Trial · NCT01308580
Outcomes18
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 18 of 18
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Overall Survival (OS) | From baseline up to death due to any cause or study cut-off date, whichever was earlier (maximum duration: 48 months) | Analysis was performed on Intent-to-Treat (ITT) population, which included all randomized participants. | months | MEDIAN |
| SECONDARY | Progression Free Survival (PFS) | From baseline up to tumor progression, PSA progression, pain progression, death due to any cause or study cut-off date, whichever was earlier (maximum duration: 48 months) | Analysis was performed on ITT population. | months | MEDIAN |
| SECONDARY | Time to Tumor Progression | From baseline up to tumor progression or death due to any cause or study cut-off date, whichever was earlier (maximum duration: 48 months) | Analysis was performed on ITT population. | months | MEDIAN |
| SECONDARY | Percentage of Participants With Overall Objective Tumor Response | From baseline up to DP or death due to any cause or study cut-off date, whichever was earlier (maximum duration: 48 months) | Analysis was performed on ITT population. Number of participants analyzed= participants evaluable for tumor response with measurable disease at baseline and at least one valid post-baseline value. | percentage of participants | NUMBER |
| SECONDARY | Time to PSA Progression | From baseline up to PSA progression or death due to any cause or study cut-off date, whichever was earlier (maximum duration: 48 months) | Analysis was performed on ITT population. | months | MEDIAN |
| SECONDARY | Percentage of Participants With PSA Response | From baseline up to PSA progression or death due to any cause or study cut-off date, whichever was earlier (maximum duration: 48 months) | Analysis was performed on ITT population. Number of participants analyzed= participants evaluable for PSA response with PSA value ≥10 ng/mL at baseline and at least one valid post-baseline value. | percentage of participants | NUMBER |
| SECONDARY | Time to Pain Progression | From baseline until DP, start of another anti-cancer therapy, death or study cut-off date (maximum duration: 48 months) | Analysis was performed on ITT population. | months | MEDIAN |
| SECONDARY | Percentage of Participants With Pain Response | From baseline until DP, start of another anti-cancer therapy, death or study cut-off date (maximum duration: 48 months) | 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. | percentage of participants | NUMBER |
| SECONDARY | Change From Baseline in Functional Assessment of Cancer Therapy-Prostate (FACT-P):Trial Outcome Index (TOI) as a Measure of Health Related Quality of Life (HRQoL) | Baseline, Day 1 of each Cycle 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 (each cycle 21-day); post-treatment follow up 1 (up to 12 weeks) | FACT-P population included randomized participants who completed FACT-P questionnaire at baseline \& in at least one post-baseline assessment. Number of participants analyzed=participants with evaluable FACT-P TOI for specified outcome measure. Here, 'n' signifies number of participants with available data for specified category. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in FACT-P:Total Score as a Measure of HRQoL | Baseline, Day 1 of each Cycle 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 (each cycle 21-day); post-treatment follow up 1 (up to 12 weeks) | Analysis was performed on FACT-P population. Number of participants analyzed=participants with evaluable FACT-P Total Score for specified outcome measure. Here, 'n' signifies number of participants with available data for specified category. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage of Participants With FACT-P Total Score Response | From baseline until DP, start of another anti-cancer therapy, death or study cut-off date (maximum duration: 48 months) | Analysis was performed on FACT-P population. Number of participants analyzed= participants with evaluable FACT-P total score for specified outcome measure. | percentage of participants | NUMBER |
| SECONDARY | Time to Definitive Deterioration of Score by 10% From Baseline on FACT-P Sub-Scales | From baseline until DP, start of another anti-cancer therapy, death or study cut-off date (maximum duration: 48 months) | Analysis was performed on FACT-P population. | months | MEDIAN |
| SECONDARY | Time to Definitive Deterioration of ECOG PS Score From Baseline | From baseline until death or study cut-off date (maximum duration: 48 months) | Analysis was performed on ITT population. | months | MEDIAN |
| SECONDARY | Time to Definitive Weight Loss by 5% and 10% From Baseline | From baseline until death or study cut-off date (maximum duration: 48 months) | Analysis was performed on ITT population. | months | MEDIAN |
| SECONDARY | Time to First Definitive Consumption of Narcotic Medication | From baseline until DP, start of another anti-cancer therapy, death or study cut-off date (maximum duration: 48 months) | Analysis was performed on ITT population. | months | MEDIAN |
| SECONDARY | Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) | From first administration of study treatment until 30 days after the last administration of study treatment (Maximum duration: 48 months) | Safety population included all randomized participants who received at least one dose of the study drug during study treatment period. | percentage of participants | NUMBER |
| SECONDARY | Plasma Clearance (CL) for Cabazitaxel | Day 1 of Cycle 1: 5 minutes before the end of infusion (EOI), 15 minutes, 1 to 4 hour, 6 to 24 hours, 48 to 168 hour after EOI | Analysis was performed on PK population that included participants who had evaluable PK data. Number of participants analyzed= participants with PK assessment at specified time-points. | Litre/hour | MEAN |
| SECONDARY | Plasma Steady State Volume of Distribution (Vss) for Cabazitaxel | Day 1 of Cycle 1: 5 minutes before the EOI, 15 minutes, 1 to 4 hour, 6 to 24 hours, 48 to 168 hour after EOI | Analysis was performed on PK population. Number of participants analyzed= participants with PK assessment at specified time-points. | litre | MEAN |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this list from software.
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GET https://conductscience.org/api/trials/v1/NCT01308580/outcomes