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NCT00282087 · OUTCOME

Two-year Progression-free Survival Among Women Treated With This Adjuvant Regimen for High Risk Uterine LMS

Adjuvant Chemotherapy for High Risk Uterine Leiomyosarcoma · Source last updated 2014-12-01

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

Measure
NUMBER
Unit
percentage of participants
Interval / dispersion
95% Confidence Interval
Time frame
Every 3 months up to two years

Groups in this outcome

Women Treated With Adjuvant Regimen for High Risk Uterine LMS

Not reported

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

Analysis denominator · Participants

GroupSource count
Women Treated With Adjuvant Regimen for High Risk Uterine LMS46

Reported measurements

Source class 1
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Women Treated With Adjuvant Regimen for High Risk Uterine LMS78Not reported6791Not reported

Source statistical analyses

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

  1. ci Lower Limit
    67
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    91
    group Description
    The primary endpoint is progression-free survival time, with progression defined as a patient having evidence of recurrent LMS on follow-up evaluation and CT scan. Futility monitoring will be based on the accumulating right-censored PFS time data. The monitoring rules will be based on a Bayesian model.
    group Ids
    1. OG000
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.15
    param Type
    Two year PFS
    param Value
    78
    statistical Method
    Bayesian Posterior Probability
    tested Non Inferiority
    false
Complete source fields
analyses
  1. ci Lower Limit
    67
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    91
    group Description
    The primary endpoint is progression-free survival time, with progression defined as a patient having evidence of recurrent LMS on follow-up evaluation and CT scan. Futility monitoring will be based on the accumulating right-censored PFS time data. The monitoring rules will be based on a Bayesian model.
    group Ids
    1. OG000
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.15
    param Type
    Two year PFS
    param Value
    78
    statistical Method
    Bayesian Posterior Probability
    tested Non Inferiority
    false
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        67
        upper Limit
        91
        value
        78
denoms
  1. counts
    1. group Id
      OG000
      value
      46
    units
    Participants
dispersion Type
95% Confidence Interval
groups
  1. id
    OG000
    title
    Women Treated With Adjuvant Regimen for High Risk Uterine LMS
param Type
NUMBER
reporting Status
POSTED
time Frame
Every 3 months up to two years
title
Two-year Progression-free Survival Among Women Treated With This Adjuvant Regimen for High Risk Uterine LMS
type
PRIMARY
unit Of Measure
percentage of participants

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

Preserved source evidence · Not medical advice