TriangleNCT01308567 · OUTCOME
Skeletal Related Events (SRE) Free Survival
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
- Baseline until occurrence of first SRE or death (maximum duration: 51 months)
What was measured
SRE free survival was defined as the time interval between the date of randomization and the date of the occurrence of the first event defining a SRE or death due to any cause, whichever was earlier. SRE were assessed by clinical evaluation. Occurrence of SRE was defined as: pathological fracture(s) and/or spinal cord compression; need for bone irradiation, including radioisotopes or bone surgery; and change of antineoplastic therapy (including introduction of bisphosphonates or denosumab in the setting of increased pain) to treat bone pain. Analysis was performed by Kaplan-Meier method.
Analysis population: Analysis was performed on ITT population which included all randomized participants.
Groups in this outcome
Docetaxel 75 mg/m^2
Docetaxel (TXT) 75 mg/m\^2 IV infusion on Day 1 of each 21-day cycle in combination with Prednisone 10 mg orally, once daily until DP, unacceptable toxicity or participant's refusal.
Cabazitaxel 20 mg/m^2
Cabazitaxel 20 mg/m\^2 IV infusion on Day 1 of each 21 -day cycle in combination with Prednisone 10 mg orally, once daily until DP, unacceptable toxicity or participant's refusal.
Cabazitaxel 25 mg/m^2
Cabazitaxel 25 mg/m\^2 IV infusion on Day 1 of each 21-day cycle in combination with Prednisone 10 mg orally, once daily until DP, unacceptable toxicity or participant's refusal.
| Group | Source count |
|---|---|
| Docetaxel 75 mg/m^2 | 391 |
| Cabazitaxel 20 mg/m^2 | 389 |
| Cabazitaxel 25 mg/m^2 | 388 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Docetaxel 75 mg/m^2 | 19.0 | Not reported | 15.24 | 22.44 | Not reported |
| Cabazitaxel 20 mg/m^2 | 19.2 | Not reported | 15.21 | 24.61 | Not reported |
| Cabazitaxel 25 mg/m^2 | 17.1 | Not reported | 14.59 | 20.50 | Not reported |
Source statistical analyses
- ci Lower Limit
- 0.886
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.417
- estimate Comment
- Cabazitaxel 25 mg/m\^2 vs Docetaxel 75 mg/m\^2
- group Description
- Hazard ratio was estimated using a Cox Proportional Hazards regression model. The Cox proportional hazard model was adjusted by ECOG PS score at baseline, measurable disease at baseline, and region with commercial availability of cabazitaxel at the time of randomization.
- group Ids
- OG000
- OG002
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- param Type
- Hazard Ratio (HR)
- param Value
- 1.121
- ci Lower Limit
- 0.798
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.288
- estimate Comment
- Cabazitaxel 20 mg/m\^2 vs Docetaxel 75 mg/m\^2
- group Description
- Hazard ratio was estimated using a Cox Proportional Hazards regression model. The Cox proportional hazard model was adjusted by ECOG PS score at baseline, measurable disease at baseline, and region with commercial availability of cabazitaxel at the time of randomization.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- param Type
- Hazard Ratio (HR)
- param Value
- 1.014
Complete source fields
- analyses
- ci Lower Limit
- 0.886
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.417
- estimate Comment
- Cabazitaxel 25 mg/m\^2 vs Docetaxel 75 mg/m\^2
- group Description
- Hazard ratio was estimated using a Cox Proportional Hazards regression model. The Cox proportional hazard model was adjusted by ECOG PS score at baseline, measurable disease at baseline, and region with commercial availability of cabazitaxel at the time of randomization.
- group Ids
- OG000
- OG002
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- param Type
- Hazard Ratio (HR)
- param Value
- 1.121
- ci Lower Limit
- 0.798
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.288
- estimate Comment
- Cabazitaxel 20 mg/m\^2 vs Docetaxel 75 mg/m\^2
- group Description
- Hazard ratio was estimated using a Cox Proportional Hazards regression model. The Cox proportional hazard model was adjusted by ECOG PS score at baseline, measurable disease at baseline, and region with commercial availability of cabazitaxel at the time of randomization.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- param Type
- Hazard Ratio (HR)
- param Value
- 1.014
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 15.24
- upper Limit
- 22.44
- value
- 19.0
- group Id
- OG001
- lower Limit
- 15.21
- upper Limit
- 24.61
- value
- 19.2
- group Id
- OG002
- lower Limit
- 14.59
- upper Limit
- 20.50
- value
- 17.1
- denoms
- counts
- group Id
- OG000
- value
- 391
- group Id
- OG001
- value
- 389
- group Id
- OG002
- value
- 388
- units
- Participants
- description
- SRE free survival was defined as the time interval between the date of randomization and the date of the occurrence of the first event defining a SRE or death due to any cause, whichever was earlier. SRE were assessed by clinical evaluation. Occurrence of SRE was defined as: pathological fracture(s) and/or spinal cord compression; need for bone irradiation, including radioisotopes or bone surgery; and change of antineoplastic therapy (including introduction of bisphosphonates or denosumab in the setting of increased pain) to treat bone pain. Analysis was performed by Kaplan-Meier method.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Docetaxel (TXT) 75 mg/m\^2 IV infusion on Day 1 of each 21-day cycle in combination with Prednisone 10 mg orally, once daily until DP, unacceptable toxicity or participant's refusal.
- id
- OG000
- title
- Docetaxel 75 mg/m^2
- description
- Cabazitaxel 20 mg/m\^2 IV infusion on Day 1 of each 21 -day cycle in combination with Prednisone 10 mg orally, once daily until DP, unacceptable toxicity or participant's refusal.
- id
- OG001
- title
- Cabazitaxel 20 mg/m^2
- description
- Cabazitaxel 25 mg/m\^2 IV infusion on Day 1 of each 21-day cycle in combination with Prednisone 10 mg orally, once daily until DP, unacceptable toxicity or participant's refusal.
- id
- OG002
- title
- Cabazitaxel 25 mg/m^2
- param Type
- MEDIAN
- population Description
- Analysis was performed on ITT population which included all randomized participants.
- reporting Status
- POSTED
- time Frame
- Baseline until occurrence of first SRE or death (maximum duration: 51 months)
- title
- Skeletal Related Events (SRE) Free Survival
- type
- SECONDARY
- unit Of Measure
- months
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Preserved source evidence · Not medical advice