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NCT00434161 · OUTCOME

Incidence of Adverse Events and Laboratory Abnormalities

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

Incidence of Adverse Events CTCAE grade 3 or higher reported

Groups in this outcome

Palifermin Before Only

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

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

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 Only111
Placebo57
Palifermin Before and After109

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Palifermin Before Only56Not reportedNot reportedNot reportedNot reported
Placebo26Not reportedNot reportedNot reportedNot reported
Palifermin Before and After65Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        56
      2. group Id
        OG001
        value
        26
      3. group Id
        OG002
        value
        65
denoms
  1. counts
    1. group Id
      OG000
      value
      111
    2. group Id
      OG001
      value
      57
    3. group Id
      OG002
      value
      109
    units
    Participants
description
Incidence of Adverse Events CTCAE grade 3 or higher reported
groups
  1. description
    Subjects to receive palifermin before-high dose chemotherapy and matched placebo after-high dose chemotherapy
    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
    id
    OG002
    title
    Palifermin Before and After
param Type
NUMBER
reporting Status
POSTED
time Frame
at Day 32
title
Incidence of Adverse Events and Laboratory Abnormalities
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice