Comparison · NCT01308580-sae
Cabazitaxel 20 mg/m^2 vs Cabazitaxel 25 mg/m^2: 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. Cabazitaxel 20 mg/m^2 vs Cabazitaxel 25 mg/m^2: serious adverse events. Trial comparisons, record NCT01308580-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01308580-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 | 0.305 | 0.269 | 0.344 | wilson | |
| Risk in group 2 | 0.432 | 0.393 | 0.472 | wilson | |
| Risk difference, group 1 minus group 2 | -0.127 | -0.181 | -0.0717 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.707 | 0.606 | 0.824 | log | |
| Odds ratio, group 1 over group 2 | 0.578 | 0.454 | 0.734 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Cabazitaxel 20 mg/m^2 than on Cabazitaxel 25 mg/m^2 | 7.89 | 5.53 | 14 | 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 | Cabazitaxel 20 mg/m^2 | Cabazitaxel 20 mg/m\^2 IV infusion over 1 hour on Day 1 of each 21-day cycle in combination with Prednisone (or Prednisolone) 10 mg orally daily until DP, unacceptable toxicity, participant's refusal of further study treatment or for a maximum of 10 cycles. | 177 | 580 | EG000 |
| Group 2 | Cabazitaxel 25 mg/m^2 | Cabazitaxel 25 mg/m\^2 IV infusion over 1 hour on Day 1 of each 21-day cycle in combination with Prednisone (or Prednisolone) 10 mg orally daily until DP, unacceptable toxicity, participant's refusal of further study treatment or for a maximum of 10 cycles. | 257 | 595 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- All AEs were collected from signature of the informed consent form up to the final visit (48 months) regardless of seriousness or relationship to investigational product.
Source ClinicalTrials.gov
Trial
- Title
- Cabazitaxel at 20 mg/m² Compared to 25 mg/m² With Prednisone for the Treatment of Metastatic Castration Resistant Prostate Cancer
- NCT number
- NCT01308580
- Phases
- PHASE3
- Conditions
- Prostate Cancer
- Interventions
- Cabazitaxel (XRP6258), Prednisone (or Prednisolone)
- Lead sponsor
- Sanofi
- Results first posted
- 2016-10-11
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01308580?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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