TriangleNCT01308567 · OUTCOME
Percentage of Participants With Overall Objective Tumor 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 DP or death due to any cause or study cut-off date, whichever was earlier (maximum duration: 51 months)
What was measured
Overall objective tumor response was defined as having a partial response (PR) or complete response (CR) according to the RECIST version 1.1. CR was defined as disappearance of all target and non-target lesions and normalization of tumor marker level. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Analysis population: Analysis was performed on ITT population. Number of participants analyzed=participants with measurable disease at baseline and at least one valid post-baseline value analyzed 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 | 175 |
| Cabazitaxel 20 mg/m^2 | 188 |
| Cabazitaxel 25 mg/m^2 | 173 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Docetaxel 75 mg/m^2 | 30.9 | Not reported | 24.0 | 37.7 | Not reported |
| Cabazitaxel 20 mg/m^2 | 32.4 | Not reported | 25.8 | 39.1 | Not reported |
| Cabazitaxel 25 mg/m^2 | 41.6 | Not reported | 34.3 | 49.0 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 24.0
- upper Limit
- 37.7
- value
- 30.9
- group Id
- OG001
- lower Limit
- 25.8
- upper Limit
- 39.1
- value
- 32.4
- group Id
- OG002
- lower Limit
- 34.3
- upper Limit
- 49.0
- value
- 41.6
- denoms
- counts
- group Id
- OG000
- value
- 175
- group Id
- OG001
- value
- 188
- group Id
- OG002
- value
- 173
- units
- Participants
- description
- Overall objective tumor response was defined as having a partial response (PR) or complete response (CR) according to the RECIST version 1.1. CR was defined as disappearance of all target and non-target lesions and normalization of tumor marker level. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
- 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 measurable disease at baseline and at least one valid post-baseline value analyzed for specified outcome measure.
- reporting Status
- POSTED
- time Frame
- Baseline up to DP or death due to any cause or study cut-off date, whichever was earlier (maximum duration: 51 months)
- title
- Percentage of Participants With Overall Objective Tumor Response
- type
- SECONDARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice