant abnormalities meet the protocol definition for an AE or SAE. Complete the additional ECG Abnormalities page if clinically significant abnormalities are present.

Data type

integer

Alias
UMLS CUI [1,1]
C0013801
UMLS CUI [1,2]
C1274040
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Similar models

24 hours Holter ECG

1 forms
  1. StudyEvent: ODM
    1. 24 hours Holter ECG
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
24 hours Holter ECG
C0013801 (UMLS CUI-1)
Start Date of Holter
Item
Start Date of Holter
date
C0013801 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Start Time of Holter
Item
Start Time of Holter
time
C0013801 (UMLS CUI [1,1])
C1301880 (UMLS CUI [1,2])
End Date of Holter
Item
End Date of Holter
date
C0013801 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
End Time of Holter
Item
End Time of Holter
time
C0013801 (UMLS CUI [1,1])
C1522314 (UMLS CUI [1,2])
Item
Result of the Holter
integer
C0013801 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
Result of the Holter
Code List
Result of the Holter
CL Item
Normal (1)
CL Item
Abnormal - Not clinically significant (2)
CL Item
Abnormal - Clinically significant (3)
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