NCT00720941 · OUTCOME
Overall Response Rate (ORR) as Assessed by Independent Review
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- COUNT_OF_PARTICIPANTS
- Unit
- Participants
- Interval / dispersion
- Not reported
- Time frame
- From randomization until date of radiographic progression or date of death from any cause, whichever comes first, assessed up to approximately 39 months
What was measured
The number of participants with evidence of Complete Response (CR) (the disappearance of all target and non-target lesions), Partial Response (PR) (at least a 30% decrease in the sum of the longest diameters \[LD\] of target lesions, taking as a reference the Baseline sum LD), Stable Disease (small changes that do not meet previously given criteria, taking as reference the smallest sum LD since the treatment started), or Progressive Disease (a \>=20% increase in the sum of the LD of target lesions, taking as a reference the smallest sum LD recorded since the treatment started) was evaluated by an independent review per RECIST, Version 1.
Analysis population: Intent-to-Treat (ITT) Population. Analysis was based on the assigned randomized treatment, not on the actual treatment received/not received.
Groups in this outcome
Pazopanib 800 mg
Participants were administered pazopanib 800 mg (2 x 400 mg tablets) orally OD continuously. Pazopanib was to be taken at least one hour before or at least two hours after a meal. Participants received study treatment until disease progression, death, unacceptable toxicity, or withdrawal of consent for any other reasons.
Sunitinib 50 mg
Participants were administered sunitinib 50 mg orally once daily in 6-week cycles (4 weeks of treatment, followed by 2 weeks without treatment). Participants received study treatment until disease progression, death, unacceptable toxicity, or withdrawal of consent for any other reasons.
| Group | Source count |
|---|---|
| Pazopanib 800 mg | 557 |
| Sunitinib 50 mg | 553 |
Reported measurements
Source class 1
Complete Response
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Pazopanib 800 mg | 1 | Not reported | Not reported | Not reported | Not reported |
| Sunitinib 50 mg | 3 | Not reported | Not reported | Not reported | Not reported |
Partial Response
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Pazopanib 800 mg | 170 | Not reported | Not reported | Not reported | Not reported |
| Sunitinib 50 mg | 134 | Not reported | Not reported | Not reported | Not reported |
Stable Disease
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Pazopanib 800 mg | 216 | Not reported | Not reported | Not reported | Not reported |
| Sunitinib 50 mg | 242 | Not reported | Not reported | Not reported | Not reported |
Progressive Disease
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Pazopanib 800 mg | 97 | Not reported | Not reported | Not reported | Not reported |
| Sunitinib 50 mg | 105 | Not reported | Not reported | Not reported | Not reported |
Unknown
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Pazopanib 800 mg | 73 | Not reported | Not reported | Not reported | Not reported |
| Sunitinib 50 mg | 69 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 3
- title
- Complete Response
- measurements
- group Id
- OG000
- value
- 170
- group Id
- OG001
- value
- 134
- title
- Partial Response
- measurements
- group Id
- OG000
- value
- 216
- group Id
- OG001
- value
- 242
- title
- Stable Disease
- measurements
- group Id
- OG000
- value
- 97
- group Id
- OG001
- value
- 105
- title
- Progressive Disease
- measurements
- group Id
- OG000
- value
- 73
- group Id
- OG001
- value
- 69
- title
- Unknown
- denoms
- counts
- group Id
- OG000
- value
- 557
- group Id
- OG001
- value
- 553
- units
- Participants
- description
- The number of participants with evidence of Complete Response (CR) (the disappearance of all target and non-target lesions), Partial Response (PR) (at least a 30% decrease in the sum of the longest diameters \[LD\] of target lesions, taking as a reference the Baseline sum LD), Stable Disease (small changes that do not meet previously given criteria, taking as reference the smallest sum LD since the treatment started), or Progressive Disease (a \>=20% increase in the sum of the LD of target lesions, taking as a reference the smallest sum LD recorded since the treatment started) was evaluated by an independent review per RECIST, Version 1.
- groups
- description
- Participants were administered pazopanib 800 mg (2 x 400 mg tablets) orally OD continuously. Pazopanib was to be taken at least one hour before or at least two hours after a meal. Participants received study treatment until disease progression, death, unacceptable toxicity, or withdrawal of consent for any other reasons.
- id
- OG000
- title
- Pazopanib 800 mg
- description
- Participants were administered sunitinib 50 mg orally once daily in 6-week cycles (4 weeks of treatment, followed by 2 weeks without treatment). Participants received study treatment until disease progression, death, unacceptable toxicity, or withdrawal of consent for any other reasons.
- id
- OG001
- title
- Sunitinib 50 mg
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- Intent-to-Treat (ITT) Population. Analysis was based on the assigned randomized treatment, not on the actual treatment received/not received.
- reporting Status
- POSTED
- time Frame
- From randomization until date of radiographic progression or date of death from any cause, whichever comes first, assessed up to approximately 39 months
- title
- Overall Response Rate (ORR) as Assessed by Independent Review
- type
- SECONDARY
- unit Of Measure
- Participants
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Preserved source evidence · Not medical advice
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