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 @ 4:06 AM
Ignite Modification Date:
2025-12-26 @ 3:02 AM
NCT ID:
NCT01214720
Group ID:
EG001
Title:
Placebo + Gemcitabine + Erlotinib
Description:
Cycle 1 (8-week cycle): Participants received placebo IV on Days 1, 15, 29, and 43 (followed by 1 week off); gemcitabine 1000 mg/m\^2 IV on Days 1, 8, 15, 22, 29, 36, and 43 (followed by 1 week off); and erlotinib 100 mg tablets/capsules, PO, QD for 8 weeks.
Cycles 2 and beyond (4-week cycle): Participants received placebo IV on Days 1 and 15 (followed by 2 weeks off); gemcitabine 1000 mg/m\^2 IV on Days 1, 8, and 15 (followed by 1 week off); and erlotinib 100 mg tablets/capsules PO QD. Participants continued on treatment until disease progression, unacceptable toxicity, or participant withdrawal.
Deaths Number Affected:
None
Deaths Number At Risk:
None
Serious Number Affected:
119
Serious Number At Risk:
286
Other Number Affected:
276
Other Number At Risk:
286
Study:
NCT01214720
Results Section:
NCT01214720
Adverse Events Module:
NCT01214720