Comparison · NCT03072238-sae
Pbo + Abi vs Ipat + Abi: 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. Pbo + Abi vs Ipat + Abi: serious adverse events. Trial comparisons, record NCT03072238-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03072238-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 | 0.289 | 0.253 | 0.329 | wilson | |
| Risk in group 2 | 0.457 | 0.416 | 0.499 | wilson | |
| Risk difference, group 1 minus group 2 | -0.168 | -0.223 | -0.111 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.633 | 0.539 | 0.742 | log | |
| Odds ratio, group 1 over group 2 | 0.483 | 0.376 | 0.62 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Pbo + Abi than on Ipat + Abi | 5.95 | 4.48 | 9.01 | 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 | Pbo + Abi | Participants received matching placebo along with abiraterone 1000 mg, QD and prednisone/prednisolone, 5 mg, BID administered orally in each 28 day treatment cycle until disease progression, intolerable toxicity, elective withdrawal from the study, or study completion or termination. | 158 | 546 | EG000 |
| Group 2 | Ipat + Abi | Participants received ipatasertib, 400 mg, QD along with abiraterone, 1000 mg, QD and prednisone/prednisolone, 5 mg, BID administered orally in each 28 day treatment cycle until disease progression, intolerable toxicity, elective withdrawal from the study, or study completion or termination. | 252 | 551 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Up to approximately 6.5 years
Source ClinicalTrials.gov
Trial
- Title
- Ipatasertib Plus Abiraterone Plus Prednisone/Prednisolone, Relative to Placebo Plus Abiraterone Plus Prednisone/Prednisolone in Adult Male Patients With Metastatic Castrate-Resistant Prostate Cancer
- NCT number
- NCT03072238
- Phases
- PHASE3
- Conditions
- Metastatic Prostate Cancer
- Interventions
- Ipatasertib, Abiraterone, Placebo, Prednisone/Prednisolone
- Lead sponsor
- Hoffmann-La Roche
- Results first posted
- 2023-04-10
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03072238?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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