Comparison · NCT03521934-sae
Sotagliflozin 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. Sotagliflozin vs Placebo: serious adverse events. Trial comparisons, record NCT03521934-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03521934-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 | 0.388 | 0.35 | 0.428 | wilson | |
| Risk in group 2 | 0.411 | 0.372 | 0.45 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0224 | -0.0772 | 0.0326 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.946 | 0.824 | 1.09 | log | |
| Odds ratio, group 1 over group 2 | 0.911 | 0.724 | 1.15 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Sotagliflozin than on Placebo | 44.7 | 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 | Sotagliflozin | Sotagliflozin 200 mg tablet once daily, with possible up-titration in the first 8 months to 400 mg, for up to 21.2 months. | 235 | 605 | EG000 |
| Group 2 | Placebo | Matching placebo to sotagliflozin 200 mg once daily, with possible up-titration in the first 8 months to matching placebo to sotagliflozin 400 mg, for up to 21.6 months. | 251 | 611 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Source ClinicalTrials.gov
Trial
- Title
- Effect of Sotagliflozin on Cardiovascular Events in Participants With Type 2 Diabetes Post Worsening Heart Failure (SOLOIST-WHF Trial)
- NCT number
- NCT03521934
- Phases
- PHASE3
- Conditions
- Heart Failure, Type 2 Diabetes Mellitus
- Interventions
- Sotagliflozin, Placebo
- Lead sponsor
- Lexicon Pharmaceuticals
- Results first posted
- 2022-10-28
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03521934?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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