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NCT01614821 · OUTCOME

To Determine Time to Next Therapy (TTNT) of PCI-32765 in Symptomatic WM Patients With Relapsed/Refractory Disease

Ibrutinib (PCI-32765) in Waldenstrom's Macroglobulinemia · Source last updated 2020-01-21

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

Measure
MEDIAN
Unit
months
Interval / dispersion
Full Range
Time frame
6 years

What was measured

Time to Next Therapy is the duration of time from of starting ibrutinib until next therapy. Participants were treated for 40 cycles and then followed for 2 years or until next therapy or death. Participants had the option to continue ibrutinib commercially. 40 participants were censored while still on commercial ibrutinib therapy.

Groups in this outcome

Treatment Arm

PCI-32765; ibrutinib PCI-32765: Taken orally, once daily in the morning

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

Analysis denominator · Participants

GroupSource count
Treatment Arm63

Reported measurements

Source class 1
Values in months · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Treatment Arm49Not reported167Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        1
        upper Limit
        67
        value
        49
denoms
  1. counts
    1. group Id
      OG000
      value
      63
    units
    Participants
description
Time to Next Therapy is the duration of time from of starting ibrutinib until next therapy. Participants were treated for 40 cycles and then followed for 2 years or until next therapy or death. Participants had the option to continue ibrutinib commercially. 40 participants were censored while still on commercial ibrutinib therapy.
dispersion Type
Full Range
groups
  1. description
    PCI-32765; ibrutinib PCI-32765: Taken orally, once daily in the morning
    id
    OG000
    title
    Treatment Arm
param Type
MEDIAN
reporting Status
POSTED
time Frame
6 years
title
To Determine Time to Next Therapy (TTNT) of PCI-32765 in Symptomatic WM Patients With Relapsed/Refractory Disease
type
SECONDARY
unit Of Measure
months

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice