Comparison · NCT03701399-sae
Troriluzole 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. Troriluzole vs Placebo: serious adverse events. Trial comparisons, record NCT03701399-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03701399-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 | 0.0556 | 0.0257 | 0.116 | wilson | |
| Risk in group 2 | 0.0734 | 0.0377 | 0.138 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0178 | -0.0892 | 0.0523 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.757 | 0.272 | 2.11 | log | |
| Odds ratio, group 1 over group 2 | 0.743 | 0.249 | 2.22 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Troriluzole than on Placebo | 56.1 | 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 | Troriluzole | Randomization phase (Randomization through Week 48) Participants received starting dose of troriluzole 140 milligrams (mg) capsules orally once daily for first 4 weeks, followed by 200 mg once daily for the remaining 44 weeks of 48-week duration of the double-blind randomization phase. | 6 | 108 | EG000 |
| Group 2 | Placebo | Randomization phase (Randomization through Week 48) Participants received troriluzole matching placebo capsules orally once daily for 48 weeks duration of the double-blind randomization phase. | 8 | 109 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
For Adverse events (AEs): From first dose of study drug up to Week 48 plus 30 days (maximum duration: 52 weeks) For All-cause mortality: From randomization up to Week 48 plus 30 days (maximum duration: 52 weeks)
Source ClinicalTrials.gov
Trial
- Title
- Troriluzole in Adult Participants With Spinocerebellar Ataxia
- NCT number
- NCT03701399
- Phases
- PHASE3
- Conditions
Spinocerebellar Ataxias, Spinocerebellar Ataxia Type 1, Spinocerebellar Ataxia Type 2, Spinocerebellar Ataxia Type 3, Spinocerebellar Ataxia Type 6, Spinocerebellar Ataxia Type 7, Spinocerebellar Ataxia Type 8, Spinocerebellar Ataxia Type 10
- Interventions
- troriluzole, Placebo
- Lead sponsor
- Biohaven Pharmaceuticals, Inc.
- Results first posted
- 2025-02-10
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03701399?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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