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NCT01750697 · OUTCOME

Percentage of Participants With Adverse Events (AEs), Including Serious AEs

A Phase IIa Study of Intravenous Rituximab in Pediatric Participants With Severe Granulomatosis With Polyangiitis (Wegener's) or Microscopic Polyangiitis · Source last updated 2019-06-26

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 (Day 1) up to last visit (1.5-5 years)

What was measured

An AE is any unfavourable and unintended sign (including abnormal laboratory finding), symptom, or disease temporarily associated with the use of a study drug, whether or not considered related to the study drug. A SAE is any experience that results in death, is life-threatening, requires in-patient hospitalisation or prolongation of existing hospitalisation, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is medically significant.

Analysis population: The safety population included all participants who received at least part of one infusion of rituximab.

Groups in this outcome

Remission Induction Phase (up to 6 Mos.) Rituximab

Participants received rituximab as an intravenous (IV) infusion of 375 milligrams per metre squared (mg/m\^2) once a week on Days 1, 8, 15 and 22 during Remission Induction Phase (Day 1 (baseline) to Month 6)

Overall Follow-up Phase (up to 4.5 Yrs) Rituximab

Participants who received rituximab during the Remission Induction Phase were followed for a minimum of 18 months during the Follow-up Phase and could receive additional rituximab or other treatments for GPA/MPA (Day 1 (baseline) up to 4.5 yrs)

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

Analysis denominator · Participants

GroupSource count
Remission Induction Phase (up to 6 Mos.) Rituximab25
Overall Follow-up Phase (up to 4.5 Yrs) Rituximab25

Reported measurements

Percentage of Participants with AEs
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Remission Induction Phase (up to 6 Mos.) Rituximab100Not reportedNot reportedNot reportedNot reported
Overall Follow-up Phase (up to 4.5 Yrs) Rituximab100Not reportedNot reportedNot reportedNot reported
Percentage of Participants with SAEs
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Remission Induction Phase (up to 6 Mos.) Rituximab28Not reportedNot reportedNot reportedNot reported
Overall Follow-up Phase (up to 4.5 Yrs) Rituximab48Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        100
      2. group Id
        OG001
        value
        100
    title
    Percentage of Participants with AEs
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        28
      2. group Id
        OG001
        value
        48
    title
    Percentage of Participants with SAEs
denoms
  1. counts
    1. group Id
      OG000
      value
      25
    2. group Id
      OG001
      value
      25
    units
    Participants
description
An AE is any unfavourable and unintended sign (including abnormal laboratory finding), symptom, or disease temporarily associated with the use of a study drug, whether or not considered related to the study drug. A SAE is any experience that results in death, is life-threatening, requires in-patient hospitalisation or prolongation of existing hospitalisation, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is medically significant.
groups
  1. description
    Participants received rituximab as an intravenous (IV) infusion of 375 milligrams per metre squared (mg/m\^2) once a week on Days 1, 8, 15 and 22 during Remission Induction Phase (Day 1 (baseline) to Month 6)
    id
    OG000
    title
    Remission Induction Phase (up to 6 Mos.) Rituximab
  2. description
    Participants who received rituximab during the Remission Induction Phase were followed for a minimum of 18 months during the Follow-up Phase and could receive additional rituximab or other treatments for GPA/MPA (Day 1 (baseline) up to 4.5 yrs)
    id
    OG001
    title
    Overall Follow-up Phase (up to 4.5 Yrs) Rituximab
param Type
NUMBER
population Description
The safety population included all participants who received at least part of one infusion of rituximab.
reporting Status
POSTED
time Frame
Baseline (Day 1) up to last visit (1.5-5 years)
title
Percentage of Participants With Adverse Events (AEs), Including Serious AEs
type
PRIMARY
unit Of Measure
percentage of participants

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

Preserved source evidence · Not medical advice