Comparison · NCT02720744-sae
FT218 9g Group vs Placebo 9g Group: 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. FT218 9g Group vs Placebo 9g Group: serious adverse events. Trial comparisons, record NCT02720744-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02720744-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 | 0.013 | 0.0023 | 0.07 | wilson | |
| Risk in group 2 | 0 | 0 | 0.0458 | wilson | |
| Risk difference, group 1 minus group 2 | 0.013 | -0.0341 | 0.07 | 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 FT218 9g Group than on Placebo 9g Group | 77 | 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 | FT218 9g Group | Patients treated with FT218 who completed the 9g dosing period | 1 | 77 | EG000 |
| Group 2 | Placebo 9g Group | Patients treated with FT218 who completed the 9g dosing period | 0 | 80 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- AE (adverse event) data were obtained at all study visits (scheduled or unscheduled) from the time of the signing of informed consent until seven days after the last dose of study drug, at 14 weeks.
Source ClinicalTrials.gov
Trial
- Title
- Once-Nightly Sodium Oxybate for Treatment of Excessive Daytime Sleepiness and Cataplexy in Narcolepsy
- NCT number
- NCT02720744
- Phases
- PHASE3
- Conditions
- Excessive Daytime Sleepiness, Cataplexy, Narcolepsy
- Interventions
- FT218, Placebo
- Lead sponsor
- Avadel
- Results first posted
- 2022-03-22
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02720744?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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