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NCT03416374 · OUTCOME

Healthcare Resource Utilization (HCRU): Duration of Hospital Stay Per Participants

A Study to Evaluate the Efficacy and Safety of Ixazomib in Combination With Lenalidomide and Dexamethasone in Patients With Relapsed and/or Refractory Multiple Myeloma Initially Treated With an Injection of Proteasome Inhibitor-Based Therapy · Source last updated 2022-09-27

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

Measure
MEAN
Unit
Days
Interval / dispersion
Standard Deviation
Time frame
Up to 39 months as a maximum

What was measured

HCRU was calculated from Exposure-adjusted rate of hospitalization events (per participants-months) and the duration of hospitalization among participants in Treatment Period I and Treatment Period II. Duration of hospital stay per participants in Treatment Period I and Treatment Period II was reported.

Analysis population: Full Analysis Set (FAS): all participants who were enrolled in Treatment Period I and who receive at least one dose of any therapy during the Treatment Period.

Groups in this outcome

[VRd]; Bortezomib + Lenalidomide + Dexamethasone Therapy

Bortezomib + Lenalidomide + Dexamethasone, standard recommended dose according to the package insert of each drug (Treatment Period I), followed by Ixazomib (4.0 mg) on Days 1, 8 and 15, plus Lenalidomide (25 mg) on Days 1 to 21, and Dexamethasone (40 mg) on Days 1, 8, 15 and 22, of a 28-day cycle (Treatment Period II)

[KRd]; Carfilzomib + Lenalidomide + Dexamethasone Therapy

Carfilzomib + Lenalidomide + Dexamethasone, standard recommended dose according to the package insert of each drug (Treatment Period I), followed by Ixazomib (4.0 mg) on Days 1, 8 and 15, plus Lenalidomide (25 mg) on Days 1 to 21, and Dexamethasone (40 mg) on Days 1, 8, 15 and 22, of a 28-day cycle (Treatment Period II)

[Overall]; Combination Therapy + Ixazomib Therapy

Bortezomib + Lenalidomide + Dexamethasone, or Carfilzomib + Lenalidomide + Dexamethasone, standard recommended dose according to the package insert of each drug (Treatment Period I), followed by Ixazomib (4.0 mg) on Days 1, 8 and 15, plus Lenalidomide (25 mg) on Days 1 to 21, and Dexamethasone (40 mg) on Days 1, 8, 15 and 22, of a 28-day cycle (Treatment Period II)

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

Analysis denominator · Participants

GroupSource count
[VRd]; Bortezomib + Lenalidomide + Dexamethasone Therapy6
[KRd]; Carfilzomib + Lenalidomide + Dexamethasone Therapy39
[Overall]; Combination Therapy + Ixazomib Therapy45

Reported measurements

Source class 1
Values in Days · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
[VRd]; Bortezomib + Lenalidomide + Dexamethasone Therapy14.816.01Not reportedNot reportedNot reported
[KRd]; Carfilzomib + Lenalidomide + Dexamethasone Therapy19.418.14Not reportedNot reportedNot reported
[Overall]; Combination Therapy + Ixazomib Therapy18.817.77Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        16.01
        value
        14.8
      2. group Id
        OG001
        spread
        18.14
        value
        19.4
      3. group Id
        OG002
        spread
        17.77
        value
        18.8
denoms
  1. counts
    1. group Id
      OG000
      value
      6
    2. group Id
      OG001
      value
      39
    3. group Id
      OG002
      value
      45
    units
    Participants
description
HCRU was calculated from Exposure-adjusted rate of hospitalization events (per participants-months) and the duration of hospitalization among participants in Treatment Period I and Treatment Period II. Duration of hospital stay per participants in Treatment Period I and Treatment Period II was reported.
dispersion Type
Standard Deviation
groups
  1. description
    Bortezomib + Lenalidomide + Dexamethasone, standard recommended dose according to the package insert of each drug (Treatment Period I), followed by Ixazomib (4.0 mg) on Days 1, 8 and 15, plus Lenalidomide (25 mg) on Days 1 to 21, and Dexamethasone (40 mg) on Days 1, 8, 15 and 22, of a 28-day cycle (Treatment Period II)
    id
    OG000
    title
    [VRd]; Bortezomib + Lenalidomide + Dexamethasone Therapy
  2. description
    Carfilzomib + Lenalidomide + Dexamethasone, standard recommended dose according to the package insert of each drug (Treatment Period I), followed by Ixazomib (4.0 mg) on Days 1, 8 and 15, plus Lenalidomide (25 mg) on Days 1 to 21, and Dexamethasone (40 mg) on Days 1, 8, 15 and 22, of a 28-day cycle (Treatment Period II)
    id
    OG001
    title
    [KRd]; Carfilzomib + Lenalidomide + Dexamethasone Therapy
  3. description
    Bortezomib + Lenalidomide + Dexamethasone, or Carfilzomib + Lenalidomide + Dexamethasone, standard recommended dose according to the package insert of each drug (Treatment Period I), followed by Ixazomib (4.0 mg) on Days 1, 8 and 15, plus Lenalidomide (25 mg) on Days 1 to 21, and Dexamethasone (40 mg) on Days 1, 8, 15 and 22, of a 28-day cycle (Treatment Period II)
    id
    OG002
    title
    [Overall]; Combination Therapy + Ixazomib Therapy
param Type
MEAN
population Description
Full Analysis Set (FAS): all participants who were enrolled in Treatment Period I and who receive at least one dose of any therapy during the Treatment Period.
reporting Status
POSTED
time Frame
Up to 39 months as a maximum
title
Healthcare Resource Utilization (HCRU): Duration of Hospital Stay Per Participants
type
SECONDARY
unit Of Measure
Days

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

Preserved source evidence · Not medical advice