Comparison · NCT03279250-sae
Arm A (LHRHa, Apalutamide) vs Arm B (LHRHa, Apalutamide, Abiraterone Acetate): 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 (LHRHa, Apalutamide) vs Arm B (LHRHa, Apalutamide, Abiraterone Acetate): serious adverse events. Trial comparisons, record NCT03279250-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03279250-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 | 0.0294 | 0.00521 | 0.149 | wilson | |
| Risk in group 2 | 0.0588 | 0.0163 | 0.191 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0294 | -0.164 | 0.0977 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.5 | 0.0475 | 5.26 | log | |
| Odds ratio, group 1 over group 2 | 0.485 | 0.0419 | 5.61 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Arm A (LHRHa, Apalutamide) than on Arm B (LHRHa, Apalutamide, Abiraterone Acetate) | 34 | from the risk difference interval | the interval includes no difference |
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 (LHRHa, Apalutamide) | Participants receive gonadotropin-releasing hormone analog (leuprolide, goserelin, or triptorelin as determined by treating physician) IM once every 3 months and apalutamide PO QD. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Beginning no less than 48 hours after completion of therapy, participants undergo radical prostatectomy.~Apalutamide: Given PO~Gonadotropin-releasing Hormone Analog: Given IM~Radical Prostatectomy: Undergo radical prostatectomy | 1 | 34 | EG000 |
| Group 2 | Arm B (LHRHa, Apalutamide, Abiraterone Acetate) | Participants receive gonadotropin-releasing hormone analog and apalutamide as in arm A, abiraterone acetate PO QD, and prednisone PO QD. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Beginning no less than 48 hours after completion of therapy, participants undergo radical prostatectomy.~Abiraterone Acetate: Given PO~Apalutamide: Given PO~Gonadotropin-releasing Hormone Analog: Given IM~Prednisone: Given PO~Radical Prostatectomy: Undergo radical prostatectomy | 2 | 34 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- From screening up to 4 weeks post-surgery, an average of 7 months
Source ClinicalTrials.gov
Trial
- Title
- Apalutamide and Gonadotropin-Releasing Hormone Analog With or Without Abiraterone Acetate in Treating Participants With Prostate Cancer
- NCT number
- NCT03279250
- Phases
- PHASE2
- Conditions
- Prostate Adenocarcinoma, Stage IIB Prostate Cancer AJCC v8, Stage IIC Prostate Cancer AJCC v8, Stage IIIA Prostate Cancer AJCC v8, Stage IIIC Prostate Cancer AJCC v8
- Interventions
- Abiraterone Acetate, Apalutamide, Gonadotropin-releasing Hormone Analog, Prednisone, Radical Prostatectomy
- Lead sponsor
- M.D. Anderson Cancer Center
- Results first posted
- 2022-08-10
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03279250?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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Read this comparison from software.
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