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NCT00434161 · OUTCOME

Incidence of Cataract Development or Progression at Month 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
12 months

What was measured

Number of participants from the primary cataract subset showing an increase from baseline of \>= 0.3 in the Lens Opacities Classification System III (LOCS III score). The LOCS III is a standard system used for grading and comparison of cataract severity and type. The ophthalmologist trained in LOCS III uses a slit lamp for examining the lens of the eye. The classification evaluates four features: posterior subcapsular cataract(P),cortical cataract(C),nuclear opalescence(NO) and nuclear color(NC). NO and NC are graded on a decimal scale of 0.1 to 6.9, based on a set of 6 standardized photographs. C and P are graded on a decimal scale of 0.1 to 5.9, based on a set of 5 standardized photographs each. In the current study, cataract development or progression was defined as an increase from baseline of ≥ 0.3 on any of the three features P, C or NO (NC is of less importance and has not been analysed further in this study).

Analysis population: Of the 281 subjects who participated in the acute phase of the study a total of 101 subjects study were eligible for participation in the cataract assessment procedures, 22 in the placebo group and 79 in the palifermin group.

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

Yes
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Placebo4Not reportedNANANot reported
Palifermin25Not reportedNANANot reported
No
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Placebo10Not reportedNANANot reported
Palifermin27Not reportedNANANot reported
Missing
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Placebo8Not reportedNANANot reported
Palifermin27Not reportedNANANot reported

Source statistical analyses

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

  1. ci Lower Limit
    -11.086
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    45.919
    group Ids
    1. OG000
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    param Type
    Mean Difference (Final Values)
    param Value
    17.417
    tested Non Inferiority
    false
Complete source fields
analyses
  1. ci Lower Limit
    -11.086
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    45.919
    group Ids
    1. OG000
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    param Type
    Mean Difference (Final Values)
    param Value
    17.417
    tested Non Inferiority
    false
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        NA
        upper Limit
        NA
        value
        4
      2. group Id
        OG001
        lower Limit
        NA
        upper Limit
        NA
        value
        25
    title
    Yes
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        NA
        upper Limit
        NA
        value
        10
      2. group Id
        OG001
        lower Limit
        NA
        upper Limit
        NA
        value
        27
    title
    No
  3. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        NA
        upper Limit
        NA
        value
        8
      2. group Id
        OG001
        lower Limit
        NA
        upper Limit
        NA
        value
        27
    title
    Missing
denoms
  1. counts
    1. group Id
      OG000
      value
      22
    2. group Id
      OG001
      value
      79
    units
    Participants
description
Number of participants from the primary cataract subset showing an increase from baseline of \>= 0.3 in the Lens Opacities Classification System III (LOCS III score). The LOCS III is a standard system used for grading and comparison of cataract severity and type. The ophthalmologist trained in LOCS III uses a slit lamp for examining the lens of the eye. The classification evaluates four features: posterior subcapsular cataract(P),cortical cataract(C),nuclear opalescence(NO) and nuclear color(NC). NO and NC are graded on a decimal scale of 0.1 to 6.9, based on a set of 6 standardized photographs. C and P are graded on a decimal scale of 0.1 to 5.9, based on a set of 5 standardized photographs each. In the current study, cataract development or progression was defined as an increase from baseline of ≥ 0.3 on any of the three features P, C or NO (NC is of less importance and has not been analysed further in this study).
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
Of the 281 subjects who participated in the acute phase of the study a total of 101 subjects study were eligible for participation in the cataract assessment procedures, 22 in the placebo group and 79 in the palifermin group.
reporting Status
POSTED
time Frame
12 months
title
Incidence of Cataract Development or Progression at Month 12.
type
PRIMARY
unit Of Measure
Participants

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Preserved source evidence · Not medical advice