TriangleNCT01715285 · 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 66 months
What was measured
Overall survival was defined as the time from randomization to date of death from any cause.
Analysis population: ITT analysis set included all subjects randomized into the study and who were classified according to their assigned treatment group, regardless of the actual treatment received.
Groups in this outcome
Abiraterone Acetate+Prednisone+ADT
Participants received abiraterone acetate tablet at a total dose of 1000 milligram (mg) plus 5 mg capsule of prednisone orally once daily until disease progression, withdrawal of consent or unacceptable toxicity. Stable regimen of androgen deprivation therapy (ADT) was administered.
Placebo + ADT
Participants received placebo matched to abiraterone acetate plus prednisone orally once daily until disease progression, withdrawal of consent or unacceptable toxicity. Stable regimen of ADT was administered.
| Group | Source count |
|---|---|
| Abiraterone Acetate+Prednisone+ADT | 597 |
| Placebo + ADT | 602 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Abiraterone Acetate+Prednisone+ADT | 53.32 | Not reported | 48.23 | NA | Here 'NA' represents that upper limit of 95% CI was not estimable due to lesser number of events. |
| Placebo + ADT | 36.53 | Not reported | 33.54 | 39.95 | Not reported |
Source statistical analyses
- ci Lower Limit
- 0.564
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.775
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- < 0.0001
- param Type
- Hazard Ratio (HR)
- param Value
- 0.661
- statistical Method
- Log Rank
Complete source fields
- analyses
- ci Lower Limit
- 0.564
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.775
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- < 0.0001
- param Type
- Hazard Ratio (HR)
- param Value
- 0.661
- statistical Method
- Log Rank
- classes
- categories
- measurements
- comment
- Here 'NA' represents that upper limit of 95% CI was not estimable due to lesser number of events.
- group Id
- OG000
- lower Limit
- 48.23
- upper Limit
- NA
- value
- 53.32
- group Id
- OG001
- lower Limit
- 33.54
- upper Limit
- 39.95
- value
- 36.53
- denoms
- counts
- group Id
- OG000
- value
- 597
- group Id
- OG001
- value
- 602
- units
- Participants
- description
- Overall survival was defined as the time from randomization to date of death from any cause.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants received abiraterone acetate tablet at a total dose of 1000 milligram (mg) plus 5 mg capsule of prednisone orally once daily until disease progression, withdrawal of consent or unacceptable toxicity. Stable regimen of androgen deprivation therapy (ADT) was administered.
- id
- OG000
- title
- Abiraterone Acetate+Prednisone+ADT
- description
- Participants received placebo matched to abiraterone acetate plus prednisone orally once daily until disease progression, withdrawal of consent or unacceptable toxicity. Stable regimen of ADT was administered.
- id
- OG001
- title
- Placebo + ADT
- param Type
- MEDIAN
- population Description
- ITT analysis set included all subjects randomized into the study and who were classified according to their assigned treatment group, regardless of the actual treatment received.
- reporting Status
- POSTED
- time Frame
- Up to 66 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