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 @ 4:31 AM
Ignite Modification Date:
2025-12-26 @ 3:33 AM
NCT ID:
NCT03074318
Group ID:
EG000
Title:
Phase 1 - 1.5 mg/m^2 Trabectedin
Description:
Avelumab will be administered every 2 weeks. Trabectedin will be administered every 3 weeks for the first two doses (Week 1 and Week 4), and then every four weeks (Week 7, Week 11,…) moving forward. After Cycle 2 of trabectedin, dosing may extend to every 5 weeks at investigator discretion, for management of trabectedin-associated toxicity only. Delays of trabectedin beyond 5 weeks may be allowed but require written approval from the Sponsor-Investigator. On days where both drugs are scheduled to be administered, avelumab will be administered first. This will continue until unacceptable toxicity or confirmed disease progression.
Avelumab: Given IV
Trabectedin: Given IV
Deaths Number Affected:
4
Deaths Number At Risk:
None
Serious Number Affected:
2
Serious Number At Risk:
6
Other Number Affected:
6
Other Number At Risk:
6
Study:
NCT03074318
Results Section:
NCT03074318
Adverse Events Module:
NCT03074318