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 @ 3:01 AM
Ignite Modification Date:
2025-12-26 @ 1:42 AM
NCT ID:
NCT02041533
Group ID:
EG001
Title:
Investigator Choice of Chemotherapy
Description:
Administered in 3-week cycles for up to 6 cycles:
Squamous:
* gemcitabine (1250 mg/mg2) with cisplatin (75 mg/m2); or
* gemcitabine (1000 mg/m2) with carboplatin (AUC 5); or
* paclitaxel (200 mg/m2) with carboplatin (AUC 6)
Non-Squamous:
* pemetrexed (500 mg/m2) with cisplatin (75 mg/m2); or
* pemetrexed (500 mg/m2) with carboplatin (AUC 6) Subjects who discontinued cisplatin could be switched to gemcitabine/carboplatin for the remainder of the platinum doublet cycles (up to 6 cycles in total). Participants who progressed on or after chemotherapy could be eligible to receive optional crossover nivolumab 3 mg/kg administered every 2 weeks until disease progression, discontinuation due to unacceptable toxicity, withdrawal of consent or study closure.
Deaths Number Affected:
92
Deaths Number At Risk:
None
Serious Number Affected:
203
Serious Number At Risk:
263
Other Number Affected:
252
Other Number At Risk:
263
Study:
NCT02041533
Results Section:
NCT02041533
Adverse Events Module:
NCT02041533