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NCT00434161 · OUTCOME

Incidence of an Increase Posterior Subcapsular Cataract (P), Cortical Cataract (C) and Nuclear Opalescence (NO) at Month 6 and 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
at Month 6 and Month 12

What was measured

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 (P), Cortical Cataract (C) and Nuclear Opalescence (NO). For Subcapsular cataract (P), Cortical Cataract (C) and Nuclear Opalescence (NO): at month 6 and 12 adjusted difference of rate of cataract, Palifermin - Placebo were used and the confidence interval were calculated on the adjusted difference.

Analysis population: 281 subjects participated in the acute phase study of those 101 subjects were eligible for the cataract assessment study, 22 placebo and 79 palifermin. Month 6: 69 completed (17/22 \[77.3%\] in the placebo, 52/79 \[65.8%\] in the palifermin. Month 12: 66 completed (14/22 \[63.6%\] in the placebo, 52/79 \[65.8%\] 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

P month 6 - Yes
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Placebo0Not reportedNot reportedNot reportedNot reported
Palifermin5Not reportedNot reportedNot reportedNot reported
P, month 6 - No
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Placebo17Not reportedNot reportedNot reportedNot reported
Palifermin47Not reportedNot reportedNot reportedNot reported
P, month 12 - Yes
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Placebo1Not reportedNot reportedNot reportedNot reported
Palifermin13Not reportedNot reportedNot reportedNot reported
P, month 12 - No
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Placebo13Not reportedNot reportedNot reportedNot reported
Palifermin39Not reportedNot reportedNot reportedNot reported
C month 6 - Yes
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Placebo3Not reportedNot reportedNot reportedNot reported
Palifermin9Not reportedNot reportedNot reportedNot reported
C, month 6 - No
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Placebo14Not reportedNot reportedNot reportedNot reported
Palifermin43Not reportedNot reportedNot reportedNot reported
C, month 12 - Yes
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Placebo2Not reportedNot reportedNot reportedNot reported
Palifermin13Not reportedNot reportedNot reportedNot reported
C, month 12 - No
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Placebo12Not reportedNot reportedNot reportedNot reported
Palifermin39Not reportedNot reportedNot reportedNot reported
NO month 6 - Yes
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Placebo3Not reportedNot reportedNot reportedNot reported
Palifermin19Not reportedNot reportedNot reportedNot reported
NO month 6 - No
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Placebo14Not reportedNot reportedNot reportedNot reported
Palifermin33Not reportedNot reportedNot reportedNot reported
NO month 12 - Yes
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Placebo4Not reportedNot reportedNot reportedNot reported
Palifermin20Not reportedNot reportedNot reportedNot reported
NO month 12 - No
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Placebo10Not reportedNot reportedNot reportedNot reported
Palifermin32Not reportedNot reportedNot reportedNot reported
P, C and NO, month 6 - Subjects who discontinued
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Placebo5Not reportedNot reportedNot reportedNot reported
Palifermin27Not reportedNot reportedNot reportedNot reported
P, C and NO, month 12 - Subjects who discontinued
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Placebo8Not reportedNot reportedNot reportedNot reported
Palifermin27Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        5
    title
    P month 6 - Yes
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        17
      2. group Id
        OG001
        value
        47
    title
    P, month 6 - No
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        13
    title
    P, month 12 - Yes
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        13
      2. group Id
        OG001
        value
        39
    title
    P, month 12 - No
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        3
      2. group Id
        OG001
        value
        9
    title
    C month 6 - Yes
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        14
      2. group Id
        OG001
        value
        43
    title
    C, month 6 - No
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        13
    title
    C, month 12 - Yes
  8. categories
    1. measurements
      1. group Id
        OG000
        value
        12
      2. group Id
        OG001
        value
        39
    title
    C, month 12 - No
  9. categories
    1. measurements
      1. group Id
        OG000
        value
        3
      2. group Id
        OG001
        value
        19
    title
    NO month 6 - Yes
  10. categories
    1. measurements
      1. group Id
        OG000
        value
        14
      2. group Id
        OG001
        value
        33
    title
    NO month 6 - No
  11. categories
    1. measurements
      1. group Id
        OG000
        value
        4
      2. group Id
        OG001
        value
        20
    title
    NO month 12 - Yes
  12. categories
    1. measurements
      1. group Id
        OG000
        value
        10
      2. group Id
        OG001
        value
        32
    title
    NO month 12 - No
denoms
  1. counts
    1. group Id
      OG000
      value
      22
    2. group Id
      OG001
      value
      79
    units
    Participants
description
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 (P), Cortical Cataract (C) and Nuclear Opalescence (NO). For Subcapsular cataract (P), Cortical Cataract (C) and Nuclear Opalescence (NO): at month 6 and 12 adjusted difference of rate of cataract, Palifermin - Placebo were used and the confidence interval were calculated on the adjusted difference.
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
281 subjects participated in the acute phase study of those 101 subjects were eligible for the cataract assessment study, 22 placebo and 79 palifermin. Month 6: 69 completed (17/22 \[77.3%\] in the placebo, 52/79 \[65.8%\] in the palifermin. Month 12: 66 completed (14/22 \[63.6%\] in the placebo, 52/79 \[65.8%\] in the palifermin group.
reporting Status
POSTED
time Frame
at Month 6 and Month 12
title
Incidence of an Increase Posterior Subcapsular Cataract (P), Cortical Cataract (C) and Nuclear Opalescence (NO) at Month 6 and 12
type
SECONDARY
unit Of Measure
participants

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Preserved source evidence · Not medical advice