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 @ 4:29 AM
Ignite Modification Date:
2025-12-26 @ 3:32 AM
NCT ID:
NCT02839720
Group ID:
EG000
Title:
Treatment (Selumetinib)
Description:
Participants receive selumetinib capsules at a dose of 50mg by mouth (PO) twice daily (BID) every 12 hours with option to increase to 75mg PO BID after first cycle. Treatment repeats every 28 days (1 cycle = 28 days) for up to 24 cycles in the absence of disease progression or unacceptable toxicity. Participants who experience a volume decrease in the target cutaneous neurofibromas may continue treatment for 12 additional cycles. Volume decrease defined as a greater than or equal to 20 percent decrease in the sum of the volumes of the smaller and/or larger target cutaneous neurofibromas.
Deaths Number Affected:
0
Deaths Number At Risk:
None
Serious Number Affected:
5
Serious Number At Risk:
11
Other Number Affected:
11
Other Number At Risk:
11
Study:
NCT02839720
Results Section:
NCT02839720
Adverse Events Module:
NCT02839720