Comparison · NCT03595579-sae
AXS-05 vs Bupropion: 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 Bupropion: serious adverse events. Trial comparisons, record NCT03595579-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03595579-sae
On this page
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 | 0.00000000000000000694 | 0.0741 | wilson | |
| Risk in group 2 | 0 | 0.00000000000000000694 | 0.0741 | wilson | |
| Risk difference, group 1 minus group 2 | 0 | -0.0741 | 0.0741 | 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 | AXS-05 | AXS-05: AXS-05 taken twice daily for 6 weeks. | 0 | 48 | EG000 |
| Group 2 | Bupropion | Bupropion: Bupropion taken twice daily for 6 weeks. | 0 | 48 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Adverse events were collected from the time of signing the ICF through 30 days after the last study visit or Early Termination (ET), whichever occurred first, an average of 11 weeks per participant.
Source ClinicalTrials.gov
Trial
- Title
- Assessing Symptomatic Clinical Episodes in Depression
- NCT number
- NCT03595579
- Phases
- PHASE2
- Conditions
- Major Depressive Disorder
- Interventions
- AXS-05, Bupropion
- Lead sponsor
- Axsome Therapeutics, Inc.
- Results first posted
- 2021-09-24
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03595579?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.
For software
Read this comparison from software.
The record is JSON. No key.
GET https://conductscience.org/api/comparisons/v1/NCT03595579-sae