TriangleNCT01865747 · OUTCOME
Overall Survival (OS)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- months
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- OS was measured from the time of randomization until 320 deaths, approximately 28 months
What was measured
Overall Survival (OS) is defined as the time from randomization to the date of death. Participants that had not died were censored at last known date alive. Median OS was calculated using Kaplan-Meier estimates. Interim analyses for OS occurred after 320 deaths (78% of the total OS events needed for final analysis).
Analysis population: The Intent to Treat (ITT) population was used and included 658 randomized subjects (330 cabozantinib, 328 everolimus) in the second interim analysis with a cutoff date of 31 December 2015.
Groups in this outcome
Cabozantinib (XL184)
Cabozantinib (XL184) 60 mg tablet once daily. Cabozantinib tablets
Everolimus (Afinitor)
Everolimus (Afinitor) 10 mg tablet once daily. Everolimus (Afinitor) tablets
| Group | Source count |
|---|---|
| Cabozantinib (XL184) | 330 |
| Everolimus (Afinitor) | 228 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cabozantinib (XL184) | 21.4 | Not reported | 18.7 | NA | Too few events to estimate the upper limit of the confidence interval. |
| Everolimus (Afinitor) | 16.5 | Not reported | 14.7 | 18.8 | Not reported |
Source statistical analyses
- ci Lower Limit
- 0.53
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.83
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.0003
- param Type
- Hazard Ratio (HR)
- param Value
- 0.66
- statistical Comment
- The Log-Rank test was stratified by the Memorial Sloan-Kettering Cancer Center (MSKCC) risk group and number of prior VEGFR TKIs.
- statistical Method
- Log Rank
Complete source fields
- analyses
- ci Lower Limit
- 0.53
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.83
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.0003
- param Type
- Hazard Ratio (HR)
- param Value
- 0.66
- statistical Comment
- The Log-Rank test was stratified by the Memorial Sloan-Kettering Cancer Center (MSKCC) risk group and number of prior VEGFR TKIs.
- statistical Method
- Log Rank
- classes
- categories
- measurements
- comment
- Too few events to estimate the upper limit of the confidence interval.
- group Id
- OG000
- lower Limit
- 18.7
- upper Limit
- NA
- value
- 21.4
- group Id
- OG001
- lower Limit
- 14.7
- upper Limit
- 18.8
- value
- 16.5
- denoms
- counts
- group Id
- OG000
- value
- 330
- group Id
- OG001
- value
- 228
- units
- Participants
- description
- Overall Survival (OS) is defined as the time from randomization to the date of death. Participants that had not died were censored at last known date alive. Median OS was calculated using Kaplan-Meier estimates. Interim analyses for OS occurred after 320 deaths (78% of the total OS events needed for final analysis).
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Cabozantinib (XL184) 60 mg tablet once daily. Cabozantinib tablets
- id
- OG000
- title
- Cabozantinib (XL184)
- description
- Everolimus (Afinitor) 10 mg tablet once daily. Everolimus (Afinitor) tablets
- id
- OG001
- title
- Everolimus (Afinitor)
- param Type
- NUMBER
- population Description
- The Intent to Treat (ITT) population was used and included 658 randomized subjects (330 cabozantinib, 328 everolimus) in the second interim analysis with a cutoff date of 31 December 2015.
- reporting Status
- POSTED
- time Frame
- OS was measured from the time of randomization until 320 deaths, approximately 28 months
- title
- Overall Survival (OS)
- type
- SECONDARY
- unit Of Measure
- months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice