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NCT02290431 · OUTCOME

Overall Response Rate (ORR)

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
95% Confidence Interval
Time frame
24 weeks (8 cycles; cycle = 21 days)

What was measured

ORR is defined as the proportion of participants with CR, nCR or partial response (PR) based on modified EBMT criteria per investigator assessment

Analysis population: FAS: The 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: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
LBH589 + Bortezomib + Dexamethasone80.6Not reported62.592.5Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        62.5
        upper Limit
        92.5
        value
        80.6
denoms
  1. counts
    1. group Id
      OG000
      value
      31
    units
    Participants
description
ORR is defined as the proportion of participants with CR, nCR or partial response (PR) based on modified EBMT criteria per investigator assessment
dispersion Type
95% 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
FAS: The FAS comprised of all subjects who took at least one dose of any study treatment component.
reporting Status
POSTED
time Frame
24 weeks (8 cycles; cycle = 21 days)
title
Overall Response Rate (ORR)
type
SECONDARY
unit Of Measure
Percentage of participants

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

Preserved source evidence · Not medical advice