Comparison · NCT04072835-sae
Etripamil vs Not Treated: 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. Etripamil vs Not Treated: serious adverse events. Trial comparisons, record NCT04072835-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT04072835-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 | 0.0676 | 0.0488 | 0.093 | wilson | |
| Risk in group 2 | 0.0359 | 0.0238 | 0.0537 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0317 | 0.00576 | 0.0598 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.88 | 1.12 | 3.18 | log | |
| Odds ratio, group 1 over group 2 | 1.95 | 1.12 | 3.37 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Etripamil than on Not Treated | 31.5 | 16.7 | 174 | from the risk difference interval |
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 | Etripamil | Participants self-administered etripamil NS 70 mg and after the implementation of protocol amendment 2.1, the participants had the option to administer a second dose of etripamil 70 mg 10 minutes later, if PSVT symptoms persisted. | 34 | 503 | EG000 |
| Group 2 | Not Treated | Participants not treated with etripamil NS. Participants were still waiting for their first perceived PSVT episode when this event-driven study was ended by the sponsor. | 22 | 613 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- From Baseline until a maximum of 4 episodes of perceived PSVT are treated with study drug, up to a maximum duration of 40 months.
Source ClinicalTrials.gov
Trial
- Title
- Safety Study of Etripamil Nasal Spray for Patients With Paroxysmal Supraventricular Tachycardia. NODE-303
- NCT number
- NCT04072835
- Phases
- PHASE3
- Conditions
- Paroxysmal Supraventricular Tachycardia
- Interventions
- Etripamil NS
- Lead sponsor
- Milestone Pharmaceuticals Inc.
- Results first posted
- 2024-05-23
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT04072835?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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