NCT00334282 · OUTCOME
Overall Response
Safety and Efficacy of GW786034 (Pazopanib) In Metastatic Renal Cell Carcinoma · Source last updated 2016-02-05
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 until either response or progression (up to 2 years)
What was measured
Overall response is the number of participants who had a complete response (CR) or a partial response (PR). Per RECIST: CR, all detectable tumor has disappeared; PR, a \>=30% decrease in the sum of the longest dimensions of the target lesions (TLs) taking as a reference the Baseline sum, no worsening of non-TLs, and no new lesions; Progressive disease (PD), a \>=20% increase in TLs, clearly worsening of non-TLs, or emergence of new lesions; Stable Disease, small changes that do not meet previously given criteria. IRC, independent review committee.
Analysis population: ITT Population
Groups in this outcome
Pazopanib 800 mg
Pazopanib 800 mg (tablets) administered orally once a day
Placebo
Matching Placebo administered orally once a day
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 |
|---|
| Pazopanib 800 mg | 290 |
|---|
| Placebo | 145 |
|---|
Reported measurements
Complete Response, IRC assessed
Values in participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Pazopanib 800 mg | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
| Placebo | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Partial Response, IRC assessed
Values in participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Pazopanib 800 mg | 87 | Not reported | Not reported | Not reported | Not reported |
|---|
| Placebo | 5 | Not reported | Not reported | Not reported | Not reported |
|---|
Stable Disease, IRC assessed
Values in participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Pazopanib 800 mg | 110 | Not reported | Not reported | Not reported | Not reported |
|---|
| Placebo | 59 | Not reported | Not reported | Not reported | Not reported |
|---|
Progressive Disease, IRC assessed
Values in participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Pazopanib 800 mg | 51 | Not reported | Not reported | Not reported | Not reported |
|---|
| Placebo | 58 | Not reported | Not reported | Not reported | Not reported |
|---|
Unknown, IRC assessed
Values in participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Pazopanib 800 mg | 41 | Not reported | Not reported | Not reported | Not reported |
|---|
| Placebo | 23 | Not reported | Not reported | Not reported | Not reported |
|---|
Complete Response, Investigator assessed
Values in participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Pazopanib 800 mg | 4 | Not reported | Not reported | Not reported | Not reported |
|---|
| Placebo | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Partial Response, Investigator assessed
Values in participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Pazopanib 800 mg | 99 | Not reported | Not reported | Not reported | Not reported |
|---|
| Placebo | 9 | Not reported | Not reported | Not reported | Not reported |
|---|
Stable Disease, Investigator assessed
Values in participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Pazopanib 800 mg | 118 | Not reported | Not reported | Not reported | Not reported |
|---|
| Placebo | 62 | Not reported | Not reported | Not reported | Not reported |
|---|
Progressive Disease, Investigator assessed
Values in participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Pazopanib 800 mg | 46 | Not reported | Not reported | Not reported | Not reported |
|---|
| Placebo | 65 | Not reported | Not reported | Not reported | Not reported |
|---|
Unknown, Investigator assessed
Values in participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Pazopanib 800 mg | 23 | Not reported | Not reported | Not reported | Not reported |
|---|
| Placebo | 9 | Not reported | Not reported | Not reported | Not reported |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 0
- title
- Complete Response, IRC assessed
- categories
- measurements
- group Id
- OG000
- value
- 87
- group Id
- OG001
- value
- 5
- title
- Partial Response, IRC assessed
- categories
- measurements
- group Id
- OG000
- value
- 110
- group Id
- OG001
- value
- 59
- title
- Stable Disease, IRC assessed
- categories
- measurements
- group Id
- OG000
- value
- 51
- group Id
- OG001
- value
- 58
- title
- Progressive Disease, IRC assessed
- categories
- measurements
- group Id
- OG000
- value
- 41
- group Id
- OG001
- value
- 23
- title
- Unknown, IRC assessed
- categories
- measurements
- group Id
- OG000
- value
- 4
- group Id
- OG001
- value
- 0
- title
- Complete Response, Investigator assessed
- categories
- measurements
- group Id
- OG000
- value
- 99
- group Id
- OG001
- value
- 9
- title
- Partial Response, Investigator assessed
- categories
- measurements
- group Id
- OG000
- value
- 118
- group Id
- OG001
- value
- 62
- title
- Stable Disease, Investigator assessed
- categories
- measurements
- group Id
- OG000
- value
- 46
- group Id
- OG001
- value
- 65
- title
- Progressive Disease, Investigator assessed
- categories
- measurements
- group Id
- OG000
- value
- 23
- group Id
- OG001
- value
- 9
- title
- Unknown, Investigator assessed
- denoms
- counts
- group Id
- OG000
- value
- 290
- group Id
- OG001
- value
- 145
- units
- Participants
- description
- Overall response is the number of participants who had a complete response (CR) or a partial response (PR). Per RECIST: CR, all detectable tumor has disappeared; PR, a \>=30% decrease in the sum of the longest dimensions of the target lesions (TLs) taking as a reference the Baseline sum, no worsening of non-TLs, and no new lesions; Progressive disease (PD), a \>=20% increase in TLs, clearly worsening of non-TLs, or emergence of new lesions; Stable Disease, small changes that do not meet previously given criteria. IRC, independent review committee.
- groups
- description
- Pazopanib 800 mg (tablets) administered orally once a day
- id
- OG000
- title
- Pazopanib 800 mg
- description
- Matching Placebo administered orally once a day
- id
- OG001
- title
- Placebo
- param Type
- NUMBER
- population Description
- ITT Population
- reporting Status
- POSTED
- time Frame
- Baseline until either response or progression (up to 2 years)
- title
- Overall Response
- type
- SECONDARY
- unit Of Measure
- participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice
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