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 @ 4:55 AM
Ignite Modification Date:
2025-12-26 @ 3:55 AM
NCT ID:
NCT04829318
Group ID:
EG000
Title:
Esketamine + Oral AD
Description:
Participants (who received esketamine nasal spray in study 54135419TRD3013 \[NCT04338321\] through Week 30 \[every 2 weeks dosing\] or Week 31 \[once weekly dosing\],and completed the maintenance phase at Week 32), received flexible dose of esketamine nasal spray 28 milligrams (mg) (one spray to each nostril at 0 minute), 56 mg (one spray to each nostril at 0 and 5 minutes) or 84 mg (one spray to each nostril at 0, 5 and 105 minutes) once weekly or every 2 weeks from Day 1 (Week 32 visit of study 54135419TRD3013 until week 104 along with oral AD, serotonin-norepinephrine reuptake inhibitor/selective serotonin reuptake inhibitor (SSRI/SNRI) in this long-term extension (LTE) study. Time 0 minute signified time of first esketamine nasal spray administration to 1 nostril. Esketamine nasal devices contained a total of 28 mg esketamine per device (2 sprays). Only one device was used at a timepoint.
Deaths Number Affected:
1
Deaths Number At Risk:
None
Serious Number Affected:
11
Serious Number At Risk:
183
Other Number Affected:
145
Other Number At Risk:
183
Study:
NCT04829318
Results Section:
NCT04829318
Adverse Events Module:
NCT04829318