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NCT03552393 · OUTCOME

Mean Hb Values and Change From Baseline

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: g/dL
Interval / dispersion: Standard Deviation
Time frame: Baseline, Weeks 3, 5, 9, 13, 17, 19, 21, 25, 29, 33, 37, 41, 45

What was measured

The mean Hb concentration over time and the mean change in Hb from baseline over time are presented.

Analysis population: ITT population included all participants enrolled in the study. Number analyzed signifies number of participants evaluable 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

Group	Source count
Mircera	40

Reported measurements

Baseline

Analysis denominator · Participants

Group	Source count
Mircera	40

Values in g/dL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Mircera	11.02	0.53	Not reported	Not reported	Not reported

Week 3

Analysis denominator · Participants

Group	Source count
Mircera	40

Values in g/dL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Mircera	11.69	0.97	Not reported	Not reported	Not reported

Change at Week 3

Analysis denominator · Participants

Group	Source count
Mircera	40

Values in g/dL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Mircera	0.67	0.74	Not reported	Not reported	Not reported

Week 5

Analysis denominator · Participants

Group	Source count
Mircera	40

Values in g/dL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Mircera	11.21	1.02	Not reported	Not reported	Not reported

Change at Week 5

Analysis denominator · Participants

Group	Source count
Mircera	40

Values in g/dL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Mircera	0.19	0.94	Not reported	Not reported	Not reported

Week 9

Analysis denominator · Participants

Group	Source count
Mircera	39

Values in g/dL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Mircera	11.68	1.42	Not reported	Not reported	Not reported

Change at Week 9

Analysis denominator · Participants

Group	Source count
Mircera	39

Values in g/dL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Mircera	0.64	1.21	Not reported	Not reported	Not reported

Week 13

Analysis denominator · Participants

Group	Source count
Mircera	38

Values in g/dL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Mircera	11.56	1.17	Not reported	Not reported	Not reported

Change at Week 13

Analysis denominator · Participants

Group	Source count
Mircera	38

Values in g/dL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Mircera	0.51	1.10	Not reported	Not reported	Not reported

Week 17

Analysis denominator · Participants

Group	Source count
Mircera	37

Values in g/dL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Mircera	11.46	1.33	Not reported	Not reported	Not reported

Change at Week 17

Analysis denominator · Participants

Group	Source count
Mircera	37

Values in g/dL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Mircera	0.42	1.39	Not reported	Not reported	Not reported

Week 19

Analysis denominator · Participants

Group	Source count
Mircera	37

Values in g/dL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Mircera	11.81	1.11	Not reported	Not reported	Not reported

Change at Week 19

Analysis denominator · Participants

Group	Source count
Mircera	37

Values in g/dL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Mircera	0.77	1.14	Not reported	Not reported	Not reported

Week 21

Analysis denominator · Participants

Group	Source count
Mircera	38

Values in g/dL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Mircera	11.10	0.91	Not reported	Not reported	Not reported

Change at Week 21

Analysis denominator · Participants

Group	Source count
Mircera	38

Values in g/dL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Mircera	0.05	0.99	Not reported	Not reported	Not reported

Week 25

Analysis denominator · Participants

Group	Source count
Mircera	25

Values in g/dL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Mircera	11.29	1.04	Not reported	Not reported	Not reported

Change at Week 25

Analysis denominator · Participants

Group	Source count
Mircera	25

Values in g/dL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Mircera	0.21	1.12	Not reported	Not reported	Not reported

Week 29

Analysis denominator · Participants

Group	Source count
Mircera	23

Values in g/dL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Mircera	11.22	1.18	Not reported	Not reported	Not reported

Change at Week 29

Analysis denominator · Participants

Group	Source count
Mircera	23

Values in g/dL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Mircera	0.15	1.11	Not reported	Not reported	Not reported

Week 33

Analysis denominator · Participants

Group	Source count
Mircera	24

Values in g/dL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Mircera	11.09	1.11	Not reported	Not reported	Not reported

Change at Week 33

Analysis denominator · Participants

Group	Source count
Mircera	24

Values in g/dL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Mircera	0.02	1.24	Not reported	Not reported	Not reported

Week 37

Analysis denominator · Participants

Group	Source count
Mircera	24

Values in g/dL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Mircera	11.04	0.77	Not reported	Not reported	Not reported

Change at Week 37

Analysis denominator · Participants

Group	Source count
Mircera	24

Values in g/dL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Mircera	-0.03	0.90	Not reported	Not reported	Not reported

Week 41

Analysis denominator · Participants

Group	Source count
Mircera	22

Values in g/dL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Mircera	10.83	0.83	Not reported	Not reported	Not reported

Change at Week 41

Analysis denominator · Participants

Group	Source count
Mircera	22

Values in g/dL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Mircera	-0.22	1.03	Not reported	Not reported	Not reported

Week 45

Analysis denominator · Participants

Group	Source count
Mircera	21

Values in g/dL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Mircera	10.68	1.02	Not reported	Not reported	Not reported

Change at Week 45

Analysis denominator · Participants

Group	Source count
Mircera	21

Values in g/dL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Mircera	-0.35	1.13	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
spread
0.53
value
11.02
denoms
counts
group Id
OG000
value
40
units
Participants
title
Baseline
categories
measurements
group Id
OG000
spread
0.97
value
11.69
denoms
counts
group Id
OG000
value
40
units
Participants
title
Week 3
categories
measurements
group Id
OG000
spread
0.74
value
0.67
denoms
counts
group Id
OG000
value
40
units
Participants
title
Change at Week 3
categories
measurements
group Id
OG000
spread
1.02
value
11.21
denoms
counts
group Id
OG000
value
40
units
Participants
title
Week 5
categories
measurements
group Id
OG000
spread
0.94
value
0.19
denoms
counts
group Id
OG000
value
40
units
Participants
title
Change at Week 5
categories
measurements
group Id
OG000
spread
1.42
value
11.68
denoms
counts
group Id
OG000
value
39
units
Participants
title
Week 9
categories
measurements
group Id
OG000
spread
1.21
value
0.64
denoms
counts
group Id
OG000
value
39
units
Participants
title
Change at Week 9
categories
measurements
group Id
OG000
spread
1.17
value
11.56
denoms
counts
group Id
OG000
value
38
units
Participants
title
Week 13
categories
measurements
group Id
OG000
spread
1.10
value
0.51
denoms
counts
group Id
OG000
value
38
units
Participants
title
Change at Week 13
categories
measurements
group Id
OG000
spread
1.33
value
11.46
denoms
counts
group Id
OG000
value
37
units
Participants
title
Week 17
categories
measurements
group Id
OG000
spread
1.39
value
0.42
denoms
counts
group Id
OG000
value
37
units
Participants
title
Change at Week 17
categories
measurements
group Id
OG000
spread
1.11
value
11.81
denoms
counts
group Id
OG000
value
37
units
Participants
title
Week 19

denoms

counts
group Id
OG000
value
40
units
Participants

description

The mean Hb concentration over time and the mean change in Hb from baseline over time are presented.

dispersion Type

Standard Deviation

groups

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 signifies number of participants evaluable at specified time points.

reporting Status

POSTED

time Frame

Baseline, Weeks 3, 5, 9, 13, 17, 19, 21, 25, 29, 33, 37, 41, 45

title

Mean Hb Values and Change From Baseline

type

SECONDARY

unit Of Measure

g/dL

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

Preserved source evidence · Not medical advice