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NCT00867113 · OUTCOME

Kaplan-Meier Estimates for Recurrence-free Survival up to 60 Months

Five Year Adjuvant Imatinib Mesylate (Gleevec®) in Gastrointestinal Stromal Tumor (GIST) · Source last updated 2018-03-14

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

Measure
NUMBER
Unit
percentage of patients
Interval / dispersion
95% Confidence Interval
Time frame
Baseline up to 60 months

What was measured

Recurrence-free survival (RFS) assessment is based on the radiologic evidence and is defined as the time from the date of first dose of imatinib to the date of the first documented disease recurrence or death due to any cause (event). RFS estimates were summarized using the Kaplan-Meier product-limit method (Kaplan 1958). Censoring rules for RFS with the earliest occurring rule used in the analysis: subjects without objective recurrence of disease who were alive at the time of their discontinuation from study were censored at the end of study date or end of treatment visit date if the subject refused to be followed post treatment and subjects recording antineoplastic therapy during the study were censored on the date of the therapy initiated

Groups in this outcome

Imatinib

All subjects received in tablet form imatinib (STI571) 400 mg once daily.

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

Analysis denominator · Participants

GroupSource count
Imatinib91

Reported measurements

12 months
Values in percentage of patients · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Imatinib97.7Not reported91.199.4Not reported
18 months
Values in percentage of patients · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Imatinib97.7Not reported91.199.4Not reported
24 months
Values in percentage of patients · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Imatinib96.5Not reported89.698.9Not reported
36 months
Values in percentage of patients · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Imatinib95.1Not reported87.598.2Not reported
48 months
Values in percentage of patients · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Imatinib95.1Not reported87.598.2Not reported
60 months
Values in percentage of patients · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Imatinib90.1Not reported80.095.2Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        91.1
        upper Limit
        99.4
        value
        97.7
    title
    12 months
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        91.1
        upper Limit
        99.4
        value
        97.7
    title
    18 months
  3. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        89.6
        upper Limit
        98.9
        value
        96.5
    title
    24 months
  4. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        87.5
        upper Limit
        98.2
        value
        95.1
    title
    36 months
  5. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        87.5
        upper Limit
        98.2
        value
        95.1
    title
    48 months
  6. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        80.0
        upper Limit
        95.2
        value
        90.1
    title
    60 months
denoms
  1. counts
    1. group Id
      OG000
      value
      91
    units
    Participants
description
Recurrence-free survival (RFS) assessment is based on the radiologic evidence and is defined as the time from the date of first dose of imatinib to the date of the first documented disease recurrence or death due to any cause (event). RFS estimates were summarized using the Kaplan-Meier product-limit method (Kaplan 1958). Censoring rules for RFS with the earliest occurring rule used in the analysis: subjects without objective recurrence of disease who were alive at the time of their discontinuation from study were censored at the end of study date or end of treatment visit date if the subject refused to be followed post treatment and subjects recording antineoplastic therapy during the study were censored on the date of the therapy initiated
dispersion Type
95% Confidence Interval
groups
  1. description
    All subjects received in tablet form imatinib (STI571) 400 mg once daily.
    id
    OG000
    title
    Imatinib
param Type
NUMBER
reporting Status
POSTED
time Frame
Baseline up to 60 months
title
Kaplan-Meier Estimates for Recurrence-free Survival up to 60 Months
type
PRIMARY
unit Of Measure
percentage of patients

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice