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NCT03552393 · OUTCOME

Number of Participants With an Average Hb Concentration During the Evaluation Period Within ± 1 g/dL of Their Baseline Hb and Above, Within or Below the Range of 10-12 g/dL

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
Week 17 up to Week 21

What was measured

Number of participants with an average Hb concentration during the evaluation period within ± 1 g/dL of their baseline Hb is reported as well as the number of participants with an average Hb concentration above, within or below the range of 10-12 g/dL. 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. Hb values within 21 days after blood transfusion(s) were excluded from analysis. 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

Hb Above 1 g/dL of Baseline
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Mircera15Not reportedNot reportedNot reportedNot reported
Hb Maintained Within ± 1 g/dL of Baseline
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Mircera19Not reportedNot reportedNot reportedNot reported
Hb Below 1 g/dL of Baseline
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Mircera4Not reportedNot reportedNot reportedNot reported
Hb Above 12 g/dL
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Mircera12Not reportedNot reportedNot reportedNot reported
Hb Maintained Within 10-12 g/dL
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Mircera24Not reportedNot reportedNot reportedNot reported
Hb Below 10 g/dL
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Mircera2Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        15
    title
    Hb Above 1 g/dL of Baseline
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        19
    title
    Hb Maintained Within ± 1 g/dL of Baseline
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        4
    title
    Hb Below 1 g/dL of Baseline
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        12
    title
    Hb Above 12 g/dL
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        24
    title
    Hb Maintained Within 10-12 g/dL
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        2
    title
    Hb Below 10 g/dL
denoms
  1. counts
    1. group Id
      OG000
      value
      38
    units
    Participants
description
Number of participants with an average Hb concentration during the evaluation period within ± 1 g/dL of their baseline Hb is reported as well as the number of participants with an average Hb concentration above, within or below the range of 10-12 g/dL. The evaluation period was defined as the period between Week 17 and Week 21 inclusive.
groups
  1. description
    Mircera was administered subcutaneously once every 4 weeks.
    id
    OG000
    title
    Mircera
param Type
NUMBER
population Description
ITT population included all participants enrolled in the study. Hb values within 21 days after blood transfusion(s) were excluded from analysis. Number analyzed is the number of participants with Hb concentration assessment at specified time points.
reporting Status
POSTED
time Frame
Week 17 up to Week 21
title
Number of Participants With an Average Hb Concentration During the Evaluation Period Within ± 1 g/dL of Their Baseline Hb and Above, Within or Below the Range of 10-12 g/dL
type
SECONDARY
unit Of Measure
participants

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

Preserved source evidence · Not medical advice