Comparison · NCT04410991-sae
Teriflunomide 14 mg vs Tolebrutinib 60 mg: 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. Teriflunomide 14 mg vs Tolebrutinib 60 mg: serious adverse events. Trial comparisons, record NCT04410991-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT04410991-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 | 0.082 | 0.0601 | 0.111 | wilson | |
| Risk in group 2 | 0.11 | 0.0839 | 0.142 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0276 | -0.0667 | 0.0112 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.748 | 0.499 | 1.12 | log | |
| Odds ratio, group 1 over group 2 | 0.726 | 0.464 | 1.14 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Teriflunomide 14 mg than on Tolebrutinib 60 mg | 36.3 | 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 | Teriflunomide 14 mg | Participants received teriflunomide 14 mg tablet orally QD along with a placebo matched to tolebrutinib orally QD up to approximately 48 months. | 37 | 451 | EG000 |
| Group 2 | Tolebrutinib 60 mg | Participants received tolebrutinib 60 mg tablet orally QD along with a placebo matched to teriflunomide orally QD up to approximately 46 months. | 49 | 447 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
From first dose of study intervention (Day 1) up to the earliest of either 10 days post last dose, death or last contact; up to approximately 48 months. Deaths were collected from baseline (Day 1) up to end of follow-up, approximately 48 months.
Source ClinicalTrials.gov
Trial
- Title
- Relapsing Forms of Multiple Sclerosis (RMS) Study of Bruton's Tyrosine Kinase (BTK) Inhibitor Tolebrutinib (SAR442168) (GEMINI 2)
- NCT number
- NCT04410991
- Phases
- PHASE3
- Conditions
- Relapsing Multiple Sclerosis
- Interventions
- Tolebrutinib, Teriflunomide HMR1726, Placebo to match Tolebrutinib, Placebo to match Teriflunomide
- Lead sponsor
- Sanofi
- Results first posted
- 2025-06-18
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT04410991?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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