Trial · NCT01193244
Outcomes23
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 23
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Radiographic Progression-free Survival (rPFS) | Baseline until radiographic disease progression or death, whichever occurred first (approximately up to 4.7 years) | ITT population included all participants who were randomized. | months | MEDIAN |
| PRIMARY | Overall Survival | Baseline until death (up to 4.7 years) | ITT population included all participants who were randomized. | months | MEDIAN |
| SECONDARY | Percentage of Participants Achieving 50 Percent Reduction From Baseline in Prostate Specific Antigen (PSA50) Response at Week 12 | Week 12 | ITT population included all participants who were randomized. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Favorable Circulating Tumor Cell Count (CTC) Levels at Week 12 | Week 12 | ITT population included all participants who were randomized. | percentage of participants | NUMBER |
| SECONDARY | Time to Pain Progression | Baseline until End of treatment (EOT) (approximately up to 4.7 years) | ITT population included all participants who were randomized. | months | MEDIAN |
| SECONDARY | Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | Baseline up to 30 days after last dose of study drug (Cycle 61 Day 58) | Safety population included all participants who received at least 1 dose of any study drug. | participants | NUMBER |
| SECONDARY | Number of Participants With Treatment-emergent Adverse Events Greater Than or Equal to (>=) Grade 3 | Baseline up to 30 days after last dose of study drug (Cycle 61 Day 58) | Safety population included all participants who received at least 1 dose of any study drug. | participants | NUMBER |
| SECONDARY | Number of Participants With TEAEs Related to Vital Signs | Baseline up to 30 days after last dose of study drug (Cycle 61 Day 58) | Safety population included all participants who received at least 1 dose of any study drug. | participants | NUMBER |
| SECONDARY | Number of Participants With TEAEs Related to Weight | Baseline up to 30 days after last dose of study drug (Cycle 61 Day 58) | Safety population included all participants who received at least 1 dose of any study drug. | participants | NUMBER |
| SECONDARY | Number of Participants With Worst Change From Baseline in Eastern Co-operative Oncology Group (ECOG) Performance Status | Baseline until EOT (approximately up to 4.7 years) | Safety population where baseline and post-baseline assessments were available. Safety population included all participants who received at least 1 dose of any study drug. | participants | NUMBER |
| SECONDARY | Number of Participants With Abnormal Clinically Significant Electrocardiogram (ECG) Findings | Baseline up to EOT (Cycle 61 Day 58) | Safety population included all participants who received at least 1 dose of any study drug. | participants | NUMBER |
| SECONDARY | Worst Change From Baseline Over Time in Cardiac Ejection Fraction | Baseline up to 30 days or EOT whichever is later (approximately up to Cycle 61 Day 58) | Safety population where baseline and post-baseline assessments were available. Safety population included all participants who received at least 1 dose of any study drug. | percent ejection fraction | MEAN |
| SECONDARY | Number of Participants With TEAEs Categorized Into Investigations Related to Chemistry, Hematology or Coagulation | Baseline up to 30 days or EOT whichever is later (approximately up to Cycle 61 Day 58) | Safety population included all participants who received at least 1 dose of any study drug. | participants | NUMBER |
| SECONDARY | Percentage of Participants With Skeletal Related Events (SRE) | Baseline up to EOT (approximately up to 4.7 years) | The ITT population included all participants who were randomized. | percentage of participants | NUMBER |
| SECONDARY | Time to SRE | Baseline up to EOT (Cycle 61 Day 58) | The ITT population included all participants who were randomized. | months | MEDIAN |
| SECONDARY | Percentage of Participants Achieving PSA50 Response at Any Time During the Study | Cycle: 4, 7, 10, 13, 16, 19, 22, 25, 28, 31, 34 and 37 | ITT population where baseline and post-baseline assessments were available. The ITT population included all participants who were randomized. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Achieving 90 Percent Reduction From Baseline in Prostate Specific Antigen (PSA90 Response) at Week 12 | Week 12 | ITT population included all participants who were randomized. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Achieving PSA90 Response at Any Time During the Study | Cycle: 4, 7, 10, 13, 16, 19, 22, 25, 28, 31, 34 and 37 | ITT population where baseline and post-baseline assessments were available. The ITT population included all participants who were randomized. | percentage of participants | NUMBER |
| SECONDARY | Time to PSA Progression | Baseline until the final on treatment assessment or until end of short term follow-up following discontinuation of treatment, whichever occurred later (approximately up to 4.7 years) | ITT population included all participants who were randomized. | months | MEDIAN |
| SECONDARY | Time to Docetaxel Chemotherapy | Baseline until start of docetaxel chemotherapy (up to 4.7 years) | ITT population included all participants who were randomized. | months | MEDIAN |
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/NCT01193244/outcomes