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NCT00721123 · OUTCOME

Percentage of Participants With at Least a 5-point Improvement From Baseline in Quality of Life Using the 36-Item Short-Form Health Survey (SF-36) Over Time, Through 264 Weeks

A Long-term Extension Study of Tocilizumab (Myeloma Receptor Antibody [MRA]) in Patients With Rheumatoid Arthritis · Source last updated 2013-11-28

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
through 264 Weeks

What was measured

The SF-36 Health Survey is a standardized questionnaire consisting of 36 questions that measures patient-reported symptoms on 8 dimensions; it is used 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. A positive change score indicates better HRQoL. The percentage of participants with at least a 5-point improvement from baseline is presented for each subscale.

Analysis population: All exposure population, which includes all participants who entered the study and received at least one dose of tocilizumab at any time, with a score at the given time point.

Groups in this outcome

Week 24

Participants with scores at 24 weeks post-baseline.

Week 48

Participants with scores at 48 weeks post-baseline.

Week 108

Participants with scores at 108 weeks post-baseline.

Week 156

Participants with scores at 156 weeks post-baseline.

Week 204

Participants with scores at 204 weeks post-baseline.

Week 264

Participants with scores at 264 weeks post-baseline.

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

Analysis denominator · Participants

GroupSource count
Week 24423
Week 48424
Week 108395
Week 156373
Week 204344
Week 264334

Reported measurements

SF-36 MCS
Values in Percentage of Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Week 2448.2Not reportedNot reportedNot reportedNot reported
Week 4846.2Not reportedNot reportedNot reportedNot reported
Week 10848.6Not reportedNot reportedNot reportedNot reported
Week 15649.9Not reportedNot reportedNot reportedNot reported
Week 20449.7Not reportedNot reportedNot reportedNot reported
Week 26449.1Not reportedNot reportedNot reportedNot reported
SF-36 PCS
Values in Percentage of Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Week 2463.8Not reportedNot reportedNot reportedNot reported
Week 4869.1Not reportedNot reportedNot reportedNot reported
Week 10871.1Not reportedNot reportedNot reportedNot reported
Week 15671.3Not reportedNot reportedNot reportedNot reported
Week 20473.3Not reportedNot reportedNot reportedNot reported
Week 26471.3Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        48.2
      2. group Id
        OG001
        value
        46.2
      3. group Id
        OG002
        value
        48.6
      4. group Id
        OG003
        value
        49.9
      5. group Id
        OG004
        value
        49.7
      6. group Id
        OG005
        value
        49.1
    title
    SF-36 MCS
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        63.8
      2. group Id
        OG001
        value
        69.1
      3. group Id
        OG002
        value
        71.1
      4. group Id
        OG003
        value
        71.3
      5. group Id
        OG004
        value
        73.3
      6. group Id
        OG005
        value
        71.3
    title
    SF-36 PCS
denoms
  1. counts
    1. group Id
      OG000
      value
      423
    2. group Id
      OG001
      value
      424
    3. group Id
      OG002
      value
      395
    4. group Id
      OG003
      value
      373
    5. group Id
      OG004
      value
      344
    6. group Id
      OG005
      value
      334
    units
    Participants
description
The SF-36 Health Survey is a standardized questionnaire consisting of 36 questions that measures patient-reported symptoms on 8 dimensions; it is used 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. A positive change score indicates better HRQoL. The percentage of participants with at least a 5-point improvement from baseline is presented for each subscale.
groups
  1. description
    Participants with scores at 24 weeks post-baseline.
    id
    OG000
    title
    Week 24
  2. description
    Participants with scores at 48 weeks post-baseline.
    id
    OG001
    title
    Week 48
  3. description
    Participants with scores at 108 weeks post-baseline.
    id
    OG002
    title
    Week 108
  4. description
    Participants with scores at 156 weeks post-baseline.
    id
    OG003
    title
    Week 156
  5. description
    Participants with scores at 204 weeks post-baseline.
    id
    OG004
    title
    Week 204
  6. description
    Participants with scores at 264 weeks post-baseline.
    id
    OG005
    title
    Week 264
param Type
NUMBER
population Description
All exposure population, which includes all participants who entered the study and received at least one dose of tocilizumab at any time, with a score at the given time point.
reporting Status
POSTED
time Frame
through 264 Weeks
title
Percentage of Participants With at Least a 5-point Improvement From Baseline in Quality of Life Using the 36-Item Short-Form Health Survey (SF-36) Over Time, Through 264 Weeks
type
SECONDARY
unit Of Measure
Percentage of Participants

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