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NCT04042376 · OUTCOME

Overall Survival (OS)

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 day of first dose (Day 1) until death due to any cause (up to 49.3 months)

What was measured

Overall survival was measured from the date of first dose to the date of the participant's death from any cause.

Analysis population: All treated analysis set included all enrolled participants who received at least 1 dose of study drug.

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 mg17

Reported measurements

Source class 1
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Ibrutinib 420 mgNANot reportedNANAHere, 'NA' signifies that median, lower and upper limit of 95% confidence interval could not be estimated due to less number of participants with event.
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        Here, 'NA' signifies that median, lower and upper limit of 95% confidence interval could not be estimated due to less number of participants with event.
        group Id
        OG000
        lower Limit
        NA
        upper Limit
        NA
        value
        NA
denoms
  1. counts
    1. group Id
      OG000
      value
      17
    units
    Participants
description
Overall survival was measured from the date of first dose to the date of the participant's death from any cause.
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
All treated analysis set included all enrolled participants who received at least 1 dose of study drug.
reporting Status
POSTED
time Frame
From day of first dose (Day 1) until death due to any cause (up to 49.3 months)
title
Overall Survival (OS)
type
SECONDARY
unit Of Measure
Months

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

Preserved source evidence · Not medical advice