Comparison · NCT04819438-sae
Riluzole Orodispersible Film (Test) vs Rilutek® (Reference): 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. Riluzole Orodispersible Film (Test) vs Rilutek® (Reference): serious adverse events. Trial comparisons, record NCT04819438-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT04819438-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 | 0 | 0.0688 | wilson | |
| Risk in group 2 | 0 | 0 | 0.0676 | wilson | |
| Risk difference, group 1 minus group 2 | 0 | -0.0676 | 0.0688 | 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 | from the risk difference interval | the two groups' risks are equal |
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 | Riluzole Orodispersible Film (Test) | The subjects were treated with one orodispersible film containing 50 mg of riluzole in two out of the four study periods according to the randomisation sequence~Riluzole 50 mg Oral Film: Before each administration, the subjects drank 20 mL of still mineral water in order to wet their mouth. Afterwards, using gloves, the investigator or deputy took the orodispersible film (32.0x22.0 mm) out of the provided pouch and placed the product directly on the top surface (dorsal aspect) of the subjects' tongue. | 0 | 52 | EG000 |
| Group 2 | Rilutek® (Reference) | The subjects were treated with one film-coated table containing 50 mg of riluzole in two out of the four study periods according to the randomisation sequence~Rilutek 50Mg Tablet: One film-coated tablet was swallowed (without chewing) with 150 mL of still mineral water. | 0 | 53 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- 36 days
Source ClinicalTrials.gov
Trial
- Title
- Riluzole Orodispersible Film Replicate Bioavailability
- NCT number
- NCT04819438
- Phases
- PHASE1
- Conditions
- Healthy Participants
- Interventions
- Riluzole 50 mg orodispersible film, Rilutek® 50 mg riluzole tablets
- Lead sponsor
- Cross Research S.A.
- Results first posted
- 2025-05-02
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT04819438?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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