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NCT01100502 · OUTCOME

Overall Survival

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
Full Range
Time frame
Up to approximately 10 years

What was measured

Time from date of randomization to date of death due to any cause

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: Full Range
GroupValueSpreadLowerUpperComment
Brentuximab VedotinNANot reported1.31117.88Due to patients lost to follow up, patient withdrawal of consent and post ASCT therapies; there were less deaths on study than anticipated. Therefore, median OS was not reached.
PlaceboNANot reported0.03119.23Due to patients lost to follow up, patient withdrawal of consent and post ASCT therapies; there were less deaths on study than anticipated. Therefore, median OS was not reached
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        Due to patients lost to follow up, patient withdrawal of consent and post ASCT therapies; there were less deaths on study than anticipated. Therefore, median OS was not reached.
        group Id
        OG000
        lower Limit
        1.31
        upper Limit
        117.88
        value
        NA
      2. comment
        Due to patients lost to follow up, patient withdrawal of consent and post ASCT therapies; there were less deaths on study than anticipated. Therefore, median OS was not reached
        group Id
        OG001
        lower Limit
        0.03
        upper Limit
        119.23
        value
        NA
denoms
  1. counts
    1. group Id
      OG000
      value
      165
    2. group Id
      OG001
      value
      164
    units
    Participants
description
Time from date of randomization to date of death due to any cause
dispersion Type
Full Range
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 10 years
title
Overall Survival
type
SECONDARY
unit Of Measure
months

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

Preserved source evidence · Not medical advice