TriangleNCT00375674 · OUTCOME
Overall Survival (OS)- (Stratified by 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
- Year
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Every 12 weeks until the time for final analysis (up to data cut-off date: 30 April 2017; maximum exposure:14.9 months)
What was measured
OS was defined as the time from the date of randomization to the date of death due to any cause.
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 | NA | Not reported | NA | NA | Data was not estimable due to small number of participants with an event. |
| Placebo | NA | Not reported | NA | NA | Data was not estimable due to small number of participants with an event. |
Source statistical analyses
- ci Lower Limit
- 0.670
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.289
- group Description
- Hazard ratio was based on the Cox Proportional hazards model stratified by UISS High-Risk Group.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.661
- param Type
- Hazard Ratio (HR)
- param Value
- 0.929
- statistical Method
- Log-rank test
Complete source fields
- analyses
- ci Lower Limit
- 0.670
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.289
- group Description
- Hazard ratio was based on the Cox Proportional hazards model stratified by UISS High-Risk Group.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.661
- param Type
- Hazard Ratio (HR)
- param Value
- 0.929
- statistical Method
- Log-rank test
- classes
- categories
- measurements
- comment
- Data was not estimable due to small number of participants with an event.
- group Id
- OG000
- lower Limit
- NA
- upper Limit
- NA
- value
- NA
- comment
- Data was not estimable due to small number of participants with an event.
- group Id
- OG001
- lower Limit
- NA
- upper Limit
- NA
- value
- NA
- denoms
- counts
- group Id
- OG000
- value
- 309
- group Id
- OG001
- value
- 306
- units
- Participants
- description
- OS was defined as the time from the date of randomization to the date of death due to any cause.
- 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 until the time for final analysis (up to data cut-off date: 30 April 2017; maximum exposure:14.9 months)
- title
- Overall Survival (OS)- (Stratified by UISS High Risk Group-Intent to Treat Population)
- type
- SECONDARY
- unit Of Measure
- Year
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice