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 @ 12:21 PM
Ignite Modification Date:
2025-12-25 @ 12:03 PM
NCT ID:
NCT03283761
Group ID:
EG000
Title:
Nab-paclitaxel and FOLFOX-A
Description:
All patients in Stage I (N=12) and Stage II (N=25) will receive FOLFOX-A on days 1 and 15 of each cycle (1 cycle = 28 days). Nab-paclitaxel will be given at a dose of 150 mg/m\^2 IV over 30 minutes, followed by oxaliplatin IV 85 mg/m\^2 and leucovorin IV 400 mg/m\^2 over 2 hours, and 5-FU as a continuous IV infusion over Day 1 and Day 2 (for a total dose of 2400mg/m\^2 over 46-48 hours.). Radiographic assessment will be performed at baseline and every other cycle (starting with Cycle 3) to evaluate response to treatment by RECIST Version 1.1 guidelines. Patients may continue to receive treatment until disease progression or unacceptable toxicity.
Nab-paclitaxel 150 mg/m\^2: Stage I (N=12), on day 1 and day 15 Stage II (N= 25), on day 1 and day 15
Oxaliplatin 85 mg/m\^2: Stage I (N= 12), on day 1 and day 15 Stage II (N= 25), on day 1 and day 15
5-FU 1200 mg/m\^2 x 2 D: Stage I (N= 12), on day 1 and day 15-16 Stage II (N= 25),on day 1 and day 15-16
Leucovorin 400 mg/m\^2: Stage I (N= 12),on day 1 and day 15 Stage II (N= 25), on day 1 and day 15
Deaths Number Affected:
29
Deaths Number At Risk:
None
Serious Number Affected:
22
Serious Number At Risk:
38
Other Number Affected:
38
Other Number At Risk:
38
Study:
NCT03283761
Results Section:
NCT03283761
Adverse Events Module:
NCT03283761