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NCT03552393 · OUTCOME

Ratio of Mircera Starting Dose (Week 1) to the Dose at Week 17

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
MEDIAN
Unit
ratio
Interval / dispersion
Full Range
Time frame
Week 1, Week 17

What was measured

The ratio of Mircera dose was calculated as the median (min-max) ratio of starting dose (Week 1) to the dose at Week 17. Participants who withdrew before Week 17 or who were not administered a Mircera dose at Week 17 visit due to the applicable dose adjustment rules were excluded from the ratio computation.

Analysis population: Participants who received a dose of study drug on Week 1 and Week 17 were included in the analysis.

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
Mircera33

Reported measurements

Source class 1
Values in ratio · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Mircera1.44Not reported0.23.8Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.2
        upper Limit
        3.8
        value
        1.44
denoms
  1. counts
    1. group Id
      OG000
      value
      33
    units
    Participants
description
The ratio of Mircera dose was calculated as the median (min-max) ratio of starting dose (Week 1) to the dose at Week 17. Participants who withdrew before Week 17 or who were not administered a Mircera dose at Week 17 visit due to the applicable dose adjustment rules were excluded from the ratio computation.
dispersion Type
Full Range
groups
  1. description
    Mircera was administered subcutaneously once every 4 weeks.
    id
    OG000
    title
    Mircera
param Type
MEDIAN
population Description
Participants who received a dose of study drug on Week 1 and Week 17 were included in the analysis.
reporting Status
POSTED
time Frame
Week 1, Week 17
title
Ratio of Mircera Starting Dose (Week 1) to the Dose at Week 17
type
SECONDARY
unit Of Measure
ratio

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

Preserved source evidence · Not medical advice