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NCT02011113 · OUTCOME

Kaplan-Meier Estimates of Duration of Response

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
Not reported
Unit
Not reported
Interval / dispersion
Not reported
Time frame
From first dose until the data cut-off date of 03 September 2014; maximum time for follow-up was 36 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: Duration of Response was not analyzed as there was insufficient data available at Cycle 2, Day 1 of study treatment. There was limited data evaluated and data were not analyzed.

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 Dexamethasone0

Reported measurements

No numerical measurement classes were posted for this outcome. Missing is not zero.

Complete source fields
denoms
  1. counts
    1. group Id
      OG000
      value
      0
    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.
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
population Description
Duration of Response was not analyzed as there was insufficient data available at Cycle 2, Day 1 of study treatment. There was limited data evaluated and data were not analyzed.
reporting Status
POSTED
time Frame
From first dose until the data cut-off date of 03 September 2014; maximum time for follow-up was 36 weeks
title
Kaplan-Meier Estimates of Duration of Response
type
SECONDARY

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

Preserved source evidence · Not medical advice