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NCT00434161 · OUTCOME

Incidence of a Decreased From Baseline in Best Corrected Visual Acuity (BCVA) as Measured by a Change of 10 Letters on the ETDRS (Early Termination Diabetic Retinopathy Study) at 4 Meters at Months 12.

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
Month 12

What was measured

To study if the treatment has effected on the visual acuity from baseline to months 12, by using Best Corrected Visual Acuity (BCVA) as measured by a Change of 10 Letters on the ETDRS (Early Termination Diabetic Retinopathy Study) at 4 Meters. To assess the effect of palifermin on the incidence of cataract development or progression at Month 6 and Month 12 based on an increase of ≥ 0.3 in the Lens Opacities Classification System (LOCS III) score for Posterior Subcapsular cataract (P), Cortical Cataract (C) and Nuclear Opalescence (NO).

Analysis population: All subjects in the acute phase study were also assessed for their eligibility for cataract assessment procedures according to predefined criteria. If a subject was not eligible for cataract assessment procedures, the subject could still have been eligible for inclusion in the study but was exempt from the cataract assessments.

Groups in this outcome

Placebo

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

Palifermin

Subjects to receive Before- and After chemotherapy, and Before chemotherapy only.

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

Analysis denominator · Participants

GroupSource count
Placebo22
Palifermin79

Reported measurements

Incidence of decrease in letters read - Yes
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Placebo0Not reportedNot reportedNot reportedNot reported
Palifermin3Not reportedNot reportedNot reportedNot reported
Incidence of decrease in letters read - No
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Placebo14Not reportedNot reportedNot reportedNot reported
Palifermin49Not reportedNot reportedNot reportedNot reported
Subjects who discontinued at month 12
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Placebo8Not reportedNot reportedNot reportedNot reported
Palifermin27Not 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
    -0.679
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    12.580
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    param Type
    Risk Difference (RD)
    param Value
    5.951
    tested Non Inferiority
    false
Complete source fields
analyses
  1. ci Lower Limit
    -0.679
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    12.580
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    param Type
    Risk Difference (RD)
    param Value
    5.951
    tested Non Inferiority
    false
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        3
    title
    Incidence of decrease in letters read - Yes
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        14
      2. group Id
        OG001
        value
        49
    title
    Incidence of decrease in letters read - No
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        8
      2. group Id
        OG001
        value
        27
    title
    Subjects who discontinued at month 12
denoms
  1. counts
    1. group Id
      OG000
      value
      22
    2. group Id
      OG001
      value
      79
    units
    Participants
description
To study if the treatment has effected on the visual acuity from baseline to months 12, by using Best Corrected Visual Acuity (BCVA) as measured by a Change of 10 Letters on the ETDRS (Early Termination Diabetic Retinopathy Study) at 4 Meters. To assess the effect of palifermin on the incidence of cataract development or progression at Month 6 and Month 12 based on an increase of ≥ 0.3 in the Lens Opacities Classification System (LOCS III) score for Posterior Subcapsular cataract (P), Cortical Cataract (C) and Nuclear Opalescence (NO).
groups
  1. description
    Subjects to receive matched placebo before- and after-high dose chemotherapy.
    id
    OG000
    title
    Placebo
  2. description
    Subjects to receive Before- and After chemotherapy, and Before chemotherapy only.
    id
    OG001
    title
    Palifermin
param Type
NUMBER
population Description
All subjects in the acute phase study were also assessed for their eligibility for cataract assessment procedures according to predefined criteria. If a subject was not eligible for cataract assessment procedures, the subject could still have been eligible for inclusion in the study but was exempt from the cataract assessments.
reporting Status
POSTED
time Frame
Month 12
title
Incidence of a Decreased From Baseline in Best Corrected Visual Acuity (BCVA) as Measured by a Change of 10 Letters on the ETDRS (Early Termination Diabetic Retinopathy Study) at 4 Meters at Months 12.
type
SECONDARY
unit Of Measure
participants

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

Preserved source evidence · Not medical advice