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 @ 6:34 PM
Ignite Modification Date:
2025-12-25 @ 4:04 PM
NCT ID:
NCT02065557
Group ID:
EG004
Title:
Integrated Study (Main + Japan Sub- Study): M-HD
Description:
Participants demonstrating a clinical response per PMS (defined as a decrease in PMS ≥ 2 points and ≥ 30% from Baseline) at Week 8 randomized to adalimumab maintenance high dose (0.6 mg/kg \[maximum dose of 40 mg\] ew). Participants were to continue their blinded treatment during the maintenance period until Week 52 unless they had ≥ 2 flares and got open label adalimumab rescue therapy after the second flare.
TEAEs during maintenance period: events with an onset date on or after first dose date of study drug in maintenance period and prior to re-randomization due to first disease flare if applicable and up to 70 days after the last dose date of the study drug in maintenance period. Events with an onset date on or after the first dose date in long-term follow-up study M10-870 (NCT02632175) are excluded. Mean duration of treatment was 241.0 days.
Deaths Number Affected:
0
Deaths Number At Risk:
None
Serious Number Affected:
5
Serious Number At Risk:
36
Other Number Affected:
20
Other Number At Risk:
36
Study:
NCT02065557
Results Section:
NCT02065557
Adverse Events Module:
NCT02065557