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NCT03170882 · OUTCOME

HU: Duration of Medical Encounters

A Study of Ixazomib, Given With Dexamethasone in Adults With Multiple Myeloma · Source last updated 2022-12-20

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

Measure
MEDIAN
Unit
days
Interval / dispersion
Full Range
Time frame
Up to approximately 3 years

What was measured

Duration of healthcare resources used during medical encounters including hospitalizations, emergency room stays, or outpatient visits was reported in days. A hospitalization was defined as at least 1 overnight stay in an Intensive Care Unit and/or non-Intensive Care Unit (acute care unit, palliative care unit, and hospice).

Analysis population: ITT Population included all participants who were randomized.

Groups in this outcome

Pomalidomide 4 mg + Dexamethasone 40 mg

Pomalidomide 4 mg, capsules, orally, once daily on Days 1 to 21 of each 28-day cycle, plus dexamethasone 40 mg, (or 20 mg if participant is aged \>=75 years), tablets, orally, once daily on Days 1, 8, 15, and 22 of each 28-day cycle until disease progression, unacceptable toxicity, withdrawal of consent, or sponsor termination of study up to 2 years.

Ixazomib 4 mg + Dexamethasone 20 mg

Ixazomib 4 mg as starting dose, capsules, orally, once daily on Days 1, 8, and 15 of each 28-day cycle, with escalation to 5.5 mg at the start of Cycle 2 for participants who tolerated the 4 mg dose in Cycle 1, plus dexamethasone 20 mg (or 10 mg if participant is aged \>=75 years), tablets, orally, once daily on Days 1, 2, 8, 9, 15, 16, 22, and 23 of every 28-day cycle until disease progression, unacceptable toxicity, withdrawal of consent, or sponsor termination of study up to 2 years.

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

Analysis denominator · Participants

GroupSource count
Pomalidomide 4 mg + Dexamethasone 40 mg49
Ixazomib 4 mg + Dexamethasone 20 mg73

Reported measurements

Hospitalizations
Values in days · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Pomalidomide 4 mg + Dexamethasone 40 mg2.0Not reported1.06.0Not reported
Ixazomib 4 mg + Dexamethasone 20 mg1.0Not reported1.010.0Not reported
Emergency Room Stays
Values in days · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Pomalidomide 4 mg + Dexamethasone 40 mg1.0Not reported1.03.0Not reported
Ixazomib 4 mg + Dexamethasone 20 mg1.0Not reported1.03.0Not reported
Outpatient Visits
Values in days · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Pomalidomide 4 mg + Dexamethasone 40 mg4.0Not reported1.057.0Not reported
Ixazomib 4 mg + Dexamethasone 20 mg3.0Not reported1.034.0Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        1.0
        upper Limit
        6.0
        value
        2.0
      2. group Id
        OG001
        lower Limit
        1.0
        upper Limit
        10.0
        value
        1.0
    title
    Hospitalizations
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        1.0
        upper Limit
        3.0
        value
        1.0
      2. group Id
        OG001
        lower Limit
        1.0
        upper Limit
        3.0
        value
        1.0
    title
    Emergency Room Stays
  3. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        1.0
        upper Limit
        57.0
        value
        4.0
      2. group Id
        OG001
        lower Limit
        1.0
        upper Limit
        34.0
        value
        3.0
    title
    Outpatient Visits
denoms
  1. counts
    1. group Id
      OG000
      value
      49
    2. group Id
      OG001
      value
      73
    units
    Participants
description
Duration of healthcare resources used during medical encounters including hospitalizations, emergency room stays, or outpatient visits was reported in days. A hospitalization was defined as at least 1 overnight stay in an Intensive Care Unit and/or non-Intensive Care Unit (acute care unit, palliative care unit, and hospice).
dispersion Type
Full Range
groups
  1. description
    Pomalidomide 4 mg, capsules, orally, once daily on Days 1 to 21 of each 28-day cycle, plus dexamethasone 40 mg, (or 20 mg if participant is aged \>=75 years), tablets, orally, once daily on Days 1, 8, 15, and 22 of each 28-day cycle until disease progression, unacceptable toxicity, withdrawal of consent, or sponsor termination of study up to 2 years.
    id
    OG000
    title
    Pomalidomide 4 mg + Dexamethasone 40 mg
  2. description
    Ixazomib 4 mg as starting dose, capsules, orally, once daily on Days 1, 8, and 15 of each 28-day cycle, with escalation to 5.5 mg at the start of Cycle 2 for participants who tolerated the 4 mg dose in Cycle 1, plus dexamethasone 20 mg (or 10 mg if participant is aged \>=75 years), tablets, orally, once daily on Days 1, 2, 8, 9, 15, 16, 22, and 23 of every 28-day cycle until disease progression, unacceptable toxicity, withdrawal of consent, or sponsor termination of study up to 2 years.
    id
    OG001
    title
    Ixazomib 4 mg + Dexamethasone 20 mg
param Type
MEDIAN
population Description
ITT Population included all participants who were randomized.
reporting Status
POSTED
time Frame
Up to approximately 3 years
title
HU: Duration of Medical Encounters
type
SECONDARY
unit Of Measure
days

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

Preserved source evidence · Not medical advice