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NCT02990338 · OUTCOME

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

Multinational Clinical Study Comparing Isatuximab, Pomalidomide, and Dexamethasone to Pomalidomide and Dexamethasone in Refractory or Relapsed and Refractory Multiple Myeloma Patients · Source last updated 2025-01-17

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 randomization up to 30 days after last dose of study drug (maximum duration up to 241.6 weeks for Pd arm and 245.6 weeks for IPd arm)

What was measured

Adverse Event (AE) was defined as any untoward medical occurrence in a participant who received study drug and did not necessarily had a causal relationship with the treatment. TEAEs were defined as AEs that developed, worsened (according to the Investigator opinion), or became serious during the treatment period (time from the first dose of study treatments up to 30 days after last dose of study treatments). An SAE is any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a medically important event.

Analysis population: Analysis was performed on safety population which included all participants from the ITT population who received at least one dose or a part of a dose of the study treatments.

Groups in this outcome

Pd (Pomalidomide + Dexamethasone)

Participants received pomalidomide 4 mg PO on Days 1 to 21 of each 28-day treatment cycle plus dexamethasone 40 mg (participants \>= 75 years of age received 20 mg dexamethasone) PO on Days 1, 8, 15 and 22 of each 28-day treatment cycle until disease progression or unacceptable toxicity or participant's wish to discontinue study treatment, or any other reason, whichever comes first (maximum exposure: 241.6 weeks).

IPd (Isatuximab + Pomalidomide + Dexamethasone)

Participants received isatuximab 10 mg/kg IV infusion on Days 1, 8, 15, and 22 at Cycle 1, and then on Days 1 and 15 of subsequent cycles plus pomalidomide 4 mg PO on Days 1 to 21 of each 28-day treatment cycle and dexamethasone 40 mg (participants \>= 75 years of age received 20 mg dexamethasone), PO or IV on Day 1, 8, 15, 22 of each 28-day treatment cycle until disease progression or unacceptable toxicity or participant's wish to discontinue study treatment, or any other reason, whichever comes first (maximum exposure: 245.6 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
Pd (Pomalidomide + Dexamethasone)149
IPd (Isatuximab + Pomalidomide + Dexamethasone)152

Reported measurements

Any TEAE
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Pd (Pomalidomide + Dexamethasone)146Not reportedNot reportedNot reportedNot reported
IPd (Isatuximab + Pomalidomide + Dexamethasone)151Not reportedNot reportedNot reportedNot reported
Any treatment emergent SAE
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Pd (Pomalidomide + Dexamethasone)91Not reportedNot reportedNot reportedNot reported
IPd (Isatuximab + Pomalidomide + Dexamethasone)112Not reportedNot reportedNot reportedNot reported
Any TEAE leading to treatment discontinuation
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Pd (Pomalidomide + Dexamethasone)22Not reportedNot reportedNot reportedNot reported
IPd (Isatuximab + Pomalidomide + Dexamethasone)19Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        146
      2. group Id
        OG001
        value
        151
    title
    Any TEAE
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        91
      2. group Id
        OG001
        value
        112
    title
    Any treatment emergent SAE
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        22
      2. group Id
        OG001
        value
        19
    title
    Any TEAE leading to treatment discontinuation
denoms
  1. counts
    1. group Id
      OG000
      value
      149
    2. group Id
      OG001
      value
      152
    units
    Participants
description
Adverse Event (AE) was defined as any untoward medical occurrence in a participant who received study drug and did not necessarily had a causal relationship with the treatment. TEAEs were defined as AEs that developed, worsened (according to the Investigator opinion), or became serious during the treatment period (time from the first dose of study treatments up to 30 days after last dose of study treatments). An SAE is any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a medically important event.
groups
  1. description
    Participants received pomalidomide 4 mg PO on Days 1 to 21 of each 28-day treatment cycle plus dexamethasone 40 mg (participants \>= 75 years of age received 20 mg dexamethasone) PO on Days 1, 8, 15 and 22 of each 28-day treatment cycle until disease progression or unacceptable toxicity or participant's wish to discontinue study treatment, or any other reason, whichever comes first (maximum exposure: 241.6 weeks).
    id
    OG000
    title
    Pd (Pomalidomide + Dexamethasone)
  2. description
    Participants received isatuximab 10 mg/kg IV infusion on Days 1, 8, 15, and 22 at Cycle 1, and then on Days 1 and 15 of subsequent cycles plus pomalidomide 4 mg PO on Days 1 to 21 of each 28-day treatment cycle and dexamethasone 40 mg (participants \>= 75 years of age received 20 mg dexamethasone), PO or IV on Day 1, 8, 15, 22 of each 28-day treatment cycle until disease progression or unacceptable toxicity or participant's wish to discontinue study treatment, or any other reason, whichever comes first (maximum exposure: 245.6 weeks).
    id
    OG001
    title
    IPd (Isatuximab + Pomalidomide + Dexamethasone)
param Type
COUNT_OF_PARTICIPANTS
population Description
Analysis was performed on safety population which included all participants from the ITT population who received at least one dose or a part of a dose of the study treatments.
reporting Status
POSTED
time Frame
From randomization up to 30 days after last dose of study drug (maximum duration up to 241.6 weeks for Pd arm and 245.6 weeks for IPd arm)
title
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice