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NCT02046070 · OUTCOME

Number of Participants With AEs, Grade 3 or Higher AEs, AEs Resulting in Treatment Discontinuation, AEs Resulting in Dose Reduction, SAEs in RRMM Participants

Phase 2 Study to Evaluate the Oral Combination of Ixazomib (MLN9708) With Cyclophosphamide and Dexamethasone in Patients With Newly Diagnosed or Relapsed and/or Refractory Multiple Myeloma · Source last updated 2019-07-17

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
First dose of study drug through 30 days after last dose of drug (Up to 45 months)

What was measured

An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product; the untoward medical occurrence does not necessarily have a causal relationship with this treatment. A SAE is any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly/birth defect or is a medically important event. Relationship of each AE to study drug was determined by the Investigator.

Analysis population: Safety population was defined as all participants who received at least 1 dose of any study drug.

Groups in this outcome

Ixazomib 4.0 mg + CYC 300 mg/m^2 + DEX 40 mg (RRMM)

Ixazomib 4.0 mg, capsules, orally, on Days 1, 8, 15 of a 28-day cycle and cyclophosphamide (CYC) 300 mg/m\^2, tablets, orally, on Days 1, 8 and 15 of a 28-day cycle and dexamethasone (DEX) 40 mg, tablets, orally, on Days 1, 8, 15 and 22 (dose reduced to 20 mg for patients \>75 years) of a 28-day cycle until PD/death or unacceptable toxicity in participants with RRMM.

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

Analysis denominator · Participants

GroupSource count
Ixazomib 4.0 mg + CYC 300 mg/m^2 + DEX 40 mg (RRMM)78

Reported measurements

Any AE
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Ixazomib 4.0 mg + CYC 300 mg/m^2 + DEX 40 mg (RRMM)72Not reportedNot reportedNot reportedNot reported
Grade 3 or Higher AE
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Ixazomib 4.0 mg + CYC 300 mg/m^2 + DEX 40 mg (RRMM)49Not reportedNot reportedNot reportedNot reported
AEs Resulting in Treatment Discontinuation
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Ixazomib 4.0 mg + CYC 300 mg/m^2 + DEX 40 mg (RRMM)19Not reportedNot reportedNot reportedNot reported
AEs Resulting in Dose Reduction
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Ixazomib 4.0 mg + CYC 300 mg/m^2 + DEX 40 mg (RRMM)30Not reportedNot reportedNot reportedNot reported
SAEs
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Ixazomib 4.0 mg + CYC 300 mg/m^2 + DEX 40 mg (RRMM)30Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        72
    title
    Any AE
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        49
    title
    Grade 3 or Higher AE
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        19
    title
    AEs Resulting in Treatment Discontinuation
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        30
    title
    AEs Resulting in Dose Reduction
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        30
    title
    SAEs
denoms
  1. counts
    1. group Id
      OG000
      value
      78
    units
    Participants
description
An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product; the untoward medical occurrence does not necessarily have a causal relationship with this treatment. A SAE is any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly/birth defect or is a medically important event. Relationship of each AE to study drug was determined by the Investigator.
groups
  1. description
    Ixazomib 4.0 mg, capsules, orally, on Days 1, 8, 15 of a 28-day cycle and cyclophosphamide (CYC) 300 mg/m\^2, tablets, orally, on Days 1, 8 and 15 of a 28-day cycle and dexamethasone (DEX) 40 mg, tablets, orally, on Days 1, 8, 15 and 22 (dose reduced to 20 mg for patients \>75 years) of a 28-day cycle until PD/death or unacceptable toxicity in participants with RRMM.
    id
    OG000
    title
    Ixazomib 4.0 mg + CYC 300 mg/m^2 + DEX 40 mg (RRMM)
param Type
COUNT_OF_PARTICIPANTS
population Description
Safety population was defined as all participants who received at least 1 dose of any study drug.
reporting Status
POSTED
time Frame
First dose of study drug through 30 days after last dose of drug (Up to 45 months)
title
Number of Participants With AEs, Grade 3 or Higher AEs, AEs Resulting in Treatment Discontinuation, AEs Resulting in Dose Reduction, SAEs in RRMM Participants
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice