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NCT02439138 · OUTCOME

Rate of Complete Response (CR)

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 CR
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

CR measured by decrease in serum IgM levels to normal range, disappearnace of monoclonal protein by immunofixation, no evidence of bone marrow involvement, and resolution of any extramedullary disease by CT scan.

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-11014

Reported measurements

Source class 1
Values in percentage of participants with CR · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
GS-11010Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        0
denoms
  1. counts
    1. group Id
      OG000
      value
      4
    units
    Participants
description
CR measured by decrease in serum IgM levels to normal range, disappearnace of monoclonal protein by immunofixation, no evidence of bone marrow involvement, and resolution of any extramedullary disease by CT scan.
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 Complete Response (CR)
type
SECONDARY
unit Of Measure
percentage of participants with CR

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

Preserved source evidence · Not medical advice