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 @ 3:54 AM
Ignite Modification Date:
2025-12-26 @ 2:44 AM
NCT ID:
NCT01198002
Group ID:
EG016
Title:
LY 120 mg Q4W to LY 90 mg Q2W (Week 16), Follow-up Period
Description:
A loading dose of 240 mg of LY2127399 (2 injections of 120 mg) followed by maintenance dosing of 120 mg of LY2127399 administered SC Q4W for 16 weeks during Treatment Period 1. For blinding purposes, participants alternated injections of LY2127399 and injections of placebo Q2W.
At Week 16, Week 16 NR received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the 52-week Treatment Period 1.
During non-blinded Treatment Period 2, Week 16 NR received 1 injection of 90 mg of LY2127399.
The Post-Treatment Follow-Up Period started after Week 100 or the early discontinuation visit and lasted up to 48 weeks following the last injection of study treatment.
Deaths Number Affected:
None
Deaths Number At Risk:
None
Serious Number Affected:
5
Serious Number At Risk:
52
Other Number Affected:
10
Other Number At Risk:
52
Study:
NCT01198002
Results Section:
NCT01198002
Adverse Events Module:
NCT01198002