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NCT02011113 · OUTCOME

Kaplan-Meier Estimates of Duration of Response (Later Cut-off Date)

Japanese Phase 2 Study to Evaluate the Efficacy and Safety of Pomalidomide in Subjects With Relapsed and Refractory Multiple Myeloma · Source last updated 2016-11-01

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

Measure
MEDIAN
Unit
weeks
Interval / dispersion
95% Confidence Interval
Time frame
From the first dose until the final data cut-off date of 25 September 2015; maximum duration on treatment was 80.9 weeks

What was measured

Duration of response (calculated for responders only) was defined as time from the initial documented response (partial response or better) to confirmed disease progression, based on IMWG criteria.

Analysis population: Efficacy Evaluable Population includes all participants who met eligibility criteria, took at least one dose of study medication, and had a baseline and a post-baseline efficacy assessment.

Groups in this outcome

Pomalidomide Plus Dexamethasone

Participants received 4 mg pomalidomide administered by mouth on Days 1-21 of each 28-day treatment cycle and 40 mg dexamethasone (participants \> 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1, 8, 15, and 22 of a 28-day cycle until disease progression.

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

Analysis denominator · Participants

GroupSource count
Pomalidomide Plus Dexamethasone15

Reported measurements

Source class 1
Values in weeks · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Pomalidomide Plus DexamethasoneNANot reported20.100NAThe median duration of response based on Kaplan-Meier estimate had not been reached. The upper limit was not calculable because an insufficient number of participants reached the event at the time point for the assessment.
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        The median duration of response based on Kaplan-Meier estimate had not been reached. The upper limit was not calculable because an insufficient number of participants reached the event at the time point for the assessment.
        group Id
        OG000
        lower Limit
        20.100
        upper Limit
        NA
        value
        NA
denoms
  1. counts
    1. group Id
      OG000
      value
      15
    units
    Participants
description
Duration of response (calculated for responders only) was defined as time from the initial documented response (partial response or better) to confirmed disease progression, based on IMWG criteria.
dispersion Type
95% Confidence Interval
groups
  1. description
    Participants received 4 mg pomalidomide administered by mouth on Days 1-21 of each 28-day treatment cycle and 40 mg dexamethasone (participants \> 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1, 8, 15, and 22 of a 28-day cycle until disease progression.
    id
    OG000
    title
    Pomalidomide Plus Dexamethasone
param Type
MEDIAN
population Description
Efficacy Evaluable Population includes all participants who met eligibility criteria, took at least one dose of study medication, and had a baseline and a post-baseline efficacy assessment.
reporting Status
POSTED
time Frame
From the first dose until the final data cut-off date of 25 September 2015; maximum duration on treatment was 80.9 weeks
title
Kaplan-Meier Estimates of Duration of Response (Later Cut-off Date)
type
SECONDARY
unit Of Measure
weeks

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

Preserved source evidence · Not medical advice