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 @ 6:51 PM
Ignite Modification Date:
2025-12-25 @ 4:23 PM
NCT ID:
NCT03450057
Group ID:
EG000
Title:
Single Arm Trial Receiving Daratumumab With Dexamethasone (DaraD)
Description:
Daratumumab:
Daratumumab was given at a dose of 16 mg/kg administered as an intravenous (IV) infusion at weekly intervals (QW) for 8 weeks, then every 2 weeks (Q2W) for an additional 16 weeks, then every 4 weeks (Q4W) thereafter. Subjects received pre-infusion medications before infusions to mitigate potential infused-related reactions (IRRs).
Dexamethasone:
Dexamethasone was administered at 40 mg (20 mg for patients \> 75 years of age) orally, once daily on Days 1, 8, 15, and 22 of each 28-day treatment cycle.
Deaths Number Affected:
17
Deaths Number At Risk:
None
Serious Number Affected:
11
Serious Number At Risk:
38
Other Number Affected:
32
Other Number At Risk:
38
Study:
NCT03450057
Results Section:
NCT03450057
Adverse Events Module:
NCT03450057