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NCT01335399 · OUTCOME

Progression Free Survival (PFS) Rate at Specific Time-points

Phase III Study of Lenalidomide and Dexamethasone With or Without Elotuzumab to Treat Newly Diagnosed, Previously Untreated Multiple Myeloma · Source last updated 2022-09-30

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

Measure
NUMBER
Unit
Percent of participants
Interval / dispersion
95% Confidence Interval
Time frame
From randomization to the specified time-point (up to 5 years)

What was measured

PFS rate is defined as the percentage of participants experiencing PFS at the defined time-points.

Analysis population: All randomized participants

Groups in this outcome

E-Ld Cohort

Participants receiving a combination of Elotuzumab (E) Lenalidomide (L) Dexamethasone (d) in a 28 day cycle

Ld Cohort

Participants receiving a combination of Lenalidomide (L) Dexamethasone (d) in a 28 day cycle

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

Analysis denominator · Participants

GroupSource count
E-Ld Cohort374
Ld Cohort374

Reported measurements

1 year
Values in Percent of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
E-Ld Cohort0.77Not reported0.720.81Not reported
Ld Cohort0.76Not reported0.710.80Not reported
2 year
Values in Percent of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
E-Ld Cohort0.59Not reported0.530.64Not reported
Ld Cohort0.55Not reported0.490.60Not reported
3 year
Values in Percent of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
E-Ld Cohort0.46Not reported0.400.51Not reported
Ld Cohort0.41Not reported0.350.46Not reported
4 year
Values in Percent of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
E-Ld Cohort0.36Not reported0.310.41Not reported
Ld Cohort0.33Not reported0.280.38Not reported
5 year
Values in Percent of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
E-Ld Cohort0.26Not reported0.210.32Not reported
Ld Cohort0.25Not reported0.200.30Not reported

Source statistical analyses

Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.

  1. ci Lower Limit
    0.78
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.12
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.4358
    param Type
    Hazard Ratio (HR)
    param Value
    0.93
    statistical Method
    Hazard Ratio
Complete source fields
analyses
  1. ci Lower Limit
    0.78
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.12
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.4358
    param Type
    Hazard Ratio (HR)
    param Value
    0.93
    statistical Method
    Hazard Ratio
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.72
        upper Limit
        0.81
        value
        0.77
      2. group Id
        OG001
        lower Limit
        0.71
        upper Limit
        0.80
        value
        0.76
    title
    1 year
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.53
        upper Limit
        0.64
        value
        0.59
      2. group Id
        OG001
        lower Limit
        0.49
        upper Limit
        0.60
        value
        0.55
    title
    2 year
  3. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.40
        upper Limit
        0.51
        value
        0.46
      2. group Id
        OG001
        lower Limit
        0.35
        upper Limit
        0.46
        value
        0.41
    title
    3 year
  4. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.31
        upper Limit
        0.41
        value
        0.36
      2. group Id
        OG001
        lower Limit
        0.28
        upper Limit
        0.38
        value
        0.33
    title
    4 year
  5. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.21
        upper Limit
        0.32
        value
        0.26
      2. group Id
        OG001
        lower Limit
        0.20
        upper Limit
        0.30
        value
        0.25
    title
    5 year
denoms
  1. counts
    1. group Id
      OG000
      value
      374
    2. group Id
      OG001
      value
      374
    units
    Participants
description
PFS rate is defined as the percentage of participants experiencing PFS at the defined time-points.
dispersion Type
95% Confidence Interval
groups
  1. description
    Participants receiving a combination of Elotuzumab (E) Lenalidomide (L) Dexamethasone (d) in a 28 day cycle
    id
    OG000
    title
    E-Ld Cohort
  2. description
    Participants receiving a combination of Lenalidomide (L) Dexamethasone (d) in a 28 day cycle
    id
    OG001
    title
    Ld Cohort
param Type
NUMBER
population Description
All randomized participants
reporting Status
POSTED
time Frame
From randomization to the specified time-point (up to 5 years)
title
Progression Free Survival (PFS) Rate at Specific Time-points
type
SECONDARY
unit Of Measure
Percent of participants

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

Preserved source evidence · Not medical advice