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NCT00104299 · OUTCOME

Number of Subjects Experiencing Serious Adverse Events

Rituximab for the Treatment of Wegener's Granulomatosis and Microscopic Polyangiitis · Source last updated 2017-04-21

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
Randomization to censor at Crossover, Open-label or Best Medical Judgment (up to 18 months post-randomization)

What was measured

Number of subjects according to originally received treatment that experienced a serious adverse event through 18 months post-randomization or prior to being censored from analyses due to crossover, switching to open-label treatment, or best medical judgment for censor. Events are categorized by coded system organ classes (SOC). Within each SOC, a participant was counted once if the participant reported one or more events coded to that SOC.

Analysis population: Intent-to-treat

Groups in this outcome

Rituximab

Participants received intravenous rituximab (Rituxan, Genentech) (at a dose of 375 mg per square meter of body-surface area once weekly for 4 weeks) plus daily placebo-cyclophosphamide. Refer to section titled "Detailed Description" for additional treatment information.

Control Group

Participants received placebo-rituximab infusions plus daily cyclophosphamide (2 mg per kilogram of body weight, adjusted for renal insufficiency). Refer to section titled "Detailed Description" for additional treatment information.

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

Analysis denominator · Participants

GroupSource count
Rituximab99
Control Group98

Reported measurements

# Participants with at least one SAE
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Rituximab42Not reportedNot reportedNot reportedNot reported
Control Group37Not reportedNot reportedNot reportedNot reported
Blood and Lymphatic System Disorders
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Rituximab4Not reportedNot reportedNot reportedNot reported
Control Group5Not reportedNot reportedNot reportedNot reported
Cardiac Disorders
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Rituximab2Not reportedNot reportedNot reportedNot reported
Control Group2Not reportedNot reportedNot reportedNot reported
Eye Disorders
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Rituximab1Not reportedNot reportedNot reportedNot reported
Control Group1Not reportedNot reportedNot reportedNot reported
Gastrointestinal Disorders
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Rituximab4Not reportedNot reportedNot reportedNot reported
Control Group1Not reportedNot reportedNot reportedNot reported
General Disorders and Administration Site
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Rituximab5Not reportedNot reportedNot reportedNot reported
Control Group3Not reportedNot reportedNot reportedNot reported
Immune System Disorders
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Rituximab2Not reportedNot reportedNot reportedNot reported
Control Group2Not reportedNot reportedNot reportedNot reported
Infections and Infestations
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Rituximab12Not reportedNot reportedNot reportedNot reported
Control Group12Not reportedNot reportedNot reportedNot reported
Injury, Poisoning, and Procedural Complications
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Rituximab2Not reportedNot reportedNot reportedNot reported
Control Group0Not reportedNot reportedNot reportedNot reported
Investigations
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Rituximab2Not reportedNot reportedNot reportedNot reported
Control Group0Not reportedNot reportedNot reportedNot reported
Metabolism and Nutrition Disorders
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Rituximab2Not reportedNot reportedNot reportedNot reported
Control Group2Not reportedNot reportedNot reportedNot reported
Musculoskeletal and Connective Tissue Disorders
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Rituximab2Not reportedNot reportedNot reportedNot reported
Control Group3Not reportedNot reportedNot reportedNot reported
Neoplasms Benign, Malignant, and Unspecified
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Rituximab1Not reportedNot reportedNot reportedNot reported
Control Group2Not reportedNot reportedNot reportedNot reported
Nervous System Disorders
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Rituximab1Not reportedNot reportedNot reportedNot reported
Control Group0Not reportedNot reportedNot reportedNot reported
Pregnancy, Puerperium, and Perinatal Conditions
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Rituximab1Not reportedNot reportedNot reportedNot reported
Control Group0Not reportedNot reportedNot reportedNot reported
Psychiatric Disorders
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Rituximab1Not reportedNot reportedNot reportedNot reported
Control Group1Not reportedNot reportedNot reportedNot reported
Renal and Urinary Disorders
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Rituximab4Not reportedNot reportedNot reportedNot reported
Control Group3Not reportedNot reportedNot reportedNot reported
Respiratory, Thoracic, and Mediastinal Disorders
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Rituximab8Not reportedNot reportedNot reportedNot reported
Control Group8Not reportedNot reportedNot reportedNot reported
Vascular Disorders
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Rituximab1Not reportedNot reportedNot reportedNot reported
Control Group7Not reportedNot reportedNot reportedNot reported

Source statistical analyses

Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.

  1. ci Pct Value
    95
    group Description
    Proportions of subjects experiencing a serious adverse event through 18 months and prior to censoring for open-label, crossover, or best medical judgment according to originally assigned treatment arm were compared using a two-sided Chi-squared test.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.504
    statistical Method
    Chi-squared
Complete source fields
analyses
  1. ci Pct Value
    95
    group Description
    Proportions of subjects experiencing a serious adverse event through 18 months and prior to censoring for open-label, crossover, or best medical judgment according to originally assigned treatment arm were compared using a two-sided Chi-squared test.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.504
    statistical Method
    Chi-squared
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        42
      2. group Id
        OG001
        value
        37
    title
    # Participants with at least one SAE
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        4
      2. group Id
        OG001
        value
        5
    title
    Blood and Lymphatic System Disorders
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        2
    title
    Cardiac Disorders
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        1
    title
    Eye Disorders
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        4
      2. group Id
        OG001
        value
        1
    title
    Gastrointestinal Disorders
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        5
      2. group Id
        OG001
        value
        3
    title
    General Disorders and Administration Site
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        2
    title
    Immune System Disorders
  8. categories
    1. measurements
      1. group Id
        OG000
        value
        12
      2. group Id
        OG001
        value
        12
    title
    Infections and Infestations
  9. categories
    1. measurements
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        0
    title
    Injury, Poisoning, and Procedural Complications
  10. categories
    1. measurements
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        0
    title
    Investigations
  11. categories
    1. measurements
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        2
    title
    Metabolism and Nutrition Disorders
  12. categories
    1. measurements
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        3
    title
    Musculoskeletal and Connective Tissue Disorders
denoms
  1. counts
    1. group Id
      OG000
      value
      99
    2. group Id
      OG001
      value
      98
    units
    Participants
description
Number of subjects according to originally received treatment that experienced a serious adverse event through 18 months post-randomization or prior to being censored from analyses due to crossover, switching to open-label treatment, or best medical judgment for censor. Events are categorized by coded system organ classes (SOC). Within each SOC, a participant was counted once if the participant reported one or more events coded to that SOC.
groups
  1. description
    Participants received intravenous rituximab (Rituxan, Genentech) (at a dose of 375 mg per square meter of body-surface area once weekly for 4 weeks) plus daily placebo-cyclophosphamide. Refer to section titled "Detailed Description" for additional treatment information.
    id
    OG000
    title
    Rituximab
  2. description
    Participants received placebo-rituximab infusions plus daily cyclophosphamide (2 mg per kilogram of body weight, adjusted for renal insufficiency). Refer to section titled "Detailed Description" for additional treatment information.
    id
    OG001
    title
    Control Group
param Type
NUMBER
population Description
Intent-to-treat
reporting Status
POSTED
time Frame
Randomization to censor at Crossover, Open-label or Best Medical Judgment (up to 18 months post-randomization)
title
Number of Subjects Experiencing Serious Adverse Events
type
POST_HOC
unit Of Measure
participants

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

Preserved source evidence · Not medical advice