NCT00753688 · OUTCOME

Change From Baseline in Heart Rate

Pazopanib Versus Placebo in Patients With Soft Tissue Sarcoma Whose Disease Has Progressed During or Following Prior Therapy · Source last updated 2013-08-22

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

Measure: MEAN
Unit: beats per minute
Interval / dispersion: Standard Deviation
Time frame: Baseline, Day 8, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 88, 96, and 104

What was measured

Change from baseline in on-therapy heart rate was calculated as the value at the indicated time points (Day 8 and Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 88, 96, and 104) minus the value at baseline.

Analysis population: Safety Population. Data were analyzed for participants who were on-therapy and provided data at the indicated time point.

Groups in this outcome

Placebo

Matching placebo tablets administered orally once daily for a duration until participants experienced disease progression, death, unacceptable toxicity, or participants withdrew consent

Pazopanib

Pazopanib 200 milligrams (mg) and 400 mg film-coated tablets (containing pazopanib monohydrochloride) administered orally at a dose of 800 mg once daily for a duration until participants experienced disease progression, death, unacceptable toxicity, or participants withdrew consent

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
Placebo	113
Pazopanib	225

Reported measurements

Day 8, n=113, 225

Values in beats per minute · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Placebo	1.6	12.61	Not reported	Not reported	Not reported
Pazopanib	-4.4	11.24	Not reported	Not reported	Not reported

Week 4, n=98, 208

Values in beats per minute · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Placebo	3.1	13.06	Not reported	Not reported	Not reported
Pazopanib	-2.7	13.51	Not reported	Not reported	Not reported

Week 8, n=66, 171

Values in beats per minute · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Placebo	2.1	15.03	Not reported	Not reported	Not reported
Pazopanib	-1.6	14.31	Not reported	Not reported	Not reported

Week 12, n=29, 103

Values in beats per minute · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Placebo	1.1	17.32	Not reported	Not reported	Not reported
Pazopanib	-2.4	11.67	Not reported	Not reported	Not reported

Week 16, n=31, 127

Values in beats per minute · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Placebo	6.0	16.78	Not reported	Not reported	Not reported
Pazopanib	-3.7	12.76	Not reported	Not reported	Not reported

Week 20, n=12, 57

Values in beats per minute · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Placebo	0.6	22.95	Not reported	Not reported	Not reported
Pazopanib	-3.4	11.71	Not reported	Not reported	Not reported

Week 24, n=21, 94

Values in beats per minute · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Placebo	4.5	18.14	Not reported	Not reported	Not reported
Pazopanib	-5.0	12.83	Not reported	Not reported	Not reported

Week 28, n=7, 37

Values in beats per minute · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Placebo	-1.1	27.99	Not reported	Not reported	Not reported
Pazopanib	-3.8	13.68	Not reported	Not reported	Not reported

Week 32, n=12, 72

Values in beats per minute · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Placebo	-1.7	18.38	Not reported	Not reported	Not reported
Pazopanib	-2.7	12.63	Not reported	Not reported	Not reported

Week 36, n=5, 24

Values in beats per minute · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Placebo	-11.8	32.57	Not reported	Not reported	Not reported
Pazopanib	0.9	13.37	Not reported	Not reported	Not reported

Week 40, n=5, 58

Values in beats per minute · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Placebo	-8.2	30.19	Not reported	Not reported	Not reported
Pazopanib	-2.4	12.84	Not reported	Not reported	Not reported

Week 44, n=3, 15

Values in beats per minute · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Placebo	7.0	16.09	Not reported	Not reported	Not reported
Pazopanib	-0.9	14.02	Not reported	Not reported	Not reported

Week 48, n=3, 33

Values in beats per minute · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Placebo	9.0	18.00	Not reported	Not reported	Not reported
Pazopanib	1.9	14.38	Not reported	Not reported	Not reported

Week 52, n=1, 5

Values in beats per minute · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Placebo	-8.0	0	Not reported	Not reported	Not reported
Pazopanib	-3.4	16.96	Not reported	Not reported	Not reported

Week 56, n=1, 24

Values in beats per minute · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Placebo	31.0	0	Not reported	Not reported	Not reported
Pazopanib	-0.4	15.14	Not reported	Not reported	Not reported

Week 60, n=0, 6

Values in beats per minute · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Placebo	0	0	Not reported	Not reported	Not reported
Pazopanib	4.3	15.13	Not reported	Not reported	Not reported

Week 64, n=1, 13

Values in beats per minute · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Placebo	36.0	0	Not reported	Not reported	Not reported
Pazopanib	-1.5	13.56	Not reported	Not reported	Not reported

Week 68, n=0, 2

Values in beats per minute · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Placebo	0	0	Not reported	Not reported	Not reported
Pazopanib	9.5	0.71	Not reported	Not reported	Not reported

Week 72, n=1, 8

Values in beats per minute · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Placebo	14.0	0	Not reported	Not reported	Not reported
Pazopanib	2.6	12.60	Not reported	Not reported	Not reported

Week 76, n=0, 1

Values in beats per minute · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Placebo	0	0	Not reported	Not reported	Not reported
Pazopanib	5.0	0	Not reported	Not reported	Not reported

Week 80, n=1, 5

Values in beats per minute · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Placebo	24.0	0	Not reported	Not reported	Not reported
Pazopanib	2.8	16.08	Not reported	Not reported	Not reported

Week 88, n=1, 3

Values in beats per minute · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Placebo	9.0	0	Not reported	Not reported	Not reported
Pazopanib	-3.0	10.58	Not reported	Not reported	Not reported

Week 96, n=1, 2

Values in beats per minute · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Placebo	17.0	0	Not reported	Not reported	Not reported
Pazopanib	-5.0	4.24	Not reported	Not reported	Not reported

Week 104, n=1, 1

Values in beats per minute · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Placebo	30.0	0	Not reported	Not reported	Not reported
Pazopanib	1.0	0	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
spread
12.61
value
1.6
group Id
OG001
spread
11.24
value
-4.4
title
Day 8, n=113, 225
categories
measurements
group Id
OG000
spread
13.06
value
3.1
group Id
OG001
spread
13.51
value
-2.7
title
Week 4, n=98, 208
categories
measurements
group Id
OG000
spread
15.03
value
2.1
group Id
OG001
spread
14.31
value
-1.6
title
Week 8, n=66, 171
categories
measurements
group Id
OG000
spread
17.32
value
1.1
group Id
OG001
spread
11.67
value
-2.4
title
Week 12, n=29, 103
categories
measurements
group Id
OG000
spread
16.78
value
6.0
group Id
OG001
spread
12.76
value
-3.7
title
Week 16, n=31, 127
categories
measurements
group Id
OG000
spread
22.95
value
0.6
group Id
OG001
spread
11.71
value
-3.4
title
Week 20, n=12, 57
categories
measurements
group Id
OG000
spread
18.14
value
4.5
group Id
OG001
spread
12.83
value
-5.0
title
Week 24, n=21, 94
categories
measurements
group Id
OG000
spread
27.99
value
-1.1
group Id
OG001
spread
13.68
value
-3.8
title
Week 28, n=7, 37
categories
measurements
group Id
OG000
spread
18.38
value
-1.7
group Id
OG001
spread
12.63
value
-2.7
title
Week 32, n=12, 72
categories
measurements
group Id
OG000
spread
32.57
value
-11.8
group Id
OG001
spread
13.37
value
0.9
title
Week 36, n=5, 24
categories
measurements
group Id
OG000
spread
30.19
value
-8.2
group Id
OG001
spread
12.84
value
-2.4
title
Week 40, n=5, 58
categories
measurements
group Id
OG000
spread
16.09
value
7.0
group Id
OG001
spread
14.02
value
-0.9
title
Week 44, n=3, 15

denoms

counts
group Id
OG000
value
113
group Id
OG001
value
225
units
Participants

description

dispersion Type

Standard Deviation

groups

description
Matching placebo tablets administered orally once daily for a duration until participants experienced disease progression, death, unacceptable toxicity, or participants withdrew consent
id
OG000
title
Placebo
description
Pazopanib 200 milligrams (mg) and 400 mg film-coated tablets (containing pazopanib monohydrochloride) administered orally at a dose of 800 mg once daily for a duration until participants experienced disease progression, death, unacceptable toxicity, or participants withdrew consent
id
OG001
title
Pazopanib

param Type

MEAN

population Description

Safety Population. Data were analyzed for participants who were on-therapy and provided data at the indicated time point.

reporting Status

POSTED

time Frame

Baseline, Day 8, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 88, 96, and 104

title

Change From Baseline in Heart Rate

type

SECONDARY

unit Of Measure

beats per minute

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice