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NCT01732926 · OUTCOME

Progression-free Survival (PFS)

Efficacy and Safety of Idelalisib (GS-1101) in Combination With Bendamustine and 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.

Measure
Not reported
Unit
Not reported
Interval / dispersion
Not reported
Time frame
Not reported

What was measured

PFS is defined as the interval from randomization to the earlier of the first documentation of definitive indolent non-Hodgkin lymphomas (iNHL) disease progression or death from any cause. Definitive iNHL disease progression is progression based on standard criteria. PFS was to be assessed by an independent review committee (IRC).

Analysis population: Due to the early termination of the study, efficacy data were not available for all participants, and therefore the prespecified analyses were not conducted.

Groups in this outcome

Idelalisib + Bendamustine + Rituximab

Idelalisib 150 mg tablet twice daily + bendamustine intravenously (starting dose of 90 mg/m\^2 for up to 12 infusions) + rituximab intravenously (375 mg/m\^2 on Day 1 for a total of 6 infusions)

Placebo + Bendamustine + Rituximab

Placebo tablet twice daily + bendamustine intravenously (starting dose of 90 mg/m\^2 for up to 12 infusions) + rituximab intravenously (375 mg/m\^2 on Day 1 for a total of 6 infusions)

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Idelalisib + Bendamustine + Rituximab0
Placebo + Bendamustine + Rituximab0

Reported measurements

No numerical measurement classes were posted for this outcome. Missing is not zero.

Complete source fields
denoms
  1. counts
    1. group Id
      OG000
      value
      0
    2. group Id
      OG001
      value
      0
    units
    Participants
description
PFS is defined as the interval from randomization to the earlier of the first documentation of definitive indolent non-Hodgkin lymphomas (iNHL) disease progression or death from any cause. Definitive iNHL disease progression is progression based on standard criteria. PFS was to be assessed by an independent review committee (IRC).
groups
  1. description
    Idelalisib 150 mg tablet twice daily + bendamustine intravenously (starting dose of 90 mg/m\^2 for up to 12 infusions) + rituximab intravenously (375 mg/m\^2 on Day 1 for a total of 6 infusions)
    id
    OG000
    title
    Idelalisib + Bendamustine + Rituximab
  2. description
    Placebo tablet twice daily + bendamustine intravenously (starting dose of 90 mg/m\^2 for up to 12 infusions) + rituximab intravenously (375 mg/m\^2 on Day 1 for a total of 6 infusions)
    id
    OG001
    title
    Placebo + Bendamustine + Rituximab
population Description
Due to the early termination of the study, efficacy data were not available for all participants, and therefore the prespecified analyses were not conducted.
reporting Status
POSTED
title
Progression-free Survival (PFS)
type
PRIMARY

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice