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NCT01109069 · OUTCOME

Death Event

Safety and Tolerability Study of PCI-32765 in B Cell Lymphoma and Chronic Lymphocytic Leukemia · Source last updated 2020-05-27

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
30 days after last dose of study drug

What was measured

All death events are due to AE, progressive disease, and other reasons.

Groups in this outcome

IBRUTINIB/PCI-32765

This was a multicenter, open-label, monotherapy, long-term extension study designed to evaluate the long-term (\> 6 months) safety and tolerability of a fixed daily dosing regimen of ibrutinib. PCI-32765: Dose based on parent protocol CLL: chronic lymphocytic leukemia/ SLL: small lymphocytic lymphoma.

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/PCI-32765199

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
IBRUTINIB/PCI-3276542Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        42
denoms
  1. counts
    1. group Id
      OG000
      value
      199
    units
    Participants
description
All death events are due to AE, progressive disease, and other reasons.
groups
  1. description
    This was a multicenter, open-label, monotherapy, long-term extension study designed to evaluate the long-term (\> 6 months) safety and tolerability of a fixed daily dosing regimen of ibrutinib. PCI-32765: Dose based on parent protocol CLL: chronic lymphocytic leukemia/ SLL: small lymphocytic lymphoma.
    id
    OG000
    title
    IBRUTINIB/PCI-32765
param Type
COUNT_OF_PARTICIPANTS
reporting Status
POSTED
time Frame
30 days after last dose of study drug
title
Death Event
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice