Comparison · NCT03753763-sae
Safinamide 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. Safinamide vs Placebo: serious adverse events. Trial comparisons, record NCT03753763-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03753763-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 | 0.0625 | 0.0173 | 0.201 | wilson | |
| Risk in group 2 | 0 | 0 | 0.184 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0625 | -0.127 | 0.201 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | log | a group has no participants with the outcome | |||
| Odds ratio, group 1 over group 2 | log | a cell of the two-by-two table is zero | |||
| Number needed to harm, for one more participant with a serious adverse event on Safinamide than on Placebo | 16 | 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 | Safinamide | Safinamide methanesulfonate film-coated tablets once daily. During the titration period of 2 weeks (Week 1 to Week 2) participants received 1 tablet (100 mg) safinamide, while during the treatment period (Week 3 to Week 12) they received 2 tablets (200 mg) safinamide once-a-day, taken in the morning, in addition to their daily levodopa dose. | 2 | 32 | EG000 |
| Group 2 | Placebo | Safinamide methanesulfonate matching placebo film-coated tablets once daily. Safinamide matching placebo was administered both during the titration period of 2 weeks (Week 1 to Week 2) and during the following period (Week 3 to Week 12), once daily, taken in the morning, in addition to their daily levodopa dose. | 0 | 17 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- At baseline, at interim visits (Weeks 2 - 8, and more precisely at days 14 ± 3, 28 ± 3, 56 ± 3), at End of Treatment visit (EOT) at Week 12 (84 ± 3 days), and at follow-up call at week 14 ( 98 ± 3).
Source ClinicalTrials.gov
Trial
- Title
- Safinamide for Multiple System Atrophy (MSA)
- NCT number
- NCT03753763
- Phases
- PHASE2
- Conditions
- Multiple System Atrophy
- Interventions
- Safinamide Methanesulfonate, Safinamide Methanesulfonate matching placebo
- Lead sponsor
- Zambon SpA
- Results first posted
- 2021-08-24
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03753763?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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