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 @ 5:19 PM
Ignite Modification Date:
2025-12-25 @ 2:55 PM
NCT ID:
NCT02289950
Group ID:
EG001
Title:
Placebo + Carboplatin/Paclitaxel or Carboplatin/PLD
Description:
Participants received either carboplatin (AUC 5) plus paclitaxel 175 mg/ m\^2 IV every 3 weeks or carboplatin (AUC 5) plus PLD 30 mg/ m\^2 IV every 4 weeks in combination with placebo loading dose of 10 mg/kg for the first 2 weeks, followed by 5 mg/kg every week thereafter administered up to maximum of 8 cycles at the investigator's discretion. Participants who completed combination treatment phase and participants who experienced intolerable toxicity to chemotherapy in combination treatment phase continued to receive maintenance treatment with placebo 5 mg/kg every week alone up to maximum of 64 cycles or until disease progression was confirmed by radiographic assessment, or subject discontinued treatment for any other reason.
Deaths Number Affected:
2
Deaths Number At Risk:
None
Serious Number Affected:
18
Serious Number At Risk:
70
Other Number Affected:
70
Other Number At Risk:
70
Study:
NCT02289950
Results Section:
NCT02289950
Adverse Events Module:
NCT02289950