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 @ 2:02 PM
Ignite Modification Date:
2025-12-25 @ 12:46 PM
NCT ID:
NCT04988295
Group ID:
EG000
Title:
Main Study: Arm A: Lazertinib + Amivantamab + Carboplatin + Pemetrexed (LACP/ACP-L)
Description:
LACP dosing (study start until 6 November 2022): Participants received Lazertinib 240 milligrams (mg) orally on Day 1 of each subsequent cycle, starting with Cycle 3, along with Amivantamab 1400 mg (1750 mg if body weight greater than or equal to \[\>=80\] kilograms \[kg\]) on Cycle 1 Days 1, 2, 8, and 15, and Cycle 2 Day 1 and 1750 mg (2100 mg if body weight \>=80 kg). Participant also received Pemetrexed 500 mg per square meter (mg/m\^2) on Day 1 21-day cycle, in combination with carboplatin 750 mg as IV infusion starting on Cycle 1 Day 1 for 4 cycles. From cycle 5 onwards, participants received Amivantamab, Pemetrexed and Lazertinib IV infusions at same dose, as maintenance until disease progression. ACP-L dosing (from 7 November 2022 until study completion): Participants received Amivantamab 1400 mg (1750 mg if body weight \>=80\] kg) on Cycle 1 Days 1,2, 8, and 15, and Cycle 2 Day 1 and 1750 mg (2100 mg if body weight \>=80 kg). Participant also received Pemetrexed 500 mg/m\^2 on Day 1 of each 21-day cycle, in combination with carboplatin 750 mg as IV infusion starting on Cycle 1 Day 1 for 4 cycles. Lazertinib 240 mg in ACP-L started on Cycle 5 Day 1 or sooner if carboplatin is discontinued before cycle 4. From cycle 5 onwards, participants received Amivantamab, Pemetrexed and Lazertinib IV infusions at same dose, as maintenance until disease progression. Each cycle consists of 21 days.
Deaths Number Affected:
69
Deaths Number At Risk:
None
Serious Number Affected:
137
Serious Number At Risk:
263
Other Number Affected:
261
Other Number At Risk:
263
Study:
NCT04988295
Results Section:
NCT04988295
Adverse Events Module:
NCT04988295