Comparison · NCT04019704-sae
AXS-05 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
Cite this record
ConductScience Library. AXS-05 vs Placebo: serious adverse events. Trial comparisons, record NCT04019704-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT04019704-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 | 0.00617 | 0.00109 | 0.0341 | wilson | |
| Risk in group 2 | 0 | 0 | 0.0229 | wilson | |
| Risk difference, group 1 minus group 2 | 0.00617 | -0.0173 | 0.0341 | 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 AXS-05 than on Placebo | 162 | 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 | AXS-05 | AXS-05 (bupropion and dextromethorphan) oral tablets~AXS-05: Oral AXS-05 tablets, taken daily for 6 weeks. | 1 | 162 | EG000 |
| Group 2 | Placebo | Placebo oral tablets to match AXS-05~Placebo: Placebo to match oral AXS-05 tablets, taken daily for 6 weeks. | 0 | 164 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Treatment-emergent adverse events (TEAEs) were AEs with an onset date on or after the date of first dose. TEAEs were collected through 30 days after the last dose.
Source ClinicalTrials.gov
Trial
- Title
- A Trial of AXS-05 in Patients With Major Depressive Disorder
- NCT number
- NCT04019704
- Phases
- PHASE3
- Conditions
- Depression, Major Depressive Disorder
- Interventions
- AXS-05, Placebo
- Lead sponsor
- Axsome Therapeutics, Inc.
- Results first posted
- 2022-10-12
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT04019704?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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