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NCT01319422 · OUTCOME

Percentage of Participants With Response, Analyzed Per International Myeloma Working Group Response Criteria

Continuous Versus Intermittent Dosing Regimens for Pomalidomide in Relapsed/Refractory Multiple Myeloma · Source last updated 2016-08-11

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
Not reported
Time frame
After the initial efficacy assessment at the completion of cycle 2 (at approximately 56 days), efficacy assessments will be made after every other cycle (approximately every 56 days).

What was measured

All partial and complete responses must be confirmed with another efficacy assessment in no less than 4 weeks apart.

Groups in this outcome

Pomalidomide 2 mg/d on 28 Days/28 Day Cycle

Pomalidomide: Comparison of different dosages and schedules of drug

Pomalidomide 4 mg/d on 21 Days/28 Day Cycle

Pomalidomide: Comparison of different dosages and schedules of drug

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 2 mg/d on 28 Days/28 Day Cycle19
Pomalidomide 4 mg/d on 21 Days/28 Day Cycle20

Reported measurements

cycle 4
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Pomalidomide 2 mg/d on 28 Days/28 Day Cycle15.8Not reportedNot reportedNot reportedNot reported
Pomalidomide 4 mg/d on 21 Days/28 Day Cycle40.0Not reportedNot reportedNot reportedNot reported
cycle 6
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Pomalidomide 2 mg/d on 28 Days/28 Day Cycle21.0Not reportedNot reportedNot reportedNot reported
Pomalidomide 4 mg/d on 21 Days/28 Day Cycle40.0Not reportedNot reportedNot reportedNot reported
cycle 8
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Pomalidomide 2 mg/d on 28 Days/28 Day Cycle21.0Not reportedNot reportedNot reportedNot reported
Pomalidomide 4 mg/d on 21 Days/28 Day Cycle45.0Not reportedNot reportedNot reportedNot reported
cycle 10
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Pomalidomide 2 mg/d on 28 Days/28 Day Cycle21.0Not reportedNot reportedNot reportedNot reported
Pomalidomide 4 mg/d on 21 Days/28 Day Cycle45.0Not reportedNot reportedNot reportedNot reported
cycle 12
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Pomalidomide 2 mg/d on 28 Days/28 Day Cycle21.0Not reportedNot reportedNot reportedNot reported
Pomalidomide 4 mg/d on 21 Days/28 Day Cycle45.0Not reportedNot reportedNot reportedNot reported
cycle 14
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Pomalidomide 2 mg/d on 28 Days/28 Day Cycle21.0Not reportedNot reportedNot reportedNot reported
Pomalidomide 4 mg/d on 21 Days/28 Day Cycle45.0Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        15.8
      2. group Id
        OG001
        value
        40.0
    title
    cycle 4
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        21.0
      2. group Id
        OG001
        value
        40.0
    title
    cycle 6
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        21.0
      2. group Id
        OG001
        value
        45.0
    title
    cycle 8
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        21.0
      2. group Id
        OG001
        value
        45.0
    title
    cycle 10
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        21.0
      2. group Id
        OG001
        value
        45.0
    title
    cycle 12
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        21.0
      2. group Id
        OG001
        value
        45.0
    title
    cycle 14
denoms
  1. counts
    1. group Id
      OG000
      value
      19
    2. group Id
      OG001
      value
      20
    units
    Participants
description
All partial and complete responses must be confirmed with another efficacy assessment in no less than 4 weeks apart.
groups
  1. description
    Pomalidomide: Comparison of different dosages and schedules of drug
    id
    OG000
    title
    Pomalidomide 2 mg/d on 28 Days/28 Day Cycle
  2. description
    Pomalidomide: Comparison of different dosages and schedules of drug
    id
    OG001
    title
    Pomalidomide 4 mg/d on 21 Days/28 Day Cycle
param Type
NUMBER
reporting Status
POSTED
time Frame
After the initial efficacy assessment at the completion of cycle 2 (at approximately 56 days), efficacy assessments will be made after every other cycle (approximately every 56 days).
title
Percentage of Participants With Response, Analyzed Per International Myeloma Working Group Response Criteria
type
PRIMARY
unit Of Measure
percentage of participants

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

Preserved source evidence · Not medical advice