Comparison · NCT02513095-sae
Ryanodex vs Standard of Care Only (SOC): serious adverse events
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
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ConductScience Library. Ryanodex vs Standard of Care Only (SOC): serious adverse events. Trial comparisons, record NCT02513095-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02513095-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 | 0.235 | 0.0956 | 0.473 | wilson | |
| Risk in group 2 | 0.176 | 0.0619 | 0.41 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0588 | -0.214 | 0.322 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.33 | 0.35 | 5.08 | log | |
| Odds ratio, group 1 over group 2 | 1.44 | 0.269 | 7.68 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Ryanodex than on Standard of Care Only (SOC) | 17 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: standard of care.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Ryanodex | Ryanodex (dantrolene sodium) for injectable suspension administered as an IV bolus, in addition to standard of care (SOC) treatment.~Dantrolene sodium for injectable suspension: Ryanodex will be administered as a rapid IV push as a single doses of 2 mg/kg or as 1 mg/kg. | 4 | 17 | EG000 |
| Group 2 | Standard of Care Only (SOC) | Standard of Care (SOC) treatment only, consisting of body cooling and supportive measures implemented immediately. | 3 | 17 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- .Up to 30 days post-discharge.
Source ClinicalTrials.gov
Trial
- Title
- Efficacy and Safety of Ryanodex® (EGL-4104) as Adjuvant Treatment in Subjects With Exertional Heat Stroke (EHS)
- NCT number
- NCT02513095
- Phases
- PHASE2
- Conditions
- Heat Stroke
- Interventions
- Dantrolene sodium for injectable suspension
- Lead sponsor
- Eagle Pharmaceuticals, Inc.
- Results first posted
- 2017-05-09
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02513095?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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