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 @ 11:52 PM
Ignite Modification Date:
2025-12-25 @ 9:47 PM
NCT ID:
NCT02657551
Group ID:
EG000
Title:
MTC Cohort
Description:
Regorafenib dose is dependent on observed significant drug related toxicities (SDRT) over cycle 1. SDRT is defined as any grade 2 or higher toxicity. For cycle 1, participants receive 80mg (2\*40mg tablets) for one week. If no SDRTs, then dose is escalated to 120mg (3 tablets) for week two. Again, if no SDRTs, then dose is escalated to 160mg (4 tablets) for week three. For cycle 2-onwards, each participant received the highest tolerated dose on cycle 1. Each cycle is one daily dose for 3 weeks and 1 week off. No actual dose-escalation occurred within cycle 1 despite this potential per protocol; all participants received 80mg.
Deaths Number Affected:
4
Deaths Number At Risk:
None
Serious Number Affected:
5
Serious Number At Risk:
8
Other Number Affected:
8
Other Number At Risk:
8
Study:
NCT02657551
Results Section:
NCT02657551
Adverse Events Module:
NCT02657551