TriangleNCT01308567 · 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
- Baseline up to death or study cut-off date, whichever was earlier (maximum duration: 51 months )
What was measured
OS was defined as the time interval from the date of randomization to the date of death due to any cause. In the absence of confirmation of death, survival time was censored at the last date participant was known to be alive, or at the cut-off date if the participant's last contact was after the cut-off date. The study cut-off date for the final analysis of OS was the date when the 774th death had been observed. Analysis was performed by Kaplan-Meier method.
Analysis population: ITT population 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 | 24.3 | Not reported | 22.18 | 27.60 | Not reported |
| Cabazitaxel 20 mg/m^2 | 24.5 | Not reported | 21.75 | 27.20 | Not reported |
| Cabazitaxel 25 mg/m^2 | 25.2 | Not reported | 22.90 | 26.97 | Not reported |
Source statistical analyses
- ci Lower Limit
- 0.819
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.16
- 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 Eastern Cooperative Oncology Group performance status (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
- p Value
- 0.7574
- p Value Comment
- P-value from two-sided stratified log-rank test, stratified for ECOG PS score at baseline, measurable disease at baseline and region with commercial availability of cabazitaxel at time of randomization. Threshold for statistical significance = 0.0479
- param Type
- Hazard Ratio (HR)
- param Value
- 0.975
- statistical Method
- Log Rank
- ci Lower Limit
- 0.85
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.197
- 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
- p Value
- 0.9967
- p Value Comment
- P-value from two-sided stratified log-rank test, stratified for ECOG PS score at baseline, measurable disease at baseline and region with commercial availability of cabazitaxel at time of randomization. Threshold for statistical significance = 0.0479
- param Type
- Hazard Ratio (HR)
- param Value
- 1.009
- statistical Method
- Log Rank
Complete source fields
- analyses
- ci Lower Limit
- 0.819
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.16
- 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 Eastern Cooperative Oncology Group performance status (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
- p Value
- 0.7574
- p Value Comment
- P-value from two-sided stratified log-rank test, stratified for ECOG PS score at baseline, measurable disease at baseline and region with commercial availability of cabazitaxel at time of randomization. Threshold for statistical significance = 0.0479
- param Type
- Hazard Ratio (HR)
- param Value
- 0.975
- statistical Method
- Log Rank
- ci Lower Limit
- 0.85
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.197
- 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
- p Value
- 0.9967
- p Value Comment
- P-value from two-sided stratified log-rank test, stratified for ECOG PS score at baseline, measurable disease at baseline and region with commercial availability of cabazitaxel at time of randomization. Threshold for statistical significance = 0.0479
- param Type
- Hazard Ratio (HR)
- param Value
- 1.009
- statistical Method
- Log Rank
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 22.18
- upper Limit
- 27.60
- value
- 24.3
- group Id
- OG001
- lower Limit
- 21.75
- upper Limit
- 27.20
- value
- 24.5
- group Id
- OG002
- lower Limit
- 22.90
- upper Limit
- 26.97
- value
- 25.2
- denoms
- counts
- group Id
- OG000
- value
- 391
- group Id
- OG001
- value
- 389
- group Id
- OG002
- value
- 388
- units
- Participants
- description
- OS was defined as the time interval from the date of randomization to the date of death due to any cause. In the absence of confirmation of death, survival time was censored at the last date participant was known to be alive, or at the cut-off date if the participant's last contact was after the cut-off date. The study cut-off date for the final analysis of OS was the date when the 774th death had been observed. 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
- ITT population included all randomized participants.
- reporting Status
- POSTED
- time Frame
- Baseline up to death or study cut-off date, whichever was earlier (maximum duration: 51 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