ID

32469

Description

Study ID: 106837 Clinical Study ID: HZA106837 Study Title: A Long-Term, Randomized, Double-Blind, Parallel Group Study of Fluticasone Furoate/GW642444 Inhalation Powder Once-Daily and Fluticasone Furoate Inhalation Powder Once-Daily in Subjects with Asthma Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01086384 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: fluticasone furoate/vilanterol Trade Name: Relvar Study Indication: Asthma

Keywords

Versions (2)
  1. 11/2/18 11/2/18 -
  2. 11/28/18 11/28/18 -
Copyright Holder

GSK group of companies

Uploaded on

November 2, 2018

DOI

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License

Creative Commons BY-NC 3.0
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A Parallel Group Study of Fluticasone Furoate/Vilanterol in Subjects with Asthma - 106837

English

12-LEAD ECG

1 forms  
  1. StudyEvent: ODM
    1. 12-LEAD ECG
12-lead ECG
Description

12-lead ECG

Date of ECG
Description

Date of ECG

Data type

date

Heart rate
Description

Heart rate

Data type

integer

Measurement units
  • bpm
bpm
PR Interval
Description

PR Interval

Data type

text

Measurement units
  • msec
msec
QRS Duration
Description

QRS Duration

Data type

text

if Machine, record QTcB values generated
Description

if Machine, record QTcB values generated

Data type

float

Measurement units
  • msec
msec
if Machine, record QTcF values generated
Description

if Machine, record QTcF values generated

Data type

float

Measurement units
  • msec
msec
If Manual, record RR Interval
Description

If Manual, record the RR Interval

Data type

text

RR Interval
Description

that precedes the measured QT interval

Data type

float

Measurement units
  • msec
msec
Is this a repeat ECG?
Description

Is this a repeat ECG?

Data type

boolean

If YES, specify reason repeated
Description

If YES, specify reason repeated

Data type

integer

Result of the ECG
Description

Result of the ECG

Data type

text

QRS Axis
Description

QRS Axis

Data type

integer

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Similar models

12-LEAD ECG

1 forms
  1. StudyEvent: ODM
    1. 12-LEAD ECG
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
12-lead ECG
Date of ECG
Item
Date of ECG
date
Heart rate
Item
Heart rate
integer
PR Interval
Item
PR Interval
text
Item
QRS Duration
text
QRS Duration
Code List
QRS Duration
CL Item
Machine (1)
CL Item
Manual (2)
if Machine, record QTcB values generated
Item
if Machine, record QTcB values generated
float
if Machine, record QTcF values generated
Item
if Machine, record QTcF values generated
float
Item
If Manual, record RR Interval
text
If Manual, record the RR Interval
Code List
If Manual, record RR Interval
CL Item
RR Interval (1)
CL Item
RR Interval not available (2)
RR Interval
Item
RR Interval
float
Is this a repeat ECG?
Item
Is this a repeat ECG?
boolean
Item
If YES, specify reason repeated
integer
If YES, specify reason repeated
Code List
If YES, specify reason repeated
CL Item
Safety (1)
CL Item
Other (2)
Item
Result of the ECG
text
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 (complete the AE/SAE form if clinically significant abnormalities meet the protocol definition for an AE/SAE) (3)
CL Item
No result (not available) (4)
QRS Axis
Item
QRS Axis
integer
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