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NCT00432458 · OUTCOME

Time to Disease Progression (TTP)

Zoledronate With or Without Thalidomide in Treating Patients With Early Stage Multiple Myeloma · Source last updated 2012-07-04

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

Measure
MEDIAN
Unit
years
Interval / dispersion
95% Confidence Interval
Time frame
randomization to progression (up to 5 years)

What was measured

Time to disease progression (TTP) was defined as the time from randomization to the earliest documentation of disease progression. Participants were followed for a maximum of 5 years from registration. The median OS with 95% CI was estimated using the Kaplan Meier method, a two-sided (stratified) log-rank test was calculated.

Analysis population: Time to disease progression was analyzed on all randomized participants on an intent to treat basis.

Groups in this outcome

Arm I: Thal/ZLD

Thalidomide (Thal) + Zolendronic acid (ZLD)

Arm II: ZLD

Zoledronic acid (ZLD)

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 I: Thal/ZLD35
Arm II: ZLD33

Reported measurements

Source class 1
Values in years · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Arm I: Thal/ZLD2.4Not reported1.43.6Not reported
Arm II: ZLD1.2Not reported0.72.5Not reported

Source statistical analyses

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

  1. ci Pct Value
    95
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.02
    statistical Comment
    Model was stratified by beta-2 microglobulin (high vs low), lytic bone lesions (present vs not) and bone marrow labeling index (high vs low)
    statistical Method
    Log Rank
    tested Non Inferiority
    false
Complete source fields
analyses
  1. ci Pct Value
    95
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.02
    statistical Comment
    Model was stratified by beta-2 microglobulin (high vs low), lytic bone lesions (present vs not) and bone marrow labeling index (high vs low)
    statistical Method
    Log Rank
    tested Non Inferiority
    false
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        1.4
        upper Limit
        3.6
        value
        2.4
      2. group Id
        OG001
        lower Limit
        0.7
        upper Limit
        2.5
        value
        1.2
denoms
  1. counts
    1. group Id
      OG000
      value
      35
    2. group Id
      OG001
      value
      33
    units
    Participants
description
Time to disease progression (TTP) was defined as the time from randomization to the earliest documentation of disease progression. Participants were followed for a maximum of 5 years from registration. The median OS with 95% CI was estimated using the Kaplan Meier method, a two-sided (stratified) log-rank test was calculated.
dispersion Type
95% Confidence Interval
groups
  1. description
    Thalidomide (Thal) + Zolendronic acid (ZLD)
    id
    OG000
    title
    Arm I: Thal/ZLD
  2. description
    Zoledronic acid (ZLD)
    id
    OG001
    title
    Arm II: ZLD
param Type
MEDIAN
population Description
Time to disease progression was analyzed on all randomized participants on an intent to treat basis.
reporting Status
POSTED
time Frame
randomization to progression (up to 5 years)
title
Time to Disease Progression (TTP)
type
PRIMARY
unit Of Measure
years

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

Preserved source evidence · Not medical advice