TriangleNCT01524783 · 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
- From date of randomization to date of death, assessed up to approximately 8 years
What was measured
OS is defined as the time from the date of randomization to date of death due to any cause. If a death had not been observed by the date of analysis cut-off, then OS was censored at the date of last contact. All participants randomized to placebo arm who crossed over to everolimus were censored.
Analysis population: The full analysis set (FAS) consists of all randomized patients. Following the intent-to-treat principle, patients were analyzed according to the treatment arm and stratification factors they were assigned to at randomization.
Groups in this outcome
Everolimus + BSC
Participants received everolimus 10 mg once daily BSC throughout the study
Placebo + BSC
Participants received matching placebo once daily plus BSC during the blinded period. Participants were allowed to crossover to treatment with everolimus 10mg once daily plus BSC during the open-label period
| Group | Source count |
|---|---|
| Everolimus + BSC | 205 |
| Placebo + BSC | 97 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Everolimus + BSC | 43.1 | Not reported | 36.27 | 54.24 | Not reported |
| Placebo + BSC | 41.76 | Not reported | 23.46 | 53.75 | Not reported |
Source statistical analyses
- ci Lower Limit
- 0.66
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.24
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER_LEGACY
- p Value
- 0.259
- param Type
- Hazard Ratio (HR)
- param Value
- 0.90
- statistical Method
- Log Rank
Complete source fields
- analyses
- ci Lower Limit
- 0.66
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.24
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER_LEGACY
- p Value
- 0.259
- param Type
- Hazard Ratio (HR)
- param Value
- 0.90
- statistical Method
- Log Rank
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 36.27
- upper Limit
- 54.24
- value
- 43.1
- group Id
- OG001
- lower Limit
- 23.46
- upper Limit
- 53.75
- value
- 41.76
- denoms
- counts
- group Id
- OG000
- value
- 205
- group Id
- OG001
- value
- 97
- units
- Participants
- description
- OS is defined as the time from the date of randomization to date of death due to any cause. If a death had not been observed by the date of analysis cut-off, then OS was censored at the date of last contact. All participants randomized to placebo arm who crossed over to everolimus were censored.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants received everolimus 10 mg once daily BSC throughout the study
- id
- OG000
- title
- Everolimus + BSC
- description
- Participants received matching placebo once daily plus BSC during the blinded period. Participants were allowed to crossover to treatment with everolimus 10mg once daily plus BSC during the open-label period
- id
- OG001
- title
- Placebo + BSC
- param Type
- MEDIAN
- population Description
- The full analysis set (FAS) consists of all randomized patients. Following the intent-to-treat principle, patients were analyzed according to the treatment arm and stratification factors they were assigned to at randomization.
- reporting Status
- POSTED
- time Frame
- From date of randomization to date of death, assessed up to approximately 8 years
- title
- Overall Survival (OS)
- type
- SECONDARY
- unit Of Measure
- Months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice