TriangleNCT02485691 · OUTCOME
Number of Symptomatic Skeletal Events (SSE)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- events
- Interval / dispersion
- Not reported
- Time frame
- Baseline until occurrence of first SSE or data cut-off, whichever comes first (maximum duration: up to 141 weeks)
What was measured
SSE was defined as occurrence of a new symptomatic pathological fracture, use of external beam radiation to relieve bone pain, occurrence of spinal cord compression or tumor- related orthopedic surgical intervention.
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 | 24 | Not reported | Not reported | Not reported | Not reported |
| Abiraterone Acetate or Enzalutamide | 35 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 24
- group Id
- OG001
- value
- 35
- denoms
- counts
- group Id
- OG000
- value
- 129
- group Id
- OG001
- value
- 126
- units
- Participants
- description
- SSE was defined as occurrence of a new symptomatic pathological fracture, use of external beam radiation to relieve bone pain, occurrence of spinal cord compression or tumor- related orthopedic surgical intervention.
- 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
- NUMBER
- population Description
- Analysis was performed on ITT population.
- reporting Status
- POSTED
- time Frame
- Baseline until occurrence of first SSE or data cut-off, whichever comes first (maximum duration: up to 141 weeks)
- title
- Number of Symptomatic Skeletal Events (SSE)
- type
- SECONDARY
- unit Of Measure
- events
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice