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 @ 4:57 PM
Ignite Modification Date:
2025-12-25 @ 2:39 PM
NCT ID:
NCT00064350
Group ID:
EG004
Title:
Crossover: Sorafenib
Description:
Patients on the placebo arm who develop progressive disease may cross over to receive sorafenib, and 27 patients from the placebo arm received sorafenib in Step 3 (crossover). Due to drug dispensing error, even though some patients actually received straight sorafenib during Step 2 (randomization) treatment, they were thought to be randomized onto the placebo arm upon progression and unblinding (before finding out the fact of the dispensing error). Consequently, these patients were crossed over to Step 3, and there were 10 of them. In total, 37 patients registered to step 3 (crossover). Of these, 35 patients received treatment and were included in the toxicity analysis for the crossover (step 3) part.
Deaths Number Affected:
None
Deaths Number At Risk:
None
Serious Number Affected:
15
Serious Number At Risk:
35
Other Number Affected:
35
Other Number At Risk:
35
Study:
NCT00064350
Results Section:
NCT00064350
Adverse Events Module:
NCT00064350