TriangleNCT01308580 · OUTCOME
Percentage of Participants With Pain Response
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- percentage of participants
- 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 response was defined as either a ≥2-point decrease from baseline median PPI score without increase in AS, or a ≥50% decrease from baseline mean AS without increase in the PPI score, maintained for 2 consecutive evaluations at least 3 weeks apart. Increases in pain during the first 12 weeks were ignored in determining pain response.
Analysis population: Analysis was performed on ITT population. Number of participants analyzed= participants evaluable for pain response with pain score with median PPI ≥2 and/or mean AS ≥10 points at baseline and at least one valid post-baseline value.
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 | 248 |
| Cabazitaxel 25 mg/m^2 | 284 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cabazitaxel 20 mg/m^2 | 34.7 | Not reported | 28.8 | 40.6 | Not reported |
| Cabazitaxel 25 mg/m^2 | 37.3 | Not reported | 31.7 | 42.9 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 28.8
- upper Limit
- 40.6
- value
- 34.7
- group Id
- OG001
- lower Limit
- 31.7
- upper Limit
- 42.9
- value
- 37.3
- denoms
- counts
- group Id
- OG000
- value
- 248
- group Id
- OG001
- value
- 284
- units
- Participants
- description
- Pain response was defined as either a ≥2-point decrease from baseline median PPI score without increase in AS, or a ≥50% decrease from baseline mean AS without increase in the PPI score, maintained for 2 consecutive evaluations at least 3 weeks apart. Increases in pain during the first 12 weeks were ignored in determining pain response.
- 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
- NUMBER
- population Description
- Analysis was performed on ITT population. Number of participants analyzed= participants evaluable for pain response with pain score with median PPI ≥2 and/or mean AS ≥10 points at baseline and at least one valid post-baseline value.
- 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
- Percentage of Participants With Pain Response
- type
- SECONDARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice