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 @ 1:02 AM
Ignite Modification Date:
2025-12-25 @ 11:15 PM
NCT ID:
NCT00614393
Group ID:
EG001
Title:
Dalotuzumab 15 mg/kg /7.5 mg/kg Q2W (OL)
Description:
In the OL portion of the study, ≥6 participants received cetuximab 400 mg/m\^2 Q1W + irinotecan Q1W at their pre-study dosage + OL dalotuzumab (loading dose of 15 mg/kg IV followed by a maintenance dose of 7.5 mg/kg 2 weeks later) to verify the safety of the regimen. In DB Week 1, participants received cetuximab 400 mg/m\^2 IV + irinotecan IV. In DB Week 2, participants received cetuximab 250 mg/m\^2 IV + irinotecan IV + DB dalotuzumab 15 mg/kg IV. In DB Week 3, participants received cetuximab 250 mg/m\^2 IV + irinotecan IV. Starting with DB Week 4, participants received cetuximab 250 mg/m\^2 IV Q1W + irinotecan IV Q1W + DB dalotuzumab 7.5 mg/kg IV Q2W for up to 32 months of treatment.
Deaths Number Affected:
None
Deaths Number At Risk:
None
Serious Number Affected:
5
Serious Number At Risk:
8
Other Number Affected:
8
Other Number At Risk:
8
Study:
NCT00614393
Results Section:
NCT00614393
Adverse Events Module:
NCT00614393