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NCT00434161 · OUTCOME

Duration of Ulcerative Mucositis (WHO Grades 2, 3, and 4)

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
Days
Interval / dispersion
Full Range
Time frame
at Day 32

What was measured

The duration of ulcerative mucositis measured the number of days the participants had different 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. Patients that did not have any ulcerative mucositis were given a value of 0 days.

Analysis population: Full analysis set that includes all randomized subjects (total 281 subjects), and was used to compare treatment effects for all efficacy endpoints. This set of subjects was analyzed according to their randomized treatment assignment.

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 Days · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Palifermin Before Only4.786.13032Not reported
Placebo4.985.95025Not reported
Palifermin Before and After7.386.82027Not reported

Source statistical analyses

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

  1. ci Lower Limit
    0.070
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    97.5
    ci Upper Limit
    4.748
    dispersion Type
    STANDARD_DEVIATION
    dispersion Value
    6.82
    group Description
    A type I error rate was protected by using the Hochberg procedure to adjust for multiple testing. 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
    0.095
    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
    2.409
    statistical Method
    van Elteren test
    tested Non Inferiority
    false
  2. ci Lower Limit
    -2.575
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    97.5
    ci Upper Limit
    2.150
    dispersion Type
    STANDARD_DEVIATION
    dispersion Value
    6.13
    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
    -0.213
    statistical Method
    van Elteren test
    tested Non Inferiority
    false
Complete source fields
analyses
  1. ci Lower Limit
    0.070
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    97.5
    ci Upper Limit
    4.748
    dispersion Type
    STANDARD_DEVIATION
    dispersion Value
    6.82
    group Description
    A type I error rate was protected by using the Hochberg procedure to adjust for multiple testing. 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
    0.095
    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
    2.409
    statistical Method
    van Elteren test
    tested Non Inferiority
    false
  2. ci Lower Limit
    -2.575
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    97.5
    ci Upper Limit
    2.150
    dispersion Type
    STANDARD_DEVIATION
    dispersion Value
    6.13
    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
    -0.213
    statistical Method
    van Elteren test
    tested Non Inferiority
    false
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0
        spread
        6.13
        upper Limit
        32
        value
        4.78
      2. group Id
        OG001
        lower Limit
        0
        spread
        5.95
        upper Limit
        25
        value
        4.98
      3. group Id
        OG002
        lower Limit
        0
        spread
        6.82
        upper Limit
        27
        value
        7.38
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 duration of ulcerative mucositis measured the number of days the participants had different 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. Patients that did not have any ulcerative mucositis were given a value of 0 days.
dispersion Type
Full Range
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
population Description
Full analysis set that includes all randomized subjects (total 281 subjects), and was used to compare treatment effects for all efficacy endpoints. This set of subjects was analyzed according to their randomized treatment assignment.
reporting Status
POSTED
time Frame
at Day 32
title
Duration of Ulcerative Mucositis (WHO Grades 2, 3, and 4)
type
SECONDARY
unit Of Measure
Days

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

Preserved source evidence · Not medical advice