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NCT00434161 · OUTCOME

The Area Under the Curve (AUC) Was Calculated From the Patient-reported Outcome Mouth and Throat Soreness (MTS) Score.

A Study of Palifermin for the Reduction of Oral Mucositis in Subjects With Multiple Myeloma · Source last updated 2015-03-30

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

Measure
MEAN
Unit
units on a scale * days
Interval / dispersion
Standard Deviation
Time frame
at Day 32

What was measured

The mean daily scores were calculated using the subject daily assessment of Patient-reported mouth and throat soreness (MTS) on the 5 point scale with higher values in MTS indicating a worse self assessed MTS. A 5-grade WHO scale (0, 1, 2, 3, or 4). 0=no findings or erythema only, 1=soreness present with or without erythema, 2=ulcers present but able to take solid food, 3=ulcers present and only able to take liquids, 4=ulcers present/not able to take anything orally. The incidence of ulcerative mucositis WHO grades 2, 3, and 4. Measured the number of participants who had WHO grades 2, 3, and 4: 2=ulcers present but able to take solid food, 3=ulcers present and only able to take liquids, 4=ulcers present/not able to take anything orally. The area under the curve were calculated at the time points; Day(D)-2, up to Day 32.

Groups in this outcome

Palifermin Before Only

Subjects to receive palifermin before-high dose chemotherapy (total 3 doses) and matched placebo after-high dose chemotherapy (total 3 doses)

Placebo

Subjects to receive matched placebo before- and after-high dose chemotherapy

Palifermin Before and After

Subjects to receive palifermin before- and after-high dose chemotherapy (total of 6 doses)

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

Analysis denominator · Participants

GroupSource count
Palifermin Before Only109
Placebo57
Palifermin Before and After115

Reported measurements

Source class 1
Values in units on a scale * days · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Palifermin Before Only29.8245.04Not reportedNot reportedNot reported
Placebo24.5532.35Not reportedNot reportedNot reported
Palifermin Before and After39.9752.90Not reportedNot reportedNot reported

Source statistical analyses

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

  1. ci Lower Limit
    -1.542
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    97.5
    ci Upper Limit
    32.415
    group Description
    For the secondary endpoints, the type I error rate was protected by using the Hochberg procedure to adjust for multiple testing16. Palifermin was not to be declared to be statistically superior to placebo with respect to secondary efficacy endpoints unless the primary endpoint was statistically significant in favor of palifermin.
    group Ids
    1. OG001
    2. OG002
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.142
    p Value Comment
    For secondary endpoints the type I error was protected by using the Hochberg procedure. The reported p-values are adjusted by the Hochberg procedure.
    param Type
    Mean Difference (Final Values)
    param Value
    15.436
    statistical Method
    van Elteren test
    tested Non Inferiority
    false
  2. ci Lower Limit
    -11.820
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    97.5
    ci Upper Limit
    22.482
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.806
    p Value Comment
    For secondary endpoints the type I error was protected by using the Hochberg procedure. The reported p-values are adjusted by the Hochberg procedure.
    param Type
    Mean Difference (Final Values)
    param Value
    5.331
    statistical Method
    van Elteren test
    tested Non Inferiority
    false
Complete source fields
analyses
  1. ci Lower Limit
    -1.542
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    97.5
    ci Upper Limit
    32.415
    group Description
    For the secondary endpoints, the type I error rate was protected by using the Hochberg procedure to adjust for multiple testing16. Palifermin was not to be declared to be statistically superior to placebo with respect to secondary efficacy endpoints unless the primary endpoint was statistically significant in favor of palifermin.
    group Ids
    1. OG001
    2. OG002
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.142
    p Value Comment
    For secondary endpoints the type I error was protected by using the Hochberg procedure. The reported p-values are adjusted by the Hochberg procedure.
    param Type
    Mean Difference (Final Values)
    param Value
    15.436
    statistical Method
    van Elteren test
    tested Non Inferiority
    false
  2. ci Lower Limit
    -11.820
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    97.5
    ci Upper Limit
    22.482
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.806
    p Value Comment
    For secondary endpoints the type I error was protected by using the Hochberg procedure. The reported p-values are adjusted by the Hochberg procedure.
    param Type
    Mean Difference (Final Values)
    param Value
    5.331
    statistical Method
    van Elteren test
    tested Non Inferiority
    false
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        45.04
        value
        29.82
      2. group Id
        OG001
        spread
        32.35
        value
        24.55
      3. group Id
        OG002
        spread
        52.90
        value
        39.97
denoms
  1. counts
    1. group Id
      OG000
      value
      109
    2. group Id
      OG001
      value
      57
    3. group Id
      OG002
      value
      115
    units
    Participants
description
The mean daily scores were calculated using the subject daily assessment of Patient-reported mouth and throat soreness (MTS) on the 5 point scale with higher values in MTS indicating a worse self assessed MTS. A 5-grade WHO scale (0, 1, 2, 3, or 4). 0=no findings or erythema only, 1=soreness present with or without erythema, 2=ulcers present but able to take solid food, 3=ulcers present and only able to take liquids, 4=ulcers present/not able to take anything orally. The incidence of ulcerative mucositis WHO grades 2, 3, and 4. Measured the number of participants who had WHO grades 2, 3, and 4: 2=ulcers present but able to take solid food, 3=ulcers present and only able to take liquids, 4=ulcers present/not able to take anything orally. The area under the curve were calculated at the time points; Day(D)-2, up to Day 32.
dispersion Type
Standard Deviation
groups
  1. description
    Subjects to receive palifermin before-high dose chemotherapy (total 3 doses) and matched placebo after-high dose chemotherapy (total 3 doses)
    id
    OG000
    title
    Palifermin Before Only
  2. description
    Subjects to receive matched placebo before- and after-high dose chemotherapy
    id
    OG001
    title
    Placebo
  3. description
    Subjects to receive palifermin before- and after-high dose chemotherapy (total of 6 doses)
    id
    OG002
    title
    Palifermin Before and After
param Type
MEAN
reporting Status
POSTED
time Frame
at Day 32
title
The Area Under the Curve (AUC) Was Calculated From the Patient-reported Outcome Mouth and Throat Soreness (MTS) Score.
type
SECONDARY
unit Of Measure
units on a scale * days

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Preserved source evidence · Not medical advice