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NCT03552393 · OUTCOME

Number of Participants With Adverse Events by Severity as Assessed by Highest World Health Organization (WHO) Toxicity Grade

Ascertain the Optimal Starting Dose of Mircera Given Subcutaneously for Maintenance Treatment of Anemia in Pediatric Patients With Chronic Kidney Disease on Dialysis or Not Yet on Dialysis. · Source last updated 2022-03-07

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
Baseline up to Week 45

What was measured

An adverse event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product, any new disease, or exacerbation of existing disease (a worsening in the character, frequency, or severity of a known condition), recurrence of an intermittent medical condition or any deterioration in a laboratory value or other clinical test.

Analysis population: Safety population included all participants who received at least one dose of study drug regardless of whether they withdrew prematurely or not.

Groups in this outcome

Mircera

Mircera was administered subcutaneously once 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
Mircera40

Reported measurements

Grade 1-2
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Mircera25Not reportedNot reportedNot reportedNot reported
Grade 3-4
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Mircera8Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        25
    title
    Grade 1-2
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        8
    title
    Grade 3-4
denoms
  1. counts
    1. group Id
      OG000
      value
      40
    units
    Participants
description
An adverse event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product, any new disease, or exacerbation of existing disease (a worsening in the character, frequency, or severity of a known condition), recurrence of an intermittent medical condition or any deterioration in a laboratory value or other clinical test.
groups
  1. description
    Mircera was administered subcutaneously once every 4 weeks.
    id
    OG000
    title
    Mircera
param Type
NUMBER
population Description
Safety population included all participants who received at least one dose of study drug regardless of whether they withdrew prematurely or not.
reporting Status
POSTED
time Frame
Baseline up to Week 45
title
Number of Participants With Adverse Events by Severity as Assessed by Highest World Health Organization (WHO) Toxicity Grade
type
SECONDARY
unit Of Measure
participants

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

Preserved source evidence · Not medical advice