Trial Outcomes & Findings for Safety and Efficacy of Peginesatide for the Treatment of Anemia in Participants With Chronic Renal Failure Not on Dialysis (NCT NCT00598442)
NCT ID: NCT00598442
Last Updated: 2013-02-12
Results Overview
The baseline hemoglobin value is defined as the mean of three hemoglobin values: the two most recent hemoglobin values taken prior to the day of randomization and the value obtained on the day of randomization. The mean hemoglobin during the Evaluation Period for each participant is calculated as the mean of the available hemoglobin values during Study Weeks 25 through 36.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
493 participants
Primary outcome timeframe
Baseline and Weeks 25-36
Results posted on
2013-02-12
Participant Flow
Participant milestones
| Measure |
Peginesatide 0.025 mg/kg
Participants received peginesatide by subcutaneous injection once every 4 weeks. The starting dose was 0.025 milligram per kilogram (mg/kg) and was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 grams per deciliter (g/dL).
|
Peginesatide 0.04 mg/kg
Participants received peginesatide by subcutaneous injection once every 4 weeks. The starting dose was 0.04 mg/kg and was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 g/dL.
|
Darbepoetin Alfa
Participants received darbepoetin alfa by subcutaneous injection once every 2 weeks, as prescribed. The starting dose was 0.75 microgram per kilogram (mcg/kg) and was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 g/dL.
|
|---|---|---|---|
|
Overall Study
STARTED
|
167
|
163
|
163
|
|
Overall Study
COMPLETED
|
124
|
124
|
139
|
|
Overall Study
NOT COMPLETED
|
43
|
39
|
24
|
Reasons for withdrawal
| Measure |
Peginesatide 0.025 mg/kg
Participants received peginesatide by subcutaneous injection once every 4 weeks. The starting dose was 0.025 milligram per kilogram (mg/kg) and was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 grams per deciliter (g/dL).
|
Peginesatide 0.04 mg/kg
Participants received peginesatide by subcutaneous injection once every 4 weeks. The starting dose was 0.04 mg/kg and was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 g/dL.
|
Darbepoetin Alfa
Participants received darbepoetin alfa by subcutaneous injection once every 2 weeks, as prescribed. The starting dose was 0.75 microgram per kilogram (mcg/kg) and was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 g/dL.
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
3
|
0
|
0
|
|
Overall Study
Death
|
19
|
11
|
11
|
|
Overall Study
Lost to Follow-up
|
4
|
3
|
3
|
|
Overall Study
Physician Decision
|
2
|
1
|
1
|
|
Overall Study
Withdrawal by Subject
|
8
|
16
|
6
|
|
Overall Study
Noncompliance
|
0
|
2
|
1
|
|
Overall Study
Relocation
|
1
|
4
|
0
|
|
Overall Study
Renal transplant
|
0
|
0
|
1
|
|
Overall Study
Site closed by sponsor
|
5
|
2
|
1
|
|
Overall Study
Started dialysis
|
1
|
0
|
0
|
Baseline Characteristics
Safety and Efficacy of Peginesatide for the Treatment of Anemia in Participants With Chronic Renal Failure Not on Dialysis
Baseline characteristics by cohort
| Measure |
Peginesatide 0.025 mg/kg
n=167 Participants
Participants received peginesatide by subcutaneous injection once every 4 weeks. The starting dose was 0.025 milligram per kilogram (mg/kg) and was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 grams per deciliter (g/dL).
|
Peginesatide 0.04 mg/kg
n=163 Participants
Participants received peginesatide by subcutaneous injection once every 4 weeks. The starting dose was 0.04 mg/kg and was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 g/dL.
|
Darbepoetin Alfa
n=163 Participants
Participants received darbepoetin alfa by subcutaneous injection once every 2 weeks, as prescribed. The starting dose was 0.75 microgram per kilogram (mcg/kg) and was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 g/dL.
|
Total
n=493 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
63 Participants
n=5 Participants
|
57 Participants
n=7 Participants
|
62 Participants
n=5 Participants
|
182 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
104 Participants
n=5 Participants
|
106 Participants
n=7 Participants
|
101 Participants
n=5 Participants
|
311 Participants
n=4 Participants
|
|
Age Continuous
|
68.1 years
STANDARD_DEVIATION 12.93 • n=5 Participants
|
68.3 years
STANDARD_DEVIATION 13.53 • n=7 Participants
|
67.2 years
STANDARD_DEVIATION 15.03 • n=5 Participants
|
67.9 years
STANDARD_DEVIATION 13.83 • n=4 Participants
|
|
Sex: Female, Male
Female
|
93 Participants
n=5 Participants
|
96 Participants
n=7 Participants
|
99 Participants
n=5 Participants
|
288 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
74 Participants
n=5 Participants
|
67 Participants
n=7 Participants
|
64 Participants
n=5 Participants
|
205 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline and Weeks 25-36Population: Full Analysis Population: All randomized participants who received at least one dose of study medication
The baseline hemoglobin value is defined as the mean of three hemoglobin values: the two most recent hemoglobin values taken prior to the day of randomization and the value obtained on the day of randomization. The mean hemoglobin during the Evaluation Period for each participant is calculated as the mean of the available hemoglobin values during Study Weeks 25 through 36.
Outcome measures
| Measure |
Peginesatide 0.025 mg/kg
n=167 Participants
Participants received peginesatide by subcutaneous injection once every 4 weeks. The starting dose was 0.025 milligram per kilogram (mg/kg) and was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 grams per deciliter (g/dL).
|
Peginesatide 0.04 mg/kg
n=163 Participants
Participants received peginesatide by subcutaneous injection once every 4 weeks. The starting dose was 0.04 mg/kg and was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 g/dL.
|
Darbepoetin Alfa
n=163 Participants
Participants received darbepoetin alfa by subcutaneous injection once every 2 weeks, as prescribed. The starting dose was 0.75 microgram per kilogram (mcg/kg) and was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 g/dL.
|
|---|---|---|---|
|
Mean Change in Hemoglobin Between Baseline and the Evaluation Period
Change from Baseline [N=151, 145, 150]
|
1.50 g/dL
Standard Deviation 0.898
|
1.68 g/dL
Standard Deviation 0.962
|
1.35 g/dL
Standard Deviation 1.004
|
|
Mean Change in Hemoglobin Between Baseline and the Evaluation Period
Baseline [N=167, 163, 163]
|
10.02 g/dL
Standard Deviation 0.626
|
10.03 g/dL
Standard Deviation 0.618
|
10.03 g/dL
Standard Deviation 0.654
|
|
Mean Change in Hemoglobin Between Baseline and the Evaluation Period
Evaluation Period [N=151, 145, 150]
|
11.55 g/dL
Standard Deviation 0.741
|
11.71 g/dL
Standard Deviation 0.855
|
11.40 g/dL
Standard Deviation 0.728
|
SECONDARY outcome
Timeframe: Weeks 0 to 36Population: Full Analysis Population: All randomized participants who received at least one dose of study medication
Outcome measures
| Measure |
Peginesatide 0.025 mg/kg
n=167 Participants
Participants received peginesatide by subcutaneous injection once every 4 weeks. The starting dose was 0.025 milligram per kilogram (mg/kg) and was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 grams per deciliter (g/dL).
|
Peginesatide 0.04 mg/kg
n=163 Participants
Participants received peginesatide by subcutaneous injection once every 4 weeks. The starting dose was 0.04 mg/kg and was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 g/dL.
|
Darbepoetin Alfa
n=163 Participants
Participants received darbepoetin alfa by subcutaneous injection once every 2 weeks, as prescribed. The starting dose was 0.75 microgram per kilogram (mcg/kg) and was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 g/dL.
|
|---|---|---|---|
|
Proportion of Participants Who Received Red Blood Cell (RBC) Transfusions During the Correction and Evaluation Periods
|
0.114 percentage of participants
|
0.104 percentage of participants
|
0.049 percentage of participants
|
SECONDARY outcome
Timeframe: Weeks 0 to 36Population: Full Analysis Population: All randomized participants who received at least one dose of study medication
A hemoglobin response is defined as a hemoglobin increase of ≥ 1.0 gram per deciliter (g/dL) above baseline and a hemoglobin ≥ 11.0 g/dL without RBC transfusion during the previous 8 weeks.
Outcome measures
| Measure |
Peginesatide 0.025 mg/kg
n=167 Participants
Participants received peginesatide by subcutaneous injection once every 4 weeks. The starting dose was 0.025 milligram per kilogram (mg/kg) and was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 grams per deciliter (g/dL).
|
Peginesatide 0.04 mg/kg
n=163 Participants
Participants received peginesatide by subcutaneous injection once every 4 weeks. The starting dose was 0.04 mg/kg and was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 g/dL.
|
Darbepoetin Alfa
n=163 Participants
Participants received darbepoetin alfa by subcutaneous injection once every 2 weeks, as prescribed. The starting dose was 0.75 microgram per kilogram (mcg/kg) and was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 g/dL.
|
|---|---|---|---|
|
Proportion of Participants Achieving Hemoglobin Response During the Correction and Evaluation Periods
|
0.910 percentage of participants
|
0.933 percentage of participants
|
0.951 percentage of participants
|
Adverse Events
Peginesatide 0.025 mg/kg
Serious events: 86 serious events
Other events: 142 other events
Deaths: 0 deaths
Peginesatide 0.04 mg/kg
Serious events: 80 serious events
Other events: 134 other events
Deaths: 0 deaths
Darbepoetin Alfa
Serious events: 70 serious events
Other events: 134 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Peginesatide 0.025 mg/kg
n=167 participants at risk
Participants received peginesatide by subcutaneous injection once every 4 weeks. The starting dose was 0.025 milligram per kilogram (mg/kg) and was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 grams per deciliter (g/dL).
|
Peginesatide 0.04 mg/kg
n=163 participants at risk
Participants received peginesatide by subcutaneous injection once every 4 weeks. The starting dose was 0.04 mg/kg and was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 g/dL.
|
Darbepoetin Alfa
n=163 participants at risk
Participants received darbepoetin alfa by subcutaneous injection once every 2 weeks, as prescribed. The starting dose was 0.75 microgram per kilogram (mcg/kg) and was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 g/dL.
|
|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary cavitation
|
0.00%
0/167
|
0.00%
0/163
|
0.61%
1/163
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary fibrosis
|
0.60%
1/167
|
0.00%
0/163
|
0.00%
0/163
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis chronic
|
0.00%
0/167
|
0.61%
1/163
|
0.00%
0/163
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/167
|
0.61%
1/163
|
0.00%
0/163
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/167
|
0.00%
0/163
|
0.61%
1/163
|
|
Cardiac disorders
Angina unstable
|
1.8%
3/167
|
1.2%
2/163
|
0.00%
0/163
|
|
Psychiatric disorders
Suicide attempt
|
0.60%
1/167
|
0.00%
0/163
|
0.61%
1/163
|
|
Psychiatric disorders
Agitation
|
0.00%
0/167
|
0.00%
0/163
|
0.61%
1/163
|
|
Psychiatric disorders
Depression
|
0.00%
0/167
|
0.61%
1/163
|
0.00%
0/163
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/167
|
0.00%
0/163
|
0.61%
1/163
|
|
Cardiac disorders
Pericarditis
|
0.60%
1/167
|
0.00%
0/163
|
0.00%
0/163
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/167
|
0.61%
1/163
|
0.61%
1/163
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/167
|
0.61%
1/163
|
0.00%
0/163
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary congestion
|
0.00%
0/167
|
0.00%
0/163
|
1.2%
2/163
|
|
Infections and infestations
Bronchopneumonia
|
0.00%
0/167
|
0.00%
0/163
|
0.61%
1/163
|
|
Blood and lymphatic system disorders
Anaemia
|
4.2%
7/167
|
3.7%
6/163
|
2.5%
4/163
|
|
Blood and lymphatic system disorders
Haemorrhagic anaemia
|
0.60%
1/167
|
0.00%
0/163
|
0.00%
0/163
|
|
Blood and lymphatic system disorders
Heparin-induced thrombocytopenia
|
0.60%
1/167
|
0.00%
0/163
|
0.00%
0/163
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/167
|
0.61%
1/163
|
0.00%
0/163
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.00%
0/167
|
0.61%
1/163
|
0.00%
0/163
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/167
|
0.61%
1/163
|
0.00%
0/163
|
|
Cardiac disorders
Cardiac failure congestive
|
4.2%
7/167
|
11.0%
18/163
|
7.4%
12/163
|
|
Cardiac disorders
Acute myocardial infarction
|
3.0%
5/167
|
2.5%
4/163
|
1.2%
2/163
|
|
Cardiac disorders
Atrial fibrillation
|
0.60%
1/167
|
3.1%
5/163
|
2.5%
4/163
|
|
Cardiac disorders
Cardiac arrest
|
3.0%
5/167
|
1.2%
2/163
|
1.8%
3/163
|
|
Cardiac disorders
Myocardial infarction
|
2.4%
4/167
|
1.2%
2/163
|
2.5%
4/163
|
|
Cardiac disorders
Bradycardia
|
2.4%
4/167
|
3.1%
5/163
|
0.00%
0/163
|
|
Cardiac disorders
Coronary artery disease
|
1.2%
2/167
|
0.61%
1/163
|
1.8%
3/163
|
|
Cardiac disorders
Angina pectoris
|
0.60%
1/167
|
1.8%
3/163
|
0.61%
1/163
|
|
Cardiac disorders
Cardiac failure
|
1.2%
2/167
|
1.2%
2/163
|
0.61%
1/163
|
|
Cardiac disorders
Acute coronary syndrome
|
0.60%
1/167
|
1.2%
2/163
|
0.00%
0/163
|
|
Cardiac disorders
Coronary artery occlusion
|
1.2%
2/167
|
0.61%
1/163
|
0.00%
0/163
|
|
Cardiac disorders
Sick sinus syndrome
|
0.60%
1/167
|
1.2%
2/163
|
0.00%
0/163
|
|
Cardiac disorders
Cardiomyopathy
|
0.60%
1/167
|
0.00%
0/163
|
0.61%
1/163
|
|
Cardiac disorders
Ischaemic cardiomyopathy
|
0.60%
1/167
|
0.61%
1/163
|
0.00%
0/163
|
|
Cardiac disorders
Tachycardia
|
0.60%
1/167
|
0.00%
0/163
|
0.61%
1/163
|
|
Cardiac disorders
Aortic valve stenosis
|
0.00%
0/167
|
0.61%
1/163
|
0.00%
0/163
|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/167
|
0.00%
0/163
|
0.61%
1/163
|
|
Cardiac disorders
Arteriosclerosis coronary artery
|
0.00%
0/167
|
0.61%
1/163
|
0.00%
0/163
|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/167
|
0.61%
1/163
|
0.00%
0/163
|
|
Cardiac disorders
Atrioventricular block
|
0.00%
0/167
|
0.00%
0/163
|
0.61%
1/163
|
|
Cardiac disorders
Atrioventricular block complete
|
0.00%
0/167
|
0.61%
1/163
|
0.00%
0/163
|
|
Cardiac disorders
Atrioventricular block second degree
|
0.00%
0/167
|
0.61%
1/163
|
0.00%
0/163
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.00%
0/167
|
0.00%
0/163
|
0.61%
1/163
|
|
Cardiac disorders
Cardiogenic shock
|
0.00%
0/167
|
0.00%
0/163
|
0.61%
1/163
|
|
Cardiac disorders
Cardiomegaly
|
0.00%
0/167
|
0.00%
0/163
|
0.61%
1/163
|
|
Cardiac disorders
Cor pulmonale
|
0.60%
1/167
|
0.00%
0/163
|
0.00%
0/163
|
|
Cardiac disorders
Intracardiac thrombus
|
0.00%
0/167
|
0.00%
0/163
|
0.61%
1/163
|
|
Cardiac disorders
Myocardial ischaemia
|
0.00%
0/167
|
0.61%
1/163
|
0.00%
0/163
|
|
Cardiac disorders
Palpitations
|
0.00%
0/167
|
0.61%
1/163
|
0.00%
0/163
|
|
Congenital, familial and genetic disorders
Gastrointestinal angiodysplasia
|
0.00%
0/167
|
0.00%
0/163
|
0.61%
1/163
|
|
Congenital, familial and genetic disorders
Vitello-intestinal duct remnant
|
0.60%
1/167
|
0.00%
0/163
|
0.00%
0/163
|
|
Endocrine disorders
Hyperthyroidism
|
0.00%
0/167
|
0.61%
1/163
|
0.00%
0/163
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/167
|
0.61%
1/163
|
0.00%
0/163
|
|
Eye disorders
Cataract
|
0.00%
0/167
|
0.61%
1/163
|
0.00%
0/163
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
1.2%
2/167
|
3.1%
5/163
|
1.2%
2/163
|
|
Gastrointestinal disorders
Pancreatitis acute
|
1.2%
2/167
|
1.2%
2/163
|
0.00%
0/163
|
|
Gastrointestinal disorders
Pancreatitis
|
0.60%
1/167
|
1.2%
2/163
|
0.00%
0/163
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
1.8%
3/167
|
0.00%
0/163
|
0.00%
0/163
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/167
|
0.61%
1/163
|
0.61%
1/163
|
|
Gastrointestinal disorders
Haematemesis
|
0.60%
1/167
|
0.61%
1/163
|
0.00%
0/163
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
1.2%
2/167
|
0.00%
0/163
|
0.00%
0/163
|
|
Gastrointestinal disorders
Retroperitoneal haematoma
|
0.00%
0/167
|
0.00%
0/163
|
1.2%
2/163
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.60%
1/167
|
0.61%
1/163
|
0.00%
0/163
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/167
|
0.61%
1/163
|
0.61%
1/163
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.60%
1/167
|
0.00%
0/163
|
0.00%
0/163
|
|
Gastrointestinal disorders
Alcoholic pancreatitis
|
0.00%
0/167
|
0.00%
0/163
|
0.61%
1/163
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/167
|
0.61%
1/163
|
0.00%
0/163
|
|
Gastrointestinal disorders
Caecitis
|
0.60%
1/167
|
0.00%
0/163
|
0.00%
0/163
|
|
Gastrointestinal disorders
Colitis
|
0.60%
1/167
|
0.00%
0/163
|
0.00%
0/163
|
|
Gastrointestinal disorders
Colonic pseudo-obstruction
|
0.00%
0/167
|
0.61%
1/163
|
0.00%
0/163
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/167
|
0.61%
1/163
|
0.00%
0/163
|
|
Gastrointestinal disorders
Diabetic gastroparesis
|
0.00%
0/167
|
0.61%
1/163
|
0.00%
0/163
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/167
|
0.61%
1/163
|
0.00%
0/163
|
|
Gastrointestinal disorders
Diverticular perforation
|
0.60%
1/167
|
0.00%
0/163
|
0.00%
0/163
|
|
Gastrointestinal disorders
Diverticulum intestinal haemorrhagic
|
0.00%
0/167
|
0.61%
1/163
|
0.00%
0/163
|
|
Gastrointestinal disorders
Duodenal ulcer haemorrhage
|
0.00%
0/167
|
0.61%
1/163
|
0.00%
0/163
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/167
|
0.00%
0/163
|
0.61%
1/163
|
|
Gastrointestinal disorders
Gastric hypomotility
|
0.00%
0/167
|
0.61%
1/163
|
0.00%
0/163
|
|
Gastrointestinal disorders
Gastritis erosive
|
0.00%
0/167
|
0.61%
1/163
|
0.00%
0/163
|
|
Gastrointestinal disorders
Gastritis haemorrhagic
|
0.00%
0/167
|
0.61%
1/163
|
0.00%
0/163
|
|
Gastrointestinal disorders
Gastroduodenal ulcer
|
0.60%
1/167
|
0.00%
0/163
|
0.00%
0/163
|
|
Gastrointestinal disorders
Gastrointestinal pain
|
0.00%
0/167
|
0.61%
1/163
|
0.00%
0/163
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/167
|
0.00%
0/163
|
0.61%
1/163
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/167
|
0.00%
0/163
|
0.61%
1/163
|
|
Gastrointestinal disorders
Impaired gastric emptying
|
0.00%
0/167
|
0.00%
0/163
|
0.61%
1/163
|
|
Gastrointestinal disorders
Intestinal mass
|
0.60%
1/167
|
0.00%
0/163
|
0.00%
0/163
|
|
Gastrointestinal disorders
Large intestinal haemorrhage
|
0.60%
1/167
|
0.00%
0/163
|
0.00%
0/163
|
|
Gastrointestinal disorders
Large intestine perforation
|
0.60%
1/167
|
0.00%
0/163
|
0.00%
0/163
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/167
|
0.61%
1/163
|
0.00%
0/163
|
|
Gastrointestinal disorders
Peritonitis
|
0.00%
0/167
|
0.61%
1/163
|
0.00%
0/163
|
|
Gastrointestinal disorders
Umbilical hernia, obstructive
|
0.00%
0/167
|
0.61%
1/163
|
0.00%
0/163
|
|
Gastrointestinal disorders
Uraemic gastropathy
|
0.00%
0/167
|
0.00%
0/163
|
0.61%
1/163
|
|
Infections and infestations
Cellulitis of male external genital organ
|
0.00%
0/167
|
0.61%
1/163
|
0.00%
0/163
|
|
Gastrointestinal disorders
Volvulus
|
0.60%
1/167
|
0.00%
0/163
|
0.00%
0/163
|
|
General disorders
Non-cardiac chest pain
|
1.2%
2/167
|
2.5%
4/163
|
0.61%
1/163
|
|
General disorders
Pyrexia
|
0.60%
1/167
|
0.61%
1/163
|
1.2%
2/163
|
|
General disorders
Generalised oedema
|
0.60%
1/167
|
1.2%
2/163
|
0.00%
0/163
|
|
General disorders
Asthenia
|
1.2%
2/167
|
0.00%
0/163
|
0.00%
0/163
|
|
General disorders
Chest pain
|
0.00%
0/167
|
0.61%
1/163
|
0.61%
1/163
|
|
General disorders
Multi-organ failure
|
1.2%
2/167
|
0.00%
0/163
|
0.00%
0/163
|
|
General disorders
Brain death
|
0.00%
0/167
|
0.61%
1/163
|
0.00%
0/163
|
|
General disorders
Cyst
|
0.60%
1/167
|
0.00%
0/163
|
0.00%
0/163
|
|
General disorders
Fatigue
|
0.60%
1/167
|
0.00%
0/163
|
0.00%
0/163
|
|
General disorders
General physical health deterioration
|
0.60%
1/167
|
0.00%
0/163
|
0.00%
0/163
|
|
General disorders
Hypothermia
|
0.60%
1/167
|
0.00%
0/163
|
0.00%
0/163
|
|
General disorders
Local swelling
|
0.00%
0/167
|
0.00%
0/163
|
0.61%
1/163
|
|
General disorders
Oedema peripheral
|
0.00%
0/167
|
0.61%
1/163
|
0.00%
0/163
|
|
General disorders
Pain
|
0.00%
0/167
|
0.61%
1/163
|
0.00%
0/163
|
|
General disorders
Sudden death
|
0.60%
1/167
|
0.00%
0/163
|
0.00%
0/163
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/167
|
1.8%
3/163
|
0.61%
1/163
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/167
|
1.2%
2/163
|
0.00%
0/163
|
|
Hepatobiliary disorders
Bile duct stone
|
0.00%
0/167
|
0.61%
1/163
|
0.00%
0/163
|
|
Hepatobiliary disorders
Cholangitis
|
0.00%
0/167
|
0.61%
1/163
|
0.00%
0/163
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.60%
1/167
|
0.00%
0/163
|
0.00%
0/163
|
|
Hepatobiliary disorders
Cholecystitis chronic
|
0.00%
0/167
|
0.61%
1/163
|
0.00%
0/163
|
|
Hepatobiliary disorders
Hepatic failure
|
0.60%
1/167
|
0.00%
0/163
|
0.00%
0/163
|
|
Hepatobiliary disorders
Hepatic ischaemia
|
0.60%
1/167
|
0.00%
0/163
|
0.00%
0/163
|
|
Hepatobiliary disorders
Jaundice
|
0.00%
0/167
|
0.61%
1/163
|
0.00%
0/163
|
|
Hepatobiliary disorders
Liver disorder
|
0.60%
1/167
|
0.00%
0/163
|
0.00%
0/163
|
|
Immune system disorders
Transplant rejection
|
0.60%
1/167
|
0.00%
0/163
|
0.00%
0/163
|
|
Infections and infestations
Pneumonia
|
2.4%
4/167
|
6.7%
11/163
|
3.1%
5/163
|
|
Infections and infestations
Urinary tract infection
|
3.0%
5/167
|
3.1%
5/163
|
0.61%
1/163
|
|
Infections and infestations
Cellulitis
|
2.4%
4/167
|
1.2%
2/163
|
1.8%
3/163
|
|
Infections and infestations
Lobar pneumonia
|
1.8%
3/167
|
1.2%
2/163
|
0.00%
0/163
|
|
Infections and infestations
Sepsis
|
0.00%
0/167
|
1.8%
3/163
|
1.2%
2/163
|
|
Infections and infestations
Gastroenteritis
|
0.60%
1/167
|
1.2%
2/163
|
0.61%
1/163
|
|
Infections and infestations
Osteomyelitis
|
0.60%
1/167
|
1.2%
2/163
|
0.61%
1/163
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/167
|
1.2%
2/163
|
0.61%
1/163
|
|
Infections and infestations
Wound infection
|
1.2%
2/167
|
0.61%
1/163
|
0.00%
0/163
|
|
Infections and infestations
Gangrene
|
0.60%
1/167
|
0.61%
1/163
|
0.00%
0/163
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/167
|
1.2%
2/163
|
0.00%
0/163
|
|
Infections and infestations
Localised infection
|
0.00%
0/167
|
1.2%
2/163
|
0.00%
0/163
|
|
Infections and infestations
Staphylococcal infection
|
0.00%
0/167
|
0.61%
1/163
|
0.61%
1/163
|
|
Infections and infestations
Urinary tract infection bacterial
|
0.00%
0/167
|
0.61%
1/163
|
0.61%
1/163
|
|
Infections and infestations
Abdominal sepsis
|
0.60%
1/167
|
0.00%
0/163
|
0.00%
0/163
|
|
Infections and infestations
Arthritis bacterial
|
0.60%
1/167
|
0.00%
0/163
|
0.00%
0/163
|
|
Infections and infestations
Bacterial pyelonephritis
|
0.00%
0/167
|
0.61%
1/163
|
0.00%
0/163
|
|
Infections and infestations
Bronchitis
|
0.00%
0/167
|
0.61%
1/163
|
0.00%
0/163
|
|
Infections and infestations
Clostridium difficile colitis
|
0.00%
0/167
|
0.00%
0/163
|
0.61%
1/163
|
|
Infections and infestations
Clostridium difficile sepsis
|
0.60%
1/167
|
0.00%
0/163
|
0.00%
0/163
|
|
Infections and infestations
Device related infection
|
0.60%
1/167
|
0.00%
0/163
|
0.00%
0/163
|
|
Infections and infestations
Diabetic foot infection
|
0.00%
0/167
|
0.61%
1/163
|
0.00%
0/163
|
|
Infections and infestations
Diabetic gangrene
|
0.60%
1/167
|
0.00%
0/163
|
0.00%
0/163
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/167
|
0.61%
1/163
|
0.00%
0/163
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/167
|
0.61%
1/163
|
0.00%
0/163
|
|
Infections and infestations
Labyrinthitis
|
0.00%
0/167
|
0.00%
0/163
|
0.61%
1/163
|
|
Infections and infestations
Necrotising fasciitis
|
0.60%
1/167
|
0.00%
0/163
|
0.00%
0/163
|
|
Infections and infestations
Osteomyelitis bacterial
|
0.00%
0/167
|
0.61%
1/163
|
0.00%
0/163
|
|
Infections and infestations
Perihepatic abscess
|
0.00%
0/167
|
0.61%
1/163
|
0.00%
0/163
|
|
Infections and infestations
Perineal abscess
|
0.60%
1/167
|
0.00%
0/163
|
0.00%
0/163
|
|
Infections and infestations
Pneumonia cryptococcal
|
0.00%
0/167
|
0.61%
1/163
|
0.00%
0/163
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/167
|
0.00%
0/163
|
0.61%
1/163
|
|
Infections and infestations
Pyelonephritis acute
|
0.00%
0/167
|
0.61%
1/163
|
0.00%
0/163
|
|
Infections and infestations
Septic shock
|
0.00%
0/167
|
0.61%
1/163
|
0.00%
0/163
|
|
Infections and infestations
Staphylococcal bacteraemia
|
0.00%
0/167
|
0.61%
1/163
|
0.00%
0/163
|
|
Infections and infestations
Staphylococcal sepsis
|
0.60%
1/167
|
0.00%
0/163
|
0.00%
0/163
|
|
Infections and infestations
Streptococcal bacteraemia
|
0.00%
0/167
|
0.61%
1/163
|
0.00%
0/163
|
|
Infections and infestations
Subcutaneous abscess
|
0.60%
1/167
|
0.00%
0/163
|
0.00%
0/163
|
|
Infections and infestations
Urinary tract infection enterococcal
|
0.00%
0/167
|
0.61%
1/163
|
0.00%
0/163
|
|
Infections and infestations
Urinary tract infection pseudomonal
|
0.60%
1/167
|
0.00%
0/163
|
0.00%
0/163
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/167
|
1.2%
2/163
|
0.61%
1/163
|
|
Injury, poisoning and procedural complications
Scapula fracture
|
0.00%
0/167
|
1.2%
2/163
|
0.00%
0/163
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.00%
0/167
|
0.00%
0/163
|
1.2%
2/163
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.00%
0/167
|
0.61%
1/163
|
0.61%
1/163
|
|
Injury, poisoning and procedural complications
Avulsion fracture
|
0.00%
0/167
|
0.61%
1/163
|
0.00%
0/163
|
|
Injury, poisoning and procedural complications
Clavicle fracture
|
0.00%
0/167
|
0.61%
1/163
|
0.00%
0/163
|
|
Injury, poisoning and procedural complications
Complications of transplanted kidney
|
0.00%
0/167
|
0.00%
0/163
|
0.61%
1/163
|
|
Injury, poisoning and procedural complications
Concussion
|
0.00%
0/167
|
0.61%
1/163
|
0.00%
0/163
|
|
Injury, poisoning and procedural complications
Drug toxicity
|
0.00%
0/167
|
0.61%
1/163
|
0.00%
0/163
|
|
Injury, poisoning and procedural complications
Facial bones fracture
|
0.00%
0/167
|
0.61%
1/163
|
0.00%
0/163
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/167
|
0.61%
1/163
|
0.00%
0/163
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.60%
1/167
|
0.00%
0/163
|
0.00%
0/163
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.60%
1/167
|
0.00%
0/163
|
0.00%
0/163
|
|
Injury, poisoning and procedural complications
Hand fracture
|
0.00%
0/167
|
0.61%
1/163
|
0.00%
0/163
|
|
Injury, poisoning and procedural complications
Head injury
|
0.00%
0/167
|
0.00%
0/163
|
0.61%
1/163
|
|
Injury, poisoning and procedural complications
Multiple injuries
|
0.00%
0/167
|
0.61%
1/163
|
0.00%
0/163
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute myeloid leukaemia
|
0.60%
1/167
|
0.00%
0/163
|
0.00%
0/163
|
|
Injury, poisoning and procedural complications
Perirenal haematoma
|
0.00%
0/167
|
0.00%
0/163
|
0.61%
1/163
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer metastatic
|
0.00%
0/167
|
0.61%
1/163
|
0.00%
0/163
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/167
|
0.61%
1/163
|
0.00%
0/163
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/167
|
0.61%
1/163
|
0.00%
0/163
|
|
Injury, poisoning and procedural complications
Seroma
|
0.00%
0/167
|
0.00%
0/163
|
0.61%
1/163
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.00%
0/167
|
0.00%
0/163
|
0.61%
1/163
|
|
Injury, poisoning and procedural complications
Wound
|
0.00%
0/167
|
0.61%
1/163
|
0.00%
0/163
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
0.60%
1/167
|
0.00%
0/163
|
0.00%
0/163
|
|
Investigations
Anticoagulation drug level above therapeutic
|
0.00%
0/167
|
0.61%
1/163
|
0.00%
0/163
|
|
Investigations
Coagulation time prolonged
|
0.00%
0/167
|
0.61%
1/163
|
0.00%
0/163
|
|
Investigations
Ejection fraction decreased
|
0.60%
1/167
|
0.00%
0/163
|
0.00%
0/163
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.60%
1/167
|
3.7%
6/163
|
3.7%
6/163
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
3.6%
6/167
|
1.2%
2/163
|
2.5%
4/163
|
|
Metabolism and nutrition disorders
Dehydration
|
1.8%
3/167
|
2.5%
4/163
|
0.00%
0/163
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
1.2%
2/167
|
0.61%
1/163
|
1.2%
2/163
|
|
Metabolism and nutrition disorders
Fluid overload
|
0.60%
1/167
|
0.61%
1/163
|
1.2%
2/163
|
|
Metabolism and nutrition disorders
Diabetes mellitus inadequate control
|
0.60%
1/167
|
1.2%
2/163
|
0.00%
0/163
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
0.00%
0/167
|
0.61%
1/163
|
0.61%
1/163
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/167
|
0.61%
1/163
|
0.00%
0/163
|
|
Metabolism and nutrition disorders
Diabetic foot
|
0.00%
0/167
|
0.61%
1/163
|
0.00%
0/163
|
|
Metabolism and nutrition disorders
Failure to thrive
|
0.00%
0/167
|
0.61%
1/163
|
0.00%
0/163
|
|
Metabolism and nutrition disorders
Fluid retention
|
0.00%
0/167
|
0.61%
1/163
|
0.00%
0/163
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.60%
1/167
|
0.61%
1/163
|
0.00%
0/163
|
|
Metabolism and nutrition disorders
Gout
|
0.00%
0/167
|
0.00%
0/163
|
0.61%
1/163
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/167
|
0.00%
0/163
|
0.61%
1/163
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.60%
1/167
|
0.00%
0/163
|
0.00%
0/163
|
|
Metabolism and nutrition disorders
Hypervolaemia
|
0.00%
0/167
|
0.61%
1/163
|
0.00%
0/163
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/167
|
0.61%
1/163
|
0.00%
0/163
|
|
Metabolism and nutrition disorders
Hypovolaemia
|
0.00%
0/167
|
0.61%
1/163
|
0.00%
0/163
|
|
Metabolism and nutrition disorders
Ketoacidosis
|
0.00%
0/167
|
0.61%
1/163
|
0.00%
0/163
|
|
Metabolism and nutrition disorders
Neuroglycopenia
|
0.00%
0/167
|
0.00%
0/163
|
0.61%
1/163
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.2%
2/167
|
1.2%
2/163
|
0.00%
0/163
|
|
Musculoskeletal and connective tissue disorders
Diabetic amyotrophy
|
0.60%
1/167
|
0.00%
0/163
|
0.00%
0/163
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/167
|
0.61%
1/163
|
0.00%
0/163
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.00%
0/167
|
0.00%
0/163
|
0.61%
1/163
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.60%
1/167
|
0.00%
0/163
|
0.00%
0/163
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.00%
0/167
|
0.00%
0/163
|
0.61%
1/163
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/167
|
0.61%
1/163
|
0.00%
0/163
|
|
Musculoskeletal and connective tissue disorders
Osteolysis
|
0.00%
0/167
|
0.00%
0/163
|
0.61%
1/163
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/167
|
0.61%
1/163
|
0.00%
0/163
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.00%
0/167
|
0.61%
1/163
|
0.00%
0/163
|
|
Musculoskeletal and connective tissue disorders
Spinal column stenosis
|
0.00%
0/167
|
0.61%
1/163
|
0.00%
0/163
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.60%
1/167
|
0.00%
0/163
|
0.61%
1/163
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer metastatic
|
0.60%
1/167
|
0.00%
0/163
|
0.00%
0/163
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung cancer metastatic
|
0.00%
0/167
|
0.61%
1/163
|
0.00%
0/163
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung squamous cell carcinoma stage unspecified
|
0.00%
0/167
|
0.00%
0/163
|
0.61%
1/163
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Seborrhoeic keratosis
|
0.60%
1/167
|
0.00%
0/163
|
0.00%
0/163
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Transitional cell carcinoma
|
0.60%
1/167
|
0.00%
0/163
|
0.00%
0/163
|
|
Nervous system disorders
Syncope
|
0.60%
1/167
|
1.8%
3/163
|
0.61%
1/163
|
|
Nervous system disorders
Cerebrovascular accident
|
1.8%
3/167
|
0.61%
1/163
|
0.00%
0/163
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/167
|
0.61%
1/163
|
1.8%
3/163
|
|
Nervous system disorders
Headache
|
0.60%
1/167
|
0.00%
0/163
|
0.61%
1/163
|
|
Nervous system disorders
Lacunar infarction
|
0.60%
1/167
|
0.61%
1/163
|
0.00%
0/163
|
|
Nervous system disorders
Presyncope
|
0.00%
0/167
|
1.2%
2/163
|
0.00%
0/163
|
|
Nervous system disorders
Carotid artery stenosis
|
0.00%
0/167
|
0.61%
1/163
|
0.00%
0/163
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.00%
0/167
|
0.00%
0/163
|
0.61%
1/163
|
|
Nervous system disorders
Cerebral infarction
|
0.00%
0/167
|
0.61%
1/163
|
0.00%
0/163
|
|
Nervous system disorders
Convulsion
|
0.60%
1/167
|
0.00%
0/163
|
0.00%
0/163
|
|
Nervous system disorders
Dizziness
|
0.00%
0/167
|
0.61%
1/163
|
0.00%
0/163
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/167
|
0.61%
1/163
|
0.00%
0/163
|
|
Nervous system disorders
Grand mal convulsion
|
0.00%
0/167
|
0.61%
1/163
|
0.00%
0/163
|
|
Nervous system disorders
Hypoxic encephalopathy
|
0.60%
1/167
|
0.00%
0/163
|
0.00%
0/163
|
|
Nervous system disorders
Migraine
|
0.00%
0/167
|
0.61%
1/163
|
0.00%
0/163
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/167
|
0.61%
1/163
|
0.00%
0/163
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
0.00%
0/167
|
0.00%
0/163
|
0.61%
1/163
|
|
Nervous system disorders
Tremor
|
0.00%
0/167
|
0.61%
1/163
|
0.00%
0/163
|
|
Nervous system disorders
Uraemic encephalopathy
|
0.60%
1/167
|
0.00%
0/163
|
0.00%
0/163
|
|
Nervous system disorders
Vocal cord paralysis
|
0.60%
1/167
|
0.00%
0/163
|
0.00%
0/163
|
|
Psychiatric disorders
Mental status changes
|
0.60%
1/167
|
0.61%
1/163
|
1.8%
3/163
|
|
Psychiatric disorders
Hallucination
|
0.00%
0/167
|
0.00%
0/163
|
0.61%
1/163
|
|
Psychiatric disorders
Psychotic disorder
|
0.60%
1/167
|
0.00%
0/163
|
0.00%
0/163
|
|
Psychiatric disorders
Schizoaffective disorder
|
0.00%
0/167
|
0.61%
1/163
|
0.00%
0/163
|
|
Psychiatric disorders
Substance abuse
|
0.00%
0/167
|
0.61%
1/163
|
0.00%
0/163
|
|
Renal and urinary disorders
Renal failure acute
|
6.6%
11/167
|
6.7%
11/163
|
3.1%
5/163
|
|
Renal and urinary disorders
Renal failure chronic
|
6.0%
10/167
|
3.7%
6/163
|
4.9%
8/163
|
|
Renal and urinary disorders
Renal failure
|
1.2%
2/167
|
1.2%
2/163
|
0.61%
1/163
|
|
Renal and urinary disorders
Azotaemia
|
1.2%
2/167
|
0.61%
1/163
|
0.61%
1/163
|
|
Renal and urinary disorders
Renal impairment
|
0.00%
0/167
|
0.61%
1/163
|
0.61%
1/163
|
|
Renal and urinary disorders
Acute prerenal failure
|
0.00%
0/167
|
0.61%
1/163
|
0.00%
0/163
|
|
Renal and urinary disorders
Glomerulonephritis chronic
|
0.60%
1/167
|
0.00%
0/163
|
0.00%
0/163
|
|
Renal and urinary disorders
Obstructive uropathy
|
0.00%
0/167
|
0.00%
0/163
|
0.61%
1/163
|
|
Renal and urinary disorders
Renal pain
|
0.00%
0/167
|
0.61%
1/163
|
0.00%
0/163
|
|
Renal and urinary disorders
Urinary retention
|
0.60%
1/167
|
0.00%
0/163
|
0.00%
0/163
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/167
|
0.61%
1/163
|
1.8%
3/163
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.60%
1/167
|
0.61%
1/163
|
1.2%
2/163
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
1.2%
2/167
|
0.61%
1/163
|
0.61%
1/163
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory arrest
|
1.2%
2/167
|
1.2%
2/163
|
0.00%
0/163
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.2%
2/167
|
0.00%
0/163
|
0.61%
1/163
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
1.8%
3/167
|
0.00%
0/163
|
0.00%
0/163
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
1.2%
2/167
|
0.00%
0/163
|
0.61%
1/163
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/167
|
0.61%
1/163
|
0.61%
1/163
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
1.2%
2/167
|
0.00%
0/163
|
0.00%
0/163
|
|
Skin and subcutaneous tissue disorders
Diabetic ulcer
|
0.00%
0/167
|
0.61%
1/163
|
0.00%
0/163
|
|
Skin and subcutaneous tissue disorders
Exfoliative rash
|
0.60%
1/167
|
0.00%
0/163
|
0.00%
0/163
|
|
Skin and subcutaneous tissue disorders
Leukocytoclastic vasculitis
|
0.00%
0/167
|
0.61%
1/163
|
0.00%
0/163
|
|
Skin and subcutaneous tissue disorders
Stasis dermatitis
|
0.00%
0/167
|
0.00%
0/163
|
0.61%
1/163
|
|
Vascular disorders
Hypotension
|
0.60%
1/167
|
0.61%
1/163
|
2.5%
4/163
|
|
Vascular disorders
Hypertensive crisis
|
1.8%
3/167
|
1.2%
2/163
|
0.00%
0/163
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/167
|
1.8%
3/163
|
0.61%
1/163
|
|
Vascular disorders
Hypertension
|
1.2%
2/167
|
0.61%
1/163
|
0.61%
1/163
|
|
Vascular disorders
Aortic aneurysm
|
1.2%
2/167
|
0.00%
0/163
|
0.61%
1/163
|
|
Vascular disorders
Hypertensive emergency
|
0.60%
1/167
|
1.2%
2/163
|
0.00%
0/163
|
|
Vascular disorders
Haematoma
|
0.00%
0/167
|
1.2%
2/163
|
0.00%
0/163
|
|
Vascular disorders
Accelerated hypertension
|
0.60%
1/167
|
0.00%
0/163
|
0.00%
0/163
|
|
Vascular disorders
Angiopathy
|
0.60%
1/167
|
0.00%
0/163
|
0.00%
0/163
|
|
Vascular disorders
Aortic aneurysm rupture
|
0.60%
1/167
|
0.00%
0/163
|
0.00%
0/163
|
|
Vascular disorders
Aortic stenosis
|
0.60%
1/167
|
0.00%
0/163
|
0.00%
0/163
|
|
Vascular disorders
Arterial occlusive disease
|
0.00%
0/167
|
0.61%
1/163
|
0.00%
0/163
|
|
Vascular disorders
Cardiovascular insufficiency
|
0.00%
0/167
|
0.61%
1/163
|
0.00%
0/163
|
|
Vascular disorders
Malignant hypertension
|
0.00%
0/167
|
0.61%
1/163
|
0.00%
0/163
|
|
Vascular disorders
Orthostatic hypotension
|
0.60%
1/167
|
0.00%
0/163
|
0.00%
0/163
|
|
Vascular disorders
Peripheral ischaemia
|
0.60%
1/167
|
0.00%
0/163
|
0.00%
0/163
|
|
Vascular disorders
Peripheral vascular disorder
|
0.00%
0/167
|
0.00%
0/163
|
0.61%
1/163
|
|
Vascular disorders
Vascular pseudoaneurysm
|
0.60%
1/167
|
0.00%
0/163
|
0.00%
0/163
|
Other adverse events
| Measure |
Peginesatide 0.025 mg/kg
n=167 participants at risk
Participants received peginesatide by subcutaneous injection once every 4 weeks. The starting dose was 0.025 milligram per kilogram (mg/kg) and was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 grams per deciliter (g/dL).
|
Peginesatide 0.04 mg/kg
n=163 participants at risk
Participants received peginesatide by subcutaneous injection once every 4 weeks. The starting dose was 0.04 mg/kg and was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 g/dL.
|
Darbepoetin Alfa
n=163 participants at risk
Participants received darbepoetin alfa by subcutaneous injection once every 2 weeks, as prescribed. The starting dose was 0.75 microgram per kilogram (mcg/kg) and was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 g/dL.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
7.8%
13/167
|
5.5%
9/163
|
2.5%
4/163
|
|
Endocrine disorders
Hyperparathyroidism
|
4.8%
8/167
|
2.5%
4/163
|
5.5%
9/163
|
|
Endocrine disorders
Hyperparathyroidism secondary
|
3.0%
5/167
|
5.5%
9/163
|
3.7%
6/163
|
|
Gastrointestinal disorders
Nausea
|
16.2%
27/167
|
15.3%
25/163
|
16.6%
27/163
|
|
Gastrointestinal disorders
Diarrhoea
|
13.2%
22/167
|
12.9%
21/163
|
19.6%
32/163
|
|
Gastrointestinal disorders
Vomiting
|
10.2%
17/167
|
14.1%
23/163
|
9.2%
15/163
|
|
Gastrointestinal disorders
Constipation
|
7.2%
12/167
|
9.8%
16/163
|
11.0%
18/163
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
7.2%
12/167
|
5.5%
9/163
|
3.1%
5/163
|
|
Gastrointestinal disorders
Abdominal pain
|
5.4%
9/167
|
3.1%
5/163
|
4.3%
7/163
|
|
Gastrointestinal disorders
Abdominal pain upper
|
4.8%
8/167
|
3.7%
6/163
|
5.5%
9/163
|
|
General disorders
Oedema peripheral
|
26.9%
45/167
|
16.0%
26/163
|
20.9%
34/163
|
|
General disorders
Fatigue
|
9.0%
15/167
|
11.0%
18/163
|
8.6%
14/163
|
|
General disorders
Asthenia
|
7.2%
12/167
|
4.9%
8/163
|
4.9%
8/163
|
|
General disorders
Pain
|
6.0%
10/167
|
1.2%
2/163
|
1.8%
3/163
|
|
Infections and infestations
Nasopharyngitis
|
13.2%
22/167
|
11.7%
19/163
|
14.7%
24/163
|
|
Infections and infestations
Urinary tract infection
|
13.2%
22/167
|
13.5%
22/163
|
13.5%
22/163
|
|
Infections and infestations
Upper respiratory tract infection
|
7.2%
12/167
|
9.2%
15/163
|
11.7%
19/163
|
|
Infections and infestations
Bronchitis
|
3.0%
5/167
|
8.6%
14/163
|
8.0%
13/163
|
|
Infections and infestations
Sinusitis
|
3.0%
5/167
|
3.1%
5/163
|
7.4%
12/163
|
|
Injury, poisoning and procedural complications
Fall
|
9.6%
16/167
|
6.7%
11/163
|
6.1%
10/163
|
|
Injury, poisoning and procedural complications
Contusion
|
7.8%
13/167
|
6.7%
11/163
|
3.1%
5/163
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
13.8%
23/167
|
14.7%
24/163
|
14.1%
23/163
|
|
Metabolism and nutrition disorders
Hyperphosphataemia
|
9.6%
16/167
|
3.7%
6/163
|
9.2%
15/163
|
|
Metabolism and nutrition disorders
Gout
|
6.6%
11/167
|
2.5%
4/163
|
5.5%
9/163
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
6.0%
10/167
|
6.7%
11/163
|
3.7%
6/163
|
|
Metabolism and nutrition disorders
Iron deficiency
|
6.0%
10/167
|
2.5%
4/163
|
2.5%
4/163
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
6.0%
10/167
|
1.8%
3/163
|
4.9%
8/163
|
|
Metabolism and nutrition disorders
Anorexia
|
5.4%
9/167
|
2.5%
4/163
|
4.3%
7/163
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
3.6%
6/167
|
4.3%
7/163
|
5.5%
9/163
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
13.8%
23/167
|
9.8%
16/163
|
8.6%
14/163
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
12.6%
21/167
|
11.0%
18/163
|
6.1%
10/163
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
8.4%
14/167
|
10.4%
17/163
|
10.4%
17/163
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
5.4%
9/167
|
6.1%
10/163
|
4.3%
7/163
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
4.8%
8/167
|
2.5%
4/163
|
8.6%
14/163
|
|
Nervous system disorders
Dizziness
|
10.2%
17/167
|
12.3%
20/163
|
12.3%
20/163
|
|
Nervous system disorders
Headache
|
9.0%
15/167
|
9.2%
15/163
|
7.4%
12/163
|
|
Psychiatric disorders
Insomnia
|
7.8%
13/167
|
4.3%
7/163
|
4.3%
7/163
|
|
Psychiatric disorders
Depression
|
6.6%
11/167
|
4.3%
7/163
|
4.3%
7/163
|
|
Psychiatric disorders
Anxiety
|
6.0%
10/167
|
4.3%
7/163
|
1.8%
3/163
|
|
Renal and urinary disorders
Renal failure chronic
|
5.4%
9/167
|
2.5%
4/163
|
8.0%
13/163
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
9.6%
16/167
|
10.4%
17/163
|
9.2%
15/163
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
7.2%
12/167
|
10.4%
17/163
|
9.8%
16/163
|
|
Vascular disorders
Hypertension
|
19.2%
32/167
|
14.7%
24/163
|
20.9%
34/163
|
|
Vascular disorders
Hypotension
|
9.0%
15/167
|
8.0%
13/163
|
11.0%
18/163
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The first publication of the primary safety and efficacy results will include data from all appropriate study sites. Either after the first multicenter publication, or following 36 months after the completion of the study, Investigators are free to publish; such publications may not contain Sponsor Confidential Information and may be subject to Sponsor review 60 days prior to submission for publication.
- Publication restrictions are in place
Restriction type: OTHER