TriangleNCT01715285 · OUTCOME
Time to Skeletal-Related Event
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
Time to skeletal-related event was defined as the earliest of the following: clinical or pathological fracture, spinal cord compression, palliative radiation to bone, or surgery to bone.
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 | NA | Not reported | NA | NA | Here 'NA' represents that median, upper limit and lower limit of 95% CI was not estimable due to lesser number of events. |
| Placebo + ADT | NA | Not reported | NA | NA | Here 'NA' represents that median, upper limit and lower limit of 95% CI was not estimable due to lesser number of events. |
Complete source fields
- classes
- categories
- measurements
- comment
- Here 'NA' represents that median, upper limit and lower limit of 95% CI was not estimable due to lesser number of events.
- group Id
- OG000
- lower Limit
- NA
- upper Limit
- NA
- value
- NA
- comment
- Here 'NA' represents that median, upper limit and lower limit of 95% CI was not estimable due to lesser number of events.
- group Id
- OG001
- lower Limit
- NA
- upper Limit
- NA
- value
- NA
- denoms
- counts
- group Id
- OG000
- value
- 597
- group Id
- OG001
- value
- 602
- units
- Participants
- description
- Time to skeletal-related event was defined as the earliest of the following: clinical or pathological fracture, spinal cord compression, palliative radiation to bone, or surgery to bone.
- 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
- Time to Skeletal-Related Event
- type
- SECONDARY
- unit Of Measure
- months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice