Comparison · NCT04940390-sae
STS101 5.2 mg vs STS101 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. STS101 5.2 mg vs STS101 Placebo: serious adverse events. Trial comparisons, record NCT04940390-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT04940390-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 | 0.0041 | 0.0014 | 0.012 | wilson | |
| Risk in group 2 | 0 | 0 | 0.00524 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0041 | -0.0018 | 0.012 | 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 STS101 5.2 mg than on STS101 Placebo | 244 | 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 | STS101 5.2 mg | Subjects received a single oral dose of STS101 (dihydroergotamine nasal powder) 5.2 mg | 3 | 731 | EG000 |
| Group 2 | STS101 Placebo | Subjects received a single oral dose of Placebo for STS101 (dihydroergotamine nasal powder) | 0 | 729 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
Adverse events (AEs) were collected from the date of randomization up to the end of subject's participation in the study which was no later than Study Day 66. Serious adverse events (SAEs) were collected from the date of informed consent up to the end of subject's participation in the study which was no later than Study Day 66.
Source ClinicalTrials.gov
Trial
- Title
- A Randomized, Double-Blind, Parallel Group, Placebo-Controlled Study to Assess STS101 in the Acute Treatment of Migraine
- NCT number
- NCT04940390
- Phases
- PHASE3
- Conditions
- Migraine, Migraine With Aura, Migraine Without Aura
- Interventions
- Dihydroergotamine, Placebo
- Lead sponsor
- Satsuma Pharmaceuticals, Inc.
- Results first posted
- 2023-07-24
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT04940390?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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