Skip to content
Triangle logo TriangleGet started
← Full study record

NCT04272775 · OUTCOME

Number of Participants Who Experienced at Least One Treatment-emergent Adverse Event (TEAE)

A Study of MLN9708 in Japanese Participants With Relapsed and/or Refractory Multiple Myeloma (RRMM) · Source last updated 2020-03-17

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
Baseline up to 29 days after last dose of study drug (up to Cycle 87 Day 44) (Each Cycle length=28 days)

Analysis population: The safety analysis set consisted of all participants who received at least one dose of ixazomib.

Groups in this outcome

Cohort 1: Ixazomib 4.0 mg

Ixazomib 4.0 mg, capsules, orally, once, on Days 1, 8, and 15 in 28-day treatment cycle for up to Cycle 87.

Cohort 2: Ixazomib 4.0 mg + Lenalidomide and Dexamethasone

Ixazomib 4.0 mg, capsules, orally, once, on Days 1, 8, and 15 in 28-day treatment cycle along with lenalidomide 25 mg/day, capsules, orally, once, from Days 1 to 21 and dexamethasone 40 mg/day, tablets, orally, once, on Days 1, 8, 15, and 22 in a 28-day treatment cycle for up to Cycle 62.

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

Analysis denominator · Participants

GroupSource count
Cohort 1: Ixazomib 4.0 mg7
Cohort 2: Ixazomib 4.0 mg + Lenalidomide and Dexamethasone7

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort 1: Ixazomib 4.0 mg7Not reportedNot reportedNot reportedNot reported
Cohort 2: Ixazomib 4.0 mg + Lenalidomide and Dexamethasone7Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        7
      2. group Id
        OG001
        value
        7
denoms
  1. counts
    1. group Id
      OG000
      value
      7
    2. group Id
      OG001
      value
      7
    units
    Participants
groups
  1. description
    Ixazomib 4.0 mg, capsules, orally, once, on Days 1, 8, and 15 in 28-day treatment cycle for up to Cycle 87.
    id
    OG000
    title
    Cohort 1: Ixazomib 4.0 mg
  2. description
    Ixazomib 4.0 mg, capsules, orally, once, on Days 1, 8, and 15 in 28-day treatment cycle along with lenalidomide 25 mg/day, capsules, orally, once, from Days 1 to 21 and dexamethasone 40 mg/day, tablets, orally, once, on Days 1, 8, 15, and 22 in a 28-day treatment cycle for up to Cycle 62.
    id
    OG001
    title
    Cohort 2: Ixazomib 4.0 mg + Lenalidomide and Dexamethasone
param Type
COUNT_OF_PARTICIPANTS
population Description
The safety analysis set consisted of all participants who received at least one dose of ixazomib.
reporting Status
POSTED
time Frame
Baseline up to 29 days after last dose of study drug (up to Cycle 87 Day 44) (Each Cycle length=28 days)
title
Number of Participants Who Experienced at Least One Treatment-emergent Adverse Event (TEAE)
type
PRIMARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice