Comparison · NCT04163185-sae
AXS-07 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-07 vs Placebo: serious adverse events. Trial comparisons, record NCT04163185-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT04163185-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 | 0.00000000000000000173 | 0.0267 | wilson | |
| Risk in group 2 | 0 | 0 | 0.0262 | wilson | |
| Risk difference, group 1 minus group 2 | 0 | -0.0262 | 0.0267 | 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
Group 2 names the comparator: placebo.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | AXS-07 | Taken once upon migraine~AXS-07 (MoSEIC meloxicam and rizatriptan): AXS-07 tablet taken once upon the earliest onset of migraine pain. | 0 | 140 | EG000 |
| Group 2 | Placebo | Taken once upon migraine~Placebo: Placebo tablet taken once upon the earliest onset of migraine pain. | 0 | 143 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
Adverse events were collected on or after the dosing date and included any new event or ongoing event that worsened in severity after the date of dosing. Adverse events were collected up to 5 days after the last study visit, up to 12 days per participant.
Source ClinicalTrials.gov
Trial
- Title
- Initiating Early Control of Migraine Pain and Associated Symptoms
- NCT number
- NCT04163185
- Phases
- PHASE3
- Conditions
- Migraine
- Interventions
- AXS-07 (MoSEIC meloxicam and rizatriptan), Placebo
- Lead sponsor
- Axsome Therapeutics, Inc.
- Results first posted
- 2026-01-28
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT04163185?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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