Trial · NCT01193244
Results by group124
Each measurement the trial posted, group by group, in the words and numbers it posted.
1 to 20 of 124
Download this page as JSON| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Radiographic Progression-free Survival (rPFS) | Placebo + Prednisone 5 mg | 8.7 | 95% Confidence Interval 8.32 to 10.91 | months | |
| Radiographic Progression-free Survival (rPFS) | Orteronel 400 mg + Prednisone 5 mg | 13.8 | 95% Confidence Interval 13.05 to 14.92 | months | |
| Overall Survival | Placebo + Prednisone 5 mg | 29.5 | 95% Confidence Interval 27.28 to 32.38 | months | |
| Overall Survival | Orteronel 400 mg + Prednisone 5 mg | 29.9 | 95% Confidence Interval 27.88 to 33.04 | months | |
| Percentage of Participants Achieving 50 Percent Reduction From Baseline in Prostate Specific Antigen (PSA50) Response at Week 12 | Placebo + Prednisone 5 mg | 24.6 | 95% Confidence Interval 21.7 to 27.8 | percentage of participants | |
| Percentage of Participants Achieving 50 Percent Reduction From Baseline in Prostate Specific Antigen (PSA50) Response at Week 12 | Orteronel 400 mg + Prednisone 5 mg | 42.6 | 95% Confidence Interval 39.1 to 46.2 | percentage of participants | |
| Percentage of Participants With Favorable Circulating Tumor Cell Count (CTC) Levels at Week 12 | Placebo + Prednisone 5 mg | 9.1 | 95% Confidence Interval 7.2 to 11.4 | percentage of participants | |
| Percentage of Participants With Favorable Circulating Tumor Cell Count (CTC) Levels at Week 12 | Orteronel 400 mg + Prednisone 5 mg | 15.4 | 95% Confidence Interval 12.9 to 18.1 | percentage of participants | |
| Time to Pain Progression | Placebo + Prednisone 5 mg | NA | 95% Confidence Interval NA to NA | months | |
| Time to Pain Progression | Orteronel 400 mg + Prednisone 5 mg | NA | 95% Confidence Interval 28.57 to NA | months | |
| Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | Placebo + Prednisone 5 mg | TEAE | 733 | participants | |
| Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | Orteronel 400 mg + Prednisone 5 mg | TEAE | 769 | participants | |
| Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | Placebo + Prednisone 5 mg | Serious Adverse Events (SAE) | 321 | participants | |
| Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | Orteronel 400 mg + Prednisone 5 mg | Serious Adverse Events (SAE) | 380 | participants | |
| Number of Participants With Treatment-emergent Adverse Events Greater Than or Equal to (>=) Grade 3 | Placebo + Prednisone 5 mg | Grade 3 or higher TEAE | 405 | participants | |
| Number of Participants With Treatment-emergent Adverse Events Greater Than or Equal to (>=) Grade 3 | Orteronel 400 mg + Prednisone 5 mg | Grade 3 or higher TEAE | 537 | participants | |
| Number of Participants With Treatment-emergent Adverse Events Greater Than or Equal to (>=) Grade 3 | Placebo + Prednisone 5 mg | Grade 5 (Death) | 78 | participants | |
| Number of Participants With Treatment-emergent Adverse Events Greater Than or Equal to (>=) Grade 3 | Orteronel 400 mg + Prednisone 5 mg | Grade 5 (Death) | 77 | participants | |
| Number of Participants With TEAEs Related to Vital Signs | Placebo + Prednisone 5 mg | Hypertension | 76 | participants | |
| Number of Participants With TEAEs Related to Vital Signs | Orteronel 400 mg + Prednisone 5 mg | Hypertension | 98 | participants |
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.
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