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NCT02579863 · OUTCOME

Number of Participants Discontinuing Study Treatment Due to an AE

Study of Lenalidomide and Dexamethasone With or Without Pembrolizumab (MK-3475) in Participants With Newly Diagnosed Treatment Naive Multiple Myeloma (MK-3475-185/KEYNOTE-185) · Source last updated 2021-07-20

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 55 months

What was measured

An AE was defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it was considered related to the medical treatment or procedure, that occurred during the course of the study. The database cutoff date was August 3, 2020.

Analysis population: The analysis population consisted of all randomized participants who received at least one dose of study treatment.

Groups in this outcome

Pembrolizumab + Lenalidomide + Dexamethasone

Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 21-day cycle PLUS lenalidomide 25 mg orally (PO) on Days 1 to 21 of each 21-day treatment cycle, and dexamethasone 40 mg PO on Days 1, 8, 15 and 22 of each 28-day cycle for up to 18 cycles.

Lenolidomide + Dexamethasone

Participants received lenalidomide 25 mg PO on Days 1 to 21 of each 21-day treatment cycle, and dexamethasone 40 mg PO on Days 1, 8, 15 and 22 of each 28-day cycle for up to 18 cycles.

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

Analysis denominator · Participants

GroupSource count
Pembrolizumab + Lenalidomide + Dexamethasone154
Lenolidomide + Dexamethasone148

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Pembrolizumab + Lenalidomide + Dexamethasone44Not reportedNot reportedNot reportedNot reported
Lenolidomide + Dexamethasone26Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        44
      2. group Id
        OG001
        value
        26
denoms
  1. counts
    1. group Id
      OG000
      value
      154
    2. group Id
      OG001
      value
      148
    units
    Participants
description
An AE was defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it was considered related to the medical treatment or procedure, that occurred during the course of the study. The database cutoff date was August 3, 2020.
groups
  1. description
    Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 21-day cycle PLUS lenalidomide 25 mg orally (PO) on Days 1 to 21 of each 21-day treatment cycle, and dexamethasone 40 mg PO on Days 1, 8, 15 and 22 of each 28-day cycle for up to 18 cycles.
    id
    OG000
    title
    Pembrolizumab + Lenalidomide + Dexamethasone
  2. description
    Participants received lenalidomide 25 mg PO on Days 1 to 21 of each 21-day treatment cycle, and dexamethasone 40 mg PO on Days 1, 8, 15 and 22 of each 28-day cycle for up to 18 cycles.
    id
    OG001
    title
    Lenolidomide + Dexamethasone
param Type
COUNT_OF_PARTICIPANTS
population Description
The analysis population consisted of all randomized participants who received at least one dose of study treatment.
reporting Status
POSTED
time Frame
Up to approximately 55 months
title
Number of Participants Discontinuing Study Treatment Due to an AE
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice