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NCT03947255 · OUTCOME

Number of Participants With Adverse Events

A Study of Retreatment With Brentuximab Vedotin in Subjects With Classic Hodgkin Lymphoma or CD30-expressing Peripheral T Cell Lymphoma · Source last updated 2023-10-13

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 36 months

What was measured

An AE is any untoward medical occurrence in a patient or clinical investigational participant administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Treatment emergent AEs (TEAEs) are defined as events that are new or worsened on or after receiving the first dose of study treatment and up through 30 days after the last dose of study treatment.

Analysis population: The full analysis set includes participants who received at least one dose of study treatment.

Groups in this outcome

Classic Hodgkin Lymphoma

Participants with classic Hodgkin lymphoma

PTCL

Participants with peripheral T cell lymphoma

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

Analysis denominator · Participants

GroupSource count
Classic Hodgkin Lymphoma5
PTCL6

Reported measurements

Any TEAE
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Classic Hodgkin Lymphoma5Not reportedNot reportedNot reportedNot reported
PTCL6Not reportedNot reportedNot reportedNot reported
Treatment-related TEAE
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Classic Hodgkin Lymphoma4Not reportedNot reportedNot reportedNot reported
PTCL5Not reportedNot reportedNot reportedNot reported
Any Treatment-Emergent SAE
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Classic Hodgkin Lymphoma0Not reportedNot reportedNot reportedNot reported
PTCL2Not reportedNot reportedNot reportedNot reported
Discontinuation of treatment due to TEAE
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Classic Hodgkin Lymphoma1Not reportedNot reportedNot reportedNot reported
PTCL3Not reportedNot reportedNot reportedNot reported
Discontinuation of treatment due to treatment-related TEAE
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Classic Hodgkin Lymphoma1Not reportedNot reportedNot reportedNot reported
PTCL3Not reportedNot reportedNot reportedNot reported
TEAE leading to death
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Classic Hodgkin Lymphoma0Not reportedNot reportedNot reportedNot reported
PTCL0Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        5
      2. group Id
        OG001
        value
        6
    title
    Any TEAE
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        4
      2. group Id
        OG001
        value
        5
    title
    Treatment-related TEAE
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        2
    title
    Any Treatment-Emergent SAE
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        3
    title
    Discontinuation of treatment due to TEAE
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        3
    title
    Discontinuation of treatment due to treatment-related TEAE
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
    title
    TEAE leading to death
denoms
  1. counts
    1. group Id
      OG000
      value
      5
    2. group Id
      OG001
      value
      6
    units
    Participants
description
An AE is any untoward medical occurrence in a patient or clinical investigational participant administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Treatment emergent AEs (TEAEs) are defined as events that are new or worsened on or after receiving the first dose of study treatment and up through 30 days after the last dose of study treatment.
groups
  1. description
    Participants with classic Hodgkin lymphoma
    id
    OG000
    title
    Classic Hodgkin Lymphoma
  2. description
    Participants with peripheral T cell lymphoma
    id
    OG001
    title
    PTCL
param Type
NUMBER
population Description
The full analysis set includes participants who received at least one dose of study treatment.
reporting Status
POSTED
time Frame
Up to 36 months
title
Number of Participants With Adverse Events
type
PRIMARY
unit Of Measure
Participants

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice