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NCT01283997 · OUTCOME

Change in the Mean Value of Patient-reported MD Anderson Symptom Inventory for Multiple Myeloma (MDASI-MM) Numbness Scores From Baseline to Week 10 Post Treatment.

Prevention of Treatment Induced Neuropathy in Multiple Myeloma · Source last updated 2024-06-13

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

Measure
MEAN
Unit
score on a scale
Interval / dispersion
Standard Deviation
Time frame
baseline and week 10

What was measured

Participants reported the severity of two cognitive symptoms numbness on a 0-10 scale, with 0 being 'not present' and 10 being 'as bad as you can imagine': Higher mean scores indicate more severe symptoms.

Analysis population: Participants with quantitative sensory testing (QST) done a week prior to the start of their minocycline treatment and with corresponding QST at week 10

Groups in this outcome

Placebo Group

Participants received one pill by mouth on Day 1. Staring on Day 2, 2 times a day (every 12 hours) by mouth for 10 weeks.

Minocycline Group

Participants received minocycline 200 mg orally for 1 dose, then 100 mg orally every 12 hours for 10 weeks beginning at initiation of induction therapy for multiple myeloma

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

Analysis denominator · Participants

GroupSource count
Placebo Group21
Minocycline Group20

Reported measurements

Source class 1
Values in score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Placebo Group1.382.36Not reportedNot reportedNot reported
Minocycline Group0.651.79Not reportedNot reportedNot reported

Source statistical analyses

Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.

  1. ci Lower Limit
    -2.06
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.59
    group Description
    Difference in Numbness severity at baseline and week 10.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    OTHER
    p Value
    0.56
    param Type
    Mean Difference (Final Values)
    param Value
    -0.73
    statistical Method
    Wilcoxon (Mann-Whitney)
Complete source fields
analyses
  1. ci Lower Limit
    -2.06
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.59
    group Description
    Difference in Numbness severity at baseline and week 10.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    OTHER
    p Value
    0.56
    param Type
    Mean Difference (Final Values)
    param Value
    -0.73
    statistical Method
    Wilcoxon (Mann-Whitney)
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        2.36
        value
        1.38
      2. group Id
        OG001
        spread
        1.79
        value
        0.65
denoms
  1. counts
    1. group Id
      OG000
      value
      21
    2. group Id
      OG001
      value
      20
    units
    Participants
description
Participants reported the severity of two cognitive symptoms numbness on a 0-10 scale, with 0 being 'not present' and 10 being 'as bad as you can imagine': Higher mean scores indicate more severe symptoms.
dispersion Type
Standard Deviation
groups
  1. description
    Participants received one pill by mouth on Day 1. Staring on Day 2, 2 times a day (every 12 hours) by mouth for 10 weeks.
    id
    OG000
    title
    Placebo Group
  2. description
    Participants received minocycline 200 mg orally for 1 dose, then 100 mg orally every 12 hours for 10 weeks beginning at initiation of induction therapy for multiple myeloma
    id
    OG001
    title
    Minocycline Group
param Type
MEAN
population Description
Participants with quantitative sensory testing (QST) done a week prior to the start of their minocycline treatment and with corresponding QST at week 10
reporting Status
POSTED
time Frame
baseline and week 10
title
Change in the Mean Value of Patient-reported MD Anderson Symptom Inventory for Multiple Myeloma (MDASI-MM) Numbness Scores From Baseline to Week 10 Post Treatment.
type
SECONDARY
unit Of Measure
score on a scale

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

Preserved source evidence · Not medical advice