NCT00753688 · OUTCOME
Number of Participants With the Indicated Absolute Percent Change From Baseline (BL) in Left Ventricular Ejection Fraction (LVEF) at Any Time Post-BL (Worst Case On-therapy)
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
- Baseline (within 14 days of the first dose of study drug) and any time post-baseline until study drug discontinuation or end of treatment (assessed for an average of 20 weeks)
What was measured
LVEF is the measurement of how much blood is being pumped out of the left ventricle of the heart (the main pumping chamber) with each contraction and is used to determine cardiac function (based on the institutional lower limit of normal \[LLN\]). LVEF was assessed at BL, Week 12, and every second scheduled visit thereafter until study drug discontinuation and end of treatment or as clinically indicated by using multi-gated acquisition scan (MUGA) or echocardiogram (ECHO). Absolute change from BL was calculated as the on-study value minus the baseline value (LVEF is calculated as a percentage).
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 | 39 |
|---|
| Pazopanib | 140 |
|---|
Reported measurements
Any Increase
Values in participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Placebo | 15 | Not reported | Not reported | Not reported | Not reported |
|---|
| Pazopanib | 39 | Not reported | Not reported | Not reported | Not reported |
|---|
No Change
Values in participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Placebo | 6 | Not reported | Not reported | Not reported | Not reported |
|---|
| Pazopanib | 14 | Not reported | Not reported | Not reported | Not reported |
|---|
0 to <10% Decrease
Values in participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Placebo | 15 | Not reported | Not reported | Not reported | Not reported |
|---|
| Pazopanib | 66 | Not reported | Not reported | Not reported | Not reported |
|---|
10 to 19% Decrease
Values in participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Placebo | 3 | Not reported | Not reported | Not reported | Not reported |
|---|
| Pazopanib | 15 | Not reported | Not reported | Not reported | Not reported |
|---|
>=20% Decrease
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 |
|---|
>=10% Decrease and >= LLN
Values in participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Placebo | 3 | Not reported | Not reported | Not reported | Not reported |
|---|
| Pazopanib | 8 | Not reported | Not reported | Not reported | Not reported |
|---|
>=10% Decrease and below LLN
Values in participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Placebo | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Pazopanib | 13 | Not reported | Not reported | Not reported | Not reported |
|---|
>=20% Decrease and >= LLN
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 |
|---|
>=20% Decrease and below LLN
Values in participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Placebo | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Pazopanib | 5 | Not reported | Not reported | Not reported | Not reported |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 15
- group Id
- OG001
- value
- 39
- title
- Any Increase
- categories
- measurements
- group Id
- OG000
- value
- 6
- group Id
- OG001
- value
- 14
- title
- No Change
- categories
- measurements
- group Id
- OG000
- value
- 15
- group Id
- OG001
- value
- 66
- title
- 0 to <10% Decrease
- categories
- measurements
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 15
- title
- 10 to 19% Decrease
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 6
- title
- >=20% Decrease
- categories
- measurements
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 8
- title
- >=10% Decrease and >= LLN
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 13
- title
- >=10% Decrease and below LLN
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 1
- title
- >=20% Decrease and >= LLN
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 5
- title
- >=20% Decrease and below LLN
- denoms
- counts
- group Id
- OG000
- value
- 39
- group Id
- OG001
- value
- 140
- units
- Participants
- description
- LVEF is the measurement of how much blood is being pumped out of the left ventricle of the heart (the main pumping chamber) with each contraction and is used to determine cardiac function (based on the institutional lower limit of normal \[LLN\]). LVEF was assessed at BL, Week 12, and every second scheduled visit thereafter until study drug discontinuation and end of treatment or as clinically indicated by using multi-gated acquisition scan (MUGA) or echocardiogram (ECHO). Absolute change from BL was calculated as the on-study value minus the baseline value (LVEF is calculated as a percentage).
- 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
- Baseline (within 14 days of the first dose of study drug) and any time post-baseline until study drug discontinuation or end of treatment (assessed for an average of 20 weeks)
- title
- Number of Participants With the Indicated Absolute Percent Change From Baseline (BL) in Left Ventricular Ejection Fraction (LVEF) at Any Time Post-BL (Worst Case On-therapy)
- type
- SECONDARY
- unit Of Measure
- participants
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Preserved source evidence · Not medical advice
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