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NCT01374217 · OUTCOME

Quality of Life Scores

Administration of Tadalafil in Conjunction With Lenalidomide and Dexamethasone in Patients With Multiple Myeloma · Source last updated 2018-12-10

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

Measure
MEDIAN
Unit
change in score on a scale
Interval / dispersion
Full Range
Time frame
3 months (M3) and 6 months (M6)

What was measured

Median change in symptom scores. Scale is the EORTC QLQ-C30. There are three domains: symptom scale (score range 7-14); past week (score range 21-82); and global health status (score range 2-14). Higher or increasing scores mean worse outcomes; lower or decreasing scores mean better outcomes.

Analysis population: Two participants returned the Month 3 survey and seven participants returned the Month 6 survey (there is some overlap). The remaining participants cannot be analyzed as there is no follow-up data.

Groups in this outcome

Tadalafil

Subject will take tadalafil in combination with with Lenalidomide and dexamethasone (Rd) or Clarithromycin/Lenalidomide/ dexamethasone (BiRd) Tadalafil: Tadalafil will be administered at a dose of 20 mg orally daily starting with day 1 of the first cycle. Each cycle will last for 28 days Lenalidomide: Lenalidomide will be administered as it was prior to study entry. Dexamethasone: Dexamethasone will be administered as it was prior to study entry. Clarithromycin: Clarithromycin will be administered as it was prior to study entry.

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

Analysis denominator · Participants

GroupSource count
Tadalafil8

Reported measurements

Symptoms (M3)

Analysis denominator · Participants

GroupSource count
Tadalafil2
Values in change in score on a scale · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Tadalafil0Not reported00Not reported
Past week (M3)

Analysis denominator · Participants

GroupSource count
Tadalafil2
Values in change in score on a scale · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Tadalafil5Not reported-111Not reported
Global health status (M3)

Analysis denominator · Participants

GroupSource count
Tadalafil2
Values in change in score on a scale · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Tadalafil-1.5Not reported-30Not reported
Symptoms (M6)

Analysis denominator · Participants

GroupSource count
Tadalafil7
Values in change in score on a scale · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Tadalafil1Not reported-13Not reported
Past week (M6)

Analysis denominator · Participants

GroupSource count
Tadalafil7
Values in change in score on a scale · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Tadalafil6Not reported-49Not reported
Global health status (M6)

Analysis denominator · Participants

GroupSource count
Tadalafil7
Values in change in score on a scale · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Tadalafil-1Not reported-70Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0
        upper Limit
        0
        value
        0
    denoms
    1. counts
      1. group Id
        OG000
        value
        2
      units
      Participants
    title
    Symptoms (M3)
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        -1
        upper Limit
        11
        value
        5
    denoms
    1. counts
      1. group Id
        OG000
        value
        2
      units
      Participants
    title
    Past week (M3)
  3. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        -3
        upper Limit
        0
        value
        -1.5
    denoms
    1. counts
      1. group Id
        OG000
        value
        2
      units
      Participants
    title
    Global health status (M3)
  4. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        -1
        upper Limit
        3
        value
        1
    denoms
    1. counts
      1. group Id
        OG000
        value
        7
      units
      Participants
    title
    Symptoms (M6)
  5. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        -4
        upper Limit
        9
        value
        6
    denoms
    1. counts
      1. group Id
        OG000
        value
        7
      units
      Participants
    title
    Past week (M6)
  6. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        -7
        upper Limit
        0
        value
        -1
    denoms
    1. counts
      1. group Id
        OG000
        value
        7
      units
      Participants
    title
    Global health status (M6)
denoms
  1. counts
    1. group Id
      OG000
      value
      8
    units
    Participants
description
Median change in symptom scores. Scale is the EORTC QLQ-C30. There are three domains: symptom scale (score range 7-14); past week (score range 21-82); and global health status (score range 2-14). Higher or increasing scores mean worse outcomes; lower or decreasing scores mean better outcomes.
dispersion Type
Full Range
groups
  1. description
    Subject will take tadalafil in combination with with Lenalidomide and dexamethasone (Rd) or Clarithromycin/Lenalidomide/ dexamethasone (BiRd) Tadalafil: Tadalafil will be administered at a dose of 20 mg orally daily starting with day 1 of the first cycle. Each cycle will last for 28 days Lenalidomide: Lenalidomide will be administered as it was prior to study entry. Dexamethasone: Dexamethasone will be administered as it was prior to study entry. Clarithromycin: Clarithromycin will be administered as it was prior to study entry.
    id
    OG000
    title
    Tadalafil
param Type
MEDIAN
population Description
Two participants returned the Month 3 survey and seven participants returned the Month 6 survey (there is some overlap). The remaining participants cannot be analyzed as there is no follow-up data.
reporting Status
POSTED
time Frame
3 months (M3) and 6 months (M6)
title
Quality of Life Scores
type
SECONDARY
unit Of Measure
change in score on a scale

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

Preserved source evidence · Not medical advice