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NCT01592370 · OUTCOME

Number of Participants That Experienced Drug Related Grade 3-4 AEs

An Investigational Immuno-Therapy Study to Determine the Safety and Effectiveness of Nivolumab and Daratumumab in Patients With Multiple Myeloma · Source last updated 2025-10-22

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
Nivo Mono: approximately up to 6 years and 9 months Nivo Ipi: approximately up to 5 months Nivo Liri: approximately up to 4 years 1 month

What was measured

Number and percent of participants that experienced drug related Grade 3-4 AEs occurring up to 100 days after the last dose of study drug.

Analysis population: All Treated Participants

Groups in this outcome

Nivolumab Monotherapy (Expansion)

3mg/kg of nivolumab

Nivolumab + Ipilimumab

3 mg/kg of nivolumab and 1 mg/kg of ipilimumab Q3W for 4 doses, followed by nivolumab alone at 3 mg/kg Q2W

Nivolumab + Lirilumab

3 mg/kg of nivolumab Q2W + 3 mg/kg of lirilumab Q4W

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

Analysis denominator · Participants

GroupSource count
Nivolumab Monotherapy (Expansion)105
Nivolumab + Ipilimumab65
Nivolumab + Lirilumab72

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Nivolumab Monotherapy (Expansion)19Not reportedNot reportedNot reportedNot reported
Nivolumab + Ipilimumab18Not reportedNot reportedNot reportedNot reported
Nivolumab + Lirilumab0Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        19
      2. group Id
        OG001
        value
        18
      3. group Id
        OG002
        value
        0
denoms
  1. counts
    1. group Id
      OG000
      value
      105
    2. group Id
      OG001
      value
      65
    3. group Id
      OG002
      value
      72
    units
    Participants
description
Number and percent of participants that experienced drug related Grade 3-4 AEs occurring up to 100 days after the last dose of study drug.
groups
  1. description
    3mg/kg of nivolumab
    id
    OG000
    title
    Nivolumab Monotherapy (Expansion)
  2. description
    3 mg/kg of nivolumab and 1 mg/kg of ipilimumab Q3W for 4 doses, followed by nivolumab alone at 3 mg/kg Q2W
    id
    OG001
    title
    Nivolumab + Ipilimumab
  3. description
    3 mg/kg of nivolumab Q2W + 3 mg/kg of lirilumab Q4W
    id
    OG002
    title
    Nivolumab + Lirilumab
param Type
COUNT_OF_PARTICIPANTS
population Description
All Treated Participants
reporting Status
POSTED
time Frame
Nivo Mono: approximately up to 6 years and 9 months Nivo Ipi: approximately up to 5 months Nivo Liri: approximately up to 4 years 1 month
title
Number of Participants That Experienced Drug Related Grade 3-4 AEs
type
PRIMARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice