NCT02603172 · OUTCOME

Part A: Mean Change From Baseline in 12-lead Electrocardiogram (ECG)

A Safety Study of GSK3039294 in Healthy Volunteers and Patients With Systemic Amyloidosis · Source last updated 2019-09-23

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure: MEAN
Unit: Millisecond
Interval / dispersion: Standard Deviation
Time frame: Baseline (pre-dose) and 15, 30 minutes, 1, 2, 4, 6, 8, 12, 24, 48 and 72 hours post-dose

What was measured

Triplicate ECG was measured in semi-supine position after 5 minutes (min) rest. A single 12-lead ECG was measured by using ECG machine that automatically measured PR, QRS, QT, and Fridericia's formula (QTcF) intervals. Baseline is defined as the latest available assessment pre the first dose of study drug within each period in Part A. Change from Baseline was calculated as any visit post Baseline value minus Baseline value.

Analysis population: Safety Population

Groups in this outcome

Part A: GSK3039294 200 mg

Participants received a single dose of GSK3039294 (dose level 1) 200 mg capsules, orally, once on Day 1 and stayed in-house until Day 4 in cohort 1.

Part A: GSK3039294 600 mg

Participants received a single dose of GSK3039294 (dose level 2) 600 mg capsules, orally, once on Day 1 and stayed in-house until Day 4 in cohort 1. The remaining participants received the same dose of GSK3039294 (dose level 3) 600 mg, capsules, orally, once on Day 1 and stayed in-house until Day 4 in cohort 2. A washout period was maintained from Day 5 to 14 between two treatment cohorts.

Part A: GSK3039294 1200 mg

Participants received a single dose of GSK3039294 (dose level 4) 1200 mg, capsules, orally, once on Day 1 and stayed in-house until Day 4 in cohort 2.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

Group	Source count
Part A: GSK3039294 200 mg	8
Part A: GSK3039294 600 mg	16
Part A: GSK3039294 1200 mg	8

Reported measurements

PR interval: 15 minutes

Values in Millisecond · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Part A: GSK3039294 200 mg	0.5	5.47	Not reported	Not reported	Not reported
Part A: GSK3039294 600 mg	0.9	7.05	Not reported	Not reported	Not reported
Part A: GSK3039294 1200 mg	-0.3	3.47	Not reported	Not reported	Not reported

PR interval: 30 minutes

Values in Millisecond · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Part A: GSK3039294 200 mg	-0.3	6.24	Not reported	Not reported	Not reported
Part A: GSK3039294 600 mg	3.1	5.65	Not reported	Not reported	Not reported
Part A: GSK3039294 1200 mg	0.2	5.35	Not reported	Not reported	Not reported

PR interval: 1 hour

Values in Millisecond · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Part A: GSK3039294 200 mg	-2.3	8.72	Not reported	Not reported	Not reported
Part A: GSK3039294 600 mg	3.2	6.06	Not reported	Not reported	Not reported
Part A: GSK3039294 1200 mg	0.3	7.19	Not reported	Not reported	Not reported

PR interval: 2 hour

Values in Millisecond · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Part A: GSK3039294 200 mg	-0.3	4.82	Not reported	Not reported	Not reported
Part A: GSK3039294 600 mg	0.2	5.50	Not reported	Not reported	Not reported
Part A: GSK3039294 1200 mg	0.3	5.42	Not reported	Not reported	Not reported

PR interval: 4 hour

Values in Millisecond · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Part A: GSK3039294 200 mg	-8.3	6.41	Not reported	Not reported	Not reported
Part A: GSK3039294 600 mg	-7.3	8.22	Not reported	Not reported	Not reported
Part A: GSK3039294 1200 mg	-7.1	4.66	Not reported	Not reported	Not reported

PR interval: 6 hour

Values in Millisecond · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Part A: GSK3039294 200 mg	-6.8	7.04	Not reported	Not reported	Not reported
Part A: GSK3039294 600 mg	-7.6	9.60	Not reported	Not reported	Not reported
Part A: GSK3039294 1200 mg	-4.0	6.98	Not reported	Not reported	Not reported

PR interval: 8 hour

Values in Millisecond · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Part A: GSK3039294 200 mg	-5.0	6.48	Not reported	Not reported	Not reported
Part A: GSK3039294 600 mg	-6.1	8.38	Not reported	Not reported	Not reported
Part A: GSK3039294 1200 mg	-5.0	5.27	Not reported	Not reported	Not reported

PR interval: 12 hour

Values in Millisecond · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Part A: GSK3039294 200 mg	-3.8	7.42	Not reported	Not reported	Not reported
Part A: GSK3039294 600 mg	-6.1	7.77	Not reported	Not reported	Not reported
Part A: GSK3039294 1200 mg	-4.7	9.69	Not reported	Not reported	Not reported

PR interval: 24 hour

Values in Millisecond · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Part A: GSK3039294 200 mg	-0.3	8.72	Not reported	Not reported	Not reported
Part A: GSK3039294 600 mg	-2.8	9.23	Not reported	Not reported	Not reported
Part A: GSK3039294 1200 mg	-1.5	6.51	Not reported	Not reported	Not reported

PR interval: 48 hour

Values in Millisecond · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Part A: GSK3039294 200 mg	4.2	10.75	Not reported	Not reported	Not reported
Part A: GSK3039294 600 mg	0.9	8.67	Not reported	Not reported	Not reported
Part A: GSK3039294 1200 mg	1.0	4.44	Not reported	Not reported	Not reported

PR interval: 72 hour

Values in Millisecond · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Part A: GSK3039294 200 mg	-3.9	12.95	Not reported	Not reported	Not reported
Part A: GSK3039294 600 mg	-1.7	11.80	Not reported	Not reported	Not reported
Part A: GSK3039294 1200 mg	-5.3	5.43	Not reported	Not reported	Not reported

QRS duration: 15 minutes

Values in Millisecond · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Part A: GSK3039294 200 mg	-0.0	2.28	Not reported	Not reported	Not reported
Part A: GSK3039294 600 mg	0.9	3.76	Not reported	Not reported	Not reported
Part A: GSK3039294 1200 mg	-1.3	2.25	Not reported	Not reported	Not reported

QRS duration: 30 minutes

Values in Millisecond · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Part A: GSK3039294 200 mg	0.7	1.89	Not reported	Not reported	Not reported
Part A: GSK3039294 600 mg	0.9	2.70	Not reported	Not reported	Not reported
Part A: GSK3039294 1200 mg	-0.3	1.63	Not reported	Not reported	Not reported

QRS duration: 1 hour

Values in Millisecond · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Part A: GSK3039294 200 mg	0.3	3.49	Not reported	Not reported	Not reported
Part A: GSK3039294 600 mg	0.1	2.61	Not reported	Not reported	Not reported
Part A: GSK3039294 1200 mg	-0.1	1.69	Not reported	Not reported	Not reported

QRS duration: 2 hour

Values in Millisecond · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Part A: GSK3039294 200 mg	-0.3	2.28	Not reported	Not reported	Not reported
Part A: GSK3039294 600 mg	0.1	1.85	Not reported	Not reported	Not reported
Part A: GSK3039294 1200 mg	-0.6	3.55	Not reported	Not reported	Not reported

QRS duration: 4 hour

Values in Millisecond · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Part A: GSK3039294 200 mg	0.8	4.12	Not reported	Not reported	Not reported
Part A: GSK3039294 600 mg	1.0	3.83	Not reported	Not reported	Not reported
Part A: GSK3039294 1200 mg	1.5	3.32	Not reported	Not reported	Not reported

QRS duration: 6 hour

Values in Millisecond · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Part A: GSK3039294 200 mg	-0.6	2.65	Not reported	Not reported	Not reported
Part A: GSK3039294 600 mg	-0.4	2.59	Not reported	Not reported	Not reported
Part A: GSK3039294 1200 mg	-1.2	2.64	Not reported	Not reported	Not reported

QRS duration: 8 hour

Values in Millisecond · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Part A: GSK3039294 200 mg	-0.0	2.71	Not reported	Not reported	Not reported
Part A: GSK3039294 600 mg	0.4	3.26	Not reported	Not reported	Not reported
Part A: GSK3039294 1200 mg	-0.6	3.05	Not reported	Not reported	Not reported

QRS duration: 12 hour

Values in Millisecond · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Part A: GSK3039294 200 mg	0.7	2.05	Not reported	Not reported	Not reported
Part A: GSK3039294 600 mg	1.0	4.28	Not reported	Not reported	Not reported
Part A: GSK3039294 1200 mg	0.9	3.85	Not reported	Not reported	Not reported

QRS duration: 24 hour

Values in Millisecond · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Part A: GSK3039294 200 mg	-0.2	1.70	Not reported	Not reported	Not reported
Part A: GSK3039294 600 mg	0.1	2.40	Not reported	Not reported	Not reported
Part A: GSK3039294 1200 mg	-0.5	2.82	Not reported	Not reported	Not reported

QRS duration: 48 hour

Values in Millisecond · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Part A: GSK3039294 200 mg	1.3	2.57	Not reported	Not reported	Not reported
Part A: GSK3039294 600 mg	2.0	4.18	Not reported	Not reported	Not reported
Part A: GSK3039294 1200 mg	0.3	3.79	Not reported	Not reported	Not reported

QRS duration: 72 hour

Values in Millisecond · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Part A: GSK3039294 200 mg	0.5	1.84	Not reported	Not reported	Not reported
Part A: GSK3039294 600 mg	2.7	3.39	Not reported	Not reported	Not reported
Part A: GSK3039294 1200 mg	-2.0	4.83	Not reported	Not reported	Not reported

QT interval: 15 minutes

Values in Millisecond · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Part A: GSK3039294 200 mg	5.6	6.72	Not reported	Not reported	Not reported
Part A: GSK3039294 600 mg	-2.4	13.95	Not reported	Not reported	Not reported
Part A: GSK3039294 1200 mg	-3.0	5.51	Not reported	Not reported	Not reported

QT interval: 30 minutes

Values in Millisecond · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Part A: GSK3039294 200 mg	1.3	7.81	Not reported	Not reported	Not reported
Part A: GSK3039294 600 mg	0.4	10.44	Not reported	Not reported	Not reported
Part A: GSK3039294 1200 mg	-2.5	5.31	Not reported	Not reported	Not reported

QT interval: 1 hour

Values in Millisecond · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Part A: GSK3039294 200 mg	4.8	11.90	Not reported	Not reported	Not reported
Part A: GSK3039294 600 mg	3.0	12.77	Not reported	Not reported	Not reported
Part A: GSK3039294 1200 mg	-3.8	8.45	Not reported	Not reported	Not reported

QT interval: 2 hour

Values in Millisecond · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Part A: GSK3039294 200 mg	3.2	7.12	Not reported	Not reported	Not reported
Part A: GSK3039294 600 mg	2.4	9.32	Not reported	Not reported	Not reported
Part A: GSK3039294 1200 mg	-1.3	5.20	Not reported	Not reported	Not reported

QT interval: 4 hour

Values in Millisecond · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Part A: GSK3039294 200 mg	-19.5	4.83	Not reported	Not reported	Not reported
Part A: GSK3039294 600 mg	-22.5	10.73	Not reported	Not reported	Not reported
Part A: GSK3039294 1200 mg	-18.7	11.62	Not reported	Not reported	Not reported

QT interval: 6 hour

Values in Millisecond · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Part A: GSK3039294 200 mg	-17.8	8.76	Not reported	Not reported	Not reported
Part A: GSK3039294 600 mg	-19.2	12.40	Not reported	Not reported	Not reported
Part A: GSK3039294 1200 mg	-21.0	15.15	Not reported	Not reported	Not reported

QT interval: 8 hour

Values in Millisecond · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Part A: GSK3039294 200 mg	-11.0	17.22	Not reported	Not reported	Not reported
Part A: GSK3039294 600 mg	-15.8	10.78	Not reported	Not reported	Not reported
Part A: GSK3039294 1200 mg	-14.2	12.45	Not reported	Not reported	Not reported

QT interval: 12 hour

Values in Millisecond · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Part A: GSK3039294 200 mg	-6.2	10.62	Not reported	Not reported	Not reported
Part A: GSK3039294 600 mg	-13.1	13.87	Not reported	Not reported	Not reported
Part A: GSK3039294 1200 mg	-16.8	11.77	Not reported	Not reported	Not reported

QT interval: 24 hour

Values in Millisecond · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Part A: GSK3039294 200 mg	-3.7	12.56	Not reported	Not reported	Not reported
Part A: GSK3039294 600 mg	-9.5	8.32	Not reported	Not reported	Not reported
Part A: GSK3039294 1200 mg	-4.5	8.43	Not reported	Not reported	Not reported

QT interval: 48 hour

Values in Millisecond · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Part A: GSK3039294 200 mg	-8.0	16.27	Not reported	Not reported	Not reported
Part A: GSK3039294 600 mg	-16.4	10.05	Not reported	Not reported	Not reported
Part A: GSK3039294 1200 mg	-19.3	23.78	Not reported	Not reported	Not reported

QT interval: 72 hour

Values in Millisecond · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Part A: GSK3039294 200 mg	-26.0	23.84	Not reported	Not reported	Not reported
Part A: GSK3039294 600 mg	-29.6	14.29	Not reported	Not reported	Not reported
Part A: GSK3039294 1200 mg	-27.5	16.36	Not reported	Not reported	Not reported

QTcF interval: 15 minutes

Values in Millisecond · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Part A: GSK3039294 200 mg	-0.7	2.58	Not reported	Not reported	Not reported
Part A: GSK3039294 600 mg	1.1	9.02	Not reported	Not reported	Not reported
Part A: GSK3039294 1200 mg	-1.5	6.95	Not reported	Not reported	Not reported

QTcF interval: 30 minutes

Values in Millisecond · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Part A: GSK3039294 200 mg	-3.6	4.56	Not reported	Not reported	Not reported
Part A: GSK3039294 600 mg	2.0	7.54	Not reported	Not reported	Not reported
Part A: GSK3039294 1200 mg	-0.2	6.75	Not reported	Not reported	Not reported

QTcF interval: 1 hour

Values in Millisecond · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Part A: GSK3039294 200 mg	-0.6	4.07	Not reported	Not reported	Not reported
Part A: GSK3039294 600 mg	1.4	6.37	Not reported	Not reported	Not reported
Part A: GSK3039294 1200 mg	0.7	6.35	Not reported	Not reported	Not reported

QTcF interval: 2 hour

Values in Millisecond · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Part A: GSK3039294 200 mg	0.3	6.54	Not reported	Not reported	Not reported
Part A: GSK3039294 600 mg	0.0	7.53	Not reported	Not reported	Not reported
Part A: GSK3039294 1200 mg	1.1	4.99	Not reported	Not reported	Not reported

QTcF interval: 4 hour

Values in Millisecond · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Part A: GSK3039294 200 mg	-2.6	8.50	Not reported	Not reported	Not reported
Part A: GSK3039294 600 mg	-0.3	10.31	Not reported	Not reported	Not reported
Part A: GSK3039294 1200 mg	1.6	8.98	Not reported	Not reported	Not reported

QTcF interval: 6 hour

Values in Millisecond · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Part A: GSK3039294 200 mg	-5.6	5.98	Not reported	Not reported	Not reported
Part A: GSK3039294 600 mg	-5.2	8.96	Not reported	Not reported	Not reported
Part A: GSK3039294 1200 mg	-2.9	11.44	Not reported	Not reported	Not reported

QTcF interval: 8 hour

Values in Millisecond · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Part A: GSK3039294 200 mg	-6.7	7.28	Not reported	Not reported	Not reported
Part A: GSK3039294 600 mg	-5.9	7.71	Not reported	Not reported	Not reported
Part A: GSK3039294 1200 mg	-1.7	8.63	Not reported	Not reported	Not reported

QTcF interval: 12 hour

Values in Millisecond · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Part A: GSK3039294 200 mg	-3.6	7.30	Not reported	Not reported	Not reported
Part A: GSK3039294 600 mg	-4.0	8.64	Not reported	Not reported	Not reported
Part A: GSK3039294 1200 mg	-1.4	9.23	Not reported	Not reported	Not reported

QTcF interval: 24 hour

Values in Millisecond · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Part A: GSK3039294 200 mg	-5.6	7.00	Not reported	Not reported	Not reported
Part A: GSK3039294 600 mg	-3.0	5.35	Not reported	Not reported	Not reported
Part A: GSK3039294 1200 mg	-3.4	7.88	Not reported	Not reported	Not reported

QTcF interval: 48 hour

Values in Millisecond · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Part A: GSK3039294 200 mg	-8.3	5.56	Not reported	Not reported	Not reported
Part A: GSK3039294 600 mg	-5.9	8.39	Not reported	Not reported	Not reported
Part A: GSK3039294 1200 mg	-1.8	14.81	Not reported	Not reported	Not reported

QTcF interval: 72 hour

Values in Millisecond · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Part A: GSK3039294 200 mg	-10.4	10.32	Not reported	Not reported	Not reported
Part A: GSK3039294 600 mg	-9.6	10.65	Not reported	Not reported	Not reported
Part A: GSK3039294 1200 mg	-3.7	13.01	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
spread
5.47
value
0.5
group Id
OG001
spread
7.05
value
0.9
group Id
OG002
spread
3.47
value
-0.3
title
PR interval: 15 minutes
categories
measurements
group Id
OG000
spread
6.24
value
-0.3
group Id
OG001
spread
5.65
value
3.1
group Id
OG002
spread
5.35
value
0.2
title
PR interval: 30 minutes
categories
measurements
group Id
OG000
spread
8.72
value
-2.3
group Id
OG001
spread
6.06
value
3.2
group Id
OG002
spread
7.19
value
0.3
title
PR interval: 1 hour
categories
measurements
group Id
OG000
spread
4.82
value
-0.3
group Id
OG001
spread
5.50
value
0.2
group Id
OG002
spread
5.42
value
0.3
title
PR interval: 2 hour
categories
measurements
group Id
OG000
spread
6.41
value
-8.3
group Id
OG001
spread
8.22
value
-7.3
group Id
OG002
spread
4.66
value
-7.1
title
PR interval: 4 hour
categories
measurements
group Id
OG000
spread
7.04
value
-6.8
group Id
OG001
spread
9.60
value
-7.6
group Id
OG002
spread
6.98
value
-4.0
title
PR interval: 6 hour
categories
measurements
group Id
OG000
spread
6.48
value
-5.0
group Id
OG001
spread
8.38
value
-6.1
group Id
OG002
spread
5.27
value
-5.0
title
PR interval: 8 hour
categories
measurements
group Id
OG000
spread
7.42
value
-3.8
group Id
OG001
spread
7.77
value
-6.1
group Id
OG002
spread
9.69
value
-4.7
title
PR interval: 12 hour
categories
measurements
group Id
OG000
spread
8.72
value
-0.3
group Id
OG001
spread
9.23
value
-2.8
group Id
OG002
spread
6.51
value
-1.5
title
PR interval: 24 hour
categories
measurements
group Id
OG000
spread
10.75
value
4.2
group Id
OG001
spread
8.67
value
0.9
group Id
OG002
spread
4.44
value
1.0
title
PR interval: 48 hour
categories
measurements
group Id
OG000
spread
12.95
value
-3.9
group Id
OG001
spread
11.80
value
-1.7
group Id
OG002
spread
5.43
value
-5.3
title
PR interval: 72 hour
categories
measurements
group Id
OG000
spread
2.28
value
-0.0
group Id
OG001
spread
3.76
value
0.9
group Id
OG002
spread
2.25
value
-1.3
title
QRS duration: 15 minutes

denoms

counts
group Id
OG000
value
8
group Id
OG001
value
16
group Id
OG002
value
8
units
Participants

description

dispersion Type

Standard Deviation

groups

description
Participants received a single dose of GSK3039294 (dose level 1) 200 mg capsules, orally, once on Day 1 and stayed in-house until Day 4 in cohort 1.
id
OG000
title
Part A: GSK3039294 200 mg
description
Participants received a single dose of GSK3039294 (dose level 2) 600 mg capsules, orally, once on Day 1 and stayed in-house until Day 4 in cohort 1. The remaining participants received the same dose of GSK3039294 (dose level 3) 600 mg, capsules, orally, once on Day 1 and stayed in-house until Day 4 in cohort 2. A washout period was maintained from Day 5 to 14 between two treatment cohorts.
id
OG001
title
Part A: GSK3039294 600 mg
description
Participants received a single dose of GSK3039294 (dose level 4) 1200 mg, capsules, orally, once on Day 1 and stayed in-house until Day 4 in cohort 2.
id
OG002
title
Part A: GSK3039294 1200 mg

param Type

MEAN

population Description

Safety Population

reporting Status

POSTED

time Frame

Baseline (pre-dose) and 15, 30 minutes, 1, 2, 4, 6, 8, 12, 24, 48 and 72 hours post-dose

title

Part A: Mean Change From Baseline in 12-lead Electrocardiogram (ECG)

type

PRIMARY

unit Of Measure

Millisecond

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Preserved source evidence · Not medical advice