ID

33130

Beskrivning

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

Nyckelord

  1. 2018-11-02 2018-11-02 -
  2. 2018-11-28 2018-11-28 -
Rättsinnehavare

GSK group of companies

Uppladdad den

28 november 2018

DOI

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Licens

Creative Commons BY-NC 3.0

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A Parallel Group Study of Fluticasone Furoate/Vilanterol in Subjects with Asthma - 106837

12-LEAD ECG

  1. StudyEvent: ODM
    1. 12-LEAD ECG
12-lead ECG
Beskrivning

12-lead ECG

Alias
UMLS CUI-1
C0430456
Date of ECG
Beskrivning

Date of ECG

Datatyp

date

Alias
UMLS CUI [1]
C2826640
Heart rate
Beskrivning

Heart rate

Datatyp

integer

Måttenheter
  • bpm
Alias
UMLS CUI [1]
C0018810
bpm
PR Interval
Beskrivning

PR Interval

Datatyp

text

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

QRS Duration

Datatyp

text

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

if Machine, record QTcB values generated

Datatyp

float

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

if Machine, record QTcF values generated

Datatyp

float

Måttenheter
  • msec
Alias
UMLS CUI [1,1]
C1882513
UMLS CUI [1,2]
C0855331
UMLS CUI [1,3]
C0336779
msec
If Manual, record RR Interval
Beskrivning

If Manual, record the RR Interval

Datatyp

text

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

that precedes the measured QT interval

Datatyp

float

Måttenheter
  • msec
Alias
UMLS CUI [1]
C0489636
msec
Is this a repeat ECG?
Beskrivning

Is this a repeat ECG?

Datatyp

boolean

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

If YES, specify reason repeated

Datatyp

integer

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

Result of the ECG

Datatyp

text

Alias
UMLS CUI [1]
C0438154
QRS Axis
Beskrivning

QRS Axis

Datatyp

integer

Alias
UMLS CUI [1]
C0429012

Similar models

12-LEAD ECG

  1. StudyEvent: ODM
    1. 12-LEAD ECG
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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])
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])
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])
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])
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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