TriangleNCT01308580 · OUTCOME
Percentage of Participants With FACT-P Total Score 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
FACT-P is a 39-item participant questionnaire that measures the concerns of participants with prostate cancer. It consists of 5 sub-scales assessing physical well-being (7 items), social/family well-being (7 items), emotional well-being (6 items), functional well-being (7 items), and prostate-specific concerns (12 items). FACT-P Total Score sums all 5 sub-scales to give a score in the range of 0 to 156, where higher values represent better HRQoL. Responder of FACT-P was defined as at least one occurrence of 7-point improvement from baseline in FACT-P total score during treatment period.
Analysis population: Analysis was performed on FACT-P population. Number of participants analyzed= participants with evaluable FACT-P total score for specified outcome measure.
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 | 540 |
| Cabazitaxel 25 mg/m^2 | 525 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cabazitaxel 20 mg/m^2 | 57.2 | Not reported | 53.0 | 61.4 | Not reported |
| Cabazitaxel 25 mg/m^2 | 59.4 | Not reported | 55.2 | 63.6 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 53.0
- upper Limit
- 61.4
- value
- 57.2
- group Id
- OG001
- lower Limit
- 55.2
- upper Limit
- 63.6
- value
- 59.4
- denoms
- counts
- group Id
- OG000
- value
- 540
- group Id
- OG001
- value
- 525
- units
- Participants
- description
- FACT-P is a 39-item participant questionnaire that measures the concerns of participants with prostate cancer. It consists of 5 sub-scales assessing physical well-being (7 items), social/family well-being (7 items), emotional well-being (6 items), functional well-being (7 items), and prostate-specific concerns (12 items). FACT-P Total Score sums all 5 sub-scales to give a score in the range of 0 to 156, where higher values represent better HRQoL. Responder of FACT-P was defined as at least one occurrence of 7-point improvement from baseline in FACT-P total score during treatment period.
- 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 FACT-P population. Number of participants analyzed= participants with evaluable FACT-P total score for specified outcome measure.
- 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 FACT-P Total Score Response
- type
- SECONDARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice