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NCT00721123 · OUTCOME

Overall Death Rate 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
Deaths per 100 PY
Interval / dispersion
95% Confidence Interval
Time frame
through 264 Weeks

What was measured

Patient year (PY) refers to duration in study, calculated from first active drug intake to last safety assessment available + 1. To calculate the death rate, the total cumulative number of years that all participants were exposed to the drug, from first active drug intake to last safety assessment available + 1, was calculated as 2461.94. Since 10 participants died during that time, the death rate per year was not informative (0.00). Therefore, the overall death rate was calculated with the confidence interval based on events per 100 patient years exposure.

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

Groups in this outcome

Tocilizumab 8 mg/kg

Patients received tocilizumab (TCZ) 8 mg/kg intravenously every 4 weeks.

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

Analysis denominator · Participants

GroupSource count
Tocilizumab 8 mg/kg538

Reported measurements

Source class 1
Values in Deaths per 100 PY · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Tocilizumab 8 mg/kg0.41Not reported0.190.75Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.19
        upper Limit
        0.75
        value
        0.41
denoms
  1. counts
    1. group Id
      OG000
      value
      538
    units
    Participants
description
Patient year (PY) refers to duration in study, calculated from first active drug intake to last safety assessment available + 1. To calculate the death rate, the total cumulative number of years that all participants were exposed to the drug, from first active drug intake to last safety assessment available + 1, was calculated as 2461.94. Since 10 participants died during that time, the death rate per year was not informative (0.00). Therefore, the overall death rate was calculated with the confidence interval based on events per 100 patient years exposure.
dispersion Type
95% Confidence Interval
groups
  1. description
    Patients received tocilizumab (TCZ) 8 mg/kg intravenously every 4 weeks.
    id
    OG000
    title
    Tocilizumab 8 mg/kg
param Type
NUMBER
population Description
All exposure population, which included 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
Overall Death Rate Over Time
type
PRIMARY
unit Of Measure
Deaths per 100 PY

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

Preserved source evidence · Not medical advice