TriangleNCT02485691 · OUTCOME
Time to Symptomatic Skeletal 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
- From date of randomization until first SSE, or data cut-off whichever comes first (maximum duration: up to 141 weeks)
What was measured
Time to SSE was defined as the time duration (in months) between the date of randomization and the date of occurrence of the first SSE. Analysis was performed by Kaplan-Meier method.
Analysis population: Analysis was performed on ITT population.
Groups in this outcome
Cabazitaxel
Participants received Cabazitaxel 25 mg/m\^2 IV infusion for over 1 hour on Day 1 of each 3 week treatment cycle in combination with Prednisone 10 mg orally once daily and primary prophylactic G-CSF as per investigator decision, until radiographic disease progression, unacceptable toxicity, or participant's refusal of further study treatment (median duration = 22 weeks).
Abiraterone Acetate or Enzalutamide
Participants received either abiraterone acetate 1000 mg orally once daily from Day 1 to Day 21 of each 3 week treatment cycle in combination with prednisone 5 mg orally twice daily; or enzalutamide 160 mg orally once daily continuously from Day 1 to Day 21 of each 3 week treatment cycle, until radiographic disease progression, unacceptable toxicity, or participant's refusal of further study treatment (median duration = 12.5 weeks).
| Group | Source count |
|---|---|
| Cabazitaxel | 129 |
| Abiraterone Acetate or Enzalutamide | 126 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cabazitaxel | NA | Not reported | 20.0 | NA | Median and upper limit of CI was not estimable because of low number of participants with events. |
| Abiraterone Acetate or Enzalutamide | 16.7 | Not reported | 10.8 | NA | Upper limit of CI was not estimable because of low number of participants with events. |
Complete source fields
- classes
- categories
- measurements
- comment
- Median and upper limit of CI was not estimable because of low number of participants with events.
- group Id
- OG000
- lower Limit
- 20.0
- upper Limit
- NA
- value
- NA
- comment
- Upper limit of CI was not estimable because of low number of participants with events.
- group Id
- OG001
- lower Limit
- 10.8
- upper Limit
- NA
- value
- 16.7
- denoms
- counts
- group Id
- OG000
- value
- 129
- group Id
- OG001
- value
- 126
- units
- Participants
- description
- Time to SSE was defined as the time duration (in months) between the date of randomization and the date of occurrence of the first SSE. Analysis was performed by Kaplan-Meier method.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants received Cabazitaxel 25 mg/m\^2 IV infusion for over 1 hour on Day 1 of each 3 week treatment cycle in combination with Prednisone 10 mg orally once daily and primary prophylactic G-CSF as per investigator decision, until radiographic disease progression, unacceptable toxicity, or participant's refusal of further study treatment (median duration = 22 weeks).
- id
- OG000
- title
- Cabazitaxel
- description
- Participants received either abiraterone acetate 1000 mg orally once daily from Day 1 to Day 21 of each 3 week treatment cycle in combination with prednisone 5 mg orally twice daily; or enzalutamide 160 mg orally once daily continuously from Day 1 to Day 21 of each 3 week treatment cycle, until radiographic disease progression, unacceptable toxicity, or participant's refusal of further study treatment (median duration = 12.5 weeks).
- id
- OG001
- title
- Abiraterone Acetate or Enzalutamide
- param Type
- MEDIAN
- population Description
- Analysis was performed on ITT population.
- reporting Status
- POSTED
- time Frame
- From date of randomization until first SSE, or data cut-off whichever comes first (maximum duration: up to 141 weeks)
- title
- Time to Symptomatic Skeletal Event
- type
- SECONDARY
- unit Of Measure
- months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice