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NCT04162210 · OUTCOME

Number of Participants With Treatment Emergent Adverse Events (TEAEs)

Study of Single Agent Belantamab Mafodotin Versus Pomalidomide Plus Low-dose Dexamethasone (Pom/Dex) in Participants With Relapsed/Refractory Multiple Myeloma (RRMM) · Source last updated 2026-07-01

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 approximately 263 weeks

What was measured

An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. TEAE is an event that emerged during treatment having been absent pre-treatment or worsened relative to the pre-treatment state. AEs were to be coded using the Medical Dictionary for Regulatory Activities (MedDRA) coding system.

Analysis population: Safety Population included all randomized participants who took at least 1 dose of study intervention

Groups in this outcome

Belantamab Mafodotin

Participants with relapsed/refractory multiple myeloma (RRMM) received 30 minutes intravenous infusion of 2.5 milligram/kilogram (mg/kg) belantamab mafodotin on day 1 of each 21-day cycle

Pomalidomide Plus Dexamethasone

Participants with RRMM received 4 mg pomalidomide capsule daily on Days 1 to 21 of each 28-day cycle, along with 40 mg or at lower 20 mg (for participants \>75 years of age) dose of dexamethasone tablet once weekly (Days 1, 8, 15 and 22)

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

Analysis denominator · Participants

GroupSource count
Belantamab Mafodotin217
Pomalidomide Plus Dexamethasone102

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Belantamab Mafodotin212Not reportedNot reportedNot reportedNot reported
Pomalidomide Plus Dexamethasone98Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        212
      2. group Id
        OG001
        value
        98
denoms
  1. counts
    1. group Id
      OG000
      value
      217
    2. group Id
      OG001
      value
      102
    units
    Participants
description
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. TEAE is an event that emerged during treatment having been absent pre-treatment or worsened relative to the pre-treatment state. AEs were to be coded using the Medical Dictionary for Regulatory Activities (MedDRA) coding system.
groups
  1. description
    Participants with relapsed/refractory multiple myeloma (RRMM) received 30 minutes intravenous infusion of 2.5 milligram/kilogram (mg/kg) belantamab mafodotin on day 1 of each 21-day cycle
    id
    OG000
    title
    Belantamab Mafodotin
  2. description
    Participants with RRMM received 4 mg pomalidomide capsule daily on Days 1 to 21 of each 28-day cycle, along with 40 mg or at lower 20 mg (for participants \>75 years of age) dose of dexamethasone tablet once weekly (Days 1, 8, 15 and 22)
    id
    OG001
    title
    Pomalidomide Plus Dexamethasone
param Type
COUNT_OF_PARTICIPANTS
population Description
Safety Population included all randomized participants who took at least 1 dose of study intervention
reporting Status
POSTED
time Frame
Up to approximately 263 weeks
title
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice