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:
2025-12-24 @ 4:18 PM
Ignite Modification Date:
2025-12-25 @ 2:15 PM
NCT ID:
NCT04681066
Group ID:
EG003
Title:
Placebo (1.25, 0.625, or 0.3125 mL/kg)
Description:
Patients randomized to placebo received one of three following volumes (1.25 mL/kg, 0.625 mL/kg, and 0.3125 mL/kg. Although patients are randomly assigned to the three volumes, all patients randomized to placebo are analyzed together as one arm. Placebo was administered intravenously over 4 hours at a constant rate of infusion. Infusions were administered every 24 hours (±1 hours) for three consecutive days for a total of 3 doses.
Placebo: Matching Placebo is administered as an IV infusion and is supplied as a sterile, non-pyrogenic emulsion carrier containing no active pharmaceutical ingredient. Placebo is supplied as an 80 mL fill in a 100 mL single-use vial. Placebo contains the same ingredients as Auxora except that it does not contain CM4620.
Deaths Number Affected:
0
Deaths Number At Risk:
None
Serious Number Affected:
6
Serious Number At Risk:
53
Other Number Affected:
23
Other Number At Risk:
53
Study:
NCT04681066
Results Section:
NCT04681066
Adverse Events Module:
NCT04681066