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NCT04213209 · OUTCOME

Percentage of Participants Who Achieve or Maintain Any Best Response for Pediatric Participants With PTCL and HL

Special Drug Use Surveillance for Brentuximab Vedotin Intravenous Infusion "Relapsed or Refractory CD30-positive Peripheral T Cell Lymphoma or Pediatric Hodgkin Lymphoma" · Source last updated 2024-09-27

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
Up to 12 Months

What was measured

Best response is defined as the cumulative numbers of participants who achieve each level of best response including complete response (CR), complete response uncertain (CRu) (for PTCL), partial response (PR), Stable Disease (SD), and Progressive Disease (PD) after treatment. Best response was assessed by the Japanese Pediatric Leukemia/Lymphoma Study Group (JPLSG) version of antitumor response criteria.

Analysis population: Efficacy analysis set: all participants who received at least one dose of protocol treatment without major protocol deviation. The number analyzed was the number of participants with data available for analysis.

Groups in this outcome

Pediatric Participants With PTCL

Pediatric participants with peripheral T-cell lymphoma (PTCL) were received brentuximab vedotin (genetic recombination) 1.8 milligrams per kilograms (mg/kg) (body weight), intravenous infusion, once every three weeks (up to 12 months). The dose should be reduced appropriately depend on the participant's condition. Participants received interventions as part of routine medical care.

Pediatric Participants With HL

Pediatric participants with Hodgkin lymphoma (HL) were received brentuximab vedotin (genetic recombination) 1.8 milligrams per kilograms (mg/kg) (body weight), intravenous infusion, once every three weeks (up to 12 months). The dose should be reduced appropriately depend on the participant's condition. Participants received interventions as part of routine medical care.

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

Analysis denominator · Participants

GroupSource count
Pediatric Participants With PTCL3
Pediatric Participants With HL3

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Pediatric Participants With PTCL3Not reportedNot reportedNot reportedNot reported
Pediatric Participants With HL2Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        3
      2. group Id
        OG001
        value
        2
denoms
  1. counts
    1. group Id
      OG000
      value
      3
    2. group Id
      OG001
      value
      3
    units
    Participants
description
Best response is defined as the cumulative numbers of participants who achieve each level of best response including complete response (CR), complete response uncertain (CRu) (for PTCL), partial response (PR), Stable Disease (SD), and Progressive Disease (PD) after treatment. Best response was assessed by the Japanese Pediatric Leukemia/Lymphoma Study Group (JPLSG) version of antitumor response criteria.
groups
  1. description
    Pediatric participants with peripheral T-cell lymphoma (PTCL) were received brentuximab vedotin (genetic recombination) 1.8 milligrams per kilograms (mg/kg) (body weight), intravenous infusion, once every three weeks (up to 12 months). The dose should be reduced appropriately depend on the participant's condition. Participants received interventions as part of routine medical care.
    id
    OG000
    title
    Pediatric Participants With PTCL
  2. description
    Pediatric participants with Hodgkin lymphoma (HL) were received brentuximab vedotin (genetic recombination) 1.8 milligrams per kilograms (mg/kg) (body weight), intravenous infusion, once every three weeks (up to 12 months). The dose should be reduced appropriately depend on the participant's condition. Participants received interventions as part of routine medical care.
    id
    OG001
    title
    Pediatric Participants With HL
param Type
COUNT_OF_PARTICIPANTS
population Description
Efficacy analysis set: all participants who received at least one dose of protocol treatment without major protocol deviation. The number analyzed was the number of participants with data available for analysis.
reporting Status
POSTED
time Frame
Up to 12 Months
title
Percentage of Participants Who Achieve or Maintain Any Best Response for Pediatric Participants With PTCL and HL
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice