Skip to content
Triangle logo TriangleGet started
← Full study record

NCT01645930 · OUTCOME

Number of Participants With Clinically Significant Vital Signs Reported as Adverse Events

Phase 1 Pharmacokinetic Study of Oral Ixazomib Plus Lenalidomide and Dexamethasone in Adult Asian Participants With Relapsed and/or Refractory Multiple Myeloma · Source last updated 2018-11-08

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 the first dose of study drug through 30 days after the last dose of study drug (up to 577 days)

What was measured

The number of participants who meet markedly abnormal criteria for vital signs, included diastolic and systolic blood pressure, heart rate, oral temperature, respiratory rate, and body weight.

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

Groups in this outcome

Ixazomib+Lenalidomide+Dexamethasone

Ixazomib 4 mg, capsules, orally, once on Days 1, 8, and 15; lenalidomide 25 mg, capsules, orally, once on Days 1 through 21; and dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15, and 22 of a 28-day treatment cycle until progressive disease (PD) or unacceptable toxicity (up to 20 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+Lenalidomide+Dexamethasone43

Reported measurements

Grade 1 or 2 Hypertension
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Ixazomib+Lenalidomide+Dexamethasone4Not reportedNot reportedNot reportedNot reported
Grade 2 Hypotension
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Ixazomib+Lenalidomide+Dexamethasone1Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        4
    title
    Grade 1 or 2 Hypertension
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Grade 2 Hypotension
denoms
  1. counts
    1. group Id
      OG000
      value
      43
    units
    Participants
description
The number of participants who meet markedly abnormal criteria for vital signs, included diastolic and systolic blood pressure, heart rate, oral temperature, respiratory rate, and body weight.
groups
  1. description
    Ixazomib 4 mg, capsules, orally, once on Days 1, 8, and 15; lenalidomide 25 mg, capsules, orally, once on Days 1 through 21; and dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15, and 22 of a 28-day treatment cycle until progressive disease (PD) or unacceptable toxicity (up to 20 cycles)
    id
    OG000
    title
    Ixazomib+Lenalidomide+Dexamethasone
param Type
NUMBER
population Description
Safety population was defined as all participants who received at least 1 dose of study drug.
reporting Status
POSTED
time Frame
From the first dose of study drug through 30 days after the last dose of study drug (up to 577 days)
title
Number of Participants With Clinically Significant Vital Signs Reported as Adverse Events
type
PRIMARY
unit Of Measure
participants

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

Preserved source evidence · Not medical advice