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NCT04113018 · OUTCOME

Number of Participants With Grade 3 or Higher Treatment-related Cardiovascular or Pulmonary-related Adverse Events During Induction

Study of Daratumumab Combined With Carfilzomib, Lenalidomide and Dexamethasone for Newly Diagnosed Multiple Myeloma · Source last updated 2026-08-13

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 enrollment to completion of induction; evaluated for approximately 32 weeks (8 28-day cycles).

What was measured

A binary variable will be determined for each subject indicating whether or not the subject experienced at least one grade 3 or higher study treatment-related cardiovascular or pulmonary-related adverse event according to the NCI Common Terminology for Adverse Events version 4.03 during induction. Only select CTCAE terms will be considered for this safety outcome including heart failure, pneumonia, dyspnea, peripheral edema, or hypertension.

Analysis population: The evaluable population is defined as all subjects who initiate treatment with daratumumab.

Groups in this outcome

KRd-Daratumumab

Induction: Carfilzomib, lenalidomide, dexamethasone (KRd) + Daratumumab Carfilzomib, lenalidomide, dexamethasone (KRd) + Daratumumab: Experimental

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

Analysis denominator · Participants

GroupSource count
KRd-Daratumumab39

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
KRd-Daratumumab2Not reportedNot reportedNot reportedNot reported

Source statistical analyses

Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.

  1. ci Lower Limit
    0.0063
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.1732
    estimate Comment
    Confidence interval estimated using the Clopper Pearson method.
    group Ids
    1. OG000
    non Inferiority Comment
    Estimation only
    non Inferiority Type
    OTHER
    param Type
    Rate
    param Value
    0.0513
Complete source fields
analyses
  1. ci Lower Limit
    0.0063
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.1732
    estimate Comment
    Confidence interval estimated using the Clopper Pearson method.
    group Ids
    1. OG000
    non Inferiority Comment
    Estimation only
    non Inferiority Type
    OTHER
    param Type
    Rate
    param Value
    0.0513
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        2
denoms
  1. counts
    1. group Id
      OG000
      value
      39
    units
    Participants
description
A binary variable will be determined for each subject indicating whether or not the subject experienced at least one grade 3 or higher study treatment-related cardiovascular or pulmonary-related adverse event according to the NCI Common Terminology for Adverse Events version 4.03 during induction. Only select CTCAE terms will be considered for this safety outcome including heart failure, pneumonia, dyspnea, peripheral edema, or hypertension.
groups
  1. description
    Induction: Carfilzomib, lenalidomide, dexamethasone (KRd) + Daratumumab Carfilzomib, lenalidomide, dexamethasone (KRd) + Daratumumab: Experimental
    id
    OG000
    title
    KRd-Daratumumab
param Type
COUNT_OF_PARTICIPANTS
population Description
The evaluable population is defined as all subjects who initiate treatment with daratumumab.
reporting Status
POSTED
time Frame
From enrollment to completion of induction; evaluated for approximately 32 weeks (8 28-day cycles).
title
Number of Participants With Grade 3 or Higher Treatment-related Cardiovascular or Pulmonary-related Adverse Events During Induction
type
OTHER_PRE_SPECIFIED
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice