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NCT02917941 · OUTCOME

Overall Survival (OS)

A Study of Ixazomib Plus Lenalidomide and Dexamethasone in Adult Japanese Participants With Relapsed and/or Refractory Multiple Myeloma · Source last updated 2021-01-12

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

Measure
MEDIAN
Unit
months
Interval / dispersion
95% Confidence Interval
Time frame
Up to approximately 33 months

What was measured

OS was defined as the time from the date of first study drug administration to the date of death.

Analysis population: FAS included all participants who received at least one dose of study drug during the treatment period. Participants without documentation of death at the time of the analysis were censored at the date when they were last known to be alive.

Groups in this outcome

Ixazomib 4 mg + Lenalidomide 25 mg + Dexamethasone 40 mg

Ixazomib 4 mg, capsules, orally on Days 1, 8, and 15 plus lenalidomide 25 mg, capsule, orally, once daily on Days 1 through 21 and dexamethasone 40 mg, tablet, orally on Days 1, 8, 15, and 22 of a 28-day cycle up to 32 cycles.

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

Analysis denominator · Participants

GroupSource count
Ixazomib 4 mg + Lenalidomide 25 mg + Dexamethasone 40 mg34

Reported measurements

Source class 1
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Ixazomib 4 mg + Lenalidomide 25 mg + Dexamethasone 40 mgNANot reported30.85NAMedian and upper limit of overall survival was not estimable due to low number of participants with events.
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        Median and upper limit of overall survival was not estimable due to low number of participants with events.
        group Id
        OG000
        lower Limit
        30.85
        upper Limit
        NA
        value
        NA
denoms
  1. counts
    1. group Id
      OG000
      value
      34
    units
    Participants
description
OS was defined as the time from the date of first study drug administration to the date of death.
dispersion Type
95% Confidence Interval
groups
  1. description
    Ixazomib 4 mg, capsules, orally on Days 1, 8, and 15 plus lenalidomide 25 mg, capsule, orally, once daily on Days 1 through 21 and dexamethasone 40 mg, tablet, orally on Days 1, 8, 15, and 22 of a 28-day cycle up to 32 cycles.
    id
    OG000
    title
    Ixazomib 4 mg + Lenalidomide 25 mg + Dexamethasone 40 mg
param Type
MEDIAN
population Description
FAS included all participants who received at least one dose of study drug during the treatment period. Participants without documentation of death at the time of the analysis were censored at the date when they were last known to be alive.
reporting Status
POSTED
time Frame
Up to approximately 33 months
title
Overall Survival (OS)
type
SECONDARY
unit Of Measure
months

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

Preserved source evidence · Not medical advice