Comparison · NCT03600376-a5ce6e79
Ryanodex and Standard of Care vs Standard of Care Only (SOC): Cumulative Incidence of Recovery of Level of Consciousness Defined as a Glasgow Coma Scale (GCS) GCS ≥ 13 [Time Frame: 90 Minutes Post-randomization]
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. Ryanodex and Standard of Care vs Standard of Care Only (SOC): Cumulative Incidence of Recovery of Level of Consciousness Defined as a Glasgow Coma Scale (GCS) GCS ≥ 13 [Time Frame: 90 Minutes Post-randomization]. Trial comparisons, record NCT03600376-a5ce6e79. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03600376-a5ce6e79
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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 | 0.444 | 0.189 | 0.733 | wilson | |
| Risk in group 2 | 0.25 | 0.0715 | 0.591 | wilson | |
| Risk difference, group 1 minus group 2 | 0.194 | -0.232 | 0.534 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.78 | 0.436 | 7.25 | log | |
| Odds ratio, group 1 over group 2 | 2.4 | 0.303 | 19 | log | |
| Number needed to treat, for one more participant with the outcome on Ryanodex and Standard of Care than on Standard of Care Only (SOC) | 5.14 | 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 and Standard of Care | In addition to Standard of Care measures, Ryanodex (dantrolene sodium) for injectable suspension; 250 mg/vial will be administered.~Ryanodex and Standard of Care: Ryanodex to be administered as a rapid IV push | 4 | 9 | OG000 |
| Group 2 | Standard of Care Only (SOC) | Standard of Care treatment will consist of the immediate start of cooling measures.~Standard of Care: Body cooling measures and supportive measures | 2 | 8 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- PRIMARY
- Title
- Cumulative Incidence of Recovery of Level of Consciousness Defined as a Glasgow Coma Scale (GCS) GCS ≥ 13 [Time Frame: 90 Minutes Post-randomization]
- Description
The GCS is a validated and reliable scale to evaluate level of consciousness in patients with acute brain injury. The scale assesses 3 functions: Eye Opening, Verbal Response, and Motor Response. GCS scores range from 15 (best) to 3 (worst).
- Time frame
- 90 minutes post-randomization
- Population
Source ClinicalTrials.gov
Trial
- Title
- Study to Assess the Efficacy and Safety of Ryanodex as Adjuvant Treatment in Subjects With EHS
- NCT number
- NCT03600376
- Phases
- PHASE3
- Conditions
- Exertional Heat Stroke
- Interventions
- Ryanodex and Standard of Care, Standard of Care
- Lead sponsor
- Eagle Pharmaceuticals, Inc.
- Results first posted
- 2021-04-26
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03600376?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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