Comparison · NCT02799602-sae
Darolutamide (BAY1841788) + Docetaxel vs Placebo + Docetaxel: 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. Darolutamide (BAY1841788) + Docetaxel vs Placebo + Docetaxel: serious adverse events. Trial comparisons, record NCT02799602-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02799602-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 | 0.469 | 0.431 | 0.508 | wilson | |
| Risk in group 2 | 0.425 | 0.387 | 0.463 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0447 | -0.00928 | 0.0983 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.11 | 0.979 | 1.25 | log | |
| Odds ratio, group 1 over group 2 | 1.2 | 0.963 | 1.49 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Darolutamide (BAY1841788) + Docetaxel than on Placebo + Docetaxel | 22.4 | 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 | Darolutamide (BAY1841788) + Docetaxel | Participants received darolutamide 600 mg (2 tablets of 300 mg) twice daily with food, equivalent to a total daily dose of 1200 mg in addition to their standard treatment with docetaxel and androgen deprivation therapy (ADT). Docetaxel was administered for six cycles after randomization. The first cycle of docetaxel was administered within 6 weeks after start of study drug. ADT administration started \<=12 weeks before randomization. | 306 | 652 | EG000 |
| Group 2 | Placebo + Docetaxel | Participants received matching placebo to darolutamide in addition to their standard treatment with docetaxel and androgen deprivation therapy (ADT). Docetaxel was administered for six cycles after randomization. The first cycle of docetaxel was administered within 6 weeks after start of study drug. ADT administration started \<=12 weeks before randomization. | 276 | 650 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
From start of study drug administration until 30 days after the last administration, including adverse event of all-cause mortality at any time during the study, up to cut-off date for the final completion analysis 11 APR 2023 (approximately 77 months)
Source ClinicalTrials.gov
Trial
- Title
- Darolutamide in Addition to Standard Androgen Deprivation Therapy and Docetaxel in Metastatic Hormone-Sensitive Prostate Cancer
- NCT number
- NCT02799602
- Phases
- PHASE3
- Conditions
- Metastatic Hormone-sensitive Prostate Cancer
- Interventions
- BAY1841788 / darolutamide (ODM-201), Standard ADT (androgen deprivation therapy), Docetaxel, Placebo
- Lead sponsor
- Bayer
- Results first posted
- 2023-02-24
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02799602?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.
For software
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GET https://conductscience.org/api/comparisons/v1/NCT02799602-sae