TriangleNCT00720941 · OUTCOME
Progression-free Survival (PFS)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- Months
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- From randomization until the earliest date of disease progression or date of death from any cause, assessed up to approximately 39 months
What was measured
PFS was defined as the interval between the date of randomization and the earliest date of progressive disease (PD), as defined by the Independent Review Committee (IRC), or death due to any cause. The IRC defined PD per Response Evaluation Criteria in Solid Tumors (RECIST), Version 1. Per RECIST, PD is defined as a \>=20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of \>=1 new lesion.
Analysis population: Intent-to-Treat (ITT) Population. Analysis was based on the assigned randomized treatment, not on the actual treatment received/not received. Participants who had neither progressed nor died were censored at the date of the last adequate tumor assessment at the time of the cut-off.
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
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Pazopanib 800 mg | 8.4 | Not reported | 8.3 | 10.9 | Not reported |
| Sunitinib 50 mg | 9.5 | Not reported | 8.3 | 11.1 | Not reported |
Source statistical analyses
- ci Lower Limit
- 0.8982
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.2195
- estimate Comment
- The HR is estimated by the Cox regression model using treatment stratification factors as covariates. The HR is adjusted for Karnofsky Performance Scale scores, prior nephrectomy, and Baseline levels of lactate dehydrogenase (\<=1.5xULN, \>1.5xULN).
- group Ids
- OG000
- OG001
- non Inferiority Comment
- Non-inferiority is defined as excluding a difference of greater than 25% in the hazards. The upper limit of the 95% confidence interval must be \<1.25.
- non Inferiority Type
- NON_INFERIORITY_OR_EQUIVALENCE_LEGACY
- param Type
- Hazard Ratio (HR)
- param Value
- 1.0466
Complete source fields
- analyses
- ci Lower Limit
- 0.8982
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.2195
- estimate Comment
- The HR is estimated by the Cox regression model using treatment stratification factors as covariates. The HR is adjusted for Karnofsky Performance Scale scores, prior nephrectomy, and Baseline levels of lactate dehydrogenase (\<=1.5xULN, \>1.5xULN).
- group Ids
- OG000
- OG001
- non Inferiority Comment
- Non-inferiority is defined as excluding a difference of greater than 25% in the hazards. The upper limit of the 95% confidence interval must be \<1.25.
- non Inferiority Type
- NON_INFERIORITY_OR_EQUIVALENCE_LEGACY
- param Type
- Hazard Ratio (HR)
- param Value
- 1.0466
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 8.3
- upper Limit
- 10.9
- value
- 8.4
- group Id
- OG001
- lower Limit
- 8.3
- upper Limit
- 11.1
- value
- 9.5
- denoms
- counts
- group Id
- OG000
- value
- 557
- group Id
- OG001
- value
- 553
- units
- Participants
- description
- PFS was defined as the interval between the date of randomization and the earliest date of progressive disease (PD), as defined by the Independent Review Committee (IRC), or death due to any cause. The IRC defined PD per Response Evaluation Criteria in Solid Tumors (RECIST), Version 1. Per RECIST, PD is defined as a \>=20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of \>=1 new lesion.
- dispersion Type
- 95% Confidence Interval
- 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
- MEDIAN
- population Description
- Intent-to-Treat (ITT) Population. Analysis was based on the assigned randomized treatment, not on the actual treatment received/not received. Participants who had neither progressed nor died were censored at the date of the last adequate tumor assessment at the time of the cut-off.
- reporting Status
- POSTED
- time Frame
- From randomization until the earliest date of disease progression or date of death from any cause, assessed up to approximately 39 months
- title
- Progression-free Survival (PFS)
- type
- PRIMARY
- unit Of Measure
- Months
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Preserved source evidence · Not medical advice