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 @ 4:39 PM
Ignite Modification Date:
2025-12-25 @ 2:29 PM
NCT ID:
NCT04551066
Group ID:
EG001
Title:
Placebo Plus Ruxolitinib
Description:
Participants were randomized to receive placebo plus ruxolitinib beginning on Day 1 and continued on this regimen until they left the study. Participants with a Baseline platelet count ≥100 × 10\^9/Liter received ruxolitinib 15 mg BID. Participants with a Baseline platelet count of 50 to \< 100 × 10\^9/Liters inclusive received ruxolitinib 5 mg BID. Participants were also stratified according to the DIPSS risk category (high versus intermediate-2 versus intermediate-1). Participants received matching placebo at a dose of 5 mg QD. After 24 weeks, participants randomized to receive placebo plus ruxolitinib could have switched to treatment with parsaclisib plus ruxolitinib per the regimen received during the first 24 weeks of the study. Treatment continued for as long as the regimen was tolerated and the participant did not meet any discontinuation criteria.
Deaths Number Affected:
3
Deaths Number At Risk:
None
Serious Number Affected:
18
Serious Number At Risk:
127
Other Number Affected:
109
Other Number At Risk:
127
Study:
NCT04551066
Results Section:
NCT04551066
Adverse Events Module:
NCT04551066