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 @ 10:10 PM
Ignite Modification Date:
2025-12-25 @ 7:46 PM
NCT ID:
NCT01284335
Group ID:
EG000
Title:
Arm A Tasisulam + Gemcitabine Dose Escalation
Description:
Gemcitabine 1000 milligrams meter squared (mg/m2) administered intravenously on Days 1 and 15 of a 28 day cycle until disease progression, unacceptable toxicity or other discontinuation criteria are met.
Tasisulam dose is dependent on participant's height, weight, gender and is adjusted to target a specific exposure range corrected for a participant's laboratory parameters. Intravenous dosing is done on Day 1 of a 28 day cycle. Participants may continue on study drug until disease progression, unacceptable toxicity, or other withdrawal criteria are met.
Deaths Number Affected:
2
Deaths Number At Risk:
None
Serious Number Affected:
9
Serious Number At Risk:
25
Other Number Affected:
24
Other Number At Risk:
25
Study:
NCT01284335
Results Section:
NCT01284335
Adverse Events Module:
NCT01284335