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NCT01613599 · OUTCOME

Incidence Rate of Malignancy, Excluding Non-melanoma Skin Cancer

An Observational Study of The Safety of MabThera/Rituxan (Rituximab) in Participants With Granulomatosis With Polyangiitis (Wegener's) or Microscopic Polyangiitis · Source last updated 2018-07-26

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

Measure
NUMBER
Unit
events per 100 patient year
Interval / dispersion
95% Confidence Interval
Time frame
From first dose until participant withdrawal or the date of last participant, last visit (up to 4.32 years)

What was measured

Malignancies were clinical findings of cancer and excluded non-melanoma skin cancer. Multiple events reported in the same participant were counted multiple times in the calculation of incidence. Incidence rate is defined as events per 100 patient years.

Analysis population: The safety population included all participants who received any active dose of rituximab.

Groups in this outcome

Rituximab

Participants with GPA (Wegener's granulomatosis) or MPA who received rituximab as per investigator's discretion were followed for a maximum of 4.32 years.

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

Analysis denominator · Participants

GroupSource count
Rituximab97

Analysis denominator · Total Patient-years at Risk

GroupSource count
Rituximab338

Reported measurements

Source class 1
Values in events per 100 patient year · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Rituximab0.89Not reported0.182.60Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.18
        upper Limit
        2.60
        value
        0.89
denom Units Selected
Total Patient-years at Risk
denoms
  1. counts
    1. group Id
      OG000
      value
      97
    units
    Participants
  2. counts
    1. group Id
      OG000
      value
      338
    units
    Total Patient-years at Risk
description
Malignancies were clinical findings of cancer and excluded non-melanoma skin cancer. Multiple events reported in the same participant were counted multiple times in the calculation of incidence. Incidence rate is defined as events per 100 patient years.
dispersion Type
95% Confidence Interval
groups
  1. description
    Participants with GPA (Wegener's granulomatosis) or MPA who received rituximab as per investigator's discretion were followed for a maximum of 4.32 years.
    id
    OG000
    title
    Rituximab
param Type
NUMBER
population Description
The safety population included all participants who received any active dose of rituximab.
reporting Status
POSTED
time Frame
From first dose until participant withdrawal or the date of last participant, last visit (up to 4.32 years)
title
Incidence Rate of Malignancy, Excluding Non-melanoma Skin Cancer
type
SECONDARY
type Units Analyzed
Total Patient-years at Risk
unit Of Measure
events per 100 patient year

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice