ID

41033

Beskrivning

Study ID: 103447 Clinical Study ID: NKV103447 Study Title:A study to evaluate the effect of casoptiant on cardiac conduction as assessed by 12-lead electrocardiogram as compared to placebo and moxifloxacin Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: casopitant Trade Name: Rezonic,Zunrisa; Zunrisa,Rezonic Study Indication: Nausea and Vomiting, Chemotherapy-Induced

Nyckelord

Versioner (1)
  1. 2020-06-15 2020-06-15 -
Rättsinnehavare

GlaxoSmithKline

Uppladdad den

15 juni 2020

DOI

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Creative Commons BY-NC 4.0
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Effect of casoptiant on cardiac conduction as compared to placebo and moxifloxacin 103447

Engelsk

12-Lead ECG

1 Formulär  
  1. StudyEvent: ODM
    1. 12-Lead ECG
Administrative
Beskrivning

Administrative

Alias
UMLS CUI-1
C1320722
Subject Identifier
Beskrivning

Subject Identifier

Datatyp

text

Alias
UMLS CUI [1]
C2348585
12-Lead ECG (Screening and Follow-up)
Beskrivning

12-Lead ECG (Screening and Follow-up)

Alias
UMLS CUI-1
C0430456
Start Date of ECG
Beskrivning

Start Date of ECG

Datatyp

date

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0808070
Start Time of ECG
Beskrivning

Start Time of ECG

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
  • ms
Alias
UMLS CUI [1]
C0429087
ms
QRS Duration
Beskrivning

QRS Duration

Datatyp

integer

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

Uncorrected QT Interval

Datatyp

integer

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

QTc Interval

Datatyp

integer

Måttenheter
  • ms
Alias
UMLS CUI [1]
C0489625
ms
QRS Axis, if available
Beskrivning

QRS Axis, if available

Datatyp

integer

Måttenheter
  • degrees
Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0429012
degrees
Result of the ECG
Beskrivning

Check one

Datatyp

integer

Alias
UMLS CUI [1]
C0438154
12-Lead ECG (Day 3 and 5)
Beskrivning

12-Lead ECG (Day 3 and 5)

Alias
UMLS CUI-1
C0430456
ECG Number
Beskrivning

ECG Number

Datatyp

integer

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0237753
Start Date of ECG
Beskrivning

Start Date of ECG

Datatyp

date

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0808070
Start Time of ECG
Beskrivning

Start Time of ECG

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
  • ms
Alias
UMLS CUI [1]
C0429087
ms
QRS Duration
Beskrivning

QRS Duration

Datatyp

integer

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

Uncorrected QT Interval

Datatyp

integer

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

QTc Interval

Datatyp

integer

Måttenheter
  • ms
Alias
UMLS CUI [1]
C0489625
ms
QRS Axis, if available
Beskrivning

QRS Axis, if available

Datatyp

integer

Måttenheter
  • degrees
Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0429012
degrees
Result of the ECG
Beskrivning

Check one

Datatyp

integer

Alias
UMLS CUI [1]
C0438154
12-Lead ECG (Unscheduled)
Beskrivning

12-Lead ECG (Unscheduled)

Alias
UMLS CUI-1
C0430456
ECG Number
Beskrivning

ECG Number

Datatyp

integer

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0237753
Start Date of ECG
Beskrivning

Start Date of ECG

Datatyp

date

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0808070
Start Time of ECG
Beskrivning

Start Time of ECG

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
  • ms
Alias
UMLS CUI [1]
C0429087
ms
QRS Duration
Beskrivning

QRS Duration

Datatyp

integer

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

Uncorrected QT Interval

Datatyp

integer

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

QTc Interval

Datatyp

integer

Måttenheter
  • ms
Alias
UMLS CUI [1]
C0489625
ms
QRS Axis, if available
Beskrivning

QRS Axis, if available

Datatyp

integer

Måttenheter
  • degrees
Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0429012
degrees
Result of the ECG
Beskrivning

Check one

Datatyp

integer

Tillbaka till toppen

Similar models

12-Lead ECG

1 Formulär
  1. StudyEvent: ODM
    1. 12-Lead ECG
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Administrative
C1320722 (UMLS CUI-1)
Subject Identifier
Item
Subject Identifier
text
C2348585 (UMLS CUI [1])
Item Group
12-Lead ECG (Screening and Follow-up)
C0430456 (UMLS CUI-1)
Start Date of ECG
Item
Start Date of ECG
date
C0430456 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
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
C0489625 (UMLS CUI [1])
QRS Axis, if available
Item
QRS Axis, if available
integer
C0430456 (UMLS CUI [1,1])
C0429012 (UMLS CUI [1,2])
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)
Item Group
12-Lead ECG (Day 3 and 5)
C0430456 (UMLS CUI-1)
Item
ECG Number
integer
C0430456 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
ECG Number
Code List
ECG Number
CL Item
ECG1 (Predose) (1)
CL Item
ECG2 (1 hr) (2)
CL Item
ECG3 (2 hr) (3)
Start Date of ECG
Item
Start Date of ECG
date
C0430456 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
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
C0489625 (UMLS CUI [1])
QRS Axis, if available
Item
QRS Axis, if available
integer
C0430456 (UMLS CUI [1,1])
C0429012 (UMLS CUI [1,2])
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)
Item Group
12-Lead ECG (Unscheduled)
C0430456 (UMLS CUI-1)
Item
ECG Number
integer
C0430456 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
ECG Number
Code List
ECG Number
CL Item
ECG1 (1)
CL Item
ECG2  (2)
CL Item
ECG3 (3)
CL Item
ECG4 (4)
Start Date of ECG
Item
Start Date of ECG
date
C0430456 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
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
C0489625 (UMLS CUI [1])
QRS Axis, if available
Item
QRS Axis, if available
integer
C0430456 (UMLS CUI [1,1])
C0429012 (UMLS CUI [1,2])
Item
Result of the ECG
integer
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 significant1  (3)
CL Item
No result (not available) (4)
Tillbaka till toppen 

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