Comparison · NCT01638000-sae
Mirabegron 50 mg vs Solifenacin 5 mg: 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. Mirabegron 50 mg vs Solifenacin 5 mg: serious adverse events. Trial comparisons, record NCT01638000-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01638000-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 | 0.015 | 0.00893 | 0.0249 | wilson | |
| Risk in group 2 | 0.0139 | 0.00815 | 0.0237 | wilson | |
| Risk difference, group 1 minus group 2 | 0.00104 | -0.0104 | 0.0126 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.07 | 0.508 | 2.27 | log | |
| Odds ratio, group 1 over group 2 | 1.08 | 0.503 | 2.3 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Mirabegron 50 mg than on Solifenacin 5 mg | 963 | 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 | Mirabegron 50 mg | Participants who received mirabegron 50 mg once daily for 12 weeks. | 14 | 936 | EG000 |
| Group 2 | Solifenacin 5 mg | Participants who received solifenacin 5 mg once daily for 12 weeks. | 13 | 934 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- From first dose of study drug up to 30 days after last dose of study drug (up to 16 weeks)
Source ClinicalTrials.gov
Trial
- Title
A Study to Evaluate the Efficacy and Safety of Mirabegron Compared to Solifenacin in Patients With Overactive Bladder Who Were Previously Treated With Another Medicine But Were Not Satisfied With That Treatment.
- NCT number
- NCT01638000
- Phases
- PHASE3
- Conditions
- Urologic Diseases, Urinary Bladder, Overactive, Urinary Bladder Diseases
- Interventions
- Mirabegron, Solifenacin succinate
- Lead sponsor
- Astellas Pharma Europe Ltd.
- Results first posted
- 2016-08-30
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01638000?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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