TriangleNCT01308567 · OUTCOME
Percentage of Participants With PSA 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
- Baseline up to PSA progression or death due to any cause or study cut-off date, whichever was earlier (maximum duration: 51 months)
What was measured
PSA response was defined as ≥50% decrease from baseline in serum PSA levels, confirmed by a second PSA value at least 3 weeks later in participants with baseline PSA value ≥10 ng/mL.
Analysis population: Analysis was performed on ITT population. Number of participants analyzed=participants with PSA value ≥10 ng/mL at baseline and at least one valid post-baseline value for specified outcome measure.
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 | 354 |
| Cabazitaxel 20 mg/m^2 | 346 |
| Cabazitaxel 25 mg/m^2 | 342 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Docetaxel 75 mg/m^2 | 68.4 | Not reported | 63.5 | 73.2 | Not reported |
| Cabazitaxel 20 mg/m^2 | 60.7 | Not reported | 55.5 | 65.8 | Not reported |
| Cabazitaxel 25 mg/m^2 | 68.7 | Not reported | 63.8 | 73.6 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 63.5
- upper Limit
- 73.2
- value
- 68.4
- group Id
- OG001
- lower Limit
- 55.5
- upper Limit
- 65.8
- value
- 60.7
- group Id
- OG002
- lower Limit
- 63.8
- upper Limit
- 73.6
- value
- 68.7
- denoms
- counts
- group Id
- OG000
- value
- 354
- group Id
- OG001
- value
- 346
- group Id
- OG002
- value
- 342
- units
- Participants
- description
- PSA response was defined as ≥50% decrease from baseline in serum PSA levels, confirmed by a second PSA value at least 3 weeks later in participants with baseline PSA value ≥10 ng/mL.
- 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
- NUMBER
- population Description
- Analysis was performed on ITT population. Number of participants analyzed=participants with PSA value ≥10 ng/mL at baseline and at least one valid post-baseline value for specified outcome measure.
- reporting Status
- POSTED
- time Frame
- Baseline up to PSA progression or death due to any cause or study cut-off date, whichever was earlier (maximum duration: 51 months)
- title
- Percentage of Participants With PSA Response
- type
- SECONDARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice