NCT01732913 · FLOW

Participant flow

Efficacy and Safety of Idelalisib (GS-1101) in Combination With Rituximab for Previously Treated Indolent Non-Hodgkin Lymphomas · Source last updated 2018-11-16

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

groups

description
Idelalisib (Zydelig®) 150 mg tablet orally twice daily + rituximab 375 mg/m\^2 intravenously starting on Day 1 for a total of 8 infusions
id
FG000
title
Idelalisib + Rituximab
description
Placebo tablet orally twice daily + rituximab 375 mg/m\^2 intravenously starting on Day 1 for a total of 8 infusions
id
FG001
title
Placebo + Rituximab

periods

drop Withdraws
reasons
group Id
FG000
num Subjects
105
group Id
FG001
num Subjects
55
type
Study Terminated by Sponsor
reasons
group Id
FG000
num Subjects
27
group Id
FG001
num Subjects
4
type
Withdrawal by Subject
reasons
group Id
FG000
num Subjects
14
group Id
FG001
num Subjects
7
type
Physician Decision
reasons
group Id
FG000
num Subjects
7
group Id
FG001
num Subjects
1
type
Other
reasons
group Id
FG000
num Subjects
3
group Id
FG001
num Subjects
2
type
Initiation of Other Anti-Cancer Therapy
milestones
achievements
group Id
FG000
num Subjects
198
group Id
FG001
num Subjects
97
type
STARTED
achievements
group Id
FG000
num Subjects
42
group Id
FG001
num Subjects
28
comment
Completed = reached primary efficacy endpoint of progressive disease or death
type
COMPLETED
achievements
group Id
FG000
num Subjects
156
group Id
FG001
num Subjects
69
type
NOT COMPLETED
title
Overall Study

pre Assignment Details

385 participants were screened.

recruitment Details

Participants were enrolled at study sites in the North America, Europe, and Asia Pacific. The first participant was screened on 16 January 2013. The last study visit occurred on 18 May 2016.

Complete source fields