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NCT03440411 · OUTCOME

Progression Free-survival 2(PFS2)

Pom-dex Versus Pom-Cyclo-dex in MM Patients With Biochemical or Clinical Relapse, During Lena Maintenance Treatment · Source last updated 2021-03-10

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

Measure
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
57 months

What was measured

PFS for the comparison B vs A will be measured from the date of randomization disclosure to the date of first observation of PD in second line therapy, or death from any cause as an event. Subjects who have not progressed or who withdraw from the study will be censored at the time of the last complete disease assessment. All subjects who were lost to FU will also be censored at the time of last complete disease assessment

Analysis population: ITT

Groups in this outcome

Arm A

Pd

Arm B

CPd

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

Analysis denominator · Participants

GroupSource count
Arm A4
Arm B4

Reported measurements

Source class 1

Events

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm A2Not reportedNot reportedNot reportedNot reported
Arm B1Not reportedNot reportedNot reportedNot reported

Censored

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm A2Not reportedNot reportedNot reportedNot reported
Arm B3Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        1
      title
      Events
    2. measurements
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        3
      title
      Censored
denoms
  1. counts
    1. group Id
      OG000
      value
      4
    2. group Id
      OG001
      value
      4
    units
    Participants
description
PFS for the comparison B vs A will be measured from the date of randomization disclosure to the date of first observation of PD in second line therapy, or death from any cause as an event. Subjects who have not progressed or who withdraw from the study will be censored at the time of the last complete disease assessment. All subjects who were lost to FU will also be censored at the time of last complete disease assessment
groups
  1. description
    Pd
    id
    OG000
    title
    Arm A
  2. description
    CPd
    id
    OG001
    title
    Arm B
param Type
COUNT_OF_PARTICIPANTS
population Description
ITT
reporting Status
POSTED
time Frame
57 months
title
Progression Free-survival 2(PFS2)
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice