TriangleNCT01308567 · OUTCOME
Time to Pain Progression Free Survival (Pain PFS)
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 disease progression, death or study cut-off date (maximum duration: 51 months)
What was measured
Time to pain PFS was defined as the time interval between date of randomization and the date of the first occurrence of pain progression or death, whichever was earlier. Pain progression was defined as an increase of ≥1 point in the median present pain intensity (PPI) score from the nadir confirmed by a second assessment at least 3 weeks later or ≥25 % increase in the mean analgesic score from baseline, due to cancer related pain 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. Analgesic score 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 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 | 10.1 | Not reported | 8.28 | 11.76 | Not reported |
| Cabazitaxel 20 mg/m^2 | 8.0 | Not reported | 6.90 | 9.66 | Not reported |
| Cabazitaxel 25 mg/m^2 | 7.3 | Not reported | 6.44 | 9.30 | Not reported |
Source statistical analyses
- ci Lower Limit
- 0.986
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.434
- 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
- 1.189
- ci Lower Limit
- 0.985
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.435
- 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
- 1.189
Complete source fields
- analyses
- ci Lower Limit
- 0.986
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.434
- 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
- 1.189
- ci Lower Limit
- 0.985
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.435
- 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
- 1.189
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 8.28
- upper Limit
- 11.76
- value
- 10.1
- group Id
- OG001
- lower Limit
- 6.90
- upper Limit
- 9.66
- value
- 8.0
- group Id
- OG002
- lower Limit
- 6.44
- upper Limit
- 9.30
- value
- 7.3
- denoms
- counts
- group Id
- OG000
- value
- 391
- group Id
- OG001
- value
- 389
- group Id
- OG002
- value
- 388
- units
- Participants
- description
- Time to pain PFS was defined as the time interval between date of randomization and the date of the first occurrence of pain progression or death, whichever was earlier. Pain progression was defined as an increase of ≥1 point in the median present pain intensity (PPI) score from the nadir confirmed by a second assessment at least 3 weeks later or ≥25 % increase in the mean analgesic score from baseline, due to cancer related pain 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. Analgesic score 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
- 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 disease progression, death or study cut-off date (maximum duration: 51 months)
- title
- Time to Pain Progression Free Survival (Pain PFS)
- type
- SECONDARY
- unit Of Measure
- months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice