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 @ 11:51 PM
Ignite Modification Date:
2025-12-25 @ 9:46 PM
NCT ID:
NCT03451851
Group ID:
EG003
Title:
Withdrawal and Re-treatment Period-Group 1 (Part 1): Placebo to Guselkumab (Week 16-52)
Description:
Participants who received placebo during PCP were assessed for psoriasis area and severity index (PASI) response at Week 16. Participants who were PASI 90 non-responders at Week 16 received weight-based doses of guselkumab (1.3 mg/kg for BW \<70 kg, 100 mg for BW \>=70 kg) as SC injection at Weeks 16, 20 and then every 8 weeks (q8w) thereafter through Week 52. Participants who were PASI 90 responders at Week 16 stopped treatment until they lost \>= 50 percent (%) of their Week 16 PASI response, at which time they were treated with guselkumab 1.3 mg/kg or 100 mg depending on their body weight followed by a dose 4 weeks later, and then guselkumab q8w thereafter through Week 52. All participants who completed Part 1 of the main study through Week 52 were offered the opportunity to participate in an open-label LTE.
Deaths Number Affected:
0
Deaths Number At Risk:
None
Serious Number Affected:
1
Serious Number At Risk:
23
Other Number Affected:
16
Other Number At Risk:
23
Study:
NCT03451851
Results Section:
NCT03451851
Adverse Events Module:
NCT03451851