ID

38134

Beschrijving

Study ID: 105036 Clinical Study ID: 105036 Study Title: A single-blind, randomized, placebo-controlled study to investigate the safety, tolerability, and potential effects on betamethasone pharmacokinetics of a co-administered infusion of GSK221149A in healthy female subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: N/A Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: betamethasone Trade Name: Retosiban Study Indication: Women's Health & Pregnancy - Other, pre-term labour

Trefwoorden

Versies (1)
  1. 21-09-19 21-09-19 -
Houder van rechten

GlaxoSmithKline

Geüploaded op

21 september 2019

DOI

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Licentie

Creative Commons BY-NC 3.0
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Betamethasone pharmacokinetics of a co-administered infusion of GSK221149A; 105036

Engels

12-Lead ECG

1 Formulieren  
  1. StudyEvent: ODM
    1. 12-Lead ECG
Dosing Date and Time
Beschrijving

Dosing Date and Time

Alias
UMLS CUI-1
C0430456
UMLS CUI-2
C0178602
UMLS CUI-3
C0011008
UMLS CUI-4
C0040223
Dosing date/time
Beschrijving

12 lead ECG, Dosage, Date in time, Time

Datatype

datetime

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0011008
UMLS CUI [1,4]
C0040223
Predose
Beschrijving

Predose

Alias
UMLS CUI-1
C0430456
UMLS CUI-2
C0439565
Time of ECG
Beschrijving

12 lead ECG, Pre-dose, Time

Datatype

time

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0439565
UMLS CUI [1,3]
C0040223
Heart rate
Beschrijving

12 lead ECG, Pre-dose, Heart rate

Datatype

integer

Maateenheden
  • bpm
Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0439565
UMLS CUI [1,3]
C0018810
bpm
PR Interval
Beschrijving

12 lead ECG, Pre-dose, P-R interval

Datatype

integer

Maateenheden
  • msec
Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0439565
UMLS CUI [1,3]
C0429087
msec
QRS Duration
Beschrijving

12 lead ECG, Pre-dose, QRS complex duration

Datatype

integer

Maateenheden
  • msec
Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0439565
UMLS CUI [1,3]
C0429025
msec
Uncorrected QT Interval
Beschrijving

12 lead ECG, Pre-dose, QT interval

Datatype

integer

Maateenheden
  • msec
Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0439565
UMLS CUI [1,3]
C1287082
msec
QTc Interval
Beschrijving

12 lead ECG, Pre-dose, Electrocardiogram QT corrected interval

Datatype

integer

Maateenheden
  • msec
Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0439565
UMLS CUI [1,3]
C0855331
msec
Method of QTc Calculation
Beschrijving

12 lead ECG, Pre-dose, Electrocardiogram QT corrected interval, Evaluation method

Datatype

text

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0439565
UMLS CUI [1,3]
C0855331
UMLS CUI [1,4]
C2911685
Result of the ECG
Beschrijving

12 lead ECG, Pre-dose, Result

Datatype

text

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0439565
UMLS CUI [1,3]
C1274040
0,5 Hours post dose
Beschrijving

0,5 Hours post dose

Alias
UMLS CUI-1
C0430456
UMLS CUI-2
C0439568
UMLS CUI-3
C1442458
Time of ECG
Beschrijving

12 lead ECG, Post-dose, 30 Minutes, Time

Datatype

time

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0439568
UMLS CUI [1,3]
C1442458
UMLS CUI [1,4]
C0040223
Heart rate
Beschrijving

12 lead ECG, Post-dose, 30 Minutes, Heart rate

Datatype

integer

Maateenheden
  • bpm
Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0439568
UMLS CUI [1,3]
C1442458
UMLS CUI [1,4]
C0018810
bpm
PR Interval
Beschrijving

12 lead ECG, Post-dose, 30 Minutes, P-R interval

Datatype

integer

Maateenheden
  • msec
Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0439568
UMLS CUI [1,3]
C1442458
UMLS CUI [1,4]
C0429087
msec
QRS Duration
Beschrijving

12 lead ECG, Post-dose, 30 Minutes, QRS complex duration

Datatype

integer

Maateenheden
  • msec
Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0439568
UMLS CUI [1,3]
C1442458
UMLS CUI [1,4]
C0429025
msec
Uncorrected QT Interval
Beschrijving

12 lead ECG, Post-dose, 30 Minutes, QT interval

Datatype

integer

Maateenheden
  • msec
Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0439568
UMLS CUI [1,3]
C1442458
UMLS CUI [1,4]
C1287082
msec
QTc Interval
Beschrijving

12 lead ECG, Post-dose, 30 Minutes, Electrocardiogram QT corrected interval

Datatype

integer

Maateenheden
  • msec
Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0439568
UMLS CUI [1,3]
C1442458
UMLS CUI [1,4]
C0855331
msec
Method of QTc Calculation
Beschrijving

12 lead ECG, Post-dose, 30 Minutes, Electrocardiogram QT corrected interval, Evaluation method

Datatype

text

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0439568
UMLS CUI [1,3]
C1442458
UMLS CUI [1,4]
C0855331
UMLS CUI [1,5]
C2911685
Result of the ECG
Beschrijving

12 lead ECG, Post-dose, 30 Minutes, Result

Datatype

text

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0439568
UMLS CUI [1,3]
C1442458
UMLS CUI [1,4]
C1274040
1 Hour post dose
Beschrijving

1 Hour post dose

Alias
UMLS CUI-1
C0430456
UMLS CUI-2
C0439568
UMLS CUI-3
C1442450
Time of ECG
Beschrijving

12 lead ECG, Post-dose, 1 Hour, Time

Datatype

time

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0439568
UMLS CUI [1,3]
C1442450
UMLS CUI [1,4]
C0040223
Heart rate
Beschrijving

12 lead ECG, Post-dose, 1 Hour, Heart rate

Datatype

integer

Maateenheden
  • bpm
Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0439568
UMLS CUI [1,3]
C1442450
UMLS CUI [1,4]
C0018810
bpm
PR Interval
Beschrijving

12 lead ECG, Post-dose, 1 Hour, P-R interval

Datatype

integer

Maateenheden
  • msec
Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0439568
UMLS CUI [1,3]
C1442450
UMLS CUI [1,4]
C0429087
msec
QRS Duration
Beschrijving

12 lead ECG, Post-dose, 1 Hour, QRS complex duration

Datatype

integer

Maateenheden
  • msec
Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0439568
UMLS CUI [1,3]
C1442450
UMLS CUI [1,4]
C0429025
msec
Uncorrected QT Interval
Beschrijving

12 lead ECG, Post-dose, 1 Hour, QT interval

Datatype

integer

Maateenheden
  • msec
Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0439568
UMLS CUI [1,3]
C1442450
UMLS CUI [1,4]
C1287082
msec
QTc Interval
Beschrijving

12 lead ECG, Post-dose, 1 Hour, Electrocardiogram QT corrected interval

Datatype

integer

Maateenheden
  • msec
Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0439568
UMLS CUI [1,3]
C1442450
UMLS CUI [1,4]
C0855331
msec
Method of QTc Calculation
Beschrijving

12 lead ECG, Post-dose, 1 Hour, Electrocardiogram QT corrected interval, Evaluation method

Datatype

text

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0439568
UMLS CUI [1,3]
C1442450
UMLS CUI [1,4]
C0855331
UMLS CUI [1,5]
C2911685
Result of the ECG
Beschrijving

12 lead ECG, Post-dose, 1 Hour, Result

Datatype

text

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0439568
UMLS CUI [1,3]
C1442450
UMLS CUI [1,4]
C1274040
2 Hours post dose
Beschrijving

2 Hours post dose

Alias
UMLS CUI-1
C0430456
UMLS CUI-2
C0439572
Time of ECG
Beschrijving

12 lead ECG, 2 Hours post dose, Time

Datatype

time

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0439572
UMLS CUI [1,3]
C0040223
Heart rate
Beschrijving

12 lead ECG, 2 Hours post dose, Heart rate

Datatype

integer

Maateenheden
  • bpm
Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0439572
UMLS CUI [1,3]
C0018810
bpm
PR Interval
Beschrijving

12 lead ECG, 2 hours post-dose, P-R interval

Datatype

integer

Maateenheden
  • msec
Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0439572
UMLS CUI [1,3]
C0429087
msec
QRS Duration
Beschrijving

12 lead ECG, 2 Hours post dose, QRS complex duration

Datatype

integer

Maateenheden
  • msec
Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0439572
UMLS CUI [1,3]
C0429025
msec
Uncorrected QT Interval
Beschrijving

12 lead ECG, 2 Hours post dose, QT interval

Datatype

integer

Maateenheden
  • msec
Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0439572
UMLS CUI [1,3]
C1287082
msec
QTc Interval
Beschrijving

12 lead ECG, 2 Hours post dose, Electrocardiogram QT corrected interval

Datatype

integer

Maateenheden
  • msec
Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0439572
UMLS CUI [1,3]
C0855331
msec
Method of QTc Calculation
Beschrijving

12 lead ECG, 2 Hours post dose, Electrocardiogram QT corrected interval, Evaluation method

Datatype

text

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0439572
UMLS CUI [1,3]
C0855331
UMLS CUI [1,4]
C2911685
Result of the ECG
Beschrijving

12 lead ECG, 2 Hours post dose, Result

Datatype

text

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0439572
UMLS CUI [1,3]
C1274040
4 Hours post dose
Beschrijving

4 Hours post dose

Alias
UMLS CUI-1
C0430456
UMLS CUI-2
C0439574
Time of ECG
Beschrijving

12 lead ECG, 4 Hours post dose, Time

Datatype

time

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0439574
UMLS CUI [1,3]
C0040223
Heart rate
Beschrijving

12 lead ECG, 4 Hours post dose, Heart rate

Datatype

integer

Maateenheden
  • bpm
Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0439574
UMLS CUI [1,3]
C0018810
bpm
PR Interval
Beschrijving

12 lead ECG, 4 hours post-dose, P-R interval

Datatype

integer

Maateenheden
  • msec
Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0439574
UMLS CUI [1,3]
C0429087
msec
QRS Duration
Beschrijving

12 lead ECG, 4 Hours post dose, QRS complex duration

Datatype

integer

Maateenheden
  • msec
Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0439574
UMLS CUI [1,3]
C0429025
msec
Uncorrected QT Interval
Beschrijving

12 lead ECG, 4 Hours post dose, QT interval

Datatype

integer

Maateenheden
  • msec
Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0439574
UMLS CUI [1,3]
C1287082
msec
QTc Interval
Beschrijving

12 lead ECG, 4 Hours post dose, Electrocardiogram QT corrected interval

Datatype

integer

Maateenheden
  • msec
Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0439574
UMLS CUI [1,3]
C0855331
msec
Method of QTc Calculation
Beschrijving

12 lead ECG, 4 Hours post dose, Electrocardiogram QT corrected interval, Evaluation method

Datatype

text

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0439574
UMLS CUI [1,3]
C0855331
UMLS CUI [1,4]
C2911685
Result of the ECG
Beschrijving

12 lead ECG, 4 Hours post dose, Result

Datatype

text

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0439574
UMLS CUI [1,3]
C1274040
8 Hours post dose
Beschrijving

8 Hours post dose

Alias
UMLS CUI-1
C0430456
UMLS CUI-2
C0439568
UMLS CUI-3
C1292429
Time of ECG
Beschrijving

12 lead ECG, Post-dose, 8 Hours, Time

Datatype

time

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0439568
UMLS CUI [1,3]
C1292429
UMLS CUI [1,4]
C0040223
Heart rate
Beschrijving

12 lead ECG, Post-dose, 8 Hours, Heart rate

Datatype

integer

Maateenheden
  • bpm
Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0439568
UMLS CUI [1,3]
C1292429
UMLS CUI [1,4]
C0018810
bpm
PR Interval
Beschrijving

12 lead ECG, Post-dose, 8 Hours, P-R interval

Datatype

integer

Maateenheden
  • msec
Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0439568
UMLS CUI [1,3]
C1292429
UMLS CUI [1,4]
C0429087
msec
QRS Duration
Beschrijving

12 lead ECG, Post-dose, 8 Hours, QRS complex duration

Datatype

integer

Maateenheden
  • msec
Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0439568
UMLS CUI [1,3]
C1292429
UMLS CUI [1,4]
C0429025
msec
Uncorrected QT Interval
Beschrijving

12 lead ECG, Post-dose, 8 Hours, QT interval

Datatype

integer

Maateenheden
  • msec
Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0439568
UMLS CUI [1,3]
C1292429
UMLS CUI [1,4]
C1287082
msec
QTc Interval
Beschrijving

12 lead ECG, Post-dose, 8 Hours, Electrocardiogram QT corrected interval

Datatype

integer

Maateenheden
  • msec
Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0439568
UMLS CUI [1,3]
C1292429
UMLS CUI [1,4]
C0855331
msec
Method of QTc Calculation
Beschrijving

12 lead ECG, Post-dose, 8 Hours, Electrocardiogram QT corrected interval, Evaluation method

Datatype

text

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0439568
UMLS CUI [1,3]
C1292429
UMLS CUI [1,4]
C0855331
UMLS CUI [1,5]
C2911685
Result of the ECG
Beschrijving

12 lead ECG, Post-dose, 8 Hours, Result

Datatype

text

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0439568
UMLS CUI [1,3]
C1292429
UMLS CUI [1,4]
C1274040
12 Hours post dose
Beschrijving

12 Hours post dose

Alias
UMLS CUI-1
C0430456
UMLS CUI-2
C0439568
UMLS CUI-3
C1292430
Time of ECG
Beschrijving

12 lead ECG, Post-dose, 12 Hours, Time

Datatype

time

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0439568
UMLS CUI [1,3]
C1292430
UMLS CUI [1,4]
C0040223
Heart rate
Beschrijving

12 lead ECG, Post-dose, 12 Hours, Heart rate

Datatype

integer

Maateenheden
  • bpm
Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0439568
UMLS CUI [1,3]
C1292430
UMLS CUI [1,4]
C0018810
bpm
PR Interval
Beschrijving

12 lead ECG, Post-dose, 12 Hours, P-R interval

Datatype

integer

Maateenheden
  • msec
Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0439568
UMLS CUI [1,3]
C1292430
UMLS CUI [1,4]
C0429087
msec
QRS Duration
Beschrijving

12 lead ECG, Post-dose, 12 Hours, QRS complex duration

Datatype

integer

Maateenheden
  • msec
Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0439568
UMLS CUI [1,3]
C1292430
UMLS CUI [1,4]
C0429025
msec
Uncorrected QT Interval
Beschrijving

12 lead ECG, Post-dose, 12 Hours, QT interval

Datatype

integer

Maateenheden
  • msec
Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0439568
UMLS CUI [1,3]
C1292430
UMLS CUI [1,4]
C1287082
msec
QTc Interval
Beschrijving

12 lead ECG, Post-dose, 12 Hours, Electrocardiogram QT corrected interval

Datatype

integer

Maateenheden
  • msec
Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0439568
UMLS CUI [1,3]
C1292430
UMLS CUI [1,4]
C0855331
msec
Method of QTc Calculation
Beschrijving

12 lead ECG, Post-dose, 12 Hours, Electrocardiogram QT corrected interval, Evaluation method

Datatype

text

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0439568
UMLS CUI [1,3]
C1292430
UMLS CUI [1,4]
C0855331
UMLS CUI [1,5]
C2911685
Result of the ECG
Beschrijving

12 lead ECG, Post-dose, 12 Hours, Result

Datatype

text

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0439568
UMLS CUI [1,3]
C1292430
UMLS CUI [1,4]
C1274040
24 Hours post dose
Beschrijving

24 Hours post dose

Alias
UMLS CUI-1
C0430456
UMLS CUI-2
C0439568
UMLS CUI-3
C1442770
Time of ECG
Beschrijving

12 lead ECG, Post-dose, 24 Hours, Time

Datatype

time

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0439568
UMLS CUI [1,3]
C1442770
UMLS CUI [1,4]
C0040223
Heart rate
Beschrijving

12 lead ECG, Post-dose, 24 Hours, Heart rate

Datatype

integer

Maateenheden
  • bpm
Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0439568
UMLS CUI [1,3]
C1442770
UMLS CUI [1,4]
C0018810
bpm
PR Interval
Beschrijving

12 lead ECG, Post-dose, 24 Hours, P-R interval

Datatype

integer

Maateenheden
  • msec
Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0439568
UMLS CUI [1,3]
C1442770
UMLS CUI [1,4]
C0429087
msec
QRS Duration
Beschrijving

12 lead ECG, Post-dose, 24 Hours, QRS complex duration

Datatype

integer

Maateenheden
  • msec
Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0439568
UMLS CUI [1,3]
C1442770
UMLS CUI [1,4]
C0429025
msec
Uncorrected QT Interval
Beschrijving

12 lead ECG, Post-dose, 24 Hours, QT interval

Datatype

integer

Maateenheden
  • msec
Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0439568
UMLS CUI [1,3]
C1442770
UMLS CUI [1,4]
C1287082
msec
QTc Interval
Beschrijving

12 lead ECG, Post-dose, 24 Hours, Electrocardiogram QT corrected interval

Datatype

integer

Maateenheden
  • msec
Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0439568
UMLS CUI [1,3]
C1442770
UMLS CUI [1,4]
C0855331
msec
Method of QTc Calculation
Beschrijving

12 lead ECG, Post-dose, 24 Hours, Electrocardiogram QT corrected interval, Evaluation method

Datatype

text

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0439568
UMLS CUI [1,3]
C1442770
UMLS CUI [1,4]
C0855331
UMLS CUI [1,5]
C2911685
Result of the ECG
Beschrijving

12 lead ECG, Post-dose, 24 Hours, Result

Datatype

text

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0439568
UMLS CUI [1,3]
C1442770
UMLS CUI [1,4]
C1274040
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Similar models

12-Lead ECG

1 Formulieren
  1. StudyEvent: ODM
    1. 12-Lead ECG
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Dosing Date and Time
C0430456 (UMLS CUI-1)
C0178602 (UMLS CUI-2)
C0011008 (UMLS CUI-3)
C0040223 (UMLS CUI-4)
12 lead ECG, Dosage, Date in time, Time
Item
Dosing date/time
datetime
C0430456 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
Item Group
Predose
C0430456 (UMLS CUI-1)
C0439565 (UMLS CUI-2)
12 lead ECG, Pre-dose, Time
Item
Time of ECG
time
C0430456 (UMLS CUI [1,1])
C0439565 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
12 lead ECG, Pre-dose, Heart rate
Item
Heart rate
integer
C0430456 (UMLS CUI [1,1])
C0439565 (UMLS CUI [1,2])
C0018810 (UMLS CUI [1,3])
12 lead ECG, Pre-dose, P-R interval
Item
PR Interval
integer
C0430456 (UMLS CUI [1,1])
C0439565 (UMLS CUI [1,2])
C0429087 (UMLS CUI [1,3])
12 lead ECG, Pre-dose, QRS complex duration
Item
QRS Duration
integer
C0430456 (UMLS CUI [1,1])
C0439565 (UMLS CUI [1,2])
C0429025 (UMLS CUI [1,3])
12 lead ECG, Pre-dose, QT interval
Item
Uncorrected QT Interval
integer
C0430456 (UMLS CUI [1,1])
C0439565 (UMLS CUI [1,2])
C1287082 (UMLS CUI [1,3])
12 lead ECG, Pre-dose, Electrocardiogram QT corrected interval
Item
QTc Interval
integer
C0430456 (UMLS CUI [1,1])
C0439565 (UMLS CUI [1,2])
C0855331 (UMLS CUI [1,3])
Item
Method of QTc Calculation
text
C0430456 (UMLS CUI [1,1])
C0439565 (UMLS CUI [1,2])
C0855331 (UMLS CUI [1,3])
C2911685 (UMLS CUI [1,4])
12 lead ECG, Pre-dose, Electrocardiogram QT corrected interval, Evaluation method
Code List
Method of QTc Calculation
CL Item
Machine (1)
CL Item
Manual (2)
Item
Result of the ECG
text
C0430456 (UMLS CUI [1,1])
C0439565 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,3])
12 lead ECG, Pre-dose, Electrocardiogram QT corrected interval, Evaluation method
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
0,5 Hours post dose
C0430456 (UMLS CUI-1)
C0439568 (UMLS CUI-2)
C1442458 (UMLS CUI-3)
12 lead ECG, Post-dose, 30 Minutes, Time
Item
Time of ECG
time
C0430456 (UMLS CUI [1,1])
C0439568 (UMLS CUI [1,2])
C1442458 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
12 lead ECG, Post-dose, 30 Minutes, Heart rate
Item
Heart rate
integer
C0430456 (UMLS CUI [1,1])
C0439568 (UMLS CUI [1,2])
C1442458 (UMLS CUI [1,3])
C0018810 (UMLS CUI [1,4])
12 lead ECG, Post-dose, 30 Minutes, P-R interval
Item
PR Interval
integer
C0430456 (UMLS CUI [1,1])
C0439568 (UMLS CUI [1,2])
C1442458 (UMLS CUI [1,3])
C0429087 (UMLS CUI [1,4])
12 lead ECG, Post-dose, 30 Minutes, QRS complex duration
Item
QRS Duration
integer
C0430456 (UMLS CUI [1,1])
C0439568 (UMLS CUI [1,2])
C1442458 (UMLS CUI [1,3])
C0429025 (UMLS CUI [1,4])
12 lead ECG, Post-dose, 30 Minutes, QT interval
Item
Uncorrected QT Interval
integer
C0430456 (UMLS CUI [1,1])
C0439568 (UMLS CUI [1,2])
C1442458 (UMLS CUI [1,3])
C1287082 (UMLS CUI [1,4])
12 lead ECG, Post-dose, 30 Minutes, Electrocardiogram QT corrected interval
Item
QTc Interval
integer
C0430456 (UMLS CUI [1,1])
C0439568 (UMLS CUI [1,2])
C1442458 (UMLS CUI [1,3])
C0855331 (UMLS CUI [1,4])
Item
Method of QTc Calculation
text
C0430456 (UMLS CUI [1,1])
C0439568 (UMLS CUI [1,2])
C1442458 (UMLS CUI [1,3])
C0855331 (UMLS CUI [1,4])
C2911685 (UMLS CUI [1,5])
12 lead ECG, Pre-dose, Electrocardiogram QT corrected interval, Evaluation method
Code List
Method of QTc Calculation
CL Item
Machine (1)
CL Item
Manual (2)
Item
Result of the ECG
text
C0430456 (UMLS CUI [1,1])
C0439568 (UMLS CUI [1,2])
C1442458 (UMLS CUI [1,3])
C1274040 (UMLS CUI [1,4])
12 lead ECG, Pre-dose, Electrocardiogram QT corrected interval, Evaluation method
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
1 Hour post dose
C0430456 (UMLS CUI-1)
C0439568 (UMLS CUI-2)
C1442450 (UMLS CUI-3)
12 lead ECG, Post-dose, 1 Hour, Time
Item
Time of ECG
time
C0430456 (UMLS CUI [1,1])
C0439568 (UMLS CUI [1,2])
C1442450 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
12 lead ECG, Post-dose, 1 Hour, Heart rate
Item
Heart rate
integer
C0430456 (UMLS CUI [1,1])
C0439568 (UMLS CUI [1,2])
C1442450 (UMLS CUI [1,3])
C0018810 (UMLS CUI [1,4])
12 lead ECG, Post-dose, 1 Hour, P-R interval
Item
PR Interval
integer
C0430456 (UMLS CUI [1,1])
C0439568 (UMLS CUI [1,2])
C1442450 (UMLS CUI [1,3])
C0429087 (UMLS CUI [1,4])
12 lead ECG, Post-dose, 1 Hour, QRS complex duration
Item
QRS Duration
integer
C0430456 (UMLS CUI [1,1])
C0439568 (UMLS CUI [1,2])
C1442450 (UMLS CUI [1,3])
C0429025 (UMLS CUI [1,4])
12 lead ECG, Post-dose, 1 Hour, QT interval
Item
Uncorrected QT Interval
integer
C0430456 (UMLS CUI [1,1])
C0439568 (UMLS CUI [1,2])
C1442450 (UMLS CUI [1,3])
C1287082 (UMLS CUI [1,4])
12 lead ECG, Post-dose, 1 Hour, Electrocardiogram QT corrected interval
Item
QTc Interval
integer
C0430456 (UMLS CUI [1,1])
C0439568 (UMLS CUI [1,2])
C1442450 (UMLS CUI [1,3])
C0855331 (UMLS CUI [1,4])
Item
Method of QTc Calculation
text
C0430456 (UMLS CUI [1,1])
C0439568 (UMLS CUI [1,2])
C1442450 (UMLS CUI [1,3])
C0855331 (UMLS CUI [1,4])
C2911685 (UMLS CUI [1,5])
12 lead ECG, Pre-dose, Electrocardiogram QT corrected interval, Evaluation method
Code List
Method of QTc Calculation
CL Item
Machine (1)
CL Item
Manual (2)
Item
Result of the ECG
text
C0430456 (UMLS CUI [1,1])
C0439568 (UMLS CUI [1,2])
C1442450 (UMLS CUI [1,3])
C1274040 (UMLS CUI [1,4])
12 lead ECG, Pre-dose, Electrocardiogram QT corrected interval, Evaluation method
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
2 Hours post dose
C0430456 (UMLS CUI-1)
C0439572 (UMLS CUI-2)
12 lead ECG, 2 Hours post dose, Time
Item
Time of ECG
time
C0430456 (UMLS CUI [1,1])
C0439572 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
12 lead ECG, 2 Hours post dose, Heart rate
Item
Heart rate
integer
C0430456 (UMLS CUI [1,1])
C0439572 (UMLS CUI [1,2])
C0018810 (UMLS CUI [1,3])
12 lead ECG, 2 hours post-dose, P-R interval
Item
PR Interval
integer
C0430456 (UMLS CUI [1,1])
C0439572 (UMLS CUI [1,2])
C0429087 (UMLS CUI [1,3])
12 lead ECG, 2 Hours post dose, QRS complex duration
Item
QRS Duration
integer
C0430456 (UMLS CUI [1,1])
C0439572 (UMLS CUI [1,2])
C0429025 (UMLS CUI [1,3])
12 lead ECG, 2 Hours post dose, QT interval
Item
Uncorrected QT Interval
integer
C0430456 (UMLS CUI [1,1])
C0439572 (UMLS CUI [1,2])
C1287082 (UMLS CUI [1,3])
12 lead ECG, 2 Hours post dose, Electrocardiogram QT corrected interval
Item
QTc Interval
integer
C0430456 (UMLS CUI [1,1])
C0439572 (UMLS CUI [1,2])
C0855331 (UMLS CUI [1,3])
Item
Method of QTc Calculation
text
C0430456 (UMLS CUI [1,1])
C0439572 (UMLS CUI [1,2])
C0855331 (UMLS CUI [1,3])
C2911685 (UMLS CUI [1,4])
12 lead ECG, Pre-dose, Electrocardiogram QT corrected interval, Evaluation method
Code List
Method of QTc Calculation
CL Item
Machine (1)
CL Item
Manual (2)
Item
Result of the ECG
text
C0430456 (UMLS CUI [1,1])
C0439572 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,3])
12 lead ECG, Pre-dose, Electrocardiogram QT corrected interval, Evaluation method
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
4 Hours post dose
C0430456 (UMLS CUI-1)
C0439574 (UMLS CUI-2)
12 lead ECG, 4 Hours post dose, Time
Item
Time of ECG
time
C0430456 (UMLS CUI [1,1])
C0439574 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
12 lead ECG, 4 Hours post dose, Heart rate
Item
Heart rate
integer
C0430456 (UMLS CUI [1,1])
C0439574 (UMLS CUI [1,2])
C0018810 (UMLS CUI [1,3])
12 lead ECG, 4 hours post-dose, P-R interval
Item
PR Interval
integer
C0430456 (UMLS CUI [1,1])
C0439574 (UMLS CUI [1,2])
C0429087 (UMLS CUI [1,3])
12 lead ECG, 4 Hours post dose, QRS complex duration
Item
QRS Duration
integer
C0430456 (UMLS CUI [1,1])
C0439574 (UMLS CUI [1,2])
C0429025 (UMLS CUI [1,3])
12 lead ECG, 4 Hours post dose, QT interval
Item
Uncorrected QT Interval
integer
C0430456 (UMLS CUI [1,1])
C0439574 (UMLS CUI [1,2])
C1287082 (UMLS CUI [1,3])
12 lead ECG, 4 Hours post dose, Electrocardiogram QT corrected interval
Item
QTc Interval
integer
C0430456 (UMLS CUI [1,1])
C0439574 (UMLS CUI [1,2])
C0855331 (UMLS CUI [1,3])
Item
Method of QTc Calculation
text
C0430456 (UMLS CUI [1,1])
C0439574 (UMLS CUI [1,2])
C0855331 (UMLS CUI [1,3])
C2911685 (UMLS CUI [1,4])
12 lead ECG, Pre-dose, Electrocardiogram QT corrected interval, Evaluation method
Code List
Method of QTc Calculation
CL Item
Machine (1)
CL Item
Manual (2)
Item
Result of the ECG
text
C0430456 (UMLS CUI [1,1])
C0439574 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,3])
12 lead ECG, Pre-dose, Electrocardiogram QT corrected interval, Evaluation method
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
8 Hours post dose
C0430456 (UMLS CUI-1)
C0439568 (UMLS CUI-2)
C1292429 (UMLS CUI-3)
12 lead ECG, Post-dose, 8 Hours, Time
Item
Time of ECG
time
C0430456 (UMLS CUI [1,1])
C0439568 (UMLS CUI [1,2])
C1292429 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
12 lead ECG, Post-dose, 8 Hours, Heart rate
Item
Heart rate
integer
C0430456 (UMLS CUI [1,1])
C0439568 (UMLS CUI [1,2])
C1292429 (UMLS CUI [1,3])
C0018810 (UMLS CUI [1,4])
12 lead ECG, Post-dose, 8 Hours, P-R interval
Item
PR Interval
integer
C0430456 (UMLS CUI [1,1])
C0439568 (UMLS CUI [1,2])
C1292429 (UMLS CUI [1,3])
C0429087 (UMLS CUI [1,4])
12 lead ECG, Post-dose, 8 Hours, QRS complex duration
Item
QRS Duration
integer
C0430456 (UMLS CUI [1,1])
C0439568 (UMLS CUI [1,2])
C1292429 (UMLS CUI [1,3])
C0429025 (UMLS CUI [1,4])
12 lead ECG, Post-dose, 8 Hours, QT interval
Item
Uncorrected QT Interval
integer
C0430456 (UMLS CUI [1,1])
C0439568 (UMLS CUI [1,2])
C1292429 (UMLS CUI [1,3])
C1287082 (UMLS CUI [1,4])
12 lead ECG, Post-dose, 8 Hours, Electrocardiogram QT corrected interval
Item
QTc Interval
integer
C0430456 (UMLS CUI [1,1])
C0439568 (UMLS CUI [1,2])
C1292429 (UMLS CUI [1,3])
C0855331 (UMLS CUI [1,4])
Item
Method of QTc Calculation
text
C0430456 (UMLS CUI [1,1])
C0439568 (UMLS CUI [1,2])
C1292429 (UMLS CUI [1,3])
C0855331 (UMLS CUI [1,4])
C2911685 (UMLS CUI [1,5])
12 lead ECG, Pre-dose, Electrocardiogram QT corrected interval, Evaluation method
Code List
Method of QTc Calculation
CL Item
Machine (1)
CL Item
Manual (2)
Item
Result of the ECG
text
C0430456 (UMLS CUI [1,1])
C0439568 (UMLS CUI [1,2])
C1292429 (UMLS CUI [1,3])
C1274040 (UMLS CUI [1,4])
12 lead ECG, Pre-dose, Electrocardiogram QT corrected interval, Evaluation method
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 Hours post dose
C0430456 (UMLS CUI-1)
C0439568 (UMLS CUI-2)
C1292430 (UMLS CUI-3)
12 lead ECG, Post-dose, 12 Hours, Time
Item
Time of ECG
time
C0430456 (UMLS CUI [1,1])
C0439568 (UMLS CUI [1,2])
C1292430 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
12 lead ECG, Post-dose, 12 Hours, Heart rate
Item
Heart rate
integer
C0430456 (UMLS CUI [1,1])
C0439568 (UMLS CUI [1,2])
C1292430 (UMLS CUI [1,3])
C0018810 (UMLS CUI [1,4])
12 lead ECG, Post-dose, 12 Hours, P-R interval
Item
PR Interval
integer
C0430456 (UMLS CUI [1,1])
C0439568 (UMLS CUI [1,2])
C1292430 (UMLS CUI [1,3])
C0429087 (UMLS CUI [1,4])
12 lead ECG, Post-dose, 12 Hours, QRS complex duration
Item
QRS Duration
integer
C0430456 (UMLS CUI [1,1])
C0439568 (UMLS CUI [1,2])
C1292430 (UMLS CUI [1,3])
C0429025 (UMLS CUI [1,4])
12 lead ECG, Post-dose, 12 Hours, QT interval
Item
Uncorrected QT Interval
integer
C0430456 (UMLS CUI [1,1])
C0439568 (UMLS CUI [1,2])
C1292430 (UMLS CUI [1,3])
C1287082 (UMLS CUI [1,4])
12 lead ECG, Post-dose, 12 Hours, Electrocardiogram QT corrected interval
Item
QTc Interval
integer
C0430456 (UMLS CUI [1,1])
C0439568 (UMLS CUI [1,2])
C1292430 (UMLS CUI [1,3])
C0855331 (UMLS CUI [1,4])
Item
Method of QTc Calculation
text
C0430456 (UMLS CUI [1,1])
C0439568 (UMLS CUI [1,2])
C1292430 (UMLS CUI [1,3])
C0855331 (UMLS CUI [1,4])
C2911685 (UMLS CUI [1,5])
12 lead ECG, Pre-dose, Electrocardiogram QT corrected interval, Evaluation method
Code List
Method of QTc Calculation
CL Item
Machine (1)
CL Item
Manual (2)
Item
Result of the ECG
text
C0430456 (UMLS CUI [1,1])
C0439568 (UMLS CUI [1,2])
C1292430 (UMLS CUI [1,3])
C1274040 (UMLS CUI [1,4])
12 lead ECG, Pre-dose, Electrocardiogram QT corrected interval, Evaluation method
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
24 Hours post dose
C0430456 (UMLS CUI-1)
C0439568 (UMLS CUI-2)
C1442770 (UMLS CUI-3)
12 lead ECG, Post-dose, 24 Hours, Time
Item
Time of ECG
time
C0430456 (UMLS CUI [1,1])
C0439568 (UMLS CUI [1,2])
C1442770 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
12 lead ECG, Post-dose, 24 Hours, Heart rate
Item
Heart rate
integer
C0430456 (UMLS CUI [1,1])
C0439568 (UMLS CUI [1,2])
C1442770 (UMLS CUI [1,3])
C0018810 (UMLS CUI [1,4])
12 lead ECG, Post-dose, 24 Hours, P-R interval
Item
PR Interval
integer
C0430456 (UMLS CUI [1,1])
C0439568 (UMLS CUI [1,2])
C1442770 (UMLS CUI [1,3])
C0429087 (UMLS CUI [1,4])
12 lead ECG, Post-dose, 24 Hours, QRS complex duration
Item
QRS Duration
integer
C0430456 (UMLS CUI [1,1])
C0439568 (UMLS CUI [1,2])
C1442770 (UMLS CUI [1,3])
C0429025 (UMLS CUI [1,4])
12 lead ECG, Post-dose, 24 Hours, QT interval
Item
Uncorrected QT Interval
integer
C0430456 (UMLS CUI [1,1])
C0439568 (UMLS CUI [1,2])
C1442770 (UMLS CUI [1,3])
C1287082 (UMLS CUI [1,4])
12 lead ECG, Post-dose, 24 Hours, Electrocardiogram QT corrected interval
Item
QTc Interval
integer
C0430456 (UMLS CUI [1,1])
C0439568 (UMLS CUI [1,2])
C1442770 (UMLS CUI [1,3])
C0855331 (UMLS CUI [1,4])
Item
Method of QTc Calculation
text
C0430456 (UMLS CUI [1,1])
C0439568 (UMLS CUI [1,2])
C1442770 (UMLS CUI [1,3])
C0855331 (UMLS CUI [1,4])
C2911685 (UMLS CUI [1,5])
12 lead ECG, Pre-dose, Electrocardiogram QT corrected interval, Evaluation method
Code List
Method of QTc Calculation
CL Item
Machine (1)
CL Item
Manual (2)
Item
Result of the ECG
text
C0430456 (UMLS CUI [1,1])
C0439568 (UMLS CUI [1,2])
C1442770 (UMLS CUI [1,3])
C1274040 (UMLS CUI [1,4])
12 lead ECG, Pre-dose, Electrocardiogram QT corrected interval, Evaluation method
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)
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