TriangleNCT01308580 · OUTCOME
Time to Pain Progression
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 baseline until DP, start of another anti-cancer therapy, death or study cut-off date (maximum duration: 48 months)
What was measured
Pain Progression was defined as an increase of ≥1 point in the median PPI from its nadir confirmed by a second assessment at least 3 weeks later or ≥25 % increase in the mean AS compared with the baseline score confirmed by a second assessment at least 3 weeks later or requirement for local palliative radiotherapy. PPI was rated by participant in a diary using a scale of 0=no pain, 1=mild, 2=discomforting, 3=distressing, 4=horrible 5=excruciating. Analgesic use was recorded by the participant in a diary. AS was calculated from the analgesic use data based on a table of analgesic medications, with non-narcotic medications assigned a value of 1 point and narcotic medications assigned a value of 4 points. Analysis was performed by Kaplan-Meier method.
Analysis population: Analysis was performed on ITT population.
Groups in this outcome
Cabazitaxel 20 mg/m^2
Cabazitaxel 20 mg/m\^2 IV infusion over 1 hour on Day 1 of each 21-day cycle in combination with Prednisone (or Prednisolone) 10 mg orally daily until DP, unacceptable toxicity, participant's refusal of further study treatment or for a maximum of 10 cycles.
Cabazitaxel 25 mg/m^2
Cabazitaxel 25 mg/m\^2 IV infusion over 1 hour on Day 1 of each 21-day cycle in combination with Prednisone (or Prednisolone) 10 mg orally daily until DP, unacceptable toxicity, participant's refusal of further study treatment or for a maximum of 10 cycles.
| Group | Source count |
|---|---|
| Cabazitaxel 20 mg/m^2 | 598 |
| Cabazitaxel 25 mg/m^2 | 602 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cabazitaxel 20 mg/m^2 | 6.2 | Not reported | 5.22 | 7.39 | Not reported |
| Cabazitaxel 25 mg/m^2 | 6.4 | Not reported | 5.55 | 7.26 | Not reported |
Source statistical analyses
- ci Lower Limit
- 0.874
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.251
- estimate Comment
- Cabazitaxel 20 mg/m\^2 vs Cabazitaxel 25 mg/m\^2
- group Description
- Hazard ratio is estimated using a Cox Proportional Hazards regression model. The Cox proportional hazard model was adjusted by measurability of the disease at baseline, ECOG PS score at baseline, and region at the time of randomization.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- param Type
- Hazard Ratio (HR)
- param Value
- 1.046
Complete source fields
- analyses
- ci Lower Limit
- 0.874
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.251
- estimate Comment
- Cabazitaxel 20 mg/m\^2 vs Cabazitaxel 25 mg/m\^2
- group Description
- Hazard ratio is estimated using a Cox Proportional Hazards regression model. The Cox proportional hazard model was adjusted by measurability of the disease at baseline, ECOG PS score at baseline, and region at the time of randomization.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- param Type
- Hazard Ratio (HR)
- param Value
- 1.046
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 5.22
- upper Limit
- 7.39
- value
- 6.2
- group Id
- OG001
- lower Limit
- 5.55
- upper Limit
- 7.26
- value
- 6.4
- denoms
- counts
- group Id
- OG000
- value
- 598
- group Id
- OG001
- value
- 602
- units
- Participants
- description
- Pain Progression was defined as an increase of ≥1 point in the median PPI from its nadir confirmed by a second assessment at least 3 weeks later or ≥25 % increase in the mean AS compared with the baseline score confirmed by a second assessment at least 3 weeks later or requirement for local palliative radiotherapy. PPI was rated by participant in a diary using a scale of 0=no pain, 1=mild, 2=discomforting, 3=distressing, 4=horrible 5=excruciating. Analgesic use was recorded by the participant in a diary. AS was calculated from the analgesic use data based on a table of analgesic medications, with non-narcotic medications assigned a value of 1 point and narcotic medications assigned a value of 4 points. Analysis was performed by Kaplan-Meier method.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Cabazitaxel 20 mg/m\^2 IV infusion over 1 hour on Day 1 of each 21-day cycle in combination with Prednisone (or Prednisolone) 10 mg orally daily until DP, unacceptable toxicity, participant's refusal of further study treatment or for a maximum of 10 cycles.
- id
- OG000
- title
- Cabazitaxel 20 mg/m^2
- description
- Cabazitaxel 25 mg/m\^2 IV infusion over 1 hour on Day 1 of each 21-day cycle in combination with Prednisone (or Prednisolone) 10 mg orally daily until DP, unacceptable toxicity, participant's refusal of further study treatment or for a maximum of 10 cycles.
- id
- OG001
- title
- Cabazitaxel 25 mg/m^2
- param Type
- MEDIAN
- population Description
- Analysis was performed on ITT population.
- reporting Status
- POSTED
- time Frame
- From baseline until DP, start of another anti-cancer therapy, death or study cut-off date (maximum duration: 48 months)
- title
- Time to Pain Progression
- type
- SECONDARY
- unit Of Measure
- months
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Preserved source evidence · Not medical advice