Comparison · NCT04562090-bbfcefdb
Mirabegron 25 mg vs Mirabegron 50 mg: Number of Participants With Treatment Emergent 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 25 mg vs Mirabegron 50 mg: Number of Participants With Treatment Emergent Adverse Events. Trial comparisons, record NCT04562090-bbfcefdb. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT04562090-bbfcefdb
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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 | 0.217 | 0.142 | 0.317 | wilson | |
| Risk in group 2 | 0.352 | 0.283 | 0.427 | wilson | |
| Risk difference, group 1 minus group 2 | -0.135 | -0.241 | -0.0132 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.617 | 0.39 | 0.976 | log | |
| Odds ratio, group 1 over group 2 | 0.511 | 0.277 | 0.942 | log | |
| Number needed to treat, for one fewer participant with the outcome on Mirabegron 25 mg than on Mirabegron 50 mg | 7.43 | 4.15 | 75.6 | 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 | Mirabegron 25 mg | Participants received single oral dose of mirabegron 25 mg tablet once daily, at the same time after a meal for a duration of 12 weeks. Dose escalation to 50 mg was permitted at Visit 3 (Week 4) or Visit 4 (Week 8) at the discretion of investigator. | 18 | 83 | OG000 |
| Group 2 | Mirabegron 50 mg | Participants received single oral dose of mirabegron 50 mg tablet once daily, at the same time after a meal for a duration of 12 weeks. | 58 | 165 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Number of Participants With Treatment Emergent Adverse Events
- Description
AE was defined as any untoward medical occurrence in a participant administered a study drug or had undergone study procedures and which did not necessarily have had a causal relationship with the treatment. An abnormality identified during a medical test (e.g., laboratory parameter, vital sign, Electrocardiography (ECG) data, and physical exam) was defined as an AE only if the abnormality induced clinical signs or symptoms or requires active intervention or requires interruption or discontinuation of study medication or the abnormality or investigational value was clinically significant in the opinion of the investigator. Treatment emergent AE was defined as an AE observed after starting administration of the IP and 30 days after the final administration of study drug.
- Time frame
- From first dose up to 30 days after last dose (up to week 16)
- Population
- Safety Analysis Set (SAF) consisted of all participants who took at least 1 dose of IP.
Source ClinicalTrials.gov
Trial
- Title
- A Study With Mirabegron 50 mg and 25 mg in Chinese Participants With Overactive Bladder
- NCT number
- NCT04562090
- Phases
- PHASE4
- Conditions
- Urge Incontinence, Overactive Bladder (OAB)
- Interventions
- mirabegron
- Lead sponsor
- Astellas Pharma China, Inc.
- Results first posted
- 2023-03-29
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT04562090?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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