Event Group
Event Groups are part of the Adverse Events Module within the Results Section. They provide a way to organize and summarize adverse event data by grouping related events together.
Each Event Group typically represents a category or class of adverse events and includes statistical information such as the number of participants affected and at risk for different event types: deaths, serious events, and other events.
Event Group path is as follows:
Study -> Results Section -> Adverse Events Module -> Event Group
Event Group
Ignite Creation Date:
2025-12-25 @ 3:04 AM
Ignite Modification Date:
2025-12-26 @ 1:43 AM
NCT ID:
NCT03189433
Group ID:
EG000
Title:
Ryanodex + Standard of Care
Description:
Ryanodex (dantrolene sodium) 50 mg/mL suspension to be administered as a rapid IV push of 2.5 mg/kg, added to Standard of Care (SOC). SOC is defined as efficient body cooling by physical methods and supportive measures \[ice packs, evaporative cooling(application of room temperature water via mist with use of a fan\], benzodiazepines to ameliorate shivering, IV fluids, respiratory support, and other treatments deemed necessary to treat complications or comorbidities\]. Administer a single dose of Ryanodex. If a subject does not show an adequate clinical response within 10 - 30 minutes post-dose, a second IV bolus dose of 2.5 mg/kg may be administered.
Ryanodex (dantrolene sodium) for injectable suspension: Ryanodex (dantrolene sodium) for injectable suspension, 250 mg/vial to be reconstituted in 5 mL of sterile water for injection to yield a 50 mg/mL suspension that will be administered as a rapid IV push of 2.5 mg/mL.
Deaths Number Affected:
0
Deaths Number At Risk:
None
Serious Number Affected:
0
Serious Number At Risk:
0
Other Number Affected:
0
Other Number At Risk:
0
Study:
NCT03189433
Results Section:
NCT03189433
Adverse Events Module:
NCT03189433