ID

36238

Description

Study ID: 109385 Clinical Study ID: 109385 Study Title: A Randomized, Open Label, 4 Period Crossover Study in Healthy Subjects to Determine the Effect of Particle Size on the Pharmacokinetics of a Single mg Dose of GW856553 Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00517543 Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: GW856553 Trade Name: N/A Study Indication: Chronic Obstructive Pulmonary Disease (COPD), Rheumatoid Arthritis, Atherosclerosis

Keywords

Versions (3)
  1. 4/17/19 4/17/19 -
  2. 4/17/19 4/17/19 -
  3. 4/23/19 4/23/19 -
Copyright Holder

GlaxoSmithKline

Uploaded on

April 23, 2019

DOI

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License

Creative Commons BY-NC 3.0
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The Effect of Particle Size on the Pharmacokinetics of a Single mg Dose of GW856553 NCT00517543

English

Period 1 - Randomisation Number; 12-Lead ECG; Vital Signs; Pharmacokinetics Blood GW856553; Electronically Transferred Lab Data; Investigational Product

1 forms  
Randomisation Number
Description

Randomisation Number

Alias
UMLS CUI-1
C0034656
UMLS CUI-2
C0237753
Was the subject able to be randomised?
Description

Was the subject able to be randomised?

Data type

boolean

Alias
UMLS CUI [1,1]
C0034656
UMLS CUI [1,2]
C0085732
Randomisation Number
Description

Randomisation Number

Data type

integer

Alias
UMLS CUI [1,1]
C0034656
UMLS CUI [1,2]
C0237753
Date of Randomisation
Description

Date of Randomisation

Data type

date

Alias
UMLS CUI [1,1]
C0034656
UMLS CUI [1,2]
C0011008
12 Lead ECG - Dosing Date and Time
Description

12 Lead ECG - Dosing Date and Time

Alias
UMLS CUI-1
C0430456
UMLS CUI-2
C0178602
UMLS CUI-3
C0011008
UMLS CUI-4
C0040223
Dosing Date and Time
Description

Dosing Date and Time

Data type

datetime

Alias
UMLS CUI [1,1]
C0178602
UMLS CUI [1,2]
C0011008
UMLS CUI [1,3]
C0040223
12-Lead ECG - Pre-dose-measurement 1 (of 3) at least 5 minutes apart
Description

12-Lead ECG - Pre-dose-measurement 1 (of 3) at least 5 minutes apart

Alias
UMLS CUI-1
C0430456
UMLS CUI-2
C3812758
Time of ECG
Description

Time of ECG

Data type

time

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0013798
UMLS CUI [1,3]
C0040223
Heart Rate
Description

Heart Rate

Data type

integer

Measurement units
  • beats/min
Alias
UMLS CUI [1]
C0018810
beats/min
RR Interval
Description

RR Interval

Data type

integer

Measurement units
  • ms
Alias
UMLS CUI [1]
C0489636
ms
PR Interval
Description

PR Interval

Data type

integer

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

QRS Duration

Data type

integer

Measurement units
  • ms
Alias
UMLS CUI [1]
C0429025
ms
Uncorrected QT Interval
Description

Uncorrected QT Interval

Data type

integer

Measurement units
  • ms
Alias
UMLS CUI [1]
C1287082
ms
QTc (b) Interval
Description

QTc (b) Interval

Data type

integer

Measurement units
  • ms
Alias
UMLS CUI [1]
C0489625
ms
Method of QTc Calculation
Description

Method of QTc Calculation

Data type

integer

Alias
UMLS CUI [1,1]
C0855331
UMLS CUI [1,2]
C2911685
Result of the ECG
Description

Result of the ECG

Data type

integer

Alias
UMLS CUI [1]
C0438154
12-Lead ECG - Pre-dose-measurement 2 (of 3) at least 5 minutes apart
Description

12-Lead ECG - Pre-dose-measurement 2 (of 3) at least 5 minutes apart

Alias
UMLS CUI-1
C0430456
UMLS CUI-2
C3812758
Time of ECG
Description

Time of ECG

Data type

time

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0013798
Heart Rate
Description

Heart Rate

Data type

integer

Measurement units
  • beats/min
Alias
UMLS CUI [1]
C0018810
beats/min
RR Interval
Description

RR Interval

Data type

integer

Measurement units
  • ms
Alias
UMLS CUI [1]
C0489636
ms
PR Interval
Description

PR Interval

Data type

integer

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

QRS Duration

Data type

integer

Measurement units
  • ms
Alias
UMLS CUI [1]
C0429025
ms
Uncorrected QT Interval
Description

Uncorrected QT Interval

Data type

integer

Measurement units
  • ms
Alias
UMLS CUI [1]
C1287082
ms
QTc (b) Interval
Description

QTc (b) Interval

Data type

integer

Measurement units
  • ms
Alias
UMLS CUI [1]
C0489625
ms
Method of QTc Calculation
Description

Method of QTc Calculation

Data type

integer

Alias
UMLS CUI [1,1]
C0855331
UMLS CUI [1,2]
C2911685
Result of the ECG
Description

Result of the ECG

Data type

integer

Alias
UMLS CUI [1]
C0438154
12-Lead ECG - Pre-dose-measurement 3 (of 3) at least 5 minutes apart
Description

12-Lead ECG - Pre-dose-measurement 3 (of 3) at least 5 minutes apart

Alias
UMLS CUI-1
C0430456
UMLS CUI-2
C3812758
Time of ECG
Description

Time of ECG

Data type

time

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0013798
Heart Rate
Description

Heart Rate

Data type

integer

Measurement units
  • beats/min
Alias
UMLS CUI [1]
C0018810
beats/min
RR Interval
Description

RR Interval

Data type

integer

Measurement units
  • ms
Alias
UMLS CUI [1]
C0489636
ms
PR Interval
Description

PR Interval

Data type

integer

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

QRS Duration

Data type

integer

Measurement units
  • ms
Alias
UMLS CUI [1]
C0429025
ms
Uncorrected QT Interval
Description

Uncorrected QT Interval

Data type

integer

Measurement units
  • ms
Alias
UMLS CUI [1]
C1287082
ms
QTc (b) Interval
Description

QTc (b) Interval

Data type

integer

Measurement units
  • ms
Alias
UMLS CUI [1]
C0489625
ms
Method of QTc Calculation
Description

Method of QTc Calculation

Data type

integer

Alias
UMLS CUI [1,1]
C0855331
UMLS CUI [1,2]
C2911685
Result of the ECG
Description

Result of the ECG

Data type

integer

Alias
UMLS CUI [1]
C0438154
12-Lead ECG - 30 mins
Description

12-Lead ECG - 30 mins

Alias
UMLS CUI-1
C0430456
Time of ECG
Description

Time of ECG

Data type

time

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0013798
Heart Rate
Description

Heart Rate

Data type

integer

Measurement units
  • beats/min
Alias
UMLS CUI [1]
C0018810
beats/min
RR Interval
Description

RR Interval

Data type

integer

Measurement units
  • ms
Alias
UMLS CUI [1]
C0489636
ms
PR Interval
Description

PR Interval

Data type

integer

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

QRS Duration

Data type

integer

Measurement units
  • ms
Alias
UMLS CUI [1]
C0429025
ms
Uncorrected QT Interval
Description

Uncorrected QT Interval

Data type

integer

Measurement units
  • ms
Alias
UMLS CUI [1]
C1287082
ms
QTc (b) Interval
Description

QTc (b) Interval

Data type

integer

Measurement units
  • ms
Alias
UMLS CUI [1]
C0489625
ms
Method of QTc Calculation
Description

Method of QTc Calculation

Data type

integer

Alias
UMLS CUI [1,1]
C0855331
UMLS CUI [1,2]
C2911685
Result of the ECG
Description

Result of the ECG

Data type

integer

Alias
UMLS CUI [1]
C0438154
12-Lead ECG - 1 hr
Description

12-Lead ECG - 1 hr

Alias
UMLS CUI-1
C0430456
Time of ECG
Description

Time of ECG

Data type

time

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0013798
Heart Rate
Description

Heart Rate

Data type

integer

Measurement units
  • beats/min
Alias
UMLS CUI [1]
C0018810
beats/min
RR Interval
Description

RR Interval

Data type

integer

Measurement units
  • ms
Alias
UMLS CUI [1]
C0489636
ms
PR Interval
Description

PR Interval

Data type

integer

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

QRS Duration

Data type

integer

Measurement units
  • ms
Alias
UMLS CUI [1]
C0429025
ms
Uncorrected QT Interval
Description

Uncorrected QT Interval

Data type

integer

Measurement units
  • ms
Alias
UMLS CUI [1]
C1287082
ms
QTc (b) Interval
Description

QTc (b) Interval

Data type

integer

Measurement units
  • ms
Alias
UMLS CUI [1]
C0489625
ms
Method of QTc Calculation
Description

Method of QTc Calculation

Data type

integer

Alias
UMLS CUI [1,1]
C0855331
UMLS CUI [1,2]
C2911685
Result of the ECG
Description

Result of the ECG

Data type

integer

Alias
UMLS CUI [1]
C0438154
12-Lead ECG - 24 hr
Description

12-Lead ECG - 24 hr

Alias
UMLS CUI-1
C0430456
Date and Time of ECG
Description

Date and Time of ECG

Data type

datetime

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0013798
Heart Rate
Description

Heart Rate

Data type

integer

Measurement units
  • beats/min
Alias
UMLS CUI [1]
C0018810
beats/min
RR Interval
Description

RR Interval

Data type

integer

Measurement units
  • ms
Alias
UMLS CUI [1]
C0489636
ms
PR Interval
Description

PR Interval

Data type

integer

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

QRS Duration

Data type

integer

Measurement units
  • ms
Alias
UMLS CUI [1]
C0429025
ms
Uncorrected QT Interval
Description

Uncorrected QT Interval

Data type

integer

Measurement units
  • ms
Alias
UMLS CUI [1]
C1287082
ms
QTc (b) Interval
Description

QTc (b) Interval

Data type

integer

Measurement units
  • ms
Alias
UMLS CUI [1]
C0489625
ms
Method of QTc Calculation
Description

Method of QTc Calculation

Data type

integer

Alias
UMLS CUI [1,1]
C0855331
UMLS CUI [1,2]
C2911685
Result of the ECG
Description

Result of the ECG

Data type

integer

Alias
UMLS CUI [1]
C0438154
Vital Signs
Description

Vital Signs

Alias
UMLS CUI-1
C0518766
Dosing date/ time
Description

Dosing date/ time

Data type

datetime

Alias
UMLS CUI [1,1]
C0178602
UMLS CUI [1,2]
C0011008
UMLS CUI [1,3]
C0040223
Vital Signs - Pre dose
Description

Vital Signs - Pre dose

Alias
UMLS CUI-1
C0518766
UMLS CUI-2
C0439565
Actual time
Description

Actual time

Data type

time

Alias
UMLS CUI [1]
C0040223
Systolic Blood Pressure
Description

Systolic Blood Pressure

Data type

integer

Measurement units
  • mm[Hg]
Alias
UMLS CUI [1]
C0871470
mm[Hg]
Diastolic Blood Pressure
Description

Diastolic Blood Pressure

Data type

integer

Measurement units
  • mm[Hg]
Alias
UMLS CUI [1]
C0428883
mm[Hg]
Heart rate
Description

Heart rate

Data type

integer

Measurement units
  • beats/min
Alias
UMLS CUI [1]
C0018810
beats/min
Respiration rate
Description

Respiration rate

Data type

integer

Measurement units
  • breaths/min
Alias
UMLS CUI [1]
C0231832
breaths/min
Temperature
Description

Temperature

Data type

float

Measurement units
  • °C
Alias
UMLS CUI [1]
C0005903
°C
Vital Signs - 30 mins
Description

Vital Signs - 30 mins

Alias
UMLS CUI-1
C0518766
Actual time
Description

Actual time

Data type

time

Alias
UMLS CUI [1]
C0040223
Systolic Blood Pressure
Description

Systolic Blood Pressure

Data type

integer

Measurement units
  • mm[Hg]
Alias
UMLS CUI [1]
C0871470
mm[Hg]
Diastolic Blood Pressure
Description

Diastolic Blood Pressure

Data type

integer

Measurement units
  • mm[Hg]
Alias
UMLS CUI [1]
C0428883
mm[Hg]
Heart rate
Description

Heart rate

Data type

integer

Measurement units
  • beats/min
Alias
UMLS CUI [1]
C0018810
beats/min
Vital Signs - 24 hrs
Description

Vital Signs - 24 hrs

Alias
UMLS CUI-1
C0518766
Actual date/time
Description

Actual date/time

Data type

datetime

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0040223
Systolic Blood Pressure
Description

Systolic Blood pressure

Data type

integer

Measurement units
  • mm[Hg]
Alias
UMLS CUI [1]
C0871470
mm[Hg]
Diastolic Blood Pressure
Description

Diastolic Blood Pressure

Data type

integer

Measurement units
  • mm[Hg]
Alias
UMLS CUI [1]
C0428883
mm[Hg]
Heart rate
Description

Heart rate

Data type

integer

Measurement units
  • beats/min
Alias
UMLS CUI [1]
C0018810
beats/min
Pharmacokinetics Blood - GW856553
Description

Pharmacokinetics Blood - GW856553

Alias
UMLS CUI-1
C0031327
UMLS CUI-2
C0005767
Dosing date/time
Description

Dosing date/time

Data type

datetime

Alias
UMLS CUI [1,1]
C0178602
UMLS CUI [1,2]
C0011008
UMLS CUI [1,3]
C0040223
Pre dose - Actual time
Description

Pre dose - Actual time

Data type

time

Alias
UMLS CUI [1,1]
C0439565
UMLS CUI [1,2]
C0040223
30 mins - Actual time
Description

30 mins - Actual time

Data type

time

Alias
UMLS CUI [1]
C0040223
1 hr - Actual time
Description

1 hr - Actual time

Data type

time

Alias
UMLS CUI [1]
C0040223
2 hrs - Actual time
Description

2 hrs - Actual time

Data type

time

Alias
UMLS CUI [1]
C0040223
3 hrs - Actual time
Description

3 hrs - Actual time

Data type

time

Alias
UMLS CUI [1]
C0040223
4 hrs - Actual time
Description

4 hrs - Actual time

Data type

time

Alias
UMLS CUI [1]
C0040223
6 hrs - Actual time
Description

6 hrs - Actual time

Data type

time

Alias
UMLS CUI [1]
C0040223
8 hrs - Actual time
Description

8 hrs - Actual time

Data type

time

Alias
UMLS CUI [1]
C0040223
10 hrs - Actual time
Description

10 hrs - Actual time

Data type

time

Alias
UMLS CUI [1]
C0040223
12 hrs - Actual date/time
Description

12 hrs - Actual date/time

Data type

datetime

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0040223
18 hrs- Actual date/time
Description

18 hrs- Actual date/time

Data type

datetime

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0040223
24 hrs (Day2) - Actual date/time
Description

24 hrs (Day2) - Actual date/time

Data type

time

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0040223
36 hrs (Day 2) - Actual date/time
Description

36 hrs (Day 2) - Actual date/time

Data type

datetime

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0040223
48 hrs (Day 3) - Actual date/time
Description

48 hrs (Day 3) - Actual date/time

Data type

datetime

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0040223
72 hrs (Day4) - Actual date/time
Description

72 hrs (Day4) - Actual date/time

Data type

datetime

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0040223
Electronically Transferred Lab Data - Pre dose
Description

Electronically Transferred Lab Data - Pre dose

Alias
UMLS CUI-1
C0200345
UMLS CUI-2
C0022885
UMLS CUI-3
C1320722
UMLS CUI-4
C0439565
Haematology Date and time sample taken
Description

Haematology Date and time sample taken

Data type

datetime

Alias
UMLS CUI [1,1]
C0018941
UMLS CUI [1,2]
C0870078
UMLS CUI [1,3]
C0011008
UMLS CUI [1,4]
C0040223
Haematology sampling not done
Description

Haematology sampling not done

Data type

integer

Alias
UMLS CUI [1,1]
C0018941
UMLS CUI [1,2]
C0870078
UMLS CUI [1,3]
C1272696
Clinical Chemistry Date and time sample taken
Description

Clinical Chemistry Date and time sample taken

Data type

datetime

Alias
UMLS CUI [1,1]
C0008000
UMLS CUI [1,2]
C0200345
UMLS CUI [1,3]
C0011008
UMLS CUI [1,4]
C0040223
Clinical Chemistry sampling not done
Description

Clinical Chemistry sampling not done

Data type

integer

Alias
UMLS CUI [1,1]
C0008000
UMLS CUI [1,2]
C0200345
UMLS CUI [1,3]
C1272696
Urinalysis Date and time sample taken
Description

Urinalysis Date and time sample taken

Data type

datetime

Alias
UMLS CUI [1,1]
C0042014
UMLS CUI [1,2]
C0870078
UMLS CUI [1,3]
C0011008
UMLS CUI [1,4]
C0040223
Urinalysis sampling not done
Description

Urinalysis sampling not done

Data type

integer

Alias
UMLS CUI [1,1]
C0042014
UMLS CUI [1,2]
C0200345
UMLS CUI [1,3]
C1272696
Electronically Transferred Lab Data - 24 hrs (Day 2)
Description

Electronically Transferred Lab Data - 24 hrs (Day 2)

Alias
UMLS CUI-1
C0200345
UMLS CUI-2
C0022885
UMLS CUI-3
C1320722
Haematology Date and time sample taken
Description

Haematology Date and time sample taken

Data type

datetime

Alias
UMLS CUI [1,1]
C0018941
UMLS CUI [1,2]
C0870078
UMLS CUI [1,3]
C0011008
UMLS CUI [1,4]
C0040223
Haematology sampling not done
Description

Haematology sampling not done

Data type

integer

Alias
UMLS CUI [1,1]
C0018941
UMLS CUI [1,2]
C0870078
UMLS CUI [1,3]
C1272696
Clinical Chemistry Date and time sample taken
Description

Clinical Chemistry Date and time sample taken

Data type

datetime

Alias
UMLS CUI [1,1]
C0008000
UMLS CUI [1,2]
C0200345
UMLS CUI [1,3]
C0011008
UMLS CUI [1,4]
C0040223
Clinical Chemistry sampling not done
Description

Clinical Chemistry sampling not done

Data type

integer

Alias
UMLS CUI [1,1]
C0008000
UMLS CUI [1,2]
C0200345
UMLS CUI [1,3]
C1272696
Urinalysis Date and time sample taken
Description

Urinalysis Date and time sample taken

Data type

datetime

Alias
UMLS CUI [1,1]
C0042014
UMLS CUI [1,2]
C0870078
UMLS CUI [1,3]
C0011008
UMLS CUI [1,4]
C0040223
Urinalysis sampling not done
Description

Urinalysis sampling not done

Data type

integer

Alias
UMLS CUI [1,1]
C0042014
UMLS CUI [1,2]
C0200345
UMLS CUI [1,3]
C1272696
Electronically Transferred Lab Data - 72 hrs (Day 4)
Description

Electronically Transferred Lab Data - 72 hrs (Day 4)

Alias
UMLS CUI-1
C0200345
UMLS CUI-2
C0022885
UMLS CUI-3
C1320722
AST/ ALT Date and time sample taken
Description

AST/ ALT Date and time sample taken

Data type

datetime

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0040223
UMLS CUI [2]
C0200345
UMLS CUI [3]
C0201836
AST/ ALT sampling not done
Description

AST/ ALT sampling not done

Data type

integer

Alias
UMLS CUI [1,1]
C0201899
UMLS CUI [1,2]
C0022885
UMLS CUI [1,3]
C0870078
UMLS CUI [1,4]
C1272696
UMLS CUI [2,1]
C0201899
UMLS CUI [2,2]
C0022885
UMLS CUI [2,3]
C0870078
UMLS CUI [2,4]
C1272696
Investigational Product
Description

Investigational Product

Alias
UMLS CUI-1
C0304229
Date/ time of dose
Description

Date/ time of dose

Data type

datetime

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0040223
UMLS CUI [1,4]
C0011008
Did the subject receive the correct treatment (e.g., treatment which the subject was assigned to) during this dosing interval?
Description

Did the subject receive the correct treatment during this dosing interval?

Data type

boolean

Alias
UMLS CUI [1,1]
C0750484
UMLS CUI [1,2]
C0087111
If subject did not receive correct treatment, record reasons.
Description

If subject did not receive correct treatment, record reasons

Data type

text

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C2349182
UMLS CUI [1,3]
C0392360
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Similar models

Period 1 - Randomisation Number; 12-Lead ECG; Vital Signs; Pharmacokinetics Blood GW856553; Electronically Transferred Lab Data; Investigational Product

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Randomisation Number
C0034656 (UMLS CUI-1)
C0237753 (UMLS CUI-2)
Was the subject able to be randomised?
Item
Was the subject able to be randomised?
boolean
C0034656 (UMLS CUI [1,1])
C0085732 (UMLS CUI [1,2])
Randomisation Number
Item
Randomisation Number
integer
C0034656 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Date of Randomisation
Item
Date of Randomisation
date
C0034656 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item Group
12 Lead ECG - Dosing Date and Time
C0430456 (UMLS CUI-1)
C0178602 (UMLS CUI-2)
C0011008 (UMLS CUI-3)
C0040223 (UMLS CUI-4)
Dosing Date and Time
Item
Dosing Date and Time
datetime
C0178602 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
Item Group
12-Lead ECG - Pre-dose-measurement 1 (of 3) at least 5 minutes apart
C0430456 (UMLS CUI-1)
C3812758 (UMLS CUI-2)
Time of ECG
Item
Time of ECG
time
C0430456 (UMLS CUI [1,1])
C0013798 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
Heart Rate
Item
Heart Rate
integer
C0018810 (UMLS CUI [1])
RR Interval
Item
RR Interval
integer
C0489636 (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 (b) Interval
Item
QTc (b) Interval
integer
C0489625 (