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 @ 3:00 AM
Ignite Modification Date:
2025-12-26 @ 1:41 AM
NCT ID:
NCT03097133
Group ID:
EG001
Title:
Esketamine 84 mg + SOC
Description:
Participants self-administered esketamine 84 milligram (mg) (1 spray containing esketamine 14 mg in each nostril at 0, 5, 10 minutes using 3 devices on single day) twice per week for 4 weeks on Days 1, 4, 8, 11, 15, 18, 22, 25 along with SOC antidepressant treatment (determined by physician based on clinical judgment and practice guidelines) on Day 1 continued for DB treatment phase. After Day 1, a single dose reduction from esketamine 84 mg to 56 mg was permitted if a participant was unable to tolerate intranasal esketamine 84 mg dose. Participants for whom dose was reduced continued to receive reduced dose for duration of DB treatment phase (Days 1 to 25).
Deaths Number Affected:
0
Deaths Number At Risk:
None
Serious Number Affected:
5
Serious Number At Risk:
114
Other Number Affected:
98
Other Number At Risk:
114
Study:
NCT03097133
Results Section:
NCT03097133
Adverse Events Module:
NCT03097133