Comparison · NCT01193244-sae
Placebo + Prednisone 5 mg vs Orteronel 400 mg + Prednisone 5 mg: serious adverse events
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 5 mg vs Orteronel 400 mg + Prednisone 5 mg: serious adverse events. Trial comparisons, record NCT01193244-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01193244-sae
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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 | 0.417 | 0.383 | 0.452 | wilson | |
| Risk in group 2 | 0.485 | 0.45 | 0.52 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0678 | -0.117 | -0.0183 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.86 | 0.77 | 0.96 | log | |
| Odds ratio, group 1 over group 2 | 0.76 | 0.622 | 0.929 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Placebo + Prednisone 5 mg than on Orteronel 400 mg + Prednisone 5 mg | 14.7 | 8.56 | 54.6 | 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 5 mg | Orteronel placebo-matching tablets, orally, twice daily (BID) and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study. | 321 | 770 | EG000 |
| Group 2 | Orteronel 400 mg + Prednisone 5 mg | Orteronel 400 mg, tablets, orally, BID and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study. In Japan, participants were administered with Orteronel 300 mg, tablets, orally, BID and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study. | 380 | 784 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Cycle 61 Day 58).
Source ClinicalTrials.gov
Trial
- Title
- Study Comparing Orteronel Plus Prednisone in Participants With Chemotherapy-Naive Metastatic Castration-Resistant Prostate Cancer
- NCT number
- NCT01193244
- Phases
- PHASE3
- Conditions
- Prostate Cancer
- Interventions
- Orteronel, Placebo, Prednisone
- Lead sponsor
- Millennium Pharmaceuticals, Inc.
- Results first posted
- 2017-05-17
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01193244?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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