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NCT04798586 · OUTCOME

Number of Participants With Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (SAEs), Treatment Emergent Treatment Related AEs and Treatment Emergent Treatment Related SAEs

MAGNETISMM-2: Study of Elranatamab (PF-06863135) in Japanese Participants With Multiple Myeloma · 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
From first dose of study intervention and up to 90 days after last dose or start of new anticancer therapy (maximum of 65.1 weeks of treatment)

What was measured

An AE was defined as any untoward medical occurrence in a participant temporally associated with the use of study intervention, whether or not considered related to the study intervention. AEs included both serious and all non-serious adverse events. An SAE was defined as any untoward medical occurrence that, at any dose resulted in any of the following outcomes: death; life-threatening; required inpatient hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect; or that was considered as an important medical event. A TEAE was defined as an AE that first occurred from the first dose of the study intervention until 90 days after the last dose or the day before starting a new anticancer therapy, whichever occurred first. Treatment related AEs and SAEs were defined as AEs and SAEs which was related to the treatment.

Analysis population: SAS included all enrolled participants who received at least 1 dose of study intervention.

Groups in this outcome

Elranatamab

Participants received an initial priming dose of 600 microgram per kilogram elranatamab subcutaneously on Cycle 0 Day 1 (7 days prior to Cycle 1 Day 1). During treatment cycle, participants were administered 1000 microgram per kilogram elranatamab weekly during each cycle (each cycle was of 3 weeks).

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

Analysis denominator · Participants

GroupSource count
Elranatamab4

Reported measurements

TEAEs
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Elranatamab4Not reportedNot reportedNot reportedNot reported
Treatment Emergent SAEs
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Elranatamab3Not reportedNot reportedNot reportedNot reported
Treatment Emergent Treatment Related AEs
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Elranatamab4Not reportedNot reportedNot reportedNot reported
Treatment Emergent Treatment Related SAEs
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Elranatamab3Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        4
    title
    TEAEs
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        3
    title
    Treatment Emergent SAEs
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        4
    title
    Treatment Emergent Treatment Related AEs
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        3
    title
    Treatment Emergent Treatment Related SAEs
denoms
  1. counts
    1. group Id
      OG000
      value
      4
    units
    Participants
description
An AE was defined as any untoward medical occurrence in a participant temporally associated with the use of study intervention, whether or not considered related to the study intervention. AEs included both serious and all non-serious adverse events. An SAE was defined as any untoward medical occurrence that, at any dose resulted in any of the following outcomes: death; life-threatening; required inpatient hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect; or that was considered as an important medical event. A TEAE was defined as an AE that first occurred from the first dose of the study intervention until 90 days after the last dose or the day before starting a new anticancer therapy, whichever occurred first. Treatment related AEs and SAEs were defined as AEs and SAEs which was related to the treatment.
groups
  1. description
    Participants received an initial priming dose of 600 microgram per kilogram elranatamab subcutaneously on Cycle 0 Day 1 (7 days prior to Cycle 1 Day 1). During treatment cycle, participants were administered 1000 microgram per kilogram elranatamab weekly during each cycle (each cycle was of 3 weeks).
    id
    OG000
    title
    Elranatamab
param Type
COUNT_OF_PARTICIPANTS
population Description
SAS included all enrolled participants who received at least 1 dose of study intervention.
reporting Status
POSTED
time Frame
From first dose of study intervention and up to 90 days after last dose or start of new anticancer therapy (maximum of 65.1 weeks of treatment)
title
Number of Participants With Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (SAEs), Treatment Emergent Treatment Related AEs and Treatment Emergent Treatment Related SAEs
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice