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NCT02004275 · OUTCOME

Baseline Level of Perceived Fatigue and QOL, Assessed Using the Registration Fatigue/Uniscale Assessment Form (Phase II)

Pomalidomide and Dexamethasone With or Without Ixazomib in Treating Patients With Relapsed Multiple Myeloma · Source last updated 2023-12-01

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
baseline

What was measured

Pre-treatment patient-report of fatigue and overall quality of life (based on a 10-point Likert scale). A higher number indicates a better quality of life where 10 is the best outcome and 0 is the worst.

Analysis population: All patients that completed and returned the QoL survey

Groups in this outcome

Arm I (Pomalidomide, Dexamethasone)

Patients receive pomalidomide PO QD on days 1-21 and dexamethasone PO QD on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients achieving disease progression may cross over to Arm II.

Arm II (Pomalidomide, Dexamethasone, Ixazomib)

Patients receive pomalidomide, dexamethasone, and ixazomib as in Phase I. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

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

Analysis denominator · Participants

GroupSource count
Arm I (Pomalidomide, Dexamethasone)37
Arm II (Pomalidomide, Dexamethasone, Ixazomib)37

Reported measurements

High QoL(7-10)
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm I (Pomalidomide, Dexamethasone)21Not reportedNot reportedNot reportedNot reported
Arm II (Pomalidomide, Dexamethasone, Ixazomib)27Not reportedNot reportedNot reportedNot reported
Medium or Low QoL (0-7)
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm I (Pomalidomide, Dexamethasone)16Not reportedNot reportedNot reportedNot reported
Arm II (Pomalidomide, Dexamethasone, Ixazomib)11Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        21
      2. group Id
        OG001
        value
        27
    title
    High QoL(7-10)
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        16
      2. group Id
        OG001
        value
        11
    title
    Medium or Low QoL (0-7)
denoms
  1. counts
    1. group Id
      OG000
      value
      37
    2. group Id
      OG001
      value
      37
    units
    Participants
description
Pre-treatment patient-report of fatigue and overall quality of life (based on a 10-point Likert scale). A higher number indicates a better quality of life where 10 is the best outcome and 0 is the worst.
groups
  1. description
    Patients receive pomalidomide PO QD on days 1-21 and dexamethasone PO QD on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients achieving disease progression may cross over to Arm II.
    id
    OG000
    title
    Arm I (Pomalidomide, Dexamethasone)
  2. description
    Patients receive pomalidomide, dexamethasone, and ixazomib as in Phase I. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
    id
    OG001
    title
    Arm II (Pomalidomide, Dexamethasone, Ixazomib)
param Type
NUMBER
population Description
All patients that completed and returned the QoL survey
reporting Status
POSTED
time Frame
baseline
title
Baseline Level of Perceived Fatigue and QOL, Assessed Using the Registration Fatigue/Uniscale Assessment Form (Phase II)
type
SECONDARY
unit Of Measure
participants

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

Preserved source evidence · Not medical advice