Comparison · NCT03397771-7fb8a9de
Litoxetine Oral Capsules vs Placebo Oral Capsules: Number of Subjects 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. Litoxetine Oral Capsules vs Placebo Oral Capsules: Number of Subjects With Treatment-Emergent Adverse Events. Trial comparisons, record NCT03397771-7fb8a9de. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03397771-7fb8a9de
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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 | 0.377 | 0.259 | 0.512 | wilson | |
| Risk in group 2 | 0.345 | 0.199 | 0.527 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0325 | -0.184 | 0.231 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.09 | 0.595 | 2.01 | log | |
| Odds ratio, group 1 over group 2 | 1.15 | 0.447 | 2.97 | log | |
| Number needed to treat, for one more participant with the outcome on Litoxetine Oral Capsules than on Placebo Oral Capsules | 30.7 | 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 | Litoxetine Oral Capsules | oral experimental study medication litoxetine~Litoxetine: oral study medication provided in a dose titration manner | 20 | 53 | OG000 |
| Group 2 | Placebo Oral Capsules | oral comparator~placebo: placebo medication provided in a dose titration manner | 10 | 29 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- PRIMARY
- Title
- Number of Subjects With Treatment-Emergent Adverse Events
- Description
- AE, SAE, AE of special interest occuring after the start of treatment (LTX or PBP)
- Time frame
- from randomisation to treatment completion, an average of 8 weeks
- Population
- The analysis of TEAE was conducted on the Safety Population
Source ClinicalTrials.gov
Trial
- Title
- DBPC Trial to Evaluate the Safety, Tolerability and Efficacy of Oral Litoxetine in Subjects With Urinary Incontinence
- NCT number
- NCT03397771
- Phases
- PHASE1, PHASE2
- Conditions
- Urinary Incontinence
- Interventions
- Litoxetine, placebo
- Lead sponsor
- Ixaltis SA
- Results first posted
- 2020-06-11
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03397771?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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