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NCT01478581 · OUTCOME

Duration of Clinical Benefit Response (DCB)

Study of the Bruton's Tyrosine Kinase Inhibitor in Subjects With Relapsed or Relapsed and Refractory Multiple Myeloma · Source last updated 2020-03-10

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
From the date of first study treatment until disease progression per IMWG, up to 60 months

What was measured

DCB is defined as the time from first observation of response to the time of disease progression.

Analysis population: Clinical benefit responders.

Groups in this outcome

Cohort 1

PCI-32765 420 mg per day PCI-32765

Cohort 2

PCI-32765 560 mg per day, 40 mg dexamethasone (oral) once per week PCI-32765 Dexamethasone

Cohort 3

PCI-32765 840 mg per day PCI-32765

Cohort 4

PCI-32765 840 mg per day, 40 mg dexamethasone (oral) once per week PCI-32765 Dexamethasone

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

Analysis denominator · Participants

GroupSource count
Cohort 11
Cohort 21
Cohort 30
Cohort 412

Reported measurements

Source class 1
Values in Months · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Cohort 127.6Not reported27.627.6Not reported
Cohort 23.7Not reported3.73.7Not reported
Cohort 411.5Not reported2.846.3Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        27.6
        upper Limit
        27.6
        value
        27.6
      2. group Id
        OG001
        lower Limit
        3.7
        upper Limit
        3.7
        value
        3.7
      3. group Id
        OG003
        lower Limit
        2.8
        upper Limit
        46.3
        value
        11.5
denoms
  1. counts
    1. group Id
      OG000
      value
      1
    2. group Id
      OG001
      value
      1
    3. group Id
      OG002
      value
      0
    4. group Id
      OG003
      value
      12
    units
    Participants
description
DCB is defined as the time from first observation of response to the time of disease progression.
dispersion Type
Full Range
groups
  1. description
    PCI-32765 420 mg per day PCI-32765
    id
    OG000
    title
    Cohort 1
  2. description
    PCI-32765 560 mg per day, 40 mg dexamethasone (oral) once per week PCI-32765 Dexamethasone
    id
    OG001
    title
    Cohort 2
  3. description
    PCI-32765 840 mg per day PCI-32765
    id
    OG002
    title
    Cohort 3
  4. description
    PCI-32765 840 mg per day, 40 mg dexamethasone (oral) once per week PCI-32765 Dexamethasone
    id
    OG003
    title
    Cohort 4
param Type
MEDIAN
population Description
Clinical benefit responders.
reporting Status
POSTED
time Frame
From the date of first study treatment until disease progression per IMWG, up to 60 months
title
Duration of Clinical Benefit Response (DCB)
type
SECONDARY
unit Of Measure
Months

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

Preserved source evidence · Not medical advice