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NCT00720798 · OUTCOME

Percentage of Participants With a Clinically Relevant Improvement in the Physical and Mental Component Scores of the Short Form 36 (SF-36) Health Survey at Weeks 24, 48, 108, 156, 204, and 264

An Extension Study of Tocilizumab (Myeloma Receptor Antibody [MRA]) in Patients Completing Treatment in Tocilizumab Core Studies · Source last updated 2014-09-30

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
NUMBER
Unit
Percentage of participants
Interval / dispersion
Not reported
Time frame
Baseline to Week 264

What was measured

The SF-36 Health Survey uses participant-reported symptoms on 8 subscales to assess health-related quality of life (HRQoL). The Physical Component Summary (PCS) score summarizes the subscales Physical Functioning, Role-Physical, Bodily Pain, and General Health. The Mental Component Summary (MCS) score summarizes the subscales Vitality, Social Functioning, Role-Emotional, and Mental Health. Each score was scaled from 0 to 100 with a higher score indicating better HRQoL. A clinically relevant improvement in the Physical and Mental Component Scores of the SF-36 was defined as a ≥ 5-point increase from Baseline.

Analysis population: All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study. Only participants with available data were included in the analysis.

Groups in this outcome

Tocilizumab

Participants received tocilizumab 8 mg/kg intravenously every 4 weeks till the end of the study (up to 7 years, 7 months). In addition, participants may have also received disease-modifying anti-rheumatic drugs, non-steroidal anti-inflammatory drugs, and oral corticosteroids at the discretion of the investigator.

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

Analysis denominator · Participants

GroupSource count
Tocilizumab2067

Reported measurements

Week 24 Mental Score (n = 1850)
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Tocilizumab42.4Not reportedNot reportedNot reportedNot reported
Week 48 Mental Score (n = 1789)
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Tocilizumab44.4Not reportedNot reportedNot reportedNot reported
Week 108 Mental Score (n = 1551)
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Tocilizumab45.3Not reportedNot reportedNot reportedNot reported
Week 156 Mental Score (n = 1468)
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Tocilizumab46.1Not reportedNot reportedNot reportedNot reported
Week 204 Mental Score (n = 1377)
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Tocilizumab47.1Not reportedNot reportedNot reportedNot reported
Week 264 Mental Score (n = 1302)
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Tocilizumab44.9Not reportedNot reportedNot reportedNot reported
Week 24 Physical Score (n = 1850)
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Tocilizumab56.2Not reportedNot reportedNot reportedNot reported
Week 48 Physical Score (n = 1789)
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Tocilizumab61.4Not reportedNot reportedNot reportedNot reported
Week 108 Physical Score (n = 1551)
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Tocilizumab63.2Not reportedNot reportedNot reportedNot reported
Week 156 Physical Score (n = 1468)
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Tocilizumab62.5Not reportedNot reportedNot reportedNot reported
Week 204 Physical Score (n = 1377)
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Tocilizumab64.1Not reportedNot reportedNot reportedNot reported
Week 264 Physical Score (n = 1302)
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Tocilizumab63.7Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        42.4
    title
    Week 24 Mental Score (n = 1850)
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        44.4
    title
    Week 48 Mental Score (n = 1789)
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        45.3
    title
    Week 108 Mental Score (n = 1551)
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        46.1
    title
    Week 156 Mental Score (n = 1468)
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        47.1
    title
    Week 204 Mental Score (n = 1377)
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        44.9
    title
    Week 264 Mental Score (n = 1302)
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        56.2
    title
    Week 24 Physical Score (n = 1850)
  8. categories
    1. measurements
      1. group Id
        OG000
        value
        61.4
    title
    Week 48 Physical Score (n = 1789)
  9. categories
    1. measurements
      1. group Id
        OG000
        value
        63.2
    title
    Week 108 Physical Score (n = 1551)
  10. categories
    1. measurements
      1. group Id
        OG000
        value
        62.5
    title
    Week 156 Physical Score (n = 1468)
  11. categories
    1. measurements
      1. group Id
        OG000
        value
        64.1
    title
    Week 204 Physical Score (n = 1377)
  12. categories
    1. measurements
      1. group Id
        OG000
        value
        63.7
    title
    Week 264 Physical Score (n = 1302)
denoms
  1. counts
    1. group Id
      OG000
      value
      2067
    units
    Participants
description
The SF-36 Health Survey uses participant-reported symptoms on 8 subscales to assess health-related quality of life (HRQoL). The Physical Component Summary (PCS) score summarizes the subscales Physical Functioning, Role-Physical, Bodily Pain, and General Health. The Mental Component Summary (MCS) score summarizes the subscales Vitality, Social Functioning, Role-Emotional, and Mental Health. Each score was scaled from 0 to 100 with a higher score indicating better HRQoL. A clinically relevant improvement in the Physical and Mental Component Scores of the SF-36 was defined as a ≥ 5-point increase from Baseline.
groups
  1. description
    Participants received tocilizumab 8 mg/kg intravenously every 4 weeks till the end of the study (up to 7 years, 7 months). In addition, participants may have also received disease-modifying anti-rheumatic drugs, non-steroidal anti-inflammatory drugs, and oral corticosteroids at the discretion of the investigator.
    id
    OG000
    title
    Tocilizumab
param Type
NUMBER
population Description
All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study. Only participants with available data were included in the analysis.
time Frame
Baseline to Week 264
title
Percentage of Participants With a Clinically Relevant Improvement in the Physical and Mental Component Scores of the Short Form 36 (SF-36) Health Survey at Weeks 24, 48, 108, 156, 204, and 264
type
SECONDARY
unit Of Measure
Percentage of participants

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Preserved source evidence · Not medical advice