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NCT00434161 · OUTCOME

Incidence 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
NUMBER
Unit
participants
Interval / dispersion
Not reported
Time frame
at Day 32

What was measured

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.

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

Incidence (n): yes
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Palifermin Before Only56Not reportedNot reportedNot reportedNot reported
Placebo33Not reportedNot reportedNot reportedNot reported
Palifermin Before and After79Not reportedNot reportedNot reportedNot reported
Incidence (n): No
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Palifermin Before Only49Not reportedNot reportedNot reportedNot reported
Placebo24Not reportedNot reportedNot reportedNot reported
Palifermin Before and After33Not reportedNot reportedNot reportedNot reported
Incidence (n): unknown
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Palifermin Before Only4Not reportedNot reportedNot reportedNot reported
Placebo0Not reportedNot reportedNot reportedNot reported
Palifermin Before and After3Not reportedNot reportedNot reportedNot reported

Source statistical analyses

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

  1. ci Lower Limit
    -4.303
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    97.5
    ci Upper Limit
    30.828
    group Ids
    1. OG001
    2. OG002
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.245
    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
    Risk Difference (RD)
    param Value
    13.262
    statistical Method
    Cochran-Mantel-Haenszel
    tested Non Inferiority
    false
  2. ci Lower Limit
    -20.519
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    97.5
    ci Upper Limit
    16.491
    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
    Risk Difference (RD)
    param Value
    -2.014
    statistical Method
    Cochran-Mantel-Haenszel
    tested Non Inferiority
    false
Complete source fields
analyses
  1. ci Lower Limit
    -4.303
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    97.5
    ci Upper Limit
    30.828
    group Ids
    1. OG001
    2. OG002
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.245
    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
    Risk Difference (RD)
    param Value
    13.262
    statistical Method
    Cochran-Mantel-Haenszel
    tested Non Inferiority
    false
  2. ci Lower Limit
    -20.519
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    97.5
    ci Upper Limit
    16.491
    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
    Risk Difference (RD)
    param Value
    -2.014
    statistical Method
    Cochran-Mantel-Haenszel
    tested Non Inferiority
    false
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        56
      2. group Id
        OG001
        value
        33
      3. group Id
        OG002
        value
        79
    title
    Incidence (n): yes
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        49
      2. group Id
        OG001
        value
        24
      3. group Id
        OG002
        value
        33
    title
    Incidence (n): No
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        4
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        3
    title
    Incidence (n): unknown
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 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.
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
NUMBER
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
Incidence Ulcerative Mucositis (WHO Grades 2, 3, and 4)
type
SECONDARY
unit Of Measure
participants

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Preserved source evidence · Not medical advice