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NCT01324947 · OUTCOME

Time to Response Based on IMWG and Assessed by the Investigator

Study to Evaluate the Safety and Efficacy of Pomalidomide Monotherapy in Subjects With Refractory or Relapsed Refractory Multiple Myeloma · Source last updated 2019-11-19

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

Measure
MEDIAN
Unit
weeks
Interval / dispersion
Full Range
Time frame
From randomization through the follow-up phase; up to the data-cut off of 31 July 2014; Maximum time to response was 23.1 weeks

What was measured

Time to Response was calculated as the time from enrollment to the initial response (PR or better) based on IMWG and assessed by the investigator.

Analysis population: Includes those who had at least a partial response or better; Intent to Treat

Groups in this outcome

Pomalidomide

Oral pomalidomide 4 mg on Days 1-21 of each 28-day cycle until progressive disease (PD) or unacceptable toxicity

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

Analysis denominator · Participants

GroupSource count
Pomalidomide17

Reported measurements

Source class 1
Values in weeks · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Pomalidomide8.3Not reported4.123.1Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        4.1
        upper Limit
        23.1
        value
        8.3
denoms
  1. counts
    1. group Id
      OG000
      value
      17
    units
    Participants
description
Time to Response was calculated as the time from enrollment to the initial response (PR or better) based on IMWG and assessed by the investigator.
dispersion Type
Full Range
groups
  1. description
    Oral pomalidomide 4 mg on Days 1-21 of each 28-day cycle until progressive disease (PD) or unacceptable toxicity
    id
    OG000
    title
    Pomalidomide
param Type
MEDIAN
population Description
Includes those who had at least a partial response or better; Intent to Treat
reporting Status
POSTED
time Frame
From randomization through the follow-up phase; up to the data-cut off of 31 July 2014; Maximum time to response was 23.1 weeks
title
Time to Response Based on IMWG and Assessed by the Investigator
type
SECONDARY
unit Of Measure
weeks

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

Preserved source evidence · Not medical advice