Skip to content
Triangle logo TriangleGet started
← Full study record

NCT01550003 · OUTCOME

Number of Participants With Serious Treatment-emergent Adverse Events (TEAEs) During the Study

Pediatric Arthritis Study of Certolizumab Pegol · Source last updated 2024-10-23

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

Measure
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
From Baseline (Week 0) up to the Final Visit (70 days after final dose of CZP) (maximum up to 12 years)

What was measured

A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose: results in deaths, is life-threatening, requires in patient hospitalization or prolongation of existing hospitalization, is a congenital anomaly or birth defect and other important medical events which based on medical or scientific judgement may jeopardize the patients, or may require medical or surgical intervention to prevent any of the above. TEAEs are defined as AEs starting on or after first administration of CZP and up to 70 days after last dose of study medication.

Analysis population: Safety Set (SS) consisted of all study participants in the Enrolled Set (ES) who have received at least 1 dose of study medication.

Groups in this outcome

Any CZP Dose - Weight Group: 10 - <20 kg

Participants received CZP sc as a fixed dose based on their body weight Q2W or Q4W throughout the study. Participants started with 3 loading doses of CZP at Weeks 0, 2, and 4 followed by a maintenance dose for the duration of the study.

Any CZP Dose - Weight Group: 20 - <40 kg

Participants received CZP sc as a fixed dose based on their body weight Q2W throughout the study. Participants started with 3 loading doses of CZP at Weeks 0, 2, and 4 followed by a maintenance dose for the duration of the study.

Any CZP Dose - Weight Group: >=40 kg

Participants received CZP sc as a fixed dose based on their body weight Q2W throughout the study. Participants started with 3 loading doses of CZP at Weeks 0, 2, and 4 followed by a maintenance dose for the duration of the study.

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

Analysis denominator · Participants

GroupSource count
Any CZP Dose - Weight Group: 10 - <20 kg18
Any CZP Dose - Weight Group: 20 - <40 kg63
Any CZP Dose - Weight Group: >=40 kg112

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Any CZP Dose - Weight Group: 10 - <20 kg5Not reportedNot reportedNot reportedNot reported
Any CZP Dose - Weight Group: 20 - <40 kg20Not reportedNot reportedNot reportedNot reported
Any CZP Dose - Weight Group: >=40 kg21Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        5
      2. group Id
        OG001
        value
        20
      3. group Id
        OG002
        value
        21
denoms
  1. counts
    1. group Id
      OG000
      value
      18
    2. group Id
      OG001
      value
      63
    3. group Id
      OG002
      value
      112
    units
    Participants
description
A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose: results in deaths, is life-threatening, requires in patient hospitalization or prolongation of existing hospitalization, is a congenital anomaly or birth defect and other important medical events which based on medical or scientific judgement may jeopardize the patients, or may require medical or surgical intervention to prevent any of the above. TEAEs are defined as AEs starting on or after first administration of CZP and up to 70 days after last dose of study medication.
groups
  1. description
    Participants received CZP sc as a fixed dose based on their body weight Q2W or Q4W throughout the study. Participants started with 3 loading doses of CZP at Weeks 0, 2, and 4 followed by a maintenance dose for the duration of the study.
    id
    OG000
    title
    Any CZP Dose - Weight Group: 10 - <20 kg
  2. description
    Participants received CZP sc as a fixed dose based on their body weight Q2W throughout the study. Participants started with 3 loading doses of CZP at Weeks 0, 2, and 4 followed by a maintenance dose for the duration of the study.
    id
    OG001
    title
    Any CZP Dose - Weight Group: 20 - <40 kg
  3. description
    Participants received CZP sc as a fixed dose based on their body weight Q2W throughout the study. Participants started with 3 loading doses of CZP at Weeks 0, 2, and 4 followed by a maintenance dose for the duration of the study.
    id
    OG002
    title
    Any CZP Dose - Weight Group: >=40 kg
param Type
COUNT_OF_PARTICIPANTS
population Description
Safety Set (SS) consisted of all study participants in the Enrolled Set (ES) who have received at least 1 dose of study medication.
reporting Status
POSTED
time Frame
From Baseline (Week 0) up to the Final Visit (70 days after final dose of CZP) (maximum up to 12 years)
title
Number of Participants With Serious Treatment-emergent Adverse Events (TEAEs) During the Study
type
PRIMARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice