Skip to content
Triangle logo TriangleGet started
← Full study record

NCT02604511 · OUTCOME

Time to Response

Study of Ibrutinib in Patients With Symptomatic, Previously Untreated Waldenstrom's Macroglobulinemia, and Impact on Tumor Genomic Evolution Using Whole Genome Sequencing · Source last updated 2022-12-07

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

Measure
MEDIAN
Unit
months
Interval / dispersion
95% Confidence Interval
Time frame
4 years

What was measured

The amount of time between starting treatment and attaining at least a minor response to therapy

Analysis population: All participants except one determined to be ineligible

Groups in this outcome

Ibrutinib

This is single arm, open label, Phase II, single center study designed to evaluate the safety and efficacy of ibrutinib in previously untreated WM patients. Treatment will be administered in 4-week cycles, and participants will receive treatment for up to 48 cycles. Treatment will be comprised of ibrutinib at 420 mg per day by oral administration. Ibrutinib

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

Analysis denominator · Participants

GroupSource count
Ibrutinib30

Reported measurements

Source class 1
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Ibrutinib0.9Not reported0.91.7Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.9
        upper Limit
        1.7
        value
        0.9
denoms
  1. counts
    1. group Id
      OG000
      value
      30
    units
    Participants
description
The amount of time between starting treatment and attaining at least a minor response to therapy
dispersion Type
95% Confidence Interval
groups
  1. description
    This is single arm, open label, Phase II, single center study designed to evaluate the safety and efficacy of ibrutinib in previously untreated WM patients. Treatment will be administered in 4-week cycles, and participants will receive treatment for up to 48 cycles. Treatment will be comprised of ibrutinib at 420 mg per day by oral administration. Ibrutinib
    id
    OG000
    title
    Ibrutinib
param Type
MEDIAN
population Description
All participants except one determined to be ineligible
reporting Status
POSTED
time Frame
4 years
title
Time to Response
type
OTHER_PRE_SPECIFIED
unit Of Measure
months

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

Preserved source evidence · Not medical advice