Comparison · NCT03627468-sae
Gel, 5% vs Gel, 15%: 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. Gel, 5% vs Gel, 15%: serious adverse events. Trial comparisons, record NCT03627468-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03627468-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 | 0.0098 | 0.00173 | 0.0535 | wilson | |
| Risk in group 2 | 0.0203 | 0.00792 | 0.051 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0105 | -0.0423 | 0.0349 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.483 | 0.0547 | 4.26 | log | |
| Odds ratio, group 1 over group 2 | 0.478 | 0.0527 | 4.33 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Gel, 5% than on Gel, 15% | 95.2 | 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 | Gel, 5% | Sofpironium Bromide Gel, 5%, applied topically to each axilla once daily for 48 weeks~Sofpironium Bromide Gel, 5%: Sofpironium Bromide Gel, 5% | 1 | 102 | EG000 |
| Group 2 | Gel, 15% | Sofpironium Bromide Gel, 15%, applied topically to each axilla once daily for 48 weeks~Sofpironium Bromide Gel, 15%: Sofpironium Bromide Gel, 15% | 4 | 197 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Each Subject's AE data was collected over approximately 52 weeks of participation, including 48 weeks of investigational treatment.
Source ClinicalTrials.gov
Trial
- Title
- A Safety Study of BBI-4000 Gel in Patients With Axillary Hyperhidrosis
- NCT number
- NCT03627468
- Phases
- PHASE3
- Conditions
- Primary Axillary Hyperhidrosis
- Interventions
- Sofpironium Bromide Gel, 5%, Sofpironium Bromide Gel, 15%
- Lead sponsor
- Botanix Pharmaceuticals
- Results first posted
- 2023-05-19
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03627468?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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