Comparison · NCT02216214-sae
Mirabegron vs Placebo: 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 vs Placebo: serious adverse events. Trial comparisons, record NCT02216214-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02216214-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 | 0.0337 | 0.0205 | 0.0549 | wilson | |
| Risk in group 2 | 0.0271 | 0.0156 | 0.0468 | wilson | |
| Risk difference, group 1 minus group 2 | 0.00656 | -0.0171 | 0.0307 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.24 | 0.588 | 2.62 | log | |
| Odds ratio, group 1 over group 2 | 1.25 | 0.578 | 2.7 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Mirabegron than on Placebo | 152 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: placebo.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Mirabegron | Participants received mirabegron at an initial dose of 25 mg and may have been increased to 50 mg mirabegron after 4 weeks or 8 weeks based on individual participant efficacy, tolerability and investigator discretion. Once a participant had increased dose, they remained on that dose for the remainder of the study unless there were safety reasons that required discontinuation of study drug. | 15 | 445 | EG001 |
| Group 2 | Placebo | Participants received placebo to match mirabegron at an initial dose of 25 mg and may have been increased to 50 mg of matching placebo after 4 weeks or 8 weeks based on individual participant efficacy, tolerability and investigator discretion. Once a participant had increased dose, they remained on that dose for the remainder of the study unless there were safety reasons that required discontinuation of study drug. | 12 | 442 | EG000 |
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 13 weeks)
Source ClinicalTrials.gov
Trial
- Title
- Study to Evaluate the Efficacy, Safety, and Tolerability of Mirabegron in Older Adult Subjects With Overactive Bladder (OAB)
- NCT number
- NCT02216214
- Phases
- PHASE4
- Conditions
- Overactive Bladder (OAB)
- Interventions
- Mirabegron, Placebo
- Lead sponsor
- Astellas Pharma Global Development, Inc.
- Results first posted
- 2019-02-15
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02216214?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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