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 @ 3:37 AM
Ignite Modification Date:
2025-12-26 @ 2:21 AM
NCT ID:
NCT01465802
Group ID:
EG003
Title:
Cohort II (Dacomitinib 45mg + VSL#3 Probiotic + Alclometasone)
Description:
Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS open-label VSL#3 probiotic 4 capsules PO taken once daily or 1 sachet PO taken once daily starting on either Days -7, -6, -5 or -4 per site/participant preference, and continuing through Cycle 1 Day 28 (for a total of up to 5 weeks \[range of 32 to 35 days\]) PLUS open-label topical alclometasone diproprionate cream 0.05% applied to face, hands, feet, neck, back and chest at bedtime for 4 weeks (prophylactic treatment).
Deaths Number Affected:
None
Deaths Number At Risk:
None
Serious Number Affected:
22
Serious Number At Risk:
67
Other Number Affected:
64
Other Number At Risk:
67
Study:
NCT01465802
Results Section:
NCT01465802
Adverse Events Module:
NCT01465802