Comparison · NCT01949337-sae
Arm A: (Enzalutamide) vs Arm B: (Enzalutamide, Abiraterone, Prednisone): 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. Arm A: (Enzalutamide) vs Arm B: (Enzalutamide, Abiraterone, Prednisone): serious adverse events. Trial comparisons, record NCT01949337-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01949337-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 | 0.353 | 0.318 | 0.39 | wilson | |
| Risk in group 2 | 0.411 | 0.374 | 0.449 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0582 | -0.11 | -0.00559 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.859 | 0.748 | 0.986 | log | |
| Odds ratio, group 1 over group 2 | 0.781 | 0.625 | 0.977 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Arm A: (Enzalutamide) than on Arm B: (Enzalutamide, Abiraterone, Prednisone) | 17.2 | 9.06 | 179 | 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 | Arm A: (Enzalutamide) | Patients receive enzalutamide 160 mg PO QD. Treatment will continue until confirmed disease progression or unacceptable toxicity. | 232 | 657 | EG000 |
| Group 2 | Arm B: (Enzalutamide, Abiraterone, Prednisone) | Patients receive enzalutamide 160 mg PO QD, abiraterone 1000 mg PO QD, and prednisone 5 mg PO BID. Treatment will continue until confirmed disease progression or unacceptable toxicity. | 269 | 654 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Up to 5 years post treatment
Source ClinicalTrials.gov
Trial
- Title
- Enzalutamide With or Without Abiraterone and Prednisone in Treating Patients With Castration-Resistant Metastatic Prostate Cancer
- NCT number
- NCT01949337
- Phases
- PHASE3
- Conditions
- Adenocarcinoma of the Prostate, Hormone-resistant Prostate Cancer, Recurrent Prostate Cancer, Stage IV Prostate Cancer
- Interventions
- enzalutamide, abiraterone, prednisone
- Lead sponsor
- Alliance for Clinical Trials in Oncology
- Results first posted
- 2020-06-01
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01949337?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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