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NCT04272775 · OUTCOME

Number of Participants With Grade 3 or Higher Laboratory Tests Abnormalities

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)

What was measured

Laboratory tests abnormalities were graded using the CTCAE version 4.03. as: Grade 1 (Mild, asymptomatic or mild symptoms); Grade 2 (Moderate, minimal, local or noninvasive intervention indicated); Grade 3 (Severe or medically significant but not immediately life-threatening, hospitalization or prolongation of hospitalization indicated); Grade 4 (Life-threatening consequences, urgent intervention indicated); Grade 5 (Death related to AE).

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

Grade 4: Neutrophils low
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort 1: Ixazomib 4.0 mg0Not reportedNot reportedNot reportedNot reported
Cohort 2: Ixazomib 4.0 mg + Lenalidomide and Dexamethasone2Not reportedNot reportedNot reportedNot reported
Grade 4: Leukocytes low
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort 1: Ixazomib 4.0 mg0Not reportedNot reportedNot reportedNot reported
Cohort 2: Ixazomib 4.0 mg + Lenalidomide and Dexamethasone1Not reportedNot reportedNot reportedNot reported
Grade 4: Lymphocytes low
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort 1: Ixazomib 4.0 mg3Not reportedNot reportedNot reportedNot reported
Cohort 2: Ixazomib 4.0 mg + Lenalidomide and Dexamethasone0Not reportedNot reportedNot reportedNot reported
Grade 4: Platelets low
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort 1: Ixazomib 4.0 mg3Not reportedNot reportedNot reportedNot reported
Cohort 2: Ixazomib 4.0 mg + Lenalidomide and Dexamethasone2Not reportedNot reportedNot reportedNot reported
Grade 4: Sodium low
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort 1: Ixazomib 4.0 mg0Not reportedNot reportedNot reportedNot reported
Cohort 2: Ixazomib 4.0 mg + Lenalidomide and Dexamethasone1Not reportedNot reportedNot reportedNot reported
Grade 4: Potassium low
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort 1: Ixazomib 4.0 mg0Not reportedNot reportedNot reportedNot reported
Cohort 2: Ixazomib 4.0 mg + Lenalidomide and Dexamethasone1Not reportedNot reportedNot reportedNot reported
Grade 3: Neutrophils low
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort 1: Ixazomib 4.0 mg4Not reportedNot reportedNot reportedNot reported
Cohort 2: Ixazomib 4.0 mg + Lenalidomide and Dexamethasone2Not reportedNot reportedNot reportedNot reported
Grade 3: Hemoglobin low
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort 1: Ixazomib 4.0 mg2Not reportedNot reportedNot reportedNot reported
Cohort 2: Ixazomib 4.0 mg + Lenalidomide and Dexamethasone2Not reportedNot reportedNot reportedNot reported
Grade 3: Leukocytes low
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort 1: Ixazomib 4.0 mg3Not reportedNot reportedNot reportedNot reported
Cohort 2: Ixazomib 4.0 mg + Lenalidomide and Dexamethasone2Not reportedNot reportedNot reportedNot reported
Grade 3: Lymphocytes low
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort 1: Ixazomib 4.0 mg3Not reportedNot reportedNot reportedNot reported
Cohort 2: Ixazomib 4.0 mg + Lenalidomide and Dexamethasone3Not reportedNot reportedNot reportedNot reported
Grade 3: Platelets low
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort 1: Ixazomib 4.0 mg0Not reportedNot reportedNot reportedNot reported
Cohort 2: Ixazomib 4.0 mg + Lenalidomide and Dexamethasone2Not reportedNot reportedNot reportedNot reported
Grade 3: Albumin low
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort 1: Ixazomib 4.0 mg1Not reportedNot reportedNot reportedNot reported
Cohort 2: Ixazomib 4.0 mg + Lenalidomide and Dexamethasone1Not reportedNot reportedNot reportedNot reported
Grade 3: Corrected calcium high
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort 1: Ixazomib 4.0 mg0Not reportedNot reportedNot reportedNot reported
Cohort 2: Ixazomib 4.0 mg + Lenalidomide and Dexamethasone1Not reportedNot reportedNot reportedNot reported
Grade 3: Sodium low
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort 1: Ixazomib 4.0 mg1Not reportedNot reportedNot reportedNot reported
Cohort 2: Ixazomib 4.0 mg + Lenalidomide and Dexamethasone0Not reportedNot reportedNot reportedNot reported
Grade 3: Potassium low
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort 1: Ixazomib 4.0 mg1Not reportedNot reportedNot reportedNot reported
Cohort 2: Ixazomib 4.0 mg + Lenalidomide and Dexamethasone0Not reportedNot reportedNot reportedNot reported
Grade 3: Phosphate low
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort 1: Ixazomib 4.0 mg1Not reportedNot reportedNot reportedNot reported
Cohort 2: Ixazomib 4.0 mg + Lenalidomide and Dexamethasone1Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        2
    title
    Grade 4: Neutrophils low
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        1
    title
    Grade 4: Leukocytes low
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        3
      2. group Id
        OG001
        value
        0
    title
    Grade 4: Lymphocytes low
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        3
      2. group Id
        OG001
        value
        2
    title
    Grade 4: Platelets low
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        1
    title
    Grade 4: Sodium low
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        1
    title
    Grade 4: Potassium low
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        4
      2. group Id
        OG001
        value
        2
    title
    Grade 3: Neutrophils low
  8. categories
    1. measurements
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        2
    title
    Grade 3: Hemoglobin low
  9. categories
    1. measurements
      1. group Id
        OG000
        value
        3
      2. group Id
        OG001
        value
        2
    title
    Grade 3: Leukocytes low
  10. categories
    1. measurements
      1. group Id
        OG000
        value
        3
      2. group Id
        OG001
        value
        3
    title
    Grade 3: Lymphocytes low
  11. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        2
    title
    Grade 3: Platelets low
  12. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        1
    title
    Grade 3: Albumin low
denoms
  1. counts
    1. group Id
      OG000
      value
      7
    2. group Id
      OG001
      value
      7
    units
    Participants
description
Laboratory tests abnormalities were graded using the CTCAE version 4.03. as: Grade 1 (Mild, asymptomatic or mild symptoms); Grade 2 (Moderate, minimal, local or noninvasive intervention indicated); Grade 3 (Severe or medically significant but not immediately life-threatening, hospitalization or prolongation of hospitalization indicated); Grade 4 (Life-threatening consequences, urgent intervention indicated); Grade 5 (Death related to AE).
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 With Grade 3 or Higher Laboratory Tests Abnormalities
type
PRIMARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice