TriangleNCT01908426 · OUTCOME
Overall Survival (OS)
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
- Up to 45 months
What was measured
The primary analysis of OS is defined as the time from randomization to death from any cause. The analysis was based on a second planned interim analysis prespecified to be performed at approximately the 75% information fraction (ie, at approximately 466 deaths). The data cutoff date for this event-driven analysis in the Intent to Treat (ITT) population was 01 June 2017. Median OS was calculated using the Kaplan-Meier estimates.
Analysis population: The ITT population was used and included 707 randomized subjects (470 cabozantinib, 237 placebo) in the second interim analysis with a cutoff date of 01 June 2017.
Groups in this outcome
Cabozantinib (XL184)
Cabozantinib (XL184) 60 mg tablet once daily Cabozantinib tablets
Placebo
Oral cabozantinib-matched placebo tablet once daily Placebo tablets
| Group | Source count |
|---|---|
| Cabozantinib (XL184) | 470 |
| Placebo | 237 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cabozantinib (XL184) | 10.2 | Not reported | 9.1 | 12.0 | Not reported |
| Placebo | 8.0 | Not reported | 6.8 | 9.4 | Not reported |
Source statistical analyses
- ci Lower Limit
- 0.63
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.92
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.0049
- param Type
- Hazard Ratio (HR)
- param Value
- 0.76
- statistical Comment
- The Log-Rank Test was stratified by etiology of disease, geo. region, presence of extrahepatic spread of disease and/or macrovascular invasion.
- statistical Method
- Log Rank
Complete source fields
- analyses
- ci Lower Limit
- 0.63
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.92
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.0049
- param Type
- Hazard Ratio (HR)
- param Value
- 0.76
- statistical Comment
- The Log-Rank Test was stratified by etiology of disease, geo. region, presence of extrahepatic spread of disease and/or macrovascular invasion.
- statistical Method
- Log Rank
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 9.1
- upper Limit
- 12.0
- value
- 10.2
- group Id
- OG001
- lower Limit
- 6.8
- upper Limit
- 9.4
- value
- 8.0
- denoms
- counts
- group Id
- OG000
- value
- 470
- group Id
- OG001
- value
- 237
- units
- Participants
- description
- The primary analysis of OS is defined as the time from randomization to death from any cause. The analysis was based on a second planned interim analysis prespecified to be performed at approximately the 75% information fraction (ie, at approximately 466 deaths). The data cutoff date for this event-driven analysis in the Intent to Treat (ITT) population was 01 June 2017. Median OS was calculated using the Kaplan-Meier estimates.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Cabozantinib (XL184) 60 mg tablet once daily Cabozantinib tablets
- id
- OG000
- title
- Cabozantinib (XL184)
- description
- Oral cabozantinib-matched placebo tablet once daily Placebo tablets
- id
- OG001
- title
- Placebo
- param Type
- MEDIAN
- population Description
- The ITT population was used and included 707 randomized subjects (470 cabozantinib, 237 placebo) in the second interim analysis with a cutoff date of 01 June 2017.
- reporting Status
- POSTED
- time Frame
- Up to 45 months
- title
- Overall Survival (OS)
- type
- PRIMARY
- unit Of Measure
- months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice