Comparison · NCT01193257-2afaee9d
Placebo + Prednisone vs Orteronel + Prednisone: Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs)
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
Cite this record
ConductScience Library. Placebo + Prednisone vs Orteronel + Prednisone: Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs). Trial comparisons, record NCT01193257-2afaee9d. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01193257-2afaee9d
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Measures6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note |
|---|---|---|---|---|---|
| Risk in group 1 | 0.95 | 0.923 | 0.968 | wilson | |
| Risk in group 2 | 0.982 | 0.97 | 0.99 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0318 | -0.0602 | -0.00998 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.968 | 0.943 | 0.993 | log | |
| Odds ratio, group 1 over group 2 | 0.347 | 0.168 | 0.715 | log | |
| Number needed to treat, for one fewer participant with the outcome on Placebo + Prednisone than on Orteronel + Prednisone | 31.4 | 16.6 | 100 | from the risk difference interval |
Source ClinicalTrials.gov
Groups2
Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Placebo + Prednisone | Orteronel placebo-matching tablets, orally, twice daily (BID) and prednisone 5 mg, tablets, orally, BID up to Day 28 of each treatment cycle throughout the study. | 345 | 363 | OG000 |
| Group 2 | Orteronel + Prednisone | Orteronel 400 mg, tablets, orally, BID and prednisone 5 mg, tablets, orally, BID up to Day 28 of each treatment cycle throughout the study. In Japan only, participants were administered with orteronel 300 mg, tablets, orally, BID and prednisone 5 mg, tablets, orally, BID up to Day 28 of each treatment cycle throughout the study. | 719 | 732 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs)
- Description
- Time frame
- Baseline up to 30 days after last dose of study drug (Cycle 59 Day 58)
- Population
- Safety population included all participants who received at least 1 dose of any study drug.
Source ClinicalTrials.gov
Trial
- Title
- Study Comparing Orteronel Plus Prednisone in Participants With Metastatic Castration-Resistant Prostate Cancer.
- NCT number
- NCT01193257
- Phases
- PHASE3
- Conditions
- Prostate Cancer
- Interventions
- Orteronel, Prednisone, Orteronel Placebo
- Lead sponsor
- Millennium Pharmaceuticals, Inc.
- Results first posted
- 2018-12-19
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01193257?tab=results
Source ClinicalTrials.gov
Source
- Release
- trial-comparisons-2026-03-23-0.1.0
- Release manifest SHA-256
- f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
- AACT copy
- 2026-03-23
- Tables read
- outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet
Source ClinicalTrials.gov
Sources 2
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
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
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.
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