NCT00753688 · OUTCOME
Number of Participants in the Indicated Categories for Overall Response Assessed by an Independent Radiologist and the Investigator
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 the start of treatment until disease progression (assessed for an average of 10 months)
What was measured
Overall response is defined as the number of participants who had a complete response (CR) or a partial response (PR). According to RECIST, Version 1.0: CR, disappearance of all lesions; PR, a \>=30% decrease in the sum of the longest dimensions (LD) of the target lesions (TLs) taking as a reference the baseline sum LD; Progressive disease (PD), a \>=20% increase in the sum of the LD of TLs, or the appearance of \>=1 new lesion; Stable Disease (SD), neither PR nor PD, persistence of \>=1 non-TL. Participants with no follow-up radiological disease assessment were categorized as not evaluable (NE).
Analysis population: ITT Population
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 | 246 |
|---|
Reported measurements
CR, Independent radiologist assessed
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 |
|---|
PR, Independent radiologist assessed
Values in participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Placebo | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Pazopanib | 11 | Not reported | Not reported | Not reported | Not reported |
|---|
SD, Independent radiologist assessed
Values in participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Placebo | 33 | Not reported | Not reported | Not reported | Not reported |
|---|
| Pazopanib | 134 | Not reported | Not reported | Not reported | Not reported |
|---|
PD, Independent radiologist assessed
Values in participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Placebo | 76 | Not reported | Not reported | Not reported | Not reported |
|---|
| Pazopanib | 66 | Not reported | Not reported | Not reported | Not reported |
|---|
NE, Independent radiologist assessed
Values in participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Placebo | 14 | Not reported | Not reported | Not reported | Not reported |
|---|
| Pazopanib | 35 | Not reported | Not reported | Not reported | Not reported |
|---|
CR, Investigator assessed
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 |
|---|
PR, Investigator assessed
Values in participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Placebo | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Pazopanib | 23 | Not reported | Not reported | Not reported | Not reported |
|---|
SD, Investigator assessed
Values in participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Placebo | 36 | Not reported | Not reported | Not reported | Not reported |
|---|
| Pazopanib | 138 | Not reported | Not reported | Not reported | Not reported |
|---|
PD, Investigator assessed
Values in participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Placebo | 83 | Not reported | Not reported | Not reported | Not reported |
|---|
| Pazopanib | 70 | Not reported | Not reported | Not reported | Not reported |
|---|
NE, Investigator assessed
Values in participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Placebo | 4 | Not reported | Not reported | Not reported | Not reported |
|---|
| Pazopanib | 15 | Not reported | Not reported | Not reported | Not reported |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- title
- CR, Independent radiologist assessed
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 11
- title
- PR, Independent radiologist assessed
- categories
- measurements
- group Id
- OG000
- value
- 33
- group Id
- OG001
- value
- 134
- title
- SD, Independent radiologist assessed
- categories
- measurements
- group Id
- OG000
- value
- 76
- group Id
- OG001
- value
- 66
- title
- PD, Independent radiologist assessed
- categories
- measurements
- group Id
- OG000
- value
- 14
- group Id
- OG001
- value
- 35
- title
- NE, Independent radiologist assessed
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- title
- CR, Investigator assessed
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 23
- title
- PR, Investigator assessed
- categories
- measurements
- group Id
- OG000
- value
- 36
- group Id
- OG001
- value
- 138
- title
- SD, Investigator assessed
- categories
- measurements
- group Id
- OG000
- value
- 83
- group Id
- OG001
- value
- 70
- title
- PD, Investigator assessed
- categories
- measurements
- group Id
- OG000
- value
- 4
- group Id
- OG001
- value
- 15
- title
- NE, Investigator assessed
- denoms
- counts
- group Id
- OG000
- value
- 123
- group Id
- OG001
- value
- 246
- units
- Participants
- description
- Overall response is defined as the number of participants who had a complete response (CR) or a partial response (PR). According to RECIST, Version 1.0: CR, disappearance of all lesions; PR, a \>=30% decrease in the sum of the longest dimensions (LD) of the target lesions (TLs) taking as a reference the baseline sum LD; Progressive disease (PD), a \>=20% increase in the sum of the LD of TLs, or the appearance of \>=1 new lesion; Stable Disease (SD), neither PR nor PD, persistence of \>=1 non-TL. Participants with no follow-up radiological disease assessment were categorized as not evaluable (NE).
- 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
- ITT Population
- reporting Status
- POSTED
- time Frame
- From the start of treatment until disease progression (assessed for an average of 10 months)
- title
- Number of Participants in the Indicated Categories for Overall Response Assessed by an Independent Radiologist and the Investigator
- type
- SECONDARY
- unit Of Measure
- participants
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Preserved source evidence · Not medical advice
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