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NCT00049673 · OUTCOME

Disease Progression-free Survival

Thalidomide and Prednisone After Autologous Stem Cell Transplantation Multiple Myeloma · Source last updated 2023-09-13

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
9 years

What was measured

Number of patients with disease progression or death

Analysis population: Intention-to-treat

Groups in this outcome

Prednisone

Patients receive oral thalidomide daily and oral prednisone every other day for 4 years in the absence of disease progression or unacceptable toxicity. prednisone: Given orally thalidomide: Given orally

Observation

Patients undergo observation.

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

Analysis denominator · Participants

GroupSource count
Prednisone166
Observation166

Reported measurements

Source class 1

Disease progression

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Prednisone100Not reportedNot reportedNot reportedNot reported
Observation127Not reportedNot reportedNot reportedNot reported

Without progression

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Prednisone66Not reportedNot reportedNot reportedNot reported
Observation39Not reportedNot reportedNot reportedNot reported

Source statistical analyses

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

  1. ci Lower Limit
    0.43
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.73
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.0001
    param Type
    Hazard Ratio (HR)
    param Value
    0.56
    statistical Method
    Log Rank
Complete source fields
analyses
  1. ci Lower Limit
    0.43
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.73
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.0001
    param Type
    Hazard Ratio (HR)
    param Value
    0.56
    statistical Method
    Log Rank
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        100
      2. group Id
        OG001
        value
        127
      title
      Disease progression
    2. measurements
      1. group Id
        OG000
        value
        66
      2. group Id
        OG001
        value
        39
      title
      Without progression
denoms
  1. counts
    1. group Id
      OG000
      value
      166
    2. group Id
      OG001
      value
      166
    units
    Participants
description
Number of patients with disease progression or death
groups
  1. description
    Patients receive oral thalidomide daily and oral prednisone every other day for 4 years in the absence of disease progression or unacceptable toxicity. prednisone: Given orally thalidomide: Given orally
    id
    OG000
    title
    Prednisone
  2. description
    Patients undergo observation.
    id
    OG001
    title
    Observation
param Type
COUNT_OF_PARTICIPANTS
population Description
Intention-to-treat
reporting Status
POSTED
time Frame
9 years
title
Disease Progression-free Survival
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice