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NCT02439138 · OUTCOME

Rate of Progressive Disease

Study of Phosphatidylinositol-3-kinase (PI3K) Inhibitor Idelalisib (GS-1101) in Waldenström Macroglobulinemia · Source last updated 2017-01-11

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

Measure
NUMBER
Unit
percentage of participants with PD
Interval / dispersion
Not reported
Time frame
Participants were followed for the duration of therapy, a median of one cycle, for up to 3 cycles.

What was measured

Progressive disease measured by an 25% increase in serum IgM level with an absolute increase of at least 500mg/dL from the lowest attained IgM on therapy.

Groups in this outcome

GS-1101

After the screening procedures confirms eligibility to participate in the research study. Treatment will be administered on an outpatient basis. \-- Idelalisib (GS-11-01) orally, predetermined dose twice daily per cycle for up to 6 cycles. After this initial 6 month period, for Cycles 7 and beyond, Idelalisib will be administered once a day until disease progression. GS-1101

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

Analysis denominator · Participants

GroupSource count
GS-11015

Reported measurements

Source class 1
Values in percentage of participants with PD · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
GS-110120Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        20
denoms
  1. counts
    1. group Id
      OG000
      value
      5
    units
    Participants
description
Progressive disease measured by an 25% increase in serum IgM level with an absolute increase of at least 500mg/dL from the lowest attained IgM on therapy.
groups
  1. description
    After the screening procedures confirms eligibility to participate in the research study. Treatment will be administered on an outpatient basis. \-- Idelalisib (GS-11-01) orally, predetermined dose twice daily per cycle for up to 6 cycles. After this initial 6 month period, for Cycles 7 and beyond, Idelalisib will be administered once a day until disease progression. GS-1101
    id
    OG000
    title
    GS-1101
param Type
NUMBER
reporting Status
POSTED
time Frame
Participants were followed for the duration of therapy, a median of one cycle, for up to 3 cycles.
title
Rate of Progressive Disease
type
SECONDARY
unit Of Measure
percentage of participants with PD

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice