Skip to content
Triangle logo TriangleGet started
← Full study record

NCT04042376 · OUTCOME

Time to Response (TTR)

A Study of Ibrutinib (PCI-32765) in Chinese Participants With Relapse or Refractory Waldenstrom's Macroglobulinemia (WM) · Source last updated 2025-05-25

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
From start of the treatment up to first documentation of PR or better (Day 1 up to 49.3 months)

What was measured

TTR was defined as the time from the date of first dose to the date of initial documentation of a response (PR or better) for responders. PR: \>=50% reduction of serum IgM from baseline, with reduction in lymphadenopathy/splenomegaly if present at baseline. VGPR: \>=90% reduction of serum IgM from baseline or normal serum IgM values, with reduction in lymphadenopathy/splenomegaly if present at baseline.

Analysis population: Analysis population included responders in all treated analysis set who achieved PR or better.

Groups in this outcome

Ibrutinib 420 mg

Participants with relapsed or refractory waldenstrom's macroglobulinemia received ibrutinib 420 milligrams (mg) (3\*140 mg capsules) orally once daily from Day 1 of Week 1 until disease progression, unacceptable toxicity, whichever occurs first.

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

Analysis denominator · Participants

GroupSource count
Ibrutinib 420 mg12

Reported measurements

Source class 1
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Ibrutinib 420 mg3.71Not reported1.843.71Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        1.84
        upper Limit
        3.71
        value
        3.71
denoms
  1. counts
    1. group Id
      OG000
      value
      12
    units
    Participants
description
TTR was defined as the time from the date of first dose to the date of initial documentation of a response (PR or better) for responders. PR: \>=50% reduction of serum IgM from baseline, with reduction in lymphadenopathy/splenomegaly if present at baseline. VGPR: \>=90% reduction of serum IgM from baseline or normal serum IgM values, with reduction in lymphadenopathy/splenomegaly if present at baseline.
dispersion Type
95% Confidence Interval
groups
  1. description
    Participants with relapsed or refractory waldenstrom's macroglobulinemia received ibrutinib 420 milligrams (mg) (3\*140 mg capsules) orally once daily from Day 1 of Week 1 until disease progression, unacceptable toxicity, whichever occurs first.
    id
    OG000
    title
    Ibrutinib 420 mg
param Type
MEDIAN
population Description
Analysis population included responders in all treated analysis set who achieved PR or better.
reporting Status
POSTED
time Frame
From start of the treatment up to first documentation of PR or better (Day 1 up to 49.3 months)
title
Time to Response (TTR)
type
SECONDARY
unit Of Measure
Months

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

Preserved source evidence · Not medical advice