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NCT00721123 · OUTCOME

Adverse Event (AE) Summary Over Time

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
Participants
Interval / dispersion
Not reported
Time frame
through 264 Weeks

What was measured

The number of participants experiencing at least one adverse event (AE) is recorded for each 12-month time period, with multiple occurrences in a single individual counted. Because months were calculated as 28 days, the periods actually equate to 48 weeks.

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

Groups in this outcome

Months 0 - 12

Participants with scores during Months 0-12, which equates to baseline through Week 48.

Months 13 - 24

Participants with scores during Months 13 - 24, which equates to Weeks 49-96.

Months 25 - 36

Participants with scores during Months 25 - 36, which equates to Weeks 97-144.

Months 37 - 48

Participants with scores during Months 37 - 48, which equates to Weeks 145-192.

Months Greater Than 48

Participants with scores during Months greater than 48, which equates to Weeks 193-264.

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

Analysis denominator · Participants

GroupSource count
Months 0 - 12538
Months 13 - 24509
Months 25 - 36463
Months 37 - 48434
Months Greater Than 48414

Reported measurements

Experienced an adverse event
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Months 0 - 12433Not reportedNot reportedNot reportedNot reported
Months 13 - 24390Not reportedNot reportedNot reportedNot reported
Months 25 - 36333Not reportedNot reportedNot reportedNot reported
Months 37 - 48294Not reportedNot reportedNot reportedNot reported
Months Greater Than 48329Not reportedNot reportedNot reportedNot reported
Experienced a serious adverse event
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Months 0 - 1255Not reportedNot reportedNot reportedNot reported
Months 13 - 2455Not reportedNot reportedNot reportedNot reported
Months 25 - 3655Not reportedNot reportedNot reportedNot reported
Months 37 - 4835Not reportedNot reportedNot reportedNot reported
Months Greater Than 4874Not reportedNot reportedNot reportedNot reported
Experienced AE leading to withdrawal
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Months 0 - 1224Not reportedNot reportedNot reportedNot reported
Months 13 - 2417Not reportedNot reportedNot reportedNot reported
Months 25 - 3622Not reportedNot reportedNot reportedNot reported
Months 37 - 488Not reportedNot reportedNot reportedNot reported
Months Greater Than 4832Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        433
      2. group Id
        OG001
        value
        390
      3. group Id
        OG002
        value
        333
      4. group Id
        OG003
        value
        294
      5. group Id
        OG004
        value
        329
    title
    Experienced an adverse event
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        55
      2. group Id
        OG001
        value
        55
      3. group Id
        OG002
        value
        55
      4. group Id
        OG003
        value
        35
      5. group Id
        OG004
        value
        74
    title
    Experienced a serious adverse event
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        24
      2. group Id
        OG001
        value
        17
      3. group Id
        OG002
        value
        22
      4. group Id
        OG003
        value
        8
      5. group Id
        OG004
        value
        32
    title
    Experienced AE leading to withdrawal
denoms
  1. counts
    1. group Id
      OG000
      value
      538
    2. group Id
      OG001
      value
      509
    3. group Id
      OG002
      value
      463
    4. group Id
      OG003
      value
      434
    5. group Id
      OG004
      value
      414
    units
    Participants
description
The number of participants experiencing at least one adverse event (AE) is recorded for each 12-month time period, with multiple occurrences in a single individual counted. Because months were calculated as 28 days, the periods actually equate to 48 weeks.
groups
  1. description
    Participants with scores during Months 0-12, which equates to baseline through Week 48.
    id
    OG000
    title
    Months 0 - 12
  2. description
    Participants with scores during Months 13 - 24, which equates to Weeks 49-96.
    id
    OG001
    title
    Months 13 - 24
  3. description
    Participants with scores during Months 25 - 36, which equates to Weeks 97-144.
    id
    OG002
    title
    Months 25 - 36
  4. description
    Participants with scores during Months 37 - 48, which equates to Weeks 145-192.
    id
    OG003
    title
    Months 37 - 48
  5. description
    Participants with scores during Months greater than 48, which equates to Weeks 193-264.
    id
    OG004
    title
    Months Greater Than 48
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.
reporting Status
POSTED
time Frame
through 264 Weeks
title
Adverse Event (AE) Summary Over Time
type
PRIMARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice