Comparison · NCT02138747-sae
Mirabegron vs Tolterodine ER: 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 Tolterodine ER: serious adverse events. Trial comparisons, record NCT02138747-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02138747-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 | 0.0094 | 0.0032 | 0.0273 | wilson | |
| Risk in group 2 | 0.0246 | 0.0125 | 0.0478 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0152 | -0.0392 | 0.00637 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.382 | 0.102 | 1.43 | log | |
| Odds ratio, group 1 over group 2 | 0.376 | 0.0989 | 1.43 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Mirabegron than on Tolterodine ER | 65.7 | 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 | Participants received 25 mg of mirabegron oral controlled absorption system (OCAS) modified-release tablets orally once a day for 8 weeks in treatment periods 1 and/or 2. Four weeks after the start of each 8-week treatment period, 25 mg of mirabegron was increased to 50 mg for the remainder of the treatment period. | 3 | 319 | EG000 |
| Group 2 | Tolterodine ER | Participants received 4 mg of tolterodine ER capsules orally once a day for 8 weeks in treatment periods 1 and/or 2. | 8 | 325 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Baseline to End of Treatment (Week 18) and follow up 2 weeks after (Week 20)
Source ClinicalTrials.gov
Trial
- Title
- A Study to Evaluate Tolerability and Participants Preference Between Mirabegron and Tolterodine Extended Release (ER) in Participants With Overactive Bladder (OAB)
- NCT number
- NCT02138747
- Phases
- PHASE4
- Conditions
- Overactive Bladder (OAB)
- Interventions
- Mirabegron, Tolterodine ER
- Lead sponsor
- Astellas Pharma Global Development, Inc.
- Results first posted
- 2017-02-14
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02138747?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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