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 @ 9:18 PM
Ignite Modification Date:
2025-12-25 @ 7:06 PM
NCT ID:
NCT02782104
Group ID:
EG001
Title:
Esketamine Nasal Spray (OP/MA Phase)
Description:
Participants who entered the OP/MA phase from the IND phase of study NCT02782104, continued on the same dose of esketamine from the IND phase, weekly. Participants who entered from studies NCT02417064, NCT02418585, NCT02493868, NCT02497287, or NCT02782104 administered esketamine nasal spray, 56 mg or 84 mg, once weekly. Participants who entered study NCT02422186 were received esketamine nasal spray (28 mg in Week 1; 28 or 56 mg in Week 2; and 28, 56 or 84 mg in Weeks 3 and 4) once weekly in optimization and maintenance phase (OP/MP). After Week 4 (starting at Week 5), based on the Investigator's clinical judgment, the dose of esketamine for all participants was adjusted based upon efficacy and tolerability.
Deaths Number Affected:
8
Deaths Number At Risk:
None
Serious Number Affected:
212
Serious Number At Risk:
1110
Other Number Affected:
1010
Other Number At Risk:
1110
Study:
NCT02782104
Results Section:
NCT02782104
Adverse Events Module:
NCT02782104