Comparison · NCT01371994-sae
Solifenacin Succinate 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
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ConductScience Library. Solifenacin Succinate vs Placebo: serious adverse events. Trial comparisons, record NCT01371994-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01371994-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 | 0.0224 | 0.0109 | 0.0454 | wilson | |
| Risk in group 2 | 0.0161 | 0.00691 | 0.0372 | wilson | |
| Risk difference, group 1 minus group 2 | 0.00624 | -0.0178 | 0.0311 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.39 | 0.445 | 4.32 | log | |
| Odds ratio, group 1 over group 2 | 1.4 | 0.438 | 4.44 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Solifenacin Succinate than on Placebo | 160 | 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 | Solifenacin Succinate | Participants received 5 mg solifenacin succinate tablets once a day for 12 weeks. At week 4, based on efficacy and safety and in agreement with the investigator, the dose might be increased to 10 mg (2 tablets of 5 mg) once daily. | 7 | 313 | EG001 |
| Group 2 | Placebo | Participants received matching placebo tablets once a day for 12 weeks. | 5 | 310 | EG000 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- From the first dose of study drug and within 7 days after last dose of study drug (13 weeks).
Source ClinicalTrials.gov
Trial
- Title
- A Study to Assess Efficacy and Safety With Solifenacin Succinate to Improve Urinary Continence After Robotic Assisted Radical Prostatectomy
- NCT number
- NCT01371994
- Phases
- PHASE4
- Conditions
- Urinary Incontinence
- Interventions
- solifenacin succinate, Placebo
- Lead sponsor
- Astellas Pharma Inc
- Results first posted
- 2014-10-09
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01371994?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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