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 @ 3:22 PM
Ignite Modification Date:
2025-12-25 @ 1:40 PM
NCT ID:
NCT03559192
Group ID:
EG001
Title:
Double-blind Treatment + Withdrawal Period: Placebo
Description:
Participants who were responders (30 percent \[%\]) or more improvement on the Montgomery-Asberg Depression Rating Scale (MADRS) total score during the placebo run-in) or non-responders to lead-in placebo group were re-randomized to receive placebo matching to JNJ-67953964 capsules (2 placebo capsules) once daily during double-blind treatment period (up to 6 weeks after lead-in period) in addition to Selective serotonin reuptake inhibitors /Serotonin and norepinephrine reuptake inhibitors (SSRI/SNRI) treatment. Participants who completed the double-blind treatment period prior to the end of Week 11 entered the withdrawal period where they were treated with placebo for 2 weeks.
Deaths Number Affected:
0
Deaths Number At Risk:
None
Serious Number Affected:
1
Serious Number At Risk:
84
Other Number Affected:
10
Other Number At Risk:
84
Study:
NCT03559192
Results Section:
NCT03559192
Adverse Events Module:
NCT03559192