ID

33130

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 28, 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

Alias
UMLS CUI-1
C0430456
Date of ECG
Description

Date of ECG

Data type

date

Alias
UMLS CUI [1]
C2826640
Heart rate
Description

Heart rate

Data type

integer

Measurement units
  • bpm
Alias
UMLS CUI [1]
C0018810
bpm
PR Interval
Description

PR Interval

Data type

text

Measurement units
  • msec
Alias
UMLS CUI [1]
C0429087
msec
QRS Duration
Description

QRS Duration

Data type

text

Alias
UMLS CUI [1]
C0429025
if Machine, record QTcB values generated
Description

if Machine, record QTcB values generated

Data type

float

Measurement units
  • msec
Alias
UMLS CUI [1,1]
C1882512
UMLS CUI [1,2]
C0855331
UMLS CUI [1,3]
C0336779
msec
if Machine, record QTcF values generated
Description

if Machine, record QTcF values generated

Data type

float

Measurement units
  • msec
Alias
UMLS CUI [1,1]
C1882513
UMLS CUI [1,2]
C0855331
UMLS CUI [1,3]
C0336779
msec
If Manual, record RR Interval
Description

If Manual, record the RR Interval

Data type

text

Alias
UMLS CUI [1,1]
C0489636
UMLS CUI [1,2]
C0855331
UMLS CUI [1,3]
C0175674
RR Interval
Description

that precedes the measured QT interval

Data type

float

Measurement units
  • msec
Alias
UMLS CUI [1]
C0489636
msec
Is this a repeat ECG?
Description

Is this a repeat ECG?

Data type

boolean

Alias
UMLS CUI [1,1]
C1623258
UMLS CUI [1,2]
C0205341
If YES, specify reason repeated
Description

If YES, specify reason repeated

Data type

integer

Alias
UMLS CUI [1,1]
C1623258
UMLS CUI [1,2]
C0205341
UMLS CUI [1,3]
C0392360
Result of the ECG
Description

Result of the ECG

Data type

text

Alias
UMLS CUI [1]
C0438154
QRS Axis
Description

QRS Axis

Data type

integer

Alias
UMLS CUI [1]
C0429012
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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
C0430456 (UMLS CUI-1)
Date of ECG
Item
Date of ECG
date
C2826640 (UMLS CUI [1])
Heart rate
Item
Heart rate
integer
C0018810 (UMLS CUI [1])
PR Interval
Item
PR Interval
text
C0429087 (UMLS CUI [1])
Item
QRS Duration
text
C0429025 (UMLS CUI [1])
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
C1882512 (UMLS CUI [1,1])
C0855331 (UMLS CUI [1,2])
C0336779 (UMLS CUI [1,3])
if Machine, record QTcF values generated
Item
if Machine, record QTcF values generated
float
C1882513 (UMLS CUI [1,1])
C0855331 (UMLS CUI [1,2])
C0336779 (UMLS CUI [1,3])
Item
If Manual, record RR Interval
text
C0489636 (UMLS CUI [1,1])
C0855331 (UMLS CUI [1,2])
C0175674 (UMLS CUI [1,3])
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
C0489636 (UMLS CUI [1])
Is this a repeat ECG?
Item
Is this a repeat ECG?
boolean
C1623258 (UMLS CUI [1,1])
C0205341 (UMLS CUI [1,2])
Item
If YES, specify reason repeated
integer
C1623258 (UMLS CUI [1,1])
C0205341 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,3])
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
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 (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
C0429012 (UMLS CUI [1])
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