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:
EG005
Title:
Arm B2 Tasisulam + Docetaxel Dose Confirmation
Description:
Tasisulam individualized 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.
Docetaxel 60 mg/m2 administered intravenously over 60 minutes on Day 4 of the 28-day cycle until disease progression, unacceptable toxicity or other discontinuation criteria are met.
Deaths Number Affected:
4
Deaths Number At Risk:
None
Serious Number Affected:
12
Serious Number At Risk:
26
Other Number Affected:
26
Other Number At Risk:
26
Study:
NCT01284335
Results Section:
NCT01284335
Adverse Events Module:
NCT01284335