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NCT01698801 · OUTCOME

Overall Survival (OS)

A Phase 2 Study of Lenalidomide to Evaluate the Efficacy in Japanese Patients With Newly Diagnosed Multiple Myeloma · Source last updated 2018-11-08

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
From the first dose of study drug treatment until the data cut-off date of 15 July 2014. Median follow up is 14.2 months

What was measured

The time from the start of study treatment to death due to any cause. OS was censored at the last date that the participant was known to be alive for participants who were alive at the time of analysis and for participants who were lost to follow-up before death was documented.

Analysis population: Efficacy Evaluable (EE) Population consists of all participants who met the protocol requirements (all eligibility criteria) and were evaluated after receiving at least one dose of study drug.

Groups in this outcome

Lenalidomide Plus Dexamethasone

Lenalidomide 25 mg orally once daily for 21 days in each 28-day cycle until progressive disease or lenalidomide discontinuation for any reason. Dexamethasone 40 mg orally once daily on Days 1, 8, 15 and 22 in each 28-day cycle until progressive disease or lenalidomide discontinuation for any reason.

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

Analysis denominator · Participants

GroupSource count
Lenalidomide Plus Dexamethasone24

Reported measurements

Source class 1
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Lenalidomide Plus Dexamethasone17.71Not reported17.710NAOS data are interim at data cutoff, with only 3 events in the study treatment phase (median follow-up 14.2 mos)
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        OS data are interim at data cutoff, with only 3 events in the study treatment phase (median follow-up 14.2 mos)
        group Id
        OG000
        lower Limit
        17.710
        upper Limit
        NA
        value
        17.71
denoms
  1. counts
    1. group Id
      OG000
      value
      24
    units
    Participants
description
The time from the start of study treatment to death due to any cause. OS was censored at the last date that the participant was known to be alive for participants who were alive at the time of analysis and for participants who were lost to follow-up before death was documented.
dispersion Type
95% Confidence Interval
groups
  1. description
    Lenalidomide 25 mg orally once daily for 21 days in each 28-day cycle until progressive disease or lenalidomide discontinuation for any reason. Dexamethasone 40 mg orally once daily on Days 1, 8, 15 and 22 in each 28-day cycle until progressive disease or lenalidomide discontinuation for any reason.
    id
    OG000
    title
    Lenalidomide Plus Dexamethasone
param Type
MEDIAN
population Description
Efficacy Evaluable (EE) Population consists of all participants who met the protocol requirements (all eligibility criteria) and were evaluated after receiving at least one dose of study drug.
reporting Status
POSTED
time Frame
From the first dose of study drug treatment until the data cut-off date of 15 July 2014. Median follow up is 14.2 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