Comparison · NCT03471767-sae
AXS-05 vs Bupropion SR: 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 SR: serious adverse events. Trial comparisons, record NCT03471767-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03471767-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 | 0.0645 | 0.0179 | 0.207 | wilson | |
| Risk in group 2 | 0.037 | 0.00657 | 0.183 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0275 | -0.126 | 0.173 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.74 | 0.167 | 18.2 | log | |
| Odds ratio, group 1 over group 2 | 1.79 | 0.153 | 20.9 | log | |
| Number needed to harm, for one more participant with a serious adverse event on AXS-05 than on Bupropion SR | 36.4 | from the risk difference interval | the interval includes no difference |
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: Dextromethorphan Immediate Release + Bupropion Sustained Release: Take 1 tablet two times per day, at least 8 hours apart and 1 hour prior to a meal, and 2 hours after a meal for 4 weeks. | 2 | 31 | EG000 |
| Group 2 | Bupropion SR | Bupropion SR: Bupropion Sustained Release: Take 1 tablet two times per day, at least 8 hours apart and 1 hour prior to a meal, and 2 hours after a meal for 4 weeks | 1 | 27 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Approximately four weeks
Source ClinicalTrials.gov
Trial
- Title
- AXS-05 Phase II Trial on Smoking Behavior
- NCT number
- NCT03471767
- Phases
- PHASE2
- Conditions
- Smoking Cessation, Smoking, Cigarette, Nicotine Dependence
- Interventions
- AXS-05, Bupropion SR
- Lead sponsor
- James Davis
- Results first posted
- 2022-10-12
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03471767?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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