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NCT03170882 · OUTCOME

Health Care Utilization (HU): Number of Participants With at Least One Medical Encounter

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
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
Up to approximately 3 years

What was measured

Healthcare resources used during medical encounters included hospitalizations, emergency room stays, or outpatient visits. 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 Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Pomalidomide 4 mg + Dexamethasone 40 mg16Not reportedNot reportedNot reportedNot reported
Ixazomib 4 mg + Dexamethasone 20 mg23Not reportedNot reportedNot reportedNot reported
Emergency Room Stays
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Pomalidomide 4 mg + Dexamethasone 40 mg9Not reportedNot reportedNot reportedNot reported
Ixazomib 4 mg + Dexamethasone 20 mg11Not reportedNot reportedNot reportedNot reported
Outpatient Visits
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Pomalidomide 4 mg + Dexamethasone 40 mg29Not reportedNot reportedNot reportedNot reported
Ixazomib 4 mg + Dexamethasone 20 mg32Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        16
      2. group Id
        OG001
        value
        23
    title
    Hospitalizations
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        9
      2. group Id
        OG001
        value
        11
    title
    Emergency Room Stays
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        29
      2. group Id
        OG001
        value
        32
    title
    Outpatient Visits
denoms
  1. counts
    1. group Id
      OG000
      value
      49
    2. group Id
      OG001
      value
      73
    units
    Participants
description
Healthcare resources used during medical encounters included hospitalizations, emergency room stays, or outpatient visits. 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).
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
COUNT_OF_PARTICIPANTS
population Description
ITT Population included all participants who were randomized.
reporting Status
POSTED
time Frame
Up to approximately 3 years
title
Health Care Utilization (HU): Number of Participants With at Least One Medical Encounter
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice