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NCT02677324 · OUTCOME

Overall Response Rate

Study of ABT-199 (GDC-199) In Patients With Relapsed Or Refractory Waldenström Macroglobulinemia · Source last updated 2022-05-11

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

Measure
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
2 years

What was measured

Overall Response Rate= Minor response (\>25%-50% reduction in serum IgM from baseline) + Partial Response (\>50-90% reduction in serum IgM from baseline) + Very Good Partial Response (\>90% reduction in serum IgM from baseline) + Complete Response (resolution of all symptoms, normalization of serum IgM with disappearance of IgM paraprotein, resolution of any adenopathy or splenomegaly).

Analysis population: 1 participant was censored from the response analysis after it was determined that he had IgM Myeloma rather than Waldenstrom's macroglobulinemia.

Groups in this outcome

ABT199

ABT199 will be administered daily, with 28 consecutive days defined as a treatment cycle for a maximum for 26 cycles ABT199: Oral BCL-2 antagonist

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

Analysis denominator · Participants

GroupSource count
ABT19932

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
ABT19926Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        26
denoms
  1. counts
    1. group Id
      OG000
      value
      32
    units
    Participants
description
Overall Response Rate= Minor response (\>25%-50% reduction in serum IgM from baseline) + Partial Response (\>50-90% reduction in serum IgM from baseline) + Very Good Partial Response (\>90% reduction in serum IgM from baseline) + Complete Response (resolution of all symptoms, normalization of serum IgM with disappearance of IgM paraprotein, resolution of any adenopathy or splenomegaly).
groups
  1. description
    ABT199 will be administered daily, with 28 consecutive days defined as a treatment cycle for a maximum for 26 cycles ABT199: Oral BCL-2 antagonist
    id
    OG000
    title
    ABT199
param Type
COUNT_OF_PARTICIPANTS
population Description
1 participant was censored from the response analysis after it was determined that he had IgM Myeloma rather than Waldenstrom's macroglobulinemia.
reporting Status
POSTED
time Frame
2 years
title
Overall Response Rate
type
PRIMARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice