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NCT00304031 · OUTCOME

Overall Survival Status by Progression Status at 6 Months

Radiation Therapy (RT) and Temozolomide (TMZ) in Treating Patients With Newly Diagnosed Glioblastoma or Gliosarcoma · Source last updated 2020-06-09

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

Measure
MEDIAN
Unit
months
Interval / dispersion
95% Confidence Interval
Time frame
From randomization to last follow-up. Maximum follow-up at time of analysis was 4.4 years.

What was measured

Overall survival time is defined as time from registration to the date of death from any cause or last known follow-up (censored). Overall survival rates are estimated by the Kaplan-Meier method. Progression is defined as greater than 25% increase in tumor area (two diameters) provided that the patient has not had his/her dose of steroids decreased since the last evaluation period.

Analysis population: Per the protocol, both arms are combined to compare between 6-month progression status. Eligible pre-randomization participants with any follow-up data.

Groups in this outcome

No Progression at 6 Months

Not reported

Progression at 6 Months

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
No Progression at 6 Months676
Progression at 6 Months444

Reported measurements

Source class 1
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
No Progression at 6 Months20.7Not reported19.522.2Not reported
Progression at 6 Months10.1Not reported8.810.9Not reported

Source statistical analyses

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

  1. group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    <0.001
    p Value Comment
    Two-sided test
    statistical Method
    Log Rank
Complete source fields
analyses
  1. group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    <0.001
    p Value Comment
    Two-sided test
    statistical Method
    Log Rank
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        19.5
        upper Limit
        22.2
        value
        20.7
      2. group Id
        OG001
        lower Limit
        8.8
        upper Limit
        10.9
        value
        10.1
denoms
  1. counts
    1. group Id
      OG000
      value
      676
    2. group Id
      OG001
      value
      444
    units
    Participants
description
Overall survival time is defined as time from registration to the date of death from any cause or last known follow-up (censored). Overall survival rates are estimated by the Kaplan-Meier method. Progression is defined as greater than 25% increase in tumor area (two diameters) provided that the patient has not had his/her dose of steroids decreased since the last evaluation period.
dispersion Type
95% Confidence Interval
groups
  1. id
    OG000
    title
    No Progression at 6 Months
  2. id
    OG001
    title
    Progression at 6 Months
param Type
MEDIAN
population Description
Per the protocol, both arms are combined to compare between 6-month progression status. Eligible pre-randomization participants with any follow-up data.
reporting Status
POSTED
time Frame
From randomization to last follow-up. Maximum follow-up at time of analysis was 4.4 years.
title
Overall Survival Status by Progression Status at 6 Months
type
SECONDARY
unit Of Measure
months

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

Preserved source evidence · Not medical advice