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NCT01100502 · OUTCOME

Incidence of Anti-therapeutic Antibodies (ATA) to Brentuximab Vedotin

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
NUMBER
Unit
participants
Interval / dispersion
Not reported
Time frame
Up to 12 months

Analysis population: ATA-evaluable patients (patients with a baseline and at least 1 postbaseline sample)

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 Vedotin157
Placebo154

Reported measurements

Baseline Negative
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Brentuximab Vedotin138Not reportedNot reportedNot reportedNot reported
Placebo142Not reportedNot reportedNot reportedNot reported
Baseline Negative: -'ve Postbaseline
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Brentuximab Vedotin92Not reportedNot reportedNot reportedNot reported
Placebo104Not reportedNot reportedNot reportedNot reported
Baseline Negative: Transiently +'ve Postbaseline
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Brentuximab Vedotin36Not reportedNot reportedNot reportedNot reported
Placebo27Not reportedNot reportedNot reportedNot reported
Baseline Negative: Persistently +'ve Postbaseline
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Brentuximab Vedotin10Not reportedNot reportedNot reportedNot reported
Placebo11Not reportedNot reportedNot reportedNot reported
Baseline Positive
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Brentuximab Vedotin19Not reportedNot reportedNot reportedNot reported
Placebo12Not reportedNot reportedNot reportedNot reported
Baseline Positive: -'ve Postbaseline
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Brentuximab Vedotin7Not reportedNot reportedNot reportedNot reported
Placebo0Not reportedNot reportedNot reportedNot reported
Baseline Positive: Transiently +'ve Postbaseline
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Brentuximab Vedotin9Not reportedNot reportedNot reportedNot reported
Placebo5Not reportedNot reportedNot reportedNot reported
Baseline Positive: Persistently +'ve Postbaseline
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Brentuximab Vedotin3Not reportedNot reportedNot reportedNot reported
Placebo7Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        138
      2. group Id
        OG001
        value
        142
    title
    Baseline Negative
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        92
      2. group Id
        OG001
        value
        104
    title
    Baseline Negative: -'ve Postbaseline
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        36
      2. group Id
        OG001
        value
        27
    title
    Baseline Negative: Transiently +'ve Postbaseline
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        10
      2. group Id
        OG001
        value
        11
    title
    Baseline Negative: Persistently +'ve Postbaseline
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        19
      2. group Id
        OG001
        value
        12
    title
    Baseline Positive
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        7
      2. group Id
        OG001
        value
        0
    title
    Baseline Positive: -'ve Postbaseline
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        9
      2. group Id
        OG001
        value
        5
    title
    Baseline Positive: Transiently +'ve Postbaseline
  8. categories
    1. measurements
      1. group Id
        OG000
        value
        3
      2. group Id
        OG001
        value
        7
    title
    Baseline Positive: Persistently +'ve Postbaseline
denoms
  1. counts
    1. group Id
      OG000
      value
      157
    2. group Id
      OG001
      value
      154
    units
    Participants
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
NUMBER
population Description
ATA-evaluable patients (patients with a baseline and at least 1 postbaseline sample)
reporting Status
POSTED
time Frame
Up to 12 months
title
Incidence of Anti-therapeutic Antibodies (ATA) to Brentuximab Vedotin
type
SECONDARY
unit Of Measure
participants

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

Preserved source evidence · Not medical advice