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 @ 4:23 PM
Ignite Modification Date:
2025-12-25 @ 2:18 PM
NCT ID:
NCT03217266
Group ID:
EG002
Title:
Group I: Cohort A: Dose Level 3 (5x/Week)
Description:
Step 1: Patients undergo tumor tissue testing for p53 gene status and receive navtemadlin PO on days 1-5 of week 1 in the absence of disease progression or unacceptable toxicity.
Step 2: Starting with week 2, patients receive navtemadlin as in Step 1 and undergo radiation therapy daily for 5 weeks in the absence of disease progression or unacceptable toxicity, followed by surgery 5-8 weeks after RT completion.
Group I = Wild-type p53. Cohort A = Patients with extremity/body wall soft tissue sarcoma.
Deaths Number Affected:
1
Deaths Number At Risk:
None
Serious Number Affected:
5
Serious Number At Risk:
9
Other Number Affected:
9
Other Number At Risk:
9
Study:
NCT03217266
Results Section:
NCT03217266
Adverse Events Module:
NCT03217266