Number of Participants With the Indicated Grade Shifts From Baseline Grade for Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Albumin, Creatinine, Hyper/Hypoglycemia, Hyper/Hypokalemia, Hyper/Hyponatremia, and Total Bilirubin
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
NUMBER
Unit
participants
Interval / dispersion
Not reported
Time frame
From baseline (Day 1) until study drug discontinuation or end of treatment (assessed for an average of 20 weeks)
What was measured
Shifts in clinical chemistry values by grade were summarized based on the NCI CTCAE Version 3.0. Participants with a missing baseline grade were assumed to have a baseline Grade of 0. Any increase in grade from baseline and shifts to Grade 3 and 4 at any point in the study after baseline are reported. alkaline phosphatase, ALKP; alanine aminotransferase, ALT; aspartate aminotransferase, AST. Hyper/hypoglycemia refers to high/low glucose; hyper/hypokalemia refers to high/low potassium; hyper/hyponatremia refers to high/low sodium.
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
123
Pazopanib
239
Reported measurements
ALKP, Any Increase, n=123, 237
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Placebo
28
Not reported
Not reported
Not reported
Not reported
Pazopanib
77
Not reported
Not reported
Not reported
Not reported
ALKP, Increase to Grade 3, n=123, 237
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Placebo
1
Not reported
Not reported
Not reported
Not reported
Pazopanib
7
Not reported
Not reported
Not reported
Not reported
ALKP, Increase to Grade 4, n=123, 237
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Placebo
0
Not reported
Not reported
Not reported
Not reported
Pazopanib
0
Not reported
Not reported
Not reported
Not reported
ALT, Any Increase, n=123, 237
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Placebo
22
Not reported
Not reported
Not reported
Not reported
Pazopanib
110
Not reported
Not reported
Not reported
Not reported
ALT, Increase to Grade 3, n=123, 237
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Placebo
3
Not reported
Not reported
Not reported
Not reported
Pazopanib
18
Not reported
Not reported
Not reported
Not reported
ALT, Increase to Grade 4, n=123, 237
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Placebo
1
Not reported
Not reported
Not reported
Not reported
Pazopanib
5
Not reported
Not reported
Not reported
Not reported
AST, Any Increase, n=123, 239
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Placebo
27
Not reported
Not reported
Not reported
Not reported
Pazopanib
122
Not reported
Not reported
Not reported
Not reported
AST, Increase to Grade 3, n=123, 239
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Placebo
2
Not reported
Not reported
Not reported
Not reported
Pazopanib
13
Not reported
Not reported
Not reported
Not reported
AST, Increase to Grade 4, n=123, 239
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Placebo
0
Not reported
Not reported
Not reported
Not reported
Pazopanib
6
Not reported
Not reported
Not reported
Not reported
Albumin, Any Increase, n=123, 239
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Placebo
26
Not reported
Not reported
Not reported
Not reported
Pazopanib
81
Not reported
Not reported
Not reported
Not reported
Albumin, Increase to Grade 3, n=123, 239
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Placebo
0
Not reported
Not reported
Not reported
Not reported
Pazopanib
2
Not reported
Not reported
Not reported
Not reported
Albumin, Increase to Grade 4, n=123, 239
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Placebo
0
Not reported
Not reported
Not reported
Not reported
Pazopanib
0
Not reported
Not reported
Not reported
Not reported
Creatinine, Any Increase, n=123, 239
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Placebo
9
Not reported
Not reported
Not reported
Not reported
Pazopanib
28
Not reported
Not reported
Not reported
Not reported
Creatinine, Increase to Grade 3, n=123, 239
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Placebo
0
Not reported
Not reported
Not reported
Not reported
Pazopanib
1
Not reported
Not reported
Not reported
Not reported
Creatinine, Increase to Grade 4, n=123, 239
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Placebo
0
Not reported
Not reported
Not reported
Not reported
Pazopanib
0
Not reported
Not reported
Not reported
Not reported
Hyperglycemia, Any Increase, n=122, 238
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Placebo
43
Not reported
Not reported
Not reported
Not reported
Pazopanib
106
Not reported
Not reported
Not reported
Not reported
Hyperglycemia, Increase to Grade 3, n=122, 238
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Placebo
2
Not reported
Not reported
Not reported
Not reported
Pazopanib
1
Not reported
Not reported
Not reported
Not reported
Hyperglycemia, Increase to Grade 4, n=122, 238
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Placebo
0
Not reported
Not reported
Not reported
Not reported
Pazopanib
0
Not reported
Not reported
Not reported
Not reported
Hyperkalemia, Any Increase, n=123, 238
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Placebo
13
Not reported
Not reported
Not reported
Not reported
Pazopanib
37
Not reported
Not reported
Not reported
Not reported
Hyperkalemia, Increase to Grade 3, n=123, 238
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Placebo
0
Not reported
Not reported
Not reported
Not reported
Pazopanib
3
Not reported
Not reported
Not reported
Not reported
Hyperkalemia, Increase to Grade 4, n=123, 238
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Placebo
0
Not reported
Not reported
Not reported
Not reported
Pazopanib
0
Not reported
Not reported
Not reported
Not reported
Hypernatremia, Any Increase, n=123, 238
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Placebo
3
Not reported
Not reported
Not reported
Not reported
Pazopanib
10
Not reported
Not reported
Not reported
Not reported
Hypernatremia, Increase to Grade 3, n=123, 238
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Placebo
0
Not reported
Not reported
Not reported
Not reported
Pazopanib
0
Not reported
Not reported
Not reported
Not reported
Hypernatremia, Increase to Grade 4, n=123, 238
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Placebo
0
Not reported
Not reported
Not reported
Not reported
Pazopanib
0
Not reported
Not reported
Not reported
Not reported
Hypoglycemia, Any Increase, n=122, 238
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Placebo
4
Not reported
Not reported
Not reported
Not reported
Pazopanib
21
Not reported
Not reported
Not reported
Not reported
Hypoglycemia, Increase to Grade 3, n=122, 238
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Placebo
0
Not reported
Not reported
Not reported
Not reported
Pazopanib
1
Not reported
Not reported
Not reported
Not reported
Hypoglycemia, Increase to Grade 4, n=122, 238
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Placebo
0
Not reported
Not reported
Not reported
Not reported
Pazopanib
0
Not reported
Not reported
Not reported
Not reported
Hypokalemia, Any Increase, n=123, 238
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Placebo
11
Not reported
Not reported
Not reported
Not reported
Pazopanib
32
Not reported
Not reported
Not reported
Not reported
Hypokalemia, Increase to Grade 3, n=123, 238
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Placebo
1
Not reported
Not reported
Not reported
Not reported
Pazopanib
6
Not reported
Not reported
Not reported
Not reported
Hypokalemia, Increase to Grade 4, n=123, 238
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Placebo
0
Not reported
Not reported
Not reported
Not reported
Pazopanib
1
Not reported
Not reported
Not reported
Not reported
Hyponatremia, Any Increase, n=123, 238
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Placebo
25
Not reported
Not reported
Not reported
Not reported
Pazopanib
74
Not reported
Not reported
Not reported
Not reported
Hyponatremia, Increase to Grade 3, n=123, 238
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Placebo
4
Not reported
Not reported
Not reported
Not reported
Pazopanib
9
Not reported
Not reported
Not reported
Not reported
Hyponatremia, Increase to Grade 4, n=123, 238
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Placebo
0
Not reported
Not reported
Not reported
Not reported
Pazopanib
0
Not reported
Not reported
Not reported
Not reported
Total Bilirubin, Any Increase, n=122, 237
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Placebo
9
Not reported
Not reported
Not reported
Not reported
Pazopanib
68
Not reported
Not reported
Not reported
Not reported
Total Bilirubin, Increase to Grade 3, n=122, 237
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Placebo
2
Not reported
Not reported
Not reported
Not reported
Pazopanib
3
Not reported
Not reported
Not reported
Not reported
Total Bilirubin, Increase to Grade 4, n=122, 237
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Placebo
0
Not reported
Not reported
Not reported
Not reported
Pazopanib
0
Not reported
Not reported
Not reported
Not reported
Complete source fields
classes
categories
measurements
group Id
OG000
value
28
group Id
OG001
value
77
title
ALKP, Any Increase, n=123, 237
categories
measurements
group Id
OG000
value
1
group Id
OG001
value
7
title
ALKP, Increase to Grade 3, n=123, 237
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
title
ALKP, Increase to Grade 4, n=123, 237
categories
measurements
group Id
OG000
value
22
group Id
OG001
value
110
title
ALT, Any Increase, n=123, 237
categories
measurements
group Id
OG000
value
3
group Id
OG001
value
18
title
ALT, Increase to Grade 3, n=123, 237
categories
measurements
group Id
OG000
value
1
group Id
OG001
value
5
title
ALT, Increase to Grade 4, n=123, 237
categories
measurements
group Id
OG000
value
27
group Id
OG001
value
122
title
AST, Any Increase, n=123, 239
categories
measurements
group Id
OG000
value
2
group Id
OG001
value
13
title
AST, Increase to Grade 3, n=123, 239
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
6
title
AST, Increase to Grade 4, n=123, 239
categories
measurements
group Id
OG000
value
26
group Id
OG001
value
81
title
Albumin, Any Increase, n=123, 239
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
2
title
Albumin, Increase to Grade 3, n=123, 239
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
title
Albumin, Increase to Grade 4, n=123, 239
denoms
counts
group Id
OG000
value
123
group Id
OG001
value
239
units
Participants
description
Shifts in clinical chemistry values by grade were summarized based on the NCI CTCAE Version 3.0. Participants with a missing baseline grade were assumed to have a baseline Grade of 0. Any increase in grade from baseline and shifts to Grade 3 and 4 at any point in the study after baseline are reported. alkaline phosphatase, ALKP; alanine aminotransferase, ALT; aspartate aminotransferase, AST. Hyper/hypoglycemia refers to high/low glucose; hyper/hypokalemia refers to high/low potassium; hyper/hyponatremia refers to high/low sodium.
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
NUMBER
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
From baseline (Day 1) until study drug discontinuation or end of treatment (assessed for an average of 20 weeks)
title
Number of Participants With the Indicated Grade Shifts From Baseline Grade for Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Albumin, Creatinine, Hyper/Hypoglycemia, Hyper/Hypokalemia, Hyper/Hyponatremia, and Total Bilirubin
Triangle