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NCT02917941 · OUTCOME

Number of Participants With NCI CTCAE Grade 3 or Higher TEAEs Related to Vital Signs

A Study of Ixazomib Plus Lenalidomide and Dexamethasone in Adult Japanese Participants With Relapsed and/or Refractory Multiple Myeloma · Source last updated 2021-01-12

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 33 months

What was measured

Vital signs included temperature, blood pressure, heart rate, and respiratory rate. An AE is any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product whether or not it was related to the medicinal product. A TEAE is defined as any AE that occurred after administration of the first dose of any study drug through 30 days after the last dose of any study drug. An AE was graded as per NCI CTCAE.

Analysis population: Safety analysis set included all participants who received at least one dose of study drug during the treatment period.

Groups in this outcome

Ixazomib 4 mg + Lenalidomide 25 mg + Dexamethasone 40 mg

Ixazomib 4 mg, capsules, orally on Days 1, 8, and 15 plus lenalidomide 25 mg, capsule, orally, once daily on Days 1 through 21 and dexamethasone 40 mg, tablet, orally on Days 1, 8, 15, and 22 of a 28-day cycle up to 32 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
Ixazomib 4 mg + Lenalidomide 25 mg + Dexamethasone 40 mg34

Reported measurements

Hypertension
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Ixazomib 4 mg + Lenalidomide 25 mg + Dexamethasone 40 mg1Not reportedNot reportedNot reportedNot reported
Hypotension
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Ixazomib 4 mg + Lenalidomide 25 mg + Dexamethasone 40 mg1Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Hypertension
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Hypotension
denoms
  1. counts
    1. group Id
      OG000
      value
      34
    units
    Participants
description
Vital signs included temperature, blood pressure, heart rate, and respiratory rate. An AE is any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product whether or not it was related to the medicinal product. A TEAE is defined as any AE that occurred after administration of the first dose of any study drug through 30 days after the last dose of any study drug. An AE was graded as per NCI CTCAE.
groups
  1. description
    Ixazomib 4 mg, capsules, orally on Days 1, 8, and 15 plus lenalidomide 25 mg, capsule, orally, once daily on Days 1 through 21 and dexamethasone 40 mg, tablet, orally on Days 1, 8, 15, and 22 of a 28-day cycle up to 32 cycles.
    id
    OG000
    title
    Ixazomib 4 mg + Lenalidomide 25 mg + Dexamethasone 40 mg
param Type
COUNT_OF_PARTICIPANTS
population Description
Safety analysis set included all participants who received at least one dose of study drug during the treatment period.
reporting Status
POSTED
time Frame
Up to approximately 33 months
title
Number of Participants With NCI CTCAE Grade 3 or Higher TEAEs Related to Vital Signs
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice