NCT00559273 · ADVERSE EVENTS

Adverse events

A Study of Subcutaneous Mircera Once Monthly in the Treatment of Anemia in Participants With Chronic Kidney Disease Not on Dialysis · Source last updated 2016-11-01

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Adverse events occurred during the study; they are not necessarily caused by treatment. Serious events are not interchangeable with severe/grade 3–4 events. These safety populations may differ from efficacy populations.

Collection time frame: Baseline up to 29 weeks
Other-event reporting threshold: 5%

Safety population included all randomized participants who received at least 1 dose of study medication and attended safety follow-up, whether they withdrew prematurely or not. Participants were assigned to the treatment group as treated. One participant randomized to Mircera, received darbepoetin alfa and included in darbepoetin alfa arm.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Mircera Participants received Mircera (Methoxy polyethylene glycol-epoetin beta), administered SC at a starting dose of 1.2 mcg/kg once every 4 weeks for 28 weeks.	28 / 150	50 / 150	Not reported / Not reported
Darbepoetin Alfa Participants received darbepoetin alfa, administered SC once weekly or once every 2 weeks according to local labeling specifications for 28 weeks.	39 / 155	65 / 155	Not reported / Not reported

Group identifiers: EG000: Mircera · EG001: Darbepoetin Alfa

Serious adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Renal and urinary disorders
source Vocabulary
MedDRA (12.0)
stats
group Id
EG000
num Affected
4
num At Risk
150
group Id
EG001
num Affected
9
num At Risk
155
term
Renal impairment
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Renal and urinary disorders
source Vocabulary
MedDRA (12.0)
stats
group Id
EG000
num Affected
0
num At Risk
150
group Id
EG001
num Affected
1
num At Risk
155
term
Azotaemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Renal and urinary disorders
source Vocabulary
MedDRA (12.0)
stats
group Id
EG000
num Affected
0
num At Risk
150
group Id
EG001
num Affected
1
num At Risk
155
term
Renal cyst
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Renal and urinary disorders
source Vocabulary
MedDRA (12.0)
stats
group Id
EG000
num Affected
1
num At Risk
150
group Id
EG001
num Affected
0
num At Risk
155
term
Renal failure acute
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Renal and urinary disorders
source Vocabulary
MedDRA (12.0)
stats
group Id
EG000
num Affected
0
num At Risk
150
group Id
EG001
num Affected
1
num At Risk
155
term
Urinary retention
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (12.0)
stats
group Id
EG000
num Affected
1
num At Risk
150
group Id
EG001
num Affected
1
num At Risk
155
term
Acute myocardial infarction
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (12.0)
stats
group Id
EG000
num Affected
2
num At Risk
150
group Id
EG001
num Affected
0
num At Risk
155
term
Bradycardia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (12.0)
stats
group Id
EG000
num Affected
2
num At Risk
150
group Id
EG001
num Affected
0
num At Risk
155
term
Cardiac failure congestive
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (12.0)
stats
group Id
EG000
num Affected
2
num At Risk
150
group Id
EG001
num Affected
0
num At Risk
155
term
Myocardial ischaemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (12.0)
stats
group Id
EG000
num Affected
0
num At Risk
150
group Id
EG001
num Affected
1
num At Risk
155
term
Atrial fibrillation
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (12.0)
stats
group Id
EG000
num Affected
1
num At Risk
150
group Id
EG001
num Affected
0
num At Risk
155
term
Atrioventricular block complete
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (12.0)
stats
group Id
EG000
num Affected
1
num At Risk
150
group Id
EG001
num Affected
0
num At Risk
155
term
Cardiac failure

Other reported adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Vascular disorders
source Vocabulary
MedDRA (12.0)
stats
group Id
EG000
num Affected
24
num At Risk
150
group Id
EG001
num Affected
37
num At Risk
155
term
Hypertension
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Vascular disorders
source Vocabulary
MedDRA (12.0)
stats
group Id
EG000
num Affected
5
num At Risk
150
group Id
EG001
num Affected
8
num At Risk
155
term
Hypotension
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (12.0)
stats
group Id
EG000
num Affected
9
num At Risk
150
group Id
EG001
num Affected
11
num At Risk
155
term
Upper respiratory tract infection
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (12.0)
stats
group Id
EG000
num Affected
5
num At Risk
150
group Id
EG001
num Affected
8
num At Risk
155
term
Nasopharyngitis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (12.0)
stats
group Id
EG000
num Affected
5
num At Risk
150
group Id
EG001
num Affected
12
num At Risk
155
term
Constipation
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (12.0)
stats
group Id
EG000
num Affected
10
num At Risk
150
group Id
EG001
num Affected
6
num At Risk
155
term
Diarrhoea
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
MedDRA (12.0)
stats
group Id
EG000
num Affected
12
num At Risk
150
group Id
EG001
num Affected
7
num At Risk
155
term
Hyperkalaemia

Complete source fields

description

event Groups

description
Participants received Mircera (Methoxy polyethylene glycol-epoetin beta), administered SC at a starting dose of 1.2 mcg/kg once every 4 weeks for 28 weeks.
id
EG000
other Num Affected
50
other Num At Risk
150
serious Num Affected
28
serious Num At Risk
150
title
Mircera
description
Participants received darbepoetin alfa, administered SC once weekly or once every 2 weeks according to local labeling specifications for 28 weeks.
id
EG001
other Num Affected
65
other Num At Risk
155
serious Num Affected
39
serious Num At Risk
155
title
Darbepoetin Alfa

frequency Threshold

other Events

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Vascular disorders
source Vocabulary
MedDRA (12.0)
stats
group Id
EG000
num Affected
24
num At Risk
150
group Id
EG001
num Affected
37
num At Risk
155
term
Hypertension
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Vascular disorders
source Vocabulary
MedDRA (12.0)
stats
group Id
EG000
num Affected
5
num At Risk
150
group Id
EG001
num Affected
8
num At Risk
155
term
Hypotension
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (12.0)
stats
group Id
EG000
num Affected
9
num At Risk
150
group Id
EG001
num Affected
11
num At Risk
155
term
Upper respiratory tract infection
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (12.0)
stats
group Id
EG000
num Affected
5
num At Risk
150
group Id
EG001
num Affected
8
num At Risk
155
term
Nasopharyngitis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (12.0)
stats
group Id
EG000
num Affected
5
num At Risk
150
group Id
EG001
num Affected
12
num At Risk
155
term
Constipation
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (12.0)
stats
group Id
EG000
num Affected
10
num At Risk
150
group Id
EG001
num Affected
6
num At Risk
155
term
Diarrhoea
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
MedDRA (12.0)
stats
group Id
EG000
num Affected
12
num At Risk
150
group Id
EG001
num Affected
7
num At Risk
155
term
Hyperkalaemia

serious Events

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Renal and urinary disorders
source Vocabulary
MedDRA (12.0)
stats
group Id
EG000
num Affected
4
num At Risk
150
group Id
EG001
num Affected
9
num At Risk
155
term
Renal impairment
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Renal and urinary disorders
source Vocabulary
MedDRA (12.0)
stats
group Id
EG000
num Affected
0
num At Risk
150
group Id
EG001
num Affected
1
num At Risk
155
term
Azotaemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Renal and urinary disorders
source Vocabulary
MedDRA (12.0)
stats
group Id
EG000
num Affected
0
num At Risk
150
group Id
EG001
num Affected
1
num At Risk
155
term
Renal cyst
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Renal and urinary disorders
source Vocabulary
MedDRA (12.0)
stats
group Id
EG000
num Affected
1
num At Risk
150
group Id
EG001
num Affected
0
num At Risk
155
term
Renal failure acute
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Renal and urinary disorders
source Vocabulary
MedDRA (12.0)
stats
group Id
EG000
num Affected
0
num At Risk
150
group Id
EG001
num Affected
1
num At Risk
155
term
Urinary retention
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (12.0)
stats
group Id
EG000
num Affected
1
num At Risk
150
group Id
EG001
num Affected
1
num At Risk
155
term
Acute myocardial infarction
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (12.0)
stats
group Id
EG000
num Affected
2
num At Risk
150
group Id
EG001
num Affected
0
num At Risk
155
term
Bradycardia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (12.0)
stats
group Id
EG000
num Affected
2
num At Risk
150
group Id
EG001
num Affected
0
num At Risk
155
term
Cardiac failure congestive
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (12.0)
stats
group Id
EG000
num Affected
2
num At Risk
150
group Id
EG001
num Affected
0
num At Risk
155
term
Myocardial ischaemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (12.0)
stats
group Id
EG000
num Affected
0
num At Risk
150
group Id
EG001
num Affected
1
num At Risk
155
term
Atrial fibrillation
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (12.0)
stats
group Id
EG000
num Affected
1
num At Risk
150
group Id
EG001
num Affected
0
num At Risk
155
term
Atrioventricular block complete
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (12.0)
stats
group Id
EG000
num Affected
1
num At Risk
150
group Id
EG001
num Affected
0
num At Risk
155
term
Cardiac failure

time Frame

Baseline up to 29 weeks

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Preserved source evidence · Not medical advice