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 @ 6:54 PM
Ignite Modification Date:
2025-12-25 @ 4:27 PM
NCT ID:
NCT01338857
Group ID:
EG000
Title:
Sorafenib (Nexavar)
Description:
Sorafenib will be administered orally BID (approximately every 12 hours). A cycle is 28 days w/o interruption between cycles. Patients may receive up to a total of 12 cycles provided that no off-protocol or off-study criteria are met.
Children/adolescents (\< 18 years of age, non-NF1): 200 mg/m2/dose PO twice daily (rounded to the nearest 50 mg increment) to a maximum of 400 mg PO twice daily
Adults (greater than or equal to 18 years of age, non-NF1): 400 mg PO twice daily
NF1 patients: 80mg/m2/dose PO 2x daily to max of 150mg PO 2x daily.
Deaths Number Affected:
None
Deaths Number At Risk:
None
Serious Number Affected:
0
Serious Number At Risk:
12
Other Number Affected:
12
Other Number At Risk:
12
Study:
NCT01338857
Results Section:
NCT01338857
Adverse Events Module:
NCT01338857