NCT02354586 · FLOW

Participant flow

A Study of Niraparib in Patients With Ovarian Cancer Who Have Received Three or Four Previous Chemotherapy Regimens · Source last updated 2022-09-15

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

groups

description
Participants received Niraparib (300 milligram \[mg\], taken as 3 capsules of 100 mg once daily \[QD\]) orally beginning on Day 1 of every cycle (28 days) until treatment discontinuation.
id
FG000
title
Niraparib 300 mg

periods

drop Withdraws
reasons
group Id
FG000
num Subjects
230
type
Death
reasons
group Id
FG000
num Subjects
59
type
Withdrawal by Subject
reasons
group Id
FG000
num Subjects
11
type
Lost to Follow-up
reasons
group Id
FG000
num Subjects
51
type
Sponsor decision
reasons
group Id
FG000
num Subjects
2
type
Site closure
reasons
group Id
FG000
num Subjects
1
type
Intercurrent illness
reasons
group Id
FG000
num Subjects
3
type
Protocol Violation
reasons
group Id
FG000
num Subjects
13
type
Physician Decision
reasons
group Id
FG000
num Subjects
86
type
Lack of Efficacy
reasons
group Id
FG000
num Subjects
7
type
Adverse Event
milestones
achievements
group Id
FG000
num Subjects
463
type
STARTED
achievements
group Id
FG000
num Subjects
0
type
COMPLETED
achievements
group Id
FG000
num Subjects
463
type
NOT COMPLETED
title
Overall Study

pre Assignment Details

A total of 463 participants were enrolled in the study (Safety Population was comprised of all participants who received at least 1 dose of study drug).

recruitment Details

This was an open-label, single arm study to evaluate the safety and efficacy of niraparib in ovarian cancer participants who have received previous chemotherapy regimens.

Complete source fields