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NCT01478581 · OUTCOME

Duration of Response (DOR)

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
Month
Interval / dispersion
95% Confidence Interval
Time frame
up to 3 Years

What was measured

The time interval between the date of initial documentation of a response and the date of first documented evidence of progressive disease, death, or date of censoring for the subjects not progressed/died. The censoring date is the last adequate tumor assessment date.

Analysis population: Responders

Groups in this outcome

PCI-32765 420 mg Per Day

PCI-32765 420 mg per day PCI-32765

PCI-32765 560 mg Per Day, 40 mg Dexamethasone

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

PCI-32765 840 mg Per Day

PCI-32765 840 mg per day PCI-32765

PCI-32765 840 mg Per Day, 40 mg Dexamethasone

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
PCI-32765 420 mg Per Day0
PCI-32765 560 mg Per Day, 40 mg Dexamethasone1
PCI-32765 840 mg Per Day0
PCI-32765 840 mg Per Day, 40 mg Dexamethasone2

Reported measurements

Source class 1
Values in Month · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
PCI-32765 560 mg Per Day, 40 mg Dexamethasone3.7Not reported3.73.7Not reported
PCI-32765 840 mg Per Day, 40 mg Dexamethasone15.4Not reported3.627.2Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG001
        lower Limit
        3.7
        upper Limit
        3.7
        value
        3.7
      2. group Id
        OG003
        lower Limit
        3.6
        upper Limit
        27.2
        value
        15.4
denoms
  1. counts
    1. group Id
      OG000
      value
      0
    2. group Id
      OG001
      value
      1
    3. group Id
      OG002
      value
      0
    4. group Id
      OG003
      value
      2
    units
    Participants
description
The time interval between the date of initial documentation of a response and the date of first documented evidence of progressive disease, death, or date of censoring for the subjects not progressed/died. The censoring date is the last adequate tumor assessment date.
dispersion Type
95% Confidence Interval
groups
  1. description
    PCI-32765 420 mg per day PCI-32765
    id
    OG000
    title
    PCI-32765 420 mg Per Day
  2. description
    PCI-32765 560 mg per day, 40 mg dexamethasone (oral) once per week PCI-32765 Dexamethasone
    id
    OG001
    title
    PCI-32765 560 mg Per Day, 40 mg Dexamethasone
  3. description
    PCI-32765 840 mg per day PCI-32765
    id
    OG002
    title
    PCI-32765 840 mg Per Day
  4. description
    PCI-32765 840 mg per day, 40 mg dexamethasone (oral) once per week PCI-32765 Dexamethasone
    id
    OG003
    title
    PCI-32765 840 mg Per Day, 40 mg Dexamethasone
param Type
MEDIAN
population Description
Responders
reporting Status
POSTED
time Frame
up to 3 Years
title
Duration of Response (DOR)
type
SECONDARY
unit Of Measure
Month

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

Preserved source evidence · Not medical advice