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NCT01100502 · OUTCOME

Progression-free Survival by Independent Review

A Phase 3 Study of Brentuximab Vedotin (SGN-35) in Patients at High Risk of Residual Hodgkin Lymphoma Following Stem Cell Transplant (The AETHERA Trial) · Source last updated 2021-05-14

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
Up to approximately 4 years

What was measured

Time from date of randomization to the first documentation of disease progression by independent review or to death due to any cause, whichever comes first

Analysis population: Intention-to-Treat analysis set

Groups in this outcome

Brentuximab Vedotin

brentuximab vedotin 1.8 mg/kg every 3 weeks by IV infusion

Placebo

placebo every 3 weeks by IV infusion

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

Analysis denominator · Participants

GroupSource count
Brentuximab Vedotin165
Placebo164

Reported measurements

Source class 1
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Brentuximab Vedotin42.9Not reported30.442.9Not reported
Placebo24.1Not reported11.5NAFollow-up is not long enough to estimate an upper bound for median progression-free survival

Source statistical analyses

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

  1. ci Lower Limit
    0.40
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.81
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    p Value
    0.001
    param Type
    Hazard Ratio (HR)
    param Value
    0.57
    statistical Method
    Log Rank
Complete source fields
analyses
  1. ci Lower Limit
    0.40
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.81
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    p Value
    0.001
    param Type
    Hazard Ratio (HR)
    param Value
    0.57
    statistical Method
    Log Rank
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        30.4
        upper Limit
        42.9
        value
        42.9
      2. comment
        Follow-up is not long enough to estimate an upper bound for median progression-free survival
        group Id
        OG001
        lower Limit
        11.5
        upper Limit
        NA
        value
        24.1
denoms
  1. counts
    1. group Id
      OG000
      value
      165
    2. group Id
      OG001
      value
      164
    units
    Participants
description
Time from date of randomization to the first documentation of disease progression by independent review or to death due to any cause, whichever comes first
dispersion Type
95% Confidence Interval
groups
  1. description
    brentuximab vedotin 1.8 mg/kg every 3 weeks by IV infusion
    id
    OG000
    title
    Brentuximab Vedotin
  2. description
    placebo every 3 weeks by IV infusion
    id
    OG001
    title
    Placebo
param Type
MEDIAN
population Description
Intention-to-Treat analysis set
reporting Status
POSTED
time Frame
Up to approximately 4 years
title
Progression-free Survival by Independent Review
type
PRIMARY
unit Of Measure
months

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

Preserved source evidence · Not medical advice