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 @ 4:33 PM
Ignite Modification Date:
2025-12-25 @ 2:25 PM
NCT ID:
NCT02502266
Group ID:
EG000
Title:
Arm I (Reference Regimen)
Description:
Patients undergo physician's choice of standard of care chemotherapy, comprising either paclitaxel IV over 60 minutes on days 1, 8, 15, and 22 every 28 days (Regimen I); pegylated liposomal doxorubicin hydrochloride IV over 60 minutes on day 1 every 28 days (Regimen II); or topotecan hydrochloride IV over 30 minutes on days 1, 8, and 15 every 28 days or days 1-5 every 21 days (Regimen III). Treatment continues in the absence of disease progression or unacceptable toxicity. No modification of the assigned regimens, such as additional drugs (gemcitabine, or bevacizumab) is allowed. Patients also undergo CT and MRI throughout the study. (12/05/2016)
Computed Tomography: Undergo CT
Magnetic Resonance Imaging: Undergo MRI
Paclitaxel: Given IV
Pegylated Liposomal Doxorubicin Hydrochloride: Given IV
Questionnaire Administration: Ancillary studies
Topotecan: Given IV
Topotecan Hydrochloride: Given IV
Deaths Number Affected:
137
Deaths Number At Risk:
None
Serious Number Affected:
12
Serious Number At Risk:
156
Other Number Affected:
151
Other Number At Risk:
156
Study:
NCT02502266
Results Section:
NCT02502266
Adverse Events Module:
NCT02502266