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:
2025-12-25 @ 4:36 AM
Ignite Modification Date:
2025-12-26 @ 3:38 AM
NCT ID:
NCT03574818
Group ID:
EG000
Title:
Arm 1
Description:
Chemotherapy and Necitumumab Regimen Gemcitabine 1250mg/m2 IV over 30 minutes, days 1 and 8 following necitumumab, Cisplatin 75mg/m2 IV over 60 minutes, day 1, immediately following gemcitabine,each cycle is 3 weeks (21 days).
Necitumumab 800mg absolute dose IV over a minimum of 60 minutes, days 1 and 8 prior to chemotherapy regimen Each cycle is 3 weeks (21 days).
The regimen will be given for a total of 3 cycles.
The regimen will be given for a total of 3 cycles.
Necitumumab-Gemcitabine-Cisplatin: / Gemcitabine 1250mg/m2 IV on D1, D8
* Cisplatin 75mg / m2 IV on D1
* Necitumumab 800mg IV on D1, D8 (peripheral blood for effector cells and cytokine measurements prior to each cycle) Repeat cycle every 21 days up to 3 cycles.
Deaths Number Affected:
0
Deaths Number At Risk:
None
Serious Number Affected:
0
Serious Number At Risk:
1
Other Number Affected:
1
Other Number At Risk:
1
Study:
NCT03574818
Results Section:
NCT03574818
Adverse Events Module:
NCT03574818