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 @ 9:17 PM
Ignite Modification Date:
2025-12-25 @ 7:05 PM
NCT ID:
NCT03390504
Group ID:
EG001
Title:
Cohort 1: Arm 1B: Chemotherapy (Vinflunine 320 mg/m^2 or Docetaxel 75 mg/m^2)
Description:
Participants with advanced urothelial cancer and selected FGFR aberrations who were previously treated with PD-(L)1 agent were randomized to receive chemotherapy (vinflunine 320 milligrams per meter square \[mg/m\^2\] intravenous \[IV\] infusion or docetaxel 75 mg/m\^2 IV infusion) on Day 1 of every cycle (each cycle 21 days) until disease progression, intolerable toxicity, withdrawal of consent or decision by the investigator to discontinue treatment or end of treatment. The choice of chemotherapy regimen at each site was determined by the investigator. Participants were then followed up for safety until death, withdrawal of consent, loss of follow up or end of study. With the implementation of Protocol Amendment 6 (20 January 2023), participants who benefited from the study drug as determined by investigator, continued to receive study drug in the LTE phase. The participants who did not enter LTE phase discontinued the study.
Deaths Number Affected:
90
Deaths Number At Risk:
None
Serious Number Affected:
50
Serious Number At Risk:
117
Other Number Affected:
104
Other Number At Risk:
117
Study:
NCT03390504
Results Section:
NCT03390504
Adverse Events Module:
NCT03390504