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NCT03552393 · OUTCOME

Change in Hemoglobin (Hb) Concentration Between the Baseline and the Evaluation Period for Each Patient

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
MEAN
Unit
grams/deciliter (g/dL)
Interval / dispersion
Standard Deviation
Time frame
Baseline up to Week 21

What was measured

The Hb change from baseline was calculated on a per-participant basis using an individual's average for both the baseline and evaluation periods and taking the difference. The baseline period was defined as the time between the day of first study dose and the previous 35 days. The evaluation period was defined as the period between Week 17 and Week 21, inclusive.

Analysis population: ITT population included all participants enrolled in the study. Number analyzed is the number of participants with Hb concentration assessment at specified time points.

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
Mircera38

Reported measurements

Baseline
Values in grams/deciliter (g/dL) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Mircera11.050.51Not reportedNot reportedNot reported
Change at Evaluation Period
Values in grams/deciliter (g/dL) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Mircera0.481.03Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.51
        value
        11.05
    title
    Baseline
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        1.03
        value
        0.48
    title
    Change at Evaluation Period
denoms
  1. counts
    1. group Id
      OG000
      value
      38
    units
    Participants
description
The Hb change from baseline was calculated on a per-participant basis using an individual's average for both the baseline and evaluation periods and taking the difference. The baseline period was defined as the time between the day of first study dose and the previous 35 days. The evaluation period was defined as the period between Week 17 and Week 21, inclusive.
dispersion Type
Standard Deviation
groups
  1. description
    Mircera was administered subcutaneously once every 4 weeks.
    id
    OG000
    title
    Mircera
param Type
MEAN
population Description
ITT population included all participants enrolled in the study. Number analyzed is the number of participants with Hb concentration assessment at specified time points.
reporting Status
POSTED
time Frame
Baseline up to Week 21
title
Change in Hemoglobin (Hb) Concentration Between the Baseline and the Evaluation Period for Each Patient
type
PRIMARY
unit Of Measure
grams/deciliter (g/dL)

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

Preserved source evidence · Not medical advice