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:
2025-12-26 @ 5:19 PM
Ignite Modification Date:
2025-12-26 @ 5:19 PM
NCT ID:
NCT02425306
Group ID:
EG003
Title:
Arm D:6MHP + polyICLC + Montanide ISA-51 + Cyclophosphamide
Description:
Parts 1 and 2: 200 mcg of 6MHP plus 1 mg of polyICLC emulsified in Montanide ISA-51 adjuvant will be administered on 1, 8, 15, 36, 57 and 78. Cyclophosphamide (50 mg) will be taken orally once a day for 7 days followed by a 7 day rest period. This will be repeated for 5 cycles. Cycles will begin on the following days:
* Day -6 (Cycle 1)
* Day 8 (Cycle 2)
* Day 22 (Cycle 3)
* Day 36 (Cycle 4)
* Day 50 (Cycle 5)
6MHP: 6 melanoma helper vaccine comprised of 6 class II MHC-restricted helper peptides
Montanide ISA-51: Montanide ISA-51 (Incomplete Freund's Adjuvant), local adjuvant
polyICLC: polyICLC, local adjuvant
Cyclophosphamide: Cyclophosphamide, systemic adjuvant
Deaths Number Affected:
0
Deaths Number At Risk:
None
Serious Number Affected:
0
Serious Number At Risk:
32
Other Number Affected:
32
Other Number At Risk:
32
Study:
NCT02425306
Results Section:
NCT02425306
Adverse Events Module:
NCT02425306