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 @ 5:20 PM
Ignite Modification Date:
2025-12-25 @ 2:56 PM
NCT ID:
NCT03359850
Group ID:
EG002
Title:
Participants With Normal Hepatic Function-Extension Phase
Description:
All participants received a single dose of 300 milligrams (mg) (3X100 mg capsules) niraparib administered on Day 1 of PK phase. Upon entering extension phase, participants with screening actual body weight \>= 77 kilograms (kg) and current platelet count of \>=150,000 cells per microliter (c/μL) at C1D1 continued to receive niraparib 300 mg/day (3X100 mg) once daily (QD) on Day 1 of every cycle until treatment discontinuation(each cycle of 28-days). Participants with screening actual body weight \< 77 kg and/or current platelet count of \<150,000 c/μL continued to receive niraparib 200 mg (2X100 mg capsules) QD on Day 1 of every cycle until treatment discontinuation (each cycle of 28 days).
Deaths Number Affected:
2
Deaths Number At Risk:
None
Serious Number Affected:
3
Serious Number At Risk:
8
Other Number Affected:
8
Other Number At Risk:
8
Study:
NCT03359850
Results Section:
NCT03359850
Adverse Events Module:
NCT03359850