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:
2025-12-26 @ 5:18 PM
Ignite Modification Date:
2025-12-26 @ 5:18 PM
NCT ID:
NCT03330106
Group ID:
EG003
Title:
Part B: Pevonedistat 20 mg/m^2 + Carboplatin + Paclitaxel
Description:
Pevonedistat 20 mg/m\^2 in combination with carboplatin area under the plasma concentration (AUC) at the dose of 5 mg/min/mL, infusion, IV and paclitaxel 175 mg/m\^2, infusion, IV, once on Day 1 in each 21-day treatment cycle followed by pevonedistat 20 mg/m\^2 IV, once on Days 3 and 5 in each 21-day treatment cycle for up to 20 cycles or symptomatic deterioration or PD, or until treatment is discontinued for another reason. Pevonedistat was administered after the paclitaxel and carboplatin chemotherapy. Participants who completed Part A and provided consent for Part B continued treatment in Part B.
Deaths Number Affected:
0
Deaths Number At Risk:
None
Serious Number Affected:
5
Serious Number At Risk:
12
Other Number Affected:
12
Other Number At Risk:
12
Study:
NCT03330106
Results Section:
NCT03330106
Adverse Events Module:
NCT03330106