TriangleNCT00375674 · OUTCOME
DFS- Assessed by the Investigator [Stratified by University of California Los Angeles Integrated Staging System (UISS) High Risk Group-Intent to Treat Population]
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- Number of years
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Every 12 weeks during the first 3 years and every 6 months after that unless the participant had withdrawn consent. Performed 5 years after LSLV or when approximately 258 events survival status, whichever was later
What was measured
DFS was defined as the time interval (in years) from the date of randomization to the first date of recurrence or occurrence of a secondary malignancy or death. Recurrence refers to relapse of the primary tumor in-situ or at metastatic sites. Date of recurrence or occurrence: The date of the recurrence or occurrence of a secondary malignancy for the first time, either by BICR or investigator assessment for the respective analyses. Participants were followed with tumor imaging for recurrence or occurrence of a secondary malignancy for the remainder of the follow-up period unless the participants had withdrawn consent. According to the statistical analysis plan there are two cohorts: 1.Global Cohort: primary analysis of DFS was performed approximately 5 years after last participant in the Global Cohort is randomized; 2. China Cohort: primary analysis of DFS was performed approximately 3 years after the last participant in China Cohort was randomized.
Analysis population: ITT population included all participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug or received a different drug from that to which they were randomized.
Groups in this outcome
Sunitinib
Participants received Sunitinib on 9 6-week cycles on 4/2 dosing schedule: 4 weeks on, 2 weeks off.
Placebo
Participants received Placebo on 9 6-week cycles with 4/2 dosing schedule: 4 weeks on, 2 weeks off.
| Group | Source count |
|---|---|
| Sunitinib | 309 |
| Placebo | 306 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Sunitinib | 6.5 | Not reported | 4.7 | 7.0 | Not reported |
| Placebo | 4.5 | Not reported | 3.8 | 5.9 | Not reported |
Source statistical analyses
- ci Lower Limit
- 0.643
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.023
- group Description
- Superiority analysis
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.077
- param Type
- Cox Proportional Hazard
- param Value
- 0.811
- statistical Comment
- Based on the Cox Proportional hazards model stratified by UISS High-Risk Group
- statistical Method
- Cox Proportional hazards model
Complete source fields
- analyses
- ci Lower Limit
- 0.643
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.023
- group Description
- Superiority analysis
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.077
- param Type
- Cox Proportional Hazard
- param Value
- 0.811
- statistical Comment
- Based on the Cox Proportional hazards model stratified by UISS High-Risk Group
- statistical Method
- Cox Proportional hazards model
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 4.7
- upper Limit
- 7.0
- value
- 6.5
- group Id
- OG001
- lower Limit
- 3.8
- upper Limit
- 5.9
- value
- 4.5
- denoms
- counts
- group Id
- OG000
- value
- 309
- group Id
- OG001
- value
- 306
- units
- Participants
- description
- DFS was defined as the time interval (in years) from the date of randomization to the first date of recurrence or occurrence of a secondary malignancy or death. Recurrence refers to relapse of the primary tumor in-situ or at metastatic sites. Date of recurrence or occurrence: The date of the recurrence or occurrence of a secondary malignancy for the first time, either by BICR or investigator assessment for the respective analyses. Participants were followed with tumor imaging for recurrence or occurrence of a secondary malignancy for the remainder of the follow-up period unless the participants had withdrawn consent. According to the statistical analysis plan there are two cohorts: 1.Global Cohort: primary analysis of DFS was performed approximately 5 years after last participant in the Global Cohort is randomized; 2. China Cohort: primary analysis of DFS was performed approximately 3 years after the last participant in China Cohort was randomized.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants received Sunitinib on 9 6-week cycles on 4/2 dosing schedule: 4 weeks on, 2 weeks off.
- id
- OG000
- title
- Sunitinib
- description
- Participants received Placebo on 9 6-week cycles with 4/2 dosing schedule: 4 weeks on, 2 weeks off.
- id
- OG001
- title
- Placebo
- param Type
- MEDIAN
- population Description
- ITT population included all participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug or received a different drug from that to which they were randomized.
- reporting Status
- POSTED
- time Frame
- Every 12 weeks during the first 3 years and every 6 months after that unless the participant had withdrawn consent. Performed 5 years after LSLV or when approximately 258 events survival status, whichever was later
- title
- DFS- Assessed by the Investigator [Stratified by University of California Los Angeles Integrated Staging System (UISS) High Risk Group-Intent to Treat Population]
- type
- PRIMARY
- unit Of Measure
- Number of years
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Preserved source evidence · Not medical advice