TriangleNCT00128102 · 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
- Weeks
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Up to ~72 months (through pre-specified final statistical analysis cut-off date of 15-July-2011)
What was measured
OS was defined as the time from randomization to death due to any cause. Participants without documented death at the time of final analysis were censored at the date of the last follow up. The final analysis for OS was planned and performed at the time of the protocol pre-specified final statistical analysis with a data cut-off of 15-July-2011. OS analysis is reported here for all randomized participants.
Analysis population: All participants randomized to a study arm.
Groups in this outcome
Vorinostat
Vorinostat three 100 mg capsules twice daily for 3 consecutive days of treatment followed by 4 days of rest repeated weekly, in 21-day cycles. Treatment continued until disease progression or unacceptable toxicity.
Placebo
Placebo capsules twice daily for 3 consecutive days of treatment followed by 4 days of rest repeated weekly, in 21-day cycles. Treatment continued until disease progression or unacceptable toxicity.
| Group | Source count |
|---|---|
| Vorinostat | 329 |
| Placebo | 332 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Vorinostat | 30.7 | Not reported | 26.71 | 36.14 | Not reported |
| Placebo | 27.1 | Not reported | 23.14 | 31.86 | Not reported |
Source statistical analyses
- ci Lower Limit
- 0.83
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.17
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.858
- param Type
- Hazard Ratio (HR)
- param Value
- 0.98
- statistical Method
- Log Rank
Complete source fields
- analyses
- ci Lower Limit
- 0.83
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.17
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.858
- param Type
- Hazard Ratio (HR)
- param Value
- 0.98
- statistical Method
- Log Rank
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 26.71
- upper Limit
- 36.14
- value
- 30.7
- group Id
- OG001
- lower Limit
- 23.14
- upper Limit
- 31.86
- value
- 27.1
- denoms
- counts
- group Id
- OG000
- value
- 329
- group Id
- OG001
- value
- 332
- units
- Participants
- description
- OS was defined as the time from randomization to death due to any cause. Participants without documented death at the time of final analysis were censored at the date of the last follow up. The final analysis for OS was planned and performed at the time of the protocol pre-specified final statistical analysis with a data cut-off of 15-July-2011. OS analysis is reported here for all randomized participants.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Vorinostat three 100 mg capsules twice daily for 3 consecutive days of treatment followed by 4 days of rest repeated weekly, in 21-day cycles. Treatment continued until disease progression or unacceptable toxicity.
- id
- OG000
- title
- Vorinostat
- description
- Placebo capsules twice daily for 3 consecutive days of treatment followed by 4 days of rest repeated weekly, in 21-day cycles. Treatment continued until disease progression or unacceptable toxicity.
- id
- OG001
- title
- Placebo
- param Type
- MEDIAN
- population Description
- All participants randomized to a study arm.
- reporting Status
- POSTED
- time Frame
- Up to ~72 months (through pre-specified final statistical analysis cut-off date of 15-July-2011)
- title
- Overall Survival (OS)
- type
- PRIMARY
- unit Of Measure
- Weeks
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice