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NCT01830816 · OUTCOME

Number of Participants With Adverse Events

Pharmacokinetics Study of Oral Ixazomib (MLN9708) in Relapsed/Refractory Multiple Myeloma and Advanced Solid Tumors Participants With Normal Renal Function or Severe Renal Impairment · Source last updated 2019-06-10

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
NUMBER
Unit
participants
Interval / dispersion
Not reported
Time frame
From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)

What was measured

Adverse Event is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug.

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

Groups in this outcome

Normal Renal Function: Ixazomib

Ixazomib 3.0 mg, capsule, orally on Day 1 of Part A (15-day PK cycle) and on Days 1, 8, and 15 of each 28-day cycle in Part B (4.0, 3.0, or 2.3 mg per protocol) until disease progression or unacceptable toxicity.

Severe Renal Impairment: Ixazomib

Ixazomib 3.0 mg, capsule, orally on Day 1 of Part A (15-day PK cycle) and on Days 1, 8, and 15 of each 28-day cycle in Part B (4.0, 3.0, or 2.3 mg per protocol) until disease progression or unacceptable toxicity.

End-stage Renal Disease: Ixazomib

Ixazomib 3.0 mg, capsule, orally on Day 1 of Part A (15-day PK cycle) and on Days 1, 8, and 15 of each 28-day cycle in Part B (4.0, 3.0, or 2.3 mg per protocol) until disease progression or unacceptable toxicity.

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

Analysis denominator · Participants

GroupSource count
Normal Renal Function: Ixazomib20
Severe Renal Impairment: Ixazomib14
End-stage Renal Disease: Ixazomib7

Reported measurements

Source class 1
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Normal Renal Function: Ixazomib19Not reportedNot reportedNot reportedNot reported
Severe Renal Impairment: Ixazomib14Not reportedNot reportedNot reportedNot reported
End-stage Renal Disease: Ixazomib6Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        19
      2. group Id
        OG001
        value
        14
      3. group Id
        OG002
        value
        6
denoms
  1. counts
    1. group Id
      OG000
      value
      20
    2. group Id
      OG001
      value
      14
    3. group Id
      OG002
      value
      7
    units
    Participants
description
Adverse Event is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug.
groups
  1. description
    Ixazomib 3.0 mg, capsule, orally on Day 1 of Part A (15-day PK cycle) and on Days 1, 8, and 15 of each 28-day cycle in Part B (4.0, 3.0, or 2.3 mg per protocol) until disease progression or unacceptable toxicity.
    id
    OG000
    title
    Normal Renal Function: Ixazomib
  2. description
    Ixazomib 3.0 mg, capsule, orally on Day 1 of Part A (15-day PK cycle) and on Days 1, 8, and 15 of each 28-day cycle in Part B (4.0, 3.0, or 2.3 mg per protocol) until disease progression or unacceptable toxicity.
    id
    OG001
    title
    Severe Renal Impairment: Ixazomib
  3. description
    Ixazomib 3.0 mg, capsule, orally on Day 1 of Part A (15-day PK cycle) and on Days 1, 8, and 15 of each 28-day cycle in Part B (4.0, 3.0, or 2.3 mg per protocol) until disease progression or unacceptable toxicity.
    id
    OG002
    title
    End-stage Renal Disease: Ixazomib
param Type
NUMBER
population Description
Safety population is defined as participants who received at least 1 dose of study drug.
reporting Status
POSTED
time Frame
From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)
title
Number of Participants With Adverse Events
type
SECONDARY
unit Of Measure
participants

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

Preserved source evidence · Not medical advice