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NCT01614821 · OUTCOME

Safety and Tolerability of PCI-32765

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
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
4 years

What was measured

To assess the safety and tolerability of PCI-32765 in symptomatic WM patients with relapsed/refractory disease. Grade \> or = 2 Adverse Events determined to be associated with PCI-32765 and subsequent outcomes will constitute the safety profile of PCI-32765 in WM. Percent of participants who experienced at least 1 grade 2 or higher treatment emergent adverse event.

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 Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Treatment Arm62Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        62
denoms
  1. counts
    1. group Id
      OG000
      value
      63
    units
    Participants
description
To assess the safety and tolerability of PCI-32765 in symptomatic WM patients with relapsed/refractory disease. Grade \> or = 2 Adverse Events determined to be associated with PCI-32765 and subsequent outcomes will constitute the safety profile of PCI-32765 in WM. Percent of participants who experienced at least 1 grade 2 or higher treatment emergent adverse event.
groups
  1. description
    PCI-32765; ibrutinib PCI-32765: Taken orally, once daily in the morning
    id
    OG000
    title
    Treatment Arm
param Type
COUNT_OF_PARTICIPANTS
reporting Status
POSTED
time Frame
4 years
title
Safety and Tolerability of PCI-32765
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice