Comparison · NCT01809691-sae
LHRHa + TAK-700 vs LHRHa + Bicalutamide: 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. LHRHa + TAK-700 vs LHRHa + Bicalutamide: serious adverse events. Trial comparisons, record NCT01809691-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01809691-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 | 0.375 | 0.338 | 0.413 | wilson | |
| Risk in group 2 | 0.0238 | 0.0145 | 0.039 | wilson | |
| Risk difference, group 1 minus group 2 | 0.351 | 0.311 | 0.391 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 15.7 | 9.44 | 26.2 | log | |
| Odds ratio, group 1 over group 2 | 24.5 | 14.3 | 42 | log | |
| Number needed to harm, for one more participant with a serious adverse event on LHRHa + TAK-700 than on LHRHa + Bicalutamide | 2.85 | 2.56 | 3.22 | 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 | LHRHa + TAK-700 | Experimental: ADT + TAK-700 LHRH agonist - given as approved for androgen deprivation at a dose necessary to maintain castrate levels and equivalent to 22.5 mg of Leuprolide IM every 3 months.~TAK-700, 300 mg, PO, twice daily | 235 | 627 | EG000 |
| Group 2 | LHRHa + Bicalutamide | Active Comparator: ADT + Bicalutamide LHRH agonist - given as approved for androgen deprivation at a dose necessary to maintain castrate levels and equivalent to 22.5 mg of Leuprolide IM every 3 months.~Bicalutamide, 50 mg, PO, q daily | 15 | 629 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Duration of treatment and follow-up until death or 9 years after study start
Source ClinicalTrials.gov
Trial
- Title
- S1216, Phase III ADT+TAK-700 vs. ADT+Bicalutamide for Metastatic Prostate Cancer
- NCT number
- NCT01809691
- Phases
- PHASE3
- Conditions
- Prostate Cancer
- Interventions
- TAK-700, Bicalutamide
- Lead sponsor
- SWOG Cancer Research Network
- Results first posted
- 2022-09-08
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01809691?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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