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NCT00884741 · OUTCOME

Progression-free Survival (PFS)

Temozolomide and Radiation Therapy With or Without Bevacizumab in Treating Patients With Newly Diagnosed Glioblastoma · Source last updated 2019-07-24

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 date of progression, death, or last follow-up for progression-free survival. Analysis occurs after all 390 deaths have been reported.

What was measured

Progression-free survival was defined as time from randomization to date of progression, death, or last follow-up, and was estimated by the Kaplan-Meier method. Patients last known to be alive were censored at the date of last contact. This analysis was planned to occur when 390 deaths had been reported.

Analysis population: All eligible randomized patients

Groups in this outcome

Randomized Arm 1: TMZ+RT + Placebo

Temozolomide post-randomization,Radiation therapy post-randomization, placebo

Randomized Arm 2: TMZ+RT + Bevacizumab

Temozolomide post-randomization, radiation therapy post-randomization, bevacizumab

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

Analysis denominator · Participants

GroupSource count
Randomized Arm 1: TMZ+RT + Placebo309
Randomized Arm 2: TMZ+RT + Bevacizumab312

Reported measurements

Source class 1
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Randomized Arm 1: TMZ+RT + Placebo7.3Not reported5.67.9Not reported
Randomized Arm 2: TMZ+RT + Bevacizumab10.7Not reported10.012.2Not reported

Source statistical analyses

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

  1. ci Lower Limit
    0.66
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.94
    group Description
    The trial was designed to concurrently provide 80% power for the detection of a 25% relative reduction in mortality hazard (hazard ratio .75) and 30% reduction in progression hazard (hazard ratio .70) for the addition of bevacizumab to temozolomide and radiation. To control for type I error in testing the co-primary endpoints, the significance criterion for OS was 0.023 (one-sided) and for PFS was 0.002 (one-sided).
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.004
    p Value Comment
    To control for type I error in testing the co-primary endpoints, the significance criterion for OS was 0.023 (one-sided) and for PFS was 0.002 (one-sided).
    param Type
    Cox Proportional Hazard
    param Value
    0.79
    statistical Method
    Log Rank
Complete source fields
analyses
  1. ci Lower Limit
    0.66
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.94
    group Description
    The trial was designed to concurrently provide 80% power for the detection of a 25% relative reduction in mortality hazard (hazard ratio .75) and 30% reduction in progression hazard (hazard ratio .70) for the addition of bevacizumab to temozolomide and radiation. To control for type I error in testing the co-primary endpoints, the significance criterion for OS was 0.023 (one-sided) and for PFS was 0.002 (one-sided).
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.004
    p Value Comment
    To control for type I error in testing the co-primary endpoints, the significance criterion for OS was 0.023 (one-sided) and for PFS was 0.002 (one-sided).
    param Type
    Cox Proportional Hazard
    param Value
    0.79
    statistical Method
    Log Rank
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        5.6
        upper Limit
        7.9
        value
        7.3
      2. group Id
        OG001
        lower Limit
        10.0
        upper Limit
        12.2
        value
        10.7
denoms
  1. counts
    1. group Id
      OG000
      value
      309
    2. group Id
      OG001
      value
      312
    units
    Participants
description
Progression-free survival was defined as time from randomization to date of progression, death, or last follow-up, and was estimated by the Kaplan-Meier method. Patients last known to be alive were censored at the date of last contact. This analysis was planned to occur when 390 deaths had been reported.
dispersion Type
95% Confidence Interval
groups
  1. description
    Temozolomide post-randomization,Radiation therapy post-randomization, placebo
    id
    OG000
    title
    Randomized Arm 1: TMZ+RT + Placebo
  2. description
    Temozolomide post-randomization, radiation therapy post-randomization, bevacizumab
    id
    OG001
    title
    Randomized Arm 2: TMZ+RT + Bevacizumab
param Type
MEDIAN
population Description
All eligible randomized patients
reporting Status
POSTED
time Frame
From randomization to date of progression, death, or last follow-up for progression-free survival. Analysis occurs after all 390 deaths have been reported.
title
Progression-free Survival (PFS)
type
PRIMARY
unit Of Measure
months

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

Preserved source evidence · Not medical advice