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NCT02290431 · OUTCOME

Percentage of Participants With Near Complete Response (nCR)/ Complete Response (CR) Rate

Study of Panobinostat in Combination With Bortezomib and Dexamethasone in Japanese Patients With Relapsed/Refractory Multiple Myeloma · Source last updated 2019-11-18

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

Measure
NUMBER
Unit
Percentage of participants
Interval / dispersion
90% Confidence Interval
Time frame
after 24 weeks (8 cycles; cycle = 21 days)

What was measured

nCR plus CR rate after 8 cycles of therapy as defined by the modified European Society for Bone and Marrow Transplantation (EBMT) criteria per investigator assessment as the proportion of participants with nCR or CR as their best overall response.

Analysis population: Full Analysis Set (FAS): The Full analysis set (FAS) comprised of all subjects who took at least one dose of any study treatment component.

Groups in this outcome

LBH589 + Bortezomib + Dexamethasone

Participants were administered LBH589 (panobinostat)in combination with bortezomib and dexamethasone 2 weeks on/1 week off.

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

Analysis denominator · Participants

GroupSource count
LBH589 + Bortezomib + Dexamethasone31

Reported measurements

Source class 1
Values in Percentage of participants · Interval/dispersion: 90% Confidence Interval
GroupValueSpreadLowerUpperComment
LBH589 + Bortezomib + Dexamethasone48.4Not reported33.663.2Not reported

Source statistical analyses

Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.

  1. group Ids
    1. OG000
    non Inferiority Type
    SUPERIORITY
    p Value
    < 0.0001
    statistical Method
    single-sample binomial test
Complete source fields
analyses
  1. group Ids
    1. OG000
    non Inferiority Type
    SUPERIORITY
    p Value
    < 0.0001
    statistical Method
    single-sample binomial test
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        33.6
        upper Limit
        63.2
        value
        48.4
denoms
  1. counts
    1. group Id
      OG000
      value
      31
    units
    Participants
description
nCR plus CR rate after 8 cycles of therapy as defined by the modified European Society for Bone and Marrow Transplantation (EBMT) criteria per investigator assessment as the proportion of participants with nCR or CR as their best overall response.
dispersion Type
90% Confidence Interval
groups
  1. description
    Participants were administered LBH589 (panobinostat)in combination with bortezomib and dexamethasone 2 weeks on/1 week off.
    id
    OG000
    title
    LBH589 + Bortezomib + Dexamethasone
param Type
NUMBER
population Description
Full Analysis Set (FAS): The Full analysis set (FAS) comprised of all subjects who took at least one dose of any study treatment component.
reporting Status
POSTED
time Frame
after 24 weeks (8 cycles; cycle = 21 days)
title
Percentage of Participants With Near Complete Response (nCR)/ Complete Response (CR) Rate
type
PRIMARY
unit Of Measure
Percentage of participants

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

Preserved source evidence · Not medical advice