NCT00753688 · OUTCOME

Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)

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: Millimeters of mercury
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 SBP and DBP was calculated as the values 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: all participants who had started their allocated treatment (at least one dose of the study drug). 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	120
Pazopanib	235

Reported measurements

SBP, Day 8, n=120, 235

Values in Millimeters of mercury · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Placebo	-0.6	13.37	Not reported	Not reported	Not reported
Pazopanib	10.3	15.96	Not reported	Not reported	Not reported

SBP, Week 4, n=106, 224

Values in Millimeters of mercury · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Placebo	-0.2	12.83	Not reported	Not reported	Not reported
Pazopanib	10.9	19.47	Not reported	Not reported	Not reported

SBP, Week 8, n=71, 180

Values in Millimeters of mercury · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Placebo	0.0	13.60	Not reported	Not reported	Not reported
Pazopanib	7.2	17.46	Not reported	Not reported	Not reported

SBP, Week 12, n=31, 115

Values in Millimeters of mercury · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Placebo	-3.1	15.82	Not reported	Not reported	Not reported
Pazopanib	4.9	18.21	Not reported	Not reported	Not reported

SBP, Week 16, n=35, 136

Values in Millimeters of mercury · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Placebo	-0.6	15.91	Not reported	Not reported	Not reported
Pazopanib	4.9	18.49	Not reported	Not reported	Not reported

SBP, Week 20, n=14, 66

Values in Millimeters of mercury · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Placebo	-2.6	14.89	Not reported	Not reported	Not reported
Pazopanib	3.9	19.84	Not reported	Not reported	Not reported

SBP, Week 24, n=22, 107

Values in Millimeters of mercury · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Placebo	-3.8	16.71	Not reported	Not reported	Not reported
Pazopanib	2.7	20.24	Not reported	Not reported	Not reported

SBP, Week 28, n=9, 41

Values in Millimeters of mercury · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Placebo	0.2	22.82	Not reported	Not reported	Not reported
Pazopanib	0.9	15.70	Not reported	Not reported	Not reported

SBP, Week 32, n=12, 76

Values in Millimeters of mercury · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Placebo	2.8	12.50	Not reported	Not reported	Not reported
Pazopanib	3.2	18.89	Not reported	Not reported	Not reported

SBP, Week 36, n=5, 24

Values in Millimeters of mercury · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Placebo	3.6	10.71	Not reported	Not reported	Not reported
Pazopanib	1.9	17.71	Not reported	Not reported	Not reported

SBP, Week 40, n=5, 62

Values in Millimeters of mercury · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Placebo	6.8	15.47	Not reported	Not reported	Not reported
Pazopanib	3.2	19.75	Not reported	Not reported	Not reported

SBP, Week 44, n=3, 16

Values in Millimeters of mercury · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Placebo	6.0	19.31	Not reported	Not reported	Not reported
Pazopanib	1.2	19.45	Not reported	Not reported	Not reported

SBP, Week 48, n=3, 37

Values in Millimeters of mercury · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Placebo	-1.7	14.05	Not reported	Not reported	Not reported
Pazopanib	-1.7	16.90	Not reported	Not reported	Not reported

SBP, Week 52, n=1, 6

Values in Millimeters of mercury · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Placebo	-4.0	0	Not reported	Not reported	Not reported
Pazopanib	9.8	18.28	Not reported	Not reported	Not reported

SBP, Week 56, n=1, 27

Values in Millimeters of mercury · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Placebo	16.0	0	Not reported	Not reported	Not reported
Pazopanib	1.4	20.86	Not reported	Not reported	Not reported

SBP, Week 60, n=0, 6

Values in Millimeters of mercury · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Placebo	0	0	Not reported	Not reported	Not reported
Pazopanib	7.0	18.60	Not reported	Not reported	Not reported

SBP, Week 64, n=1, 15

Values in Millimeters of mercury · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Placebo	20.0	0	Not reported	Not reported	Not reported
Pazopanib	-3.0	19.26	Not reported	Not reported	Not reported

SBP, Week 68, n=0, 2

Values in Millimeters of mercury · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Placebo	0	0	Not reported	Not reported	Not reported
Pazopanib	14.5	3.54	Not reported	Not reported	Not reported

SBP, Week 72, n=1, 9

Values in Millimeters of mercury · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Placebo	8.0	0	Not reported	Not reported	Not reported
Pazopanib	-1.1	15.83	Not reported	Not reported	Not reported

SBP, Week 76, n=0, 1

Values in Millimeters of mercury · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Placebo	0	0	Not reported	Not reported	Not reported
Pazopanib	16.0	0	Not reported	Not reported	Not reported

SBP, Week 80, n=1, 5

Values in Millimeters of mercury · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Placebo	19.0	0	Not reported	Not reported	Not reported
Pazopanib	-0.9	22.66	Not reported	Not reported	Not reported

SBP, Week 88, n=1, 3

Values in Millimeters of mercury · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Placebo	3.0	0	Not reported	Not reported	Not reported
Pazopanib	3.9	22.90	Not reported	Not reported	Not reported

SBP, Week 96, n=1, 2

Values in Millimeters of mercury · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Placebo	13.0	0	Not reported	Not reported	Not reported
Pazopanib	-3.0	14.14	Not reported	Not reported	Not reported

SBP, Week 104, n=1, 1

Values in Millimeters of mercury · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Placebo	18.0	0	Not reported	Not reported	Not reported
Pazopanib	6.0	0	Not reported	Not reported	Not reported

DBP, Day 8, n=120, 235

Values in Millimeters of mercury · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Placebo	-0.2	9.53	Not reported	Not reported	Not reported
Pazopanib	7.2	10.68	Not reported	Not reported	Not reported

DBP, Week 4, n=106, 224

Values in Millimeters of mercury · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Placebo	-0.2	9.51	Not reported	Not reported	Not reported
Pazopanib	8.2	11.37	Not reported	Not reported	Not reported

DBP, Week 8, n=71, 180

Values in Millimeters of mercury · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Placebo	-0.3	9.24	Not reported	Not reported	Not reported
Pazopanib	6.6	12.18	Not reported	Not reported	Not reported

DBP, Week 12, n=31, 115

Values in Millimeters of mercury · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Placebo	-0.1	10.81	Not reported	Not reported	Not reported
Pazopanib	3.9	11.31	Not reported	Not reported	Not reported

DBP, Week 16, n=35, 136

Values in Millimeters of mercury · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Placebo	0.8	10.46	Not reported	Not reported	Not reported
Pazopanib	5.3	12.12	Not reported	Not reported	Not reported

DBP, Week 20, n=14, 66

Values in Millimeters of mercury · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Placebo	-0.3	8.61	Not reported	Not reported	Not reported
Pazopanib	4.5	12.22	Not reported	Not reported	Not reported

DBP, Week 24, n=22, 107

Values in Millimeters of mercury · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Placebo	-1.6	11.78	Not reported	Not reported	Not reported
Pazopanib	3.7	14.44	Not reported	Not reported	Not reported

DBP, Week 28, n=9, 41

Values in Millimeters of mercury · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Placebo	-1.9	12.33	Not reported	Not reported	Not reported
Pazopanib	3.7	11.28	Not reported	Not reported	Not reported

DBP, Week 32, n=12, 76

Values in Millimeters of mercury · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Placebo	-2.0	7.30	Not reported	Not reported	Not reported
Pazopanib	3.9	11.59	Not reported	Not reported	Not reported

DBP, Week 36, n=5, 24

Values in Millimeters of mercury · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Placebo	-6.6	9.63	Not reported	Not reported	Not reported
Pazopanib	4.1	13.28	Not reported	Not reported	Not reported

DBP, Week 40, n=5, 62

Values in Millimeters of mercury · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Placebo	3.4	9.24	Not reported	Not reported	Not reported
Pazopanib	2.9	13.34	Not reported	Not reported	Not reported

DBP, Week 44, n=3, 16

Values in Millimeters of mercury · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Placebo	4.7	5.03	Not reported	Not reported	Not reported
Pazopanib	1.7	12.48	Not reported	Not reported	Not reported

DBP, Week 48, n=3, 37

Values in Millimeters of mercury · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Placebo	2.0	4.36	Not reported	Not reported	Not reported
Pazopanib	3.7	12.01	Not reported	Not reported	Not reported

DBP, Week 52, n=1, 6

Values in Millimeters of mercury · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Placebo	1.0	0	Not reported	Not reported	Not reported
Pazopanib	12.0	15.06	Not reported	Not reported	Not reported

DBP, Week 56, n=1, 27

Values in Millimeters of mercury · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Placebo	12.0	0	Not reported	Not reported	Not reported
Pazopanib	4.4	12.28	Not reported	Not reported	Not reported

DBP, Week 60, n=0, 6

Values in Millimeters of mercury · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Placebo	0	0	Not reported	Not reported	Not reported
Pazopanib	12.7	14.39	Not reported	Not reported	Not reported

DBP, Week 64, n=1, 15

Values in Millimeters of mercury · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Placebo	10.0	0	Not reported	Not reported	Not reported
Pazopanib	-2.2	14.21	Not reported	Not reported	Not reported

DBP, Week 68, n=0, 2

Values in Millimeters of mercury · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Placebo	0	0	Not reported	Not reported	Not reported
Pazopanib	17.0	25.46	Not reported	Not reported	Not reported

DBP, Week 72, n=1, 9

Values in Millimeters of mercury · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Placebo	13.0	0	Not reported	Not reported	Not reported
Pazopanib	0.8	12.88	Not reported	Not reported	Not reported

DBP, Week 76, n=0, 1

Values in Millimeters of mercury · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Placebo	0	0	Not reported	Not reported	Not reported
Pazopanib	4.0	0	Not reported	Not reported	Not reported

DBP, Week 80, n=1, 5

Values in Millimeters of mercury · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Placebo	14.0	0	Not reported	Not reported	Not reported
Pazopanib	-3.3	15.15	Not reported	Not reported	Not reported

DBP, Week 88, n=1, 3

Values in Millimeters of mercury · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Placebo	9.0	0	Not reported	Not reported	Not reported
Pazopanib	5.2	3.87	Not reported	Not reported	Not reported

DBP, Week 96, n=1, 2

Values in Millimeters of mercury · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Placebo	6.0	0	Not reported	Not reported	Not reported
Pazopanib	7.0	5.66	Not reported	Not reported	Not reported

DBP, Week 104, n=1, 1

Values in Millimeters of mercury · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Placebo	12.0	0	Not reported	Not reported	Not reported
Pazopanib	12.0	0	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
spread
13.37
value
-0.6
group Id
OG001
spread
15.96
value
10.3
title
SBP, Day 8, n=120, 235
categories
measurements
group Id
OG000
spread
12.83
value
-0.2
group Id
OG001
spread
19.47
value
10.9
title
SBP, Week 4, n=106, 224
categories
measurements
group Id
OG000
spread
13.60
value
0.0
group Id
OG001
spread
17.46
value
7.2
title
SBP, Week 8, n=71, 180
categories
measurements
group Id
OG000
spread
15.82
value
-3.1
group Id
OG001
spread
18.21
value
4.9
title
SBP, Week 12, n=31, 115
categories
measurements
group Id
OG000
spread
15.91
value
-0.6
group Id
OG001
spread
18.49
value
4.9
title
SBP, Week 16, n=35, 136
categories
measurements
group Id
OG000
spread
14.89
value
-2.6
group Id
OG001
spread
19.84
value
3.9
title
SBP, Week 20, n=14, 66
categories
measurements
group Id
OG000
spread
16.71
value
-3.8
group Id
OG001
spread
20.24
value
2.7
title
SBP, Week 24, n=22, 107
categories
measurements
group Id
OG000
spread
22.82
value
0.2
group Id
OG001
spread
15.70
value
0.9
title
SBP, Week 28, n=9, 41
categories
measurements
group Id
OG000
spread
12.50
value
2.8
group Id
OG001
spread
18.89
value
3.2
title
SBP, Week 32, n=12, 76
categories
measurements
group Id
OG000
spread
10.71
value
3.6
group Id
OG001
spread
17.71
value
1.9
title
SBP, Week 36, n=5, 24
categories
measurements
group Id
OG000
spread
15.47
value
6.8
group Id
OG001
spread
19.75
value
3.2
title
SBP, Week 40, n=5, 62
categories
measurements
group Id
OG000
spread
19.31
value
6.0
group Id
OG001
spread
19.45
value
1.2
title
SBP, Week 44, n=3, 16

denoms

counts
group Id
OG000
value
120
group Id
OG001
value
235
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: all participants who had started their allocated treatment (at least one dose of the study drug). 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 Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)

type

SECONDARY

unit Of Measure

Millimeters of mercury

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Preserved source evidence · Not medical advice