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 @ 2:09 PM
Ignite Modification Date:
2025-12-25 @ 12:50 PM
NCT ID:
NCT02815995
Group ID:
EG006
Title:
Alveolar Soft-part Sarcoma Group
Description:
Age group ≥12 and \<18: Dosages of study drugs to be determined (TBD).
Age group ≥ 18: Durvalumab 1500 mg and Tremelimumab 75 mg every 4 weeks for 4 cycles followed by durvalumab 1500 mg every 4 weeks for up to 8 additional cycles.
Combination of both agents administered every 4 weeks for a maximum of 4 doses, after which Durvalumab continues as a single agent every 4 weeks till progression or unacceptable toxicity for a maximum of 8 additional doses.
Durvalumab: Age group ≥ 18: Durvalumab 1500 mg by vein every 4 weeks for 4 cycles. After Week 16, participant may continue to receive durvalumab alone by vein for an additional 32 weeks (8 doses).
Tremelimumab: Age group ≥ 18: Tremelimumab 75 mg every 4 weeks for 4 cycles.
Deaths Number Affected:
2
Deaths Number At Risk:
None
Serious Number Affected:
6
Serious Number At Risk:
10
Other Number Affected:
4
Other Number At Risk:
10
Study:
NCT02815995
Results Section:
NCT02815995
Adverse Events Module:
NCT02815995