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Trial Outcomes & Findings for Safety & Efficacy of Peginesatide for Maintenance Treatment of Anemia in Participants With Chronic Kidney Disease on Hemodialysis (NCT NCT00597753)

NCT ID: NCT00597753

Last Updated: 2013-02-12

Results Overview

The baseline hemoglobin value is defined as the mean of five hemoglobin values: the four 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 29 through 36.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

803 participants

Primary outcome timeframe

Baseline and Weeks 29-36

Results posted on

2013-02-12

Participant Flow

Participant milestones

Participant milestones
Measure
Peginesatide
Participants received peginesatide by intravenous injection once every 4 weeks. The starting dose was based on the participant's total weekly epoetin alfa dose during the last week of the Screening Period; the first dose was administered one week after the last epoetin alfa dose. The dose was adjusted to maintain hemoglobin levels in a target range of 10.0-12.0 grams per deciliter (g/dL) and ± 1.5 g/dL from baseline during the Titration and Evaluation Periods, and 10.0-12.0 g/dL during the Long-Term Safety and Efficacy Period.
Epoetin Alfa
Participants continued to receive commercially available epoetin alfa by intravenous injection, at the same starting dose and frequency as received during the last week of the Screening Period, with the first study dose of epoetin alfa administered after randomization at Week 0. The dose was adjusted to maintain hemoglobin levels in a target range of 10.0-12.0 g/dL and ± 1.5 g/dL from baseline during the Titration and Evaluation Periods, and 10.0-12.0 g/dL during the Long-Term Safety and Efficacy Period.
Overall Study
STARTED
532
271
Overall Study
COMPLETED
366
202
Overall Study
NOT COMPLETED
166
69

Reasons for withdrawal

Reasons for withdrawal
Measure
Peginesatide
Participants received peginesatide by intravenous injection once every 4 weeks. The starting dose was based on the participant's total weekly epoetin alfa dose during the last week of the Screening Period; the first dose was administered one week after the last epoetin alfa dose. The dose was adjusted to maintain hemoglobin levels in a target range of 10.0-12.0 grams per deciliter (g/dL) and ± 1.5 g/dL from baseline during the Titration and Evaluation Periods, and 10.0-12.0 g/dL during the Long-Term Safety and Efficacy Period.
Epoetin Alfa
Participants continued to receive commercially available epoetin alfa by intravenous injection, at the same starting dose and frequency as received during the last week of the Screening Period, with the first study dose of epoetin alfa administered after randomization at Week 0. The dose was adjusted to maintain hemoglobin levels in a target range of 10.0-12.0 g/dL and ± 1.5 g/dL from baseline during the Titration and Evaluation Periods, and 10.0-12.0 g/dL during the Long-Term Safety and Efficacy Period.
Overall Study
Adverse Event
6
2
Overall Study
Death
55
29
Overall Study
Lack of Efficacy
2
0
Overall Study
Lost to Follow-up
10
3
Overall Study
Physician Decision
5
1
Overall Study
Pregnancy
1
0
Overall Study
Withdrawal by Subject
35
12
Overall Study
Discontinued Dialysis
0
1
Overall Study
Never dosed
2
0
Overall Study
Noncompliance
2
1
Overall Study
Relocation
17
6
Overall Study
Renal transplant
10
3
Overall Study
Site closed by sponsor
19
7
Overall Study
Site elected to close
2
4

Baseline Characteristics

Safety & Efficacy of Peginesatide for Maintenance Treatment of Anemia in Participants With Chronic Kidney Disease on Hemodialysis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Peginesatide
n=524 Participants
Participants received peginesatide by intravenous injection once every 4 weeks. The starting dose was based on the participant's total weekly epoetin alfa dose during the last week of the Screening Period; the first dose was administered one week after the last epoetin alfa dose. The dose was adjusted to maintain hemoglobin levels in a target range of 10.0-12.0 grams per deciliter (g/dL) and ± 1.5 g/dL from baseline during the Titration and Evaluation Periods, and 10.0-12.0 g/dL during the Long-Term Safety and Efficacy Period.
Epoetin Alfa
n=269 Participants
Participants continued to receive commercially available epoetin alfa by intravenous injection, at the same starting dose and frequency as received during the last week of the Screening Period, with the first study dose of epoetin alfa administered after randomization at Week 0. The dose was adjusted to maintain hemoglobin levels in a target range of 10.0-12.0 g/dL and ± 1.5 g/dL from baseline during the Titration and Evaluation Periods, and 10.0-12.0 g/dL during the Long-Term Safety and Efficacy Period.
Total
n=793 Participants
Total of all reporting groups
Age, Categorical
<=18 years
0 Participants
n=93 Participants
0 Participants
n=4 Participants
0 Participants
n=27 Participants
Age, Categorical
Between 18 and 65 years
370 Participants
n=93 Participants
190 Participants
n=4 Participants
560 Participants
n=27 Participants
Age, Categorical
>=65 years
154 Participants
n=93 Participants
79 Participants
n=4 Participants
233 Participants
n=27 Participants
Age Continuous
57.3 years
STANDARD_DEVIATION 13.96 • n=93 Participants
57.5 years
STANDARD_DEVIATION 13.68 • n=4 Participants
57.4 years
STANDARD_DEVIATION 13.86 • n=27 Participants
Sex: Female, Male
Female
231 Participants
n=93 Participants
125 Participants
n=4 Participants
356 Participants
n=27 Participants
Sex: Female, Male
Male
293 Participants
n=93 Participants
144 Participants
n=4 Participants
437 Participants
n=27 Participants

PRIMARY outcome

Timeframe: Baseline and Weeks 29-36

Population: 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 five hemoglobin values: the four 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 29 through 36.

Outcome measures

Outcome measures
Measure
Peginesatide
n=524 Participants
Participants received peginesatide by intravenous injection once every 4 weeks. The starting dose was based on the participant's total weekly epoetin alfa dose during the last week of the Screening Period; the first dose was administered one week after the last epoetin alfa dose. The dose was adjusted to maintain hemoglobin levels in a target range of 10.0-12.0 grams per deciliter (g/dL) and ± 1.5 g/dL from baseline during the Titration and Evaluation Periods, and 10.0-12.0 g/dL during the Long-Term Safety and Efficacy Period.
Epoetin Alfa
n=269 Participants
Participants continued to receive commercially available epoetin alfa by intravenous injection, at the same starting dose and frequency as received during the last week of the Screening Period, with the first study dose of epoetin alfa administered after randomization at Week 0. The dose was adjusted to maintain hemoglobin levels in a target range of 10.0-12.0 g/dL and ± 1.5 g/dL from baseline during the Titration and Evaluation Periods, and 10.0-12.0 g/dL during the Long-Term Safety and Efficacy Period.
Mean Change in Hemoglobin Between Baseline and the Evaluation Period
Baseline [N=524, 269]
11.30 g/dL
Standard Deviation 0.523
11.32 g/dL
Standard Deviation 0.493
Mean Change in Hemoglobin Between Baseline and the Evaluation Period
Evaluation Period [N=445, 248]
11.06 g/dL
Standard Deviation 0.932
11.25 g/dL
Standard Deviation 0.846
Mean Change in Hemoglobin Between Baseline and the Evaluation Period
Change from Baseline [N=445, 248]
-0.24 g/dL
Standard Deviation 0.956
-0.09 g/dL
Standard Deviation 0.922

SECONDARY outcome

Timeframe: Weeks 0 to 36

Population: Full Analysis Population: All randomized participants who received at least one dose of study medication

Outcome measures

Outcome measures
Measure
Peginesatide
n=524 Participants
Participants received peginesatide by intravenous injection once every 4 weeks. The starting dose was based on the participant's total weekly epoetin alfa dose during the last week of the Screening Period; the first dose was administered one week after the last epoetin alfa dose. The dose was adjusted to maintain hemoglobin levels in a target range of 10.0-12.0 grams per deciliter (g/dL) and ± 1.5 g/dL from baseline during the Titration and Evaluation Periods, and 10.0-12.0 g/dL during the Long-Term Safety and Efficacy Period.
Epoetin Alfa
n=269 Participants
Participants continued to receive commercially available epoetin alfa by intravenous injection, at the same starting dose and frequency as received during the last week of the Screening Period, with the first study dose of epoetin alfa administered after randomization at Week 0. The dose was adjusted to maintain hemoglobin levels in a target range of 10.0-12.0 g/dL and ± 1.5 g/dL from baseline during the Titration and Evaluation Periods, and 10.0-12.0 g/dL during the Long-Term Safety and Efficacy Period.
Proportion of Participants Who Receive Red Blood Cell (RBC) Transfusions During the Titration and Evaluation Periods
0.103 percentage of participants
0.086 percentage of participants

SECONDARY outcome

Timeframe: Weeks 29 to 36

Population: Full Analysis Population: All randomized participants who received at least one dose of study medication

Outcome measures

Outcome measures
Measure
Peginesatide
n=524 Participants
Participants received peginesatide by intravenous injection once every 4 weeks. The starting dose was based on the participant's total weekly epoetin alfa dose during the last week of the Screening Period; the first dose was administered one week after the last epoetin alfa dose. The dose was adjusted to maintain hemoglobin levels in a target range of 10.0-12.0 grams per deciliter (g/dL) and ± 1.5 g/dL from baseline during the Titration and Evaluation Periods, and 10.0-12.0 g/dL during the Long-Term Safety and Efficacy Period.
Epoetin Alfa
n=269 Participants
Participants continued to receive commercially available epoetin alfa by intravenous injection, at the same starting dose and frequency as received during the last week of the Screening Period, with the first study dose of epoetin alfa administered after randomization at Week 0. The dose was adjusted to maintain hemoglobin levels in a target range of 10.0-12.0 g/dL and ± 1.5 g/dL from baseline during the Titration and Evaluation Periods, and 10.0-12.0 g/dL during the Long-Term Safety and Efficacy Period.
Proportion of Participants Whose Mean Hemoglobin Level During the Evaluation Period is Within the Target Range of 10.0 - 12.0 Grams Per Deciliter (g/dL)
0.630 percentage of participants
0.717 percentage of participants

Adverse Events

Peginesatide

Serious events: 304 serious events
Other events: 445 other events
Deaths: 0 deaths

Epoetin Alfa

Serious events: 168 serious events
Other events: 235 other events
Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure
Peginesatide
n=524 participants at risk
Participants received peginesatide by intravenous injection once every 4 weeks. The starting dose was based on the participant's total weekly epoetin alfa dose during the last week of the Screening Period; the first dose was administered one week after the last epoetin alfa dose. The dose was adjusted to maintain hemoglobin levels in a target range of 10.0-12.0 grams per deciliter (g/dL) and ± 1.5 g/dL from baseline during the Titration and Evaluation Periods, and 10.0-12.0 g/dL during the Long-Term Safety and Efficacy Period.
Epoetin Alfa
n=269 participants at risk
Participants continued to receive commercially available epoetin alfa by intravenous injection, at the same starting dose and frequency as received during the last week of the Screening Period, with the first study dose of epoetin alfa administered after randomization at Week 0. The dose was adjusted to maintain hemoglobin levels in a target range of 10.0-12.0 g/dL and ± 1.5 g/dL from baseline during the Titration and Evaluation Periods, and 10.0-12.0 g/dL during the Long-Term Safety and Efficacy Period.
Blood and lymphatic system disorders
Anaemia
1.1%
6/524
1.1%
3/269
Blood and lymphatic system disorders
Thrombocytopenia
0.57%
3/524
0.00%
0/269
Blood and lymphatic system disorders
Leukocytosis
0.00%
0/524
0.74%
2/269
Blood and lymphatic system disorders
B-lymphocyte abnormalities
0.19%
1/524
0.00%
0/269
Blood and lymphatic system disorders
Coagulopathy
0.19%
1/524
0.00%
0/269
Blood and lymphatic system disorders
Splenic infarction
0.19%
1/524
0.00%
0/269
Cardiac disorders
Cardiac failure congestive
7.1%
37/524
7.4%
20/269
Cardiac disorders
Acute myocardial infarction
3.6%
19/524
3.3%
9/269
Cardiac disorders
Myocardial infarction
2.5%
13/524
3.3%
9/269
Cardiac disorders
Atrial fibrillation
2.9%
15/524
2.2%
6/269
Cardiac disorders
Cardiac arrest
3.1%
16/524
1.9%
5/269
Cardiac disorders
Coronary artery disease
3.1%
16/524
1.9%
5/269
Cardiac disorders
Angina pectoris
2.3%
12/524
2.6%
7/269
Cardiac disorders
Cardio-respiratory arrest
2.1%
11/524
1.5%
4/269
Cardiac disorders
Atrial flutter
0.76%
4/524
1.1%
3/269
Cardiac disorders
Bradycardia
0.95%
5/524
0.74%
2/269
Cardiac disorders
Acute coronary syndrome
0.57%
3/524
1.1%
3/269
Cardiac disorders
Angina unstable
0.38%
2/524
0.74%
2/269
Cardiac disorders
Cardiomyopathy
0.76%
4/524
0.00%
0/269
Cardiac disorders
Ischaemic cardiomyopathy
0.57%
3/524
0.37%
1/269
Cardiac disorders
Myocardial ischaemia
0.57%
3/524
0.37%
1/269
Cardiac disorders
Ventricular tachycardia
0.38%
2/524
0.74%
2/269
Cardiac disorders
Ventricular fibrillation
0.57%
3/524
0.00%
0/269
Cardiac disorders
Arrhythmia
0.19%
1/524
0.37%
1/269
Cardiac disorders
Atrioventricular block complete
0.19%
1/524
0.37%
1/269
Cardiac disorders
Cardiac failure
0.19%
1/524
0.37%
1/269
Cardiac disorders
Coronary artery stenosis
0.19%
1/524
0.37%
1/269
Cardiac disorders
Pericardial effusion
0.19%
1/524
0.37%
1/269
Cardiac disorders
Supraventricular tachycardia
0.38%
2/524
0.00%
0/269
Cardiac disorders
Aortic valve stenosis
0.19%
1/524
0.00%
0/269
Cardiac disorders
Arteriosclerosis coronary artery
0.19%
1/524
0.00%
0/269
Cardiac disorders
Atrioventricular block second degree
0.19%
1/524
0.00%
0/269
Cardiac disorders
Bradyarrhythmia
0.19%
1/524
0.00%
0/269
Cardiac disorders
Cor pulmonale
0.19%
1/524
0.00%
0/269
Cardiac disorders
Coronary artery occlusion
0.00%
0/524
0.37%
1/269
Cardiac disorders
Cyanosis
0.00%
0/524
0.37%
1/269
Cardiac disorders
Electromechanical dissociation
0.19%
1/524
0.00%
0/269
Cardiac disorders
Hypertensive cardiomyopathy
0.00%
0/524
0.37%
1/269
Cardiac disorders
Hypertensive heart disease
0.00%
0/524
0.37%
1/269
Cardiac disorders
Left ventricular dysfunction
0.19%
1/524
0.00%
0/269
Cardiac disorders
Mitral valve incompetence
0.00%
0/524
0.37%
1/269
Cardiac disorders
Mitral valve stenosis
0.19%
1/524
0.00%
0/269
Cardiac disorders
Palpitations
0.19%
1/524
0.00%
0/269
Cardiac disorders
Pericarditis
0.19%
1/524
0.00%
0/269
Cardiac disorders
Pericarditis uraemic
0.19%
1/524
0.00%
0/269
Cardiac disorders
Sinus bradycardia
0.00%
0/524
0.37%
1/269
Cardiac disorders
Tachycardia
0.19%
1/524
0.00%
0/269
Cardiac disorders
Ventricular arrhythmia
0.19%
1/524
0.00%
0/269
Congenital, familial and genetic disorders
Gastrointestinal arteriovenous malformation
0.00%
0/524
0.37%
1/269
Congenital, familial and genetic disorders
Tuberous sclerosis
0.19%
1/524
0.00%
0/269
Ear and labyrinth disorders
Vertigo positional
0.19%
1/524
0.00%
0/269
Endocrine disorders
Hyperparathyroidism
0.38%
2/524
0.00%
0/269
Endocrine disorders
Hyperparathyroidism secondary
0.00%
0/524
0.37%
1/269
Endocrine disorders
Hyperparathyroidism tertiary
0.00%
0/524
0.37%
1/269
Eye disorders
Retinal detachment
0.19%
1/524
0.00%
0/269
Eye disorders
Vision blurred
0.19%
1/524
0.00%
0/269
Eye disorders
Vitreous haemorrhage
0.19%
1/524
0.00%
0/269
Gastrointestinal disorders
Gastrointestinal haemorrhage
1.7%
9/524
1.9%
5/269
Gastrointestinal disorders
Pancreatitis
1.1%
6/524
1.1%
3/269
Gastrointestinal disorders
Abdominal pain
0.76%
4/524
1.5%
4/269
Gastrointestinal disorders
Diarrhoea
0.95%
5/524
1.1%
3/269
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
0.76%
4/524
1.1%
3/269
Gastrointestinal disorders
Ascites
0.57%
3/524
1.1%
3/269
Gastrointestinal disorders
Diabetic gastroparesis
0.57%
3/524
0.74%
2/269
Gastrointestinal disorders
Gastritis
0.38%
2/524
1.1%
3/269
Gastrointestinal disorders
Colitis
0.38%
2/524
0.74%
2/269
Gastrointestinal disorders
Pancreatitis acute
0.57%
3/524
0.37%
1/269
Gastrointestinal disorders
Mallory-Weiss syndrome
0.57%
3/524
0.00%
0/269
Gastrointestinal disorders
Small intestinal obstruction
0.57%
3/524
0.00%
0/269
Gastrointestinal disorders
Vomiting
0.19%
1/524
0.74%
2/269
Gastrointestinal disorders
Colitis ischaemic
0.38%
2/524
0.00%
0/269
Gastrointestinal disorders
Colonic polyp
0.00%
0/524
0.74%
2/269
Gastrointestinal disorders
Constipation
0.00%
0/524
0.74%
2/269
Gastrointestinal disorders
Diverticulum
0.19%
1/524
0.37%
1/269
Gastrointestinal disorders
Erosive oesophagitis
0.38%
2/524
0.00%
0/269
Gastrointestinal disorders
Gastrooesophageal reflux disease
0.19%
1/524
0.37%
1/269
Gastrointestinal disorders
Haematemesis
0.19%
1/524
0.37%
1/269
Gastrointestinal disorders
Ileus
0.38%
2/524
0.00%
0/269
Gastrointestinal disorders
Intestinal ischaemia
0.38%
2/524
0.00%
0/269
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
0.00%
0/524
0.74%
2/269
Gastrointestinal disorders
Oesophagitis
0.38%
2/524
0.00%
0/269
Gastrointestinal disorders
Abdominal pain lower
0.19%
1/524
0.00%
0/269
Gastrointestinal disorders
Anal fissure
0.00%
0/524
0.37%
1/269
Gastrointestinal disorders
Duodenitis
0.19%
1/524
0.00%
0/269
Gastrointestinal disorders
Gastric ulcer haemorrhage
0.00%
0/524
0.37%
1/269
Gastrointestinal disorders
Gastritis hypertrophic
0.00%
0/524
0.37%
1/269
Gastrointestinal disorders
Gastroduodenitis
0.19%
1/524
0.00%
0/269
Gastrointestinal disorders
Gastrointestinal inflammation
0.19%
1/524
0.00%
0/269
Gastrointestinal disorders
Gastrointestinal necrosis
0.19%
1/524
0.00%
0/269
Gastrointestinal disorders
Haematochezia
0.00%
0/524
0.37%
1/269
Gastrointestinal disorders
Inguinal hernia, obstructive
0.19%
1/524
0.00%
0/269
Gastrointestinal disorders
Intestinal haemorrhage
0.19%
1/524
0.00%
0/269
Gastrointestinal disorders
Intestinal perforation
0.19%
1/524
0.00%
0/269
Gastrointestinal disorders
Intra-abdominal haemorrhage
0.00%
0/524
0.37%
1/269
Gastrointestinal disorders
Large intestinal ulcer haemorrhage
0.00%
0/524
0.37%
1/269
Gastrointestinal disorders
Nausea
0.00%
0/524
0.37%
1/269
Gastrointestinal disorders
Odynophagia
0.19%
1/524
0.00%
0/269
Gastrointestinal disorders
Oesophageal disorder
0.19%
1/524
0.00%
0/269
Gastrointestinal disorders
Oesophageal dysplasia
0.19%
1/524
0.00%
0/269
Gastrointestinal disorders
Oesophageal spasm
0.19%
1/524
0.00%
0/269
Gastrointestinal disorders
Oesophageal ulcer
0.19%
1/524
0.00%
0/269
Gastrointestinal disorders
Peritonitis
0.00%
0/524
0.37%
1/269
Gastrointestinal disorders
Rectal haemorrhage
0.19%
1/524
0.00%
0/269
Gastrointestinal disorders
Retroperitoneal haemorrhage
0.19%
1/524
0.00%
0/269
Gastrointestinal disorders
Short-bowel syndrome
0.19%
1/524
0.00%
0/269
Gastrointestinal disorders
Varices oesophageal
0.00%
0/524
0.37%
1/269
General disorders
Non-cardiac chest pain
2.5%
13/524
3.0%
8/269
General disorders
Chest pain
2.7%
14/524
1.5%
4/269
General disorders
Asthenia
0.76%
4/524
1.9%
5/269
General disorders
Pyrexia
0.95%
5/524
0.74%
2/269
General disorders
Catheter related complication
0.38%
2/524
0.74%
2/269
General disorders
Multi-organ failure
0.38%
2/524
0.37%
1/269
General disorders
Oedema peripheral
0.38%
2/524
0.00%
0/269
General disorders
Adverse drug reaction
0.00%
0/524
0.37%
1/269
General disorders
Catheter site haemorrhage
0.00%
0/524
0.37%
1/269
General disorders
Catheter thrombosis
0.19%
1/524
0.00%
0/269
General disorders
Chills
0.19%
1/524
0.00%
0/269
General disorders
Death
0.00%
0/524
0.37%
1/269
General disorders
Drug withdrawal syndrome
0.19%
1/524
0.00%
0/269
General disorders
Fatigue
0.00%
0/524
0.37%
1/269
General disorders
Local swelling
0.00%
0/524
0.37%
1/269
General disorders
Pain
0.00%
0/524
0.37%
1/269
General disorders
Sudden cardiac death
0.19%
1/524
0.00%
0/269
General disorders
Systemic inflammatory response syndrome
0.00%
0/524
0.37%
1/269
Hepatobiliary disorders
Cholelithiasis
0.76%
4/524
0.37%
1/269
Hepatobiliary disorders
Cholecystitis acute
0.76%
4/524
0.00%
0/269
Hepatobiliary disorders
Cholecystitis
0.19%
1/524
0.74%
2/269
Hepatobiliary disorders
Hepatic cirrhosis
0.00%
0/524
0.74%
2/269
Hepatobiliary disorders
Biliary colic
0.19%
1/524
0.00%
0/269
Hepatobiliary disorders
Gallbladder disorder
0.00%
0/524
0.37%
1/269
Hepatobiliary disorders
Hepatic congestion
0.19%
1/524
0.00%
0/269
Hepatobiliary disorders
Hepatic failure
0.00%
0/524
0.37%
1/269
Hepatobiliary disorders
Hepatic mass
0.00%
0/524
0.37%
1/269
Hepatobiliary disorders
Hepatic steatosis
0.00%
0/524
0.37%
1/269
Hepatobiliary disorders
Jaundice
0.00%
0/524
0.37%
1/269
Immune system disorders
Anaphylactic reaction
0.19%
1/524
0.00%
0/269
Immune system disorders
Iodine allergy
0.19%
1/524
0.00%
0/269
Infections and infestations
Pneumonia
7.1%
37/524
7.1%
19/269
Infections and infestations
Sepsis
2.9%
15/524
4.8%
13/269
Infections and infestations
Cellulitis
2.9%
15/524
3.7%
10/269
Infections and infestations
Gangrene
1.5%
8/524
1.9%
5/269
Infections and infestations
Gastroenteritis
1.5%
8/524
1.9%
5/269
Infections and infestations
Staphylococcal bacteraemia
1.1%
6/524
2.6%
7/269
Infections and infestations
Urinary tract infection
2.1%
11/524
0.74%
2/269
Infections and infestations
Bacteraemia
0.95%
5/524
1.9%
5/269
Infections and infestations
Lobar pneumonia
0.95%
5/524
1.9%
5/269
Infections and infestations
Septic shock
1.1%
6/524
1.5%
4/269
Infections and infestations
Arteriovenous graft site infection
0.38%
2/524
2.6%
7/269
Infections and infestations
Osteomyelitis
0.76%
4/524
1.9%
5/269
Infections and infestations
Staphylococcal sepsis
0.95%
5/524
1.1%
3/269
Infections and infestations
Catheter sepsis
0.38%
2/524
1.9%
5/269
Infections and infestations
Bronchitis
0.76%
4/524
0.74%
2/269
Infections and infestations
Catheter related infection
0.38%
2/524
1.1%
3/269
Infections and infestations
Clostridium difficile colitis
0.57%
3/524
0.74%
2/269
Infections and infestations
Staphylococcal infection
0.57%
3/524
0.74%
2/269
Infections and infestations
Diverticulitis
0.38%
2/524
0.74%
2/269
Infections and infestations
Upper respiratory tract infection
0.38%
2/524
0.74%
2/269
Infections and infestations
Abscess limb
0.19%
1/524
0.74%
2/269
Infections and infestations
Arteriovenous fistula site infection
0.00%
0/524
1.1%
3/269
Infections and infestations
Diabetic foot infection
0.38%
2/524
0.37%
1/269
Infections and infestations
Gastroenteritis viral
0.19%
1/524
0.74%
2/269
Infections and infestations
Localised infection
0.38%
2/524
0.37%
1/269
Infections and infestations
Oesophageal candidiasis
0.38%
2/524
0.37%
1/269
Infections and infestations
Appendicitis
0.38%
2/524
0.00%
0/269
Infections and infestations
Arthritis bacterial
0.19%
1/524
0.37%
1/269
Infections and infestations
Bacterial sepsis
0.19%
1/524
0.37%
1/269
Infections and infestations
Catheter bacteraemia
0.38%
2/524
0.00%
0/269
Infections and infestations
Device related infection
0.19%
1/524
0.37%
1/269
Infections and infestations
Enterocolitis infectious
0.38%
2/524
0.00%
0/269
Infections and infestations
Haematoma infection
0.38%
2/524
0.00%
0/269
Infections and infestations
Influenza
0.19%
1/524
0.37%
1/269
Infections and infestations
Streptococcal bacteraemia
0.38%
2/524
0.00%
0/269
Infections and infestations
Urosepsis
0.38%
2/524
0.00%
0/269
Infections and infestations
Abdominal wall abscess
0.19%
1/524
0.00%
0/269
Infections and infestations
Abscess
0.19%
1/524
0.00%
0/269
Infections and infestations
Abscess neck
0.19%
1/524
0.00%
0/269
Infections and infestations
Arteriosclerotic gangrene
0.00%
0/524
0.37%
1/269
Infections and infestations
Arteriovenous graft site abscess
0.19%
1/524
0.00%
0/269
Infections and infestations
Arthritis infective
0.19%
1/524
0.00%
0/269
Infections and infestations
Bacterial disease carrier
0.19%
1/524
0.00%
0/269
Infections and infestations
Bronchitis pneumococcal
0.19%
1/524
0.00%
0/269
Infections and infestations
Bronchitis viral
0.00%
0/524
0.37%
1/269
Infections and infestations
Campylobacter intestinal infection
0.19%
1/524
0.00%
0/269
Infections and infestations
Candida sepsis
0.00%
0/524
0.37%
1/269
Infections and infestations
Central line infection
0.19%
1/524
0.00%
0/269
Infections and infestations
Chest wall abscess
0.00%
0/524
0.37%
1/269
Infections and infestations
Clostridial infection
0.00%
0/524
0.37%
1/269
Infections and infestations
Emphysematous cystitis
0.19%
1/524
0.00%
0/269
Infections and infestations
Empyema
0.00%
0/524
0.37%
1/269
Infections and infestations
Endocarditis
0.19%
1/524
0.00%
0/269
Infections and infestations
Enterococcal sepsis
0.19%
1/524
0.00%
0/269
Infections and infestations
Escherichia urinary tract infection
0.19%
1/524
0.00%
0/269
Infections and infestations
Genital abscess
0.00%
0/524
0.37%
1/269
Infections and infestations
Groin abscess
0.19%
1/524
0.00%
0/269
Infections and infestations
Herpes zoster
0.00%
0/524
0.37%
1/269
Infections and infestations
Intervertebral discitis
0.19%
1/524
0.00%
0/269
Infections and infestations
Klebsiella bacteraemia
0.19%
1/524
0.00%
0/269
Infections and infestations
Lung infection
0.19%
1/524
0.00%
0/269
Infections and infestations
Necrotising fasciitis
0.19%
1/524
0.00%
0/269
Infections and infestations
Neurosyphilis
0.19%
1/524
0.00%
0/269
Infections and infestations
Osteomyelitis chronic
0.19%
1/524
0.00%
0/269
Infections and infestations
Paronychia
0.19%
1/524
0.00%
0/269
Infections and infestations
Pelvic abscess
0.19%
1/524
0.00%
0/269
Infections and infestations
Pleural infection bacterial
0.00%
0/524
0.37%
1/269
Infections and infestations
Pneumonia bacterial
0.19%
1/524
0.00%
0/269
Infections and infestations
Pneumonia pneumococcal
0.00%
0/524
0.37%
1/269
Infections and infestations
Pneumonia primary atypical
0.19%
1/524
0.00%
0/269
Infections and infestations
Pneumonia staphylococcal
0.00%
0/524
0.37%
1/269
Infections and infestations
Post procedural sepsis
0.00%
0/524
0.37%
1/269
Infections and infestations
Postoperative wound infection
0.19%
1/524
0.00%
0/269
Infections and infestations
Pseudomonal bacteraemia
0.19%
1/524
0.00%
0/269
Infections and infestations
Psoas abscess
0.00%
0/524
0.37%
1/269
Infections and infestations
Pyelonephritis
0.00%
0/524
0.37%
1/269
Infections and infestations
Sepsis syndrome
0.00%
0/524
0.37%
1/269
Infections and infestations
Septic embolus
0.19%
1/524
0.00%
0/269
Infections and infestations
Sinusitis
0.19%
1/524
0.00%
0/269
Infections and infestations
Tracheobronchitis
0.00%
0/524
0.37%
1/269
Infections and infestations
Viral infection
0.00%
0/524
0.37%
1/269
Infections and infestations
Viral upper respiratory tract infection
0.00%
0/524
0.37%
1/269
Infections and infestations
Wound infection
0.00%
0/524
0.37%
1/269
Infections and infestations
Wound infection bacterial
0.00%
0/524
0.37%
1/269
Injury, poisoning and procedural complications
Arteriovenous graft thrombosis
1.1%
6/524
3.0%
8/269
Injury, poisoning and procedural complications
Arteriovenous fistula thrombosis
1.1%
6/524
1.9%
5/269
Injury, poisoning and procedural complications
Post procedural haemorrhage
1.1%
6/524
0.74%
2/269
Injury, poisoning and procedural complications
Arteriovenous fistula site haemorrhage
0.76%
4/524
0.74%
2/269
Injury, poisoning and procedural complications
Femur fracture
0.57%
3/524
0.74%
2/269
Injury, poisoning and procedural complications
Hip fracture
0.57%
3/524
0.74%
2/269
Injury, poisoning and procedural complications
Vascular graft complication
0.19%
1/524
1.5%
4/269
Injury, poisoning and procedural complications
Arteriovenous fistula site complication
0.19%
1/524
1.1%
3/269
Injury, poisoning and procedural complications
Arteriovenous fistula aneurysm
0.57%
3/524
0.00%
0/269
Injury, poisoning and procedural complications
Arteriovenous graft aneurysm
0.19%
1/524
0.74%
2/269
Injury, poisoning and procedural complications
Fall
0.38%
2/524
0.37%
1/269
Injury, poisoning and procedural complications
Arteriovenous graft site haemorrhage
0.00%
0/524
0.74%
2/269
Injury, poisoning and procedural complications
Femoral neck fracture
0.19%
1/524
0.37%
1/269
Injury, poisoning and procedural complications
Head injury
0.00%
0/524
0.74%
2/269
Injury, poisoning and procedural complications
Lower limb fracture
0.38%
2/524
0.00%
0/269
Injury, poisoning and procedural complications
Pelvic fracture
0.19%
1/524
0.37%
1/269
Injury, poisoning and procedural complications
Post procedural haematoma
0.38%
2/524
0.00%
0/269
Injury, poisoning and procedural complications
Procedural hypotension
0.19%
1/524
0.37%
1/269
Injury, poisoning and procedural complications
Thoracic vertebral fracture
0.19%
1/524
0.37%
1/269
Injury, poisoning and procedural complications
Back injury
0.19%
1/524
0.00%
0/269
Injury, poisoning and procedural complications
Cervical vertebral fracture
0.00%
0/524
0.37%
1/269
Injury, poisoning and procedural complications
Contrast media reaction
0.19%
1/524
0.00%
0/269
Injury, poisoning and procedural complications
Contusion
0.19%
1/524
0.00%
0/269
Injury, poisoning and procedural complications
Drug toxicity
0.19%
1/524
0.00%
0/269
Injury, poisoning and procedural complications
Eschar
0.19%
1/524
0.00%
0/269
Injury, poisoning and procedural complications
Facial bones fracture
0.00%
0/524
0.37%
1/269
Injury, poisoning and procedural complications
Fibula fracture
0.19%
1/524
0.00%
0/269
Injury, poisoning and procedural complications
Foot fracture
0.19%
1/524
0.00%
0/269
Injury, poisoning and procedural complications
Fractured sacrum
0.19%
1/524
0.00%
0/269
Injury, poisoning and procedural complications
Gastrointestinal anastomotic leak
0.00%
0/524
0.37%
1/269
Injury, poisoning and procedural complications
Hand fracture
0.19%
1/524
0.00%
0/269
Injury, poisoning and procedural complications
Humerus fracture
0.19%
1/524
0.00%
0/269
Injury, poisoning and procedural complications
Jaw fracture
0.19%
1/524
0.00%
0/269
Injury, poisoning and procedural complications
Open wound
0.19%
1/524
0.00%
0/269
Injury, poisoning and procedural complications
Post procedural haematuria
0.19%
1/524
0.00%
0/269
Injury, poisoning and procedural complications
Postoperative fever
0.19%
1/524
0.00%
0/269
Injury, poisoning and procedural complications
Pubic rami fracture
0.19%
1/524
0.00%
0/269
Injury, poisoning and procedural complications
Rib fracture
0.00%
0/524
0.37%
1/269
Injury, poisoning and procedural complications
Seroma
0.19%
1/524
0.00%
0/269
Injury, poisoning and procedural complications
Skeletal injury
0.19%
1/524
0.00%
0/269
Injury, poisoning and procedural complications
Spinal cord injury cervical
0.19%
1/524
0.00%
0/269
Injury, poisoning and procedural complications
Spinal fracture
0.19%
1/524
0.00%
0/269
Injury, poisoning and procedural complications
Subdural haematoma
0.00%
0/524
0.37%
1/269
Injury, poisoning and procedural complications
Subdural haemorrhage
0.00%
0/524
0.37%
1/269
Injury, poisoning and procedural complications
Tendon rupture
0.19%
1/524
0.00%
0/269
Injury, poisoning and procedural complications
Therapeutic agent toxicity
0.00%
0/524
0.37%
1/269
Injury, poisoning and procedural complications
Tibia fracture
0.19%
1/524
0.00%
0/269
Injury, poisoning and procedural complications
Vascular graft occlusion
0.00%
0/524
0.37%
1/269
Injury, poisoning and procedural complications
Wound
0.19%
1/524
0.00%
0/269
Investigations
Occult blood positive
0.38%
2/524
0.00%
0/269
Investigations
Alanine aminotransferase decreased
0.19%
1/524
0.00%
0/269
Investigations
Anticoagulation drug level above therapeutic
0.19%
1/524
0.00%
0/269
Investigations
Blood alkaline phosphatase increased
0.19%
1/524
0.00%
0/269
Investigations
Blood bilirubin increased
0.19%
1/524
0.00%
0/269
Investigations
Blood pressure increased
0.19%
1/524
0.00%
0/269
Investigations
International normalised ratio decreased
0.19%
1/524
0.00%
0/269
Investigations
International normalised ratio increased
0.19%
1/524
0.00%
0/269
Investigations
Oxygen saturation decreased
0.19%
1/524
0.00%
0/269
Investigations
Prothrombin time shortened
0.19%
1/524
0.00%
0/269
Investigations
Sputum culture positive
0.00%
0/524
0.37%
1/269
Investigations
Transaminases increased
0.19%
1/524
0.00%
0/269
Investigations
Troponin increased
0.19%
1/524
0.00%
0/269
Metabolism and nutrition disorders
Fluid overload
4.0%
21/524
6.7%
18/269
Metabolism and nutrition disorders
Hyperkalaemia
4.6%
24/524
5.6%
15/269
Metabolism and nutrition disorders
Hypoglycaemia
1.5%
8/524
2.6%
7/269
Metabolism and nutrition disorders
Hyperglycaemia
1.3%
7/524
0.37%
1/269
Metabolism and nutrition disorders
Dehydration
0.57%
3/524
1.1%
3/269
Metabolism and nutrition disorders
Diabetic ketoacidosis
0.57%
3/524
0.37%
1/269
Metabolism and nutrition disorders
Hypocalcaemia
0.76%
4/524
0.00%
0/269
Metabolism and nutrition disorders
Diabetes mellitus inadequate control
0.57%
3/524
0.00%
0/269
Metabolism and nutrition disorders
Diabetic foot
0.38%
2/524
0.37%
1/269
Metabolism and nutrition disorders
Hypercalcaemia
0.19%
1/524
0.74%
2/269
Metabolism and nutrition disorders
Hypokalaemia
0.38%
2/524
0.00%
0/269
Metabolism and nutrition disorders
Hyponatraemia
0.19%
1/524
0.37%
1/269
Metabolism and nutrition disorders
Metabolic acidosis
0.38%
2/524
0.00%
0/269
Metabolism and nutrition disorders
Anorexia
0.19%
1/524
0.00%
0/269
Metabolism and nutrition disorders
Cachexia
0.19%
1/524
0.00%
0/269
Metabolism and nutrition disorders
Calciphylaxis
0.00%
0/524
0.37%
1/269
Metabolism and nutrition disorders
Diabetes mellitus
0.00%
0/524
0.37%
1/269
Metabolism and nutrition disorders
Failure to thrive
0.19%
1/524
0.00%
0/269
Metabolism and nutrition disorders
Fluid retention
0.19%
1/524
0.00%
0/269
Metabolism and nutrition disorders
Gout
0.19%
1/524
0.00%
0/269
Metabolism and nutrition disorders
Hypoglycaemic unconsciousness
0.19%
1/524
0.00%
0/269
Metabolism and nutrition disorders
Hypomagnesaemia
0.19%
1/524
0.00%
0/269
Metabolism and nutrition disorders
Hypovolaemia
0.19%
1/524
0.00%
0/269
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
0.57%
3/524
1.1%
3/269
Musculoskeletal and connective tissue disorders
Back pain
0.00%
0/524
0.74%
2/269
Musculoskeletal and connective tissue disorders
Cervical spinal stenosis
0.38%
2/524
0.00%
0/269
Musculoskeletal and connective tissue disorders
Muscular weakness
0.19%
1/524
0.37%
1/269
Musculoskeletal and connective tissue disorders
Osteoarthritis
0.19%
1/524
0.37%
1/269
Musculoskeletal and connective tissue disorders
Pain in extremity
0.19%
1/524
0.37%
1/269
Musculoskeletal and connective tissue disorders
Spinal column stenosis
0.19%
1/524
0.37%
1/269
Musculoskeletal and connective tissue disorders
Arthralgia
0.19%
1/524
0.00%
0/269
Musculoskeletal and connective tissue disorders
Bursitis
0.19%
1/524
0.00%
0/269
Musculoskeletal and connective tissue disorders
Chondrocalcinosis pyrophosphate
0.00%
0/524
0.37%
1/269
Musculoskeletal and connective tissue disorders
Connective tissue disorder
0.00%
0/524
0.37%
1/269
Musculoskeletal and connective tissue disorders
Fasciitis
0.19%
1/524
0.00%
0/269
Musculoskeletal and connective tissue disorders
Flank pain
0.00%
0/524
0.37%
1/269
Musculoskeletal and connective tissue disorders
Intervertebral disc degeneration
0.19%
1/524
0.00%
0/269
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
0.19%
1/524
0.00%
0/269
Musculoskeletal and connective tissue disorders
Muscle twitching
0.19%
1/524
0.00%
0/269
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
0.00%
0/524
0.37%
1/269
Musculoskeletal and connective tissue disorders
Pathological fracture
0.00%
0/524
0.37%
1/269
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
0.00%
0/524
0.37%
1/269
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cell carcinoma
0.76%
4/524
1.1%
3/269
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon adenoma
0.00%
0/524
0.74%
2/269
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
0.38%
2/524
0.00%
0/269
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bile duct cancer
0.00%
0/524
0.37%
1/269
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
0.19%
1/524
0.00%
0/269
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic neoplasm malignant
0.00%
0/524
0.37%
1/269
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Laryngeal cancer
0.19%
1/524
0.00%
0/269
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma metastatic
0.19%
1/524
0.00%
0/269
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung cancer metastatic
0.19%
1/524
0.00%
0/269
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm
0.00%
0/524
0.37%
1/269
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to lung
0.00%
0/524
0.37%
1/269
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neurilemmoma
0.19%
1/524
0.00%
0/269
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-small cell lung cancer
0.19%
1/524
0.00%
0/269
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
0.19%
1/524
0.00%
0/269
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Refractory anaemia
0.19%
1/524
0.00%
0/269
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Retroperitoneal neoplasm
0.00%
0/524
0.37%
1/269
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small cell lung cancer stage unspecified
0.00%
0/524
0.37%
1/269
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tongue neoplasm malignant stage unspecified
0.19%
1/524
0.00%
0/269
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tonsil cancer
0.19%
1/524
0.00%
0/269
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine cancer
0.19%
1/524
0.00%
0/269
Nervous system disorders
Cerebrovascular accident
1.5%
8/524
3.0%
8/269
Nervous system disorders
Syncope
1.1%
6/524
3.0%
8/269
Nervous system disorders
Convulsion
2.3%
12/524
0.37%
1/269
Nervous system disorders
Transient ischaemic attack
0.95%
5/524
1.9%
5/269
Nervous system disorders
Presyncope
0.76%
4/524
0.37%
1/269
Nervous system disorders
Anoxic encephalopathy
0.57%
3/524
0.00%
0/269
Nervous system disorders
Headache
0.57%
3/524
0.00%
0/269
Nervous system disorders
Subarachnoid haemorrhage
0.19%
1/524
0.74%
2/269
Nervous system disorders
Aphasia
0.00%
0/524
0.74%
2/269
Nervous system disorders
Carotid artery stenosis
0.19%
1/524
0.37%
1/269
Nervous system disorders
Cerebral infarction
0.00%
0/524
0.74%
2/269
Nervous system disorders
Cerebral ischaemia
0.19%
1/524
0.37%
1/269
Nervous system disorders
Depressed level of consciousness
0.19%
1/524
0.37%
1/269
Nervous system disorders
Facial palsy
0.38%
2/524
0.00%
0/269
Nervous system disorders
Haemorrhagic stroke
0.19%
1/524
0.37%
1/269
Nervous system disorders
Metabolic encephalopathy
0.19%
1/524
0.37%
1/269
Nervous system disorders
Altered state of consciousness
0.19%
1/524
0.00%
0/269
Nervous system disorders
Cervical myelopathy
0.19%
1/524
0.00%
0/269
Nervous system disorders
Cervicobrachial syndrome
0.19%
1/524
0.00%
0/269
Nervous system disorders
Complex partial seizures
0.00%
0/524
0.37%
1/269
Nervous system disorders
Dementia Alzheimer's type
0.19%
1/524
0.00%
0/269
Nervous system disorders
Diabetic autonomic neuropathy
0.00%
0/524
0.37%
1/269
Nervous system disorders
Embolic stroke
0.00%
0/524
0.37%
1/269
Nervous system disorders
Encephalitis
0.19%
1/524
0.00%
0/269
Nervous system disorders
Encephalopathy
0.19%
1/524
0.00%
0/269
Nervous system disorders
Haemorrhage intracranial
0.19%
1/524
0.00%
0/269
Nervous system disorders
Hypoglycaemic encephalopathy
0.00%
0/524
0.37%
1/269
Nervous system disorders
Ischaemic cerebral infarction
0.19%
1/524
0.00%
0/269
Nervous system disorders
Ischaemic stroke
0.19%
1/524
0.00%
0/269
Nervous system disorders
Lacunar infarction
0.19%
1/524
0.00%
0/269
Nervous system disorders
Lethargy
0.19%
1/524
0.00%
0/269
Nervous system disorders
Lumbar radiculopathy
0.19%
1/524
0.00%
0/269
Nervous system disorders
Myoclonic epilepsy
0.19%
1/524
0.00%
0/269
Nervous system disorders
Myoclonus
0.19%
1/524
0.00%
0/269
Nervous system disorders
Neuropathy peripheral
0.19%
1/524
0.00%
0/269
Nervous system disorders
Reversible ischaemic neurological deficit
0.19%
1/524
0.00%
0/269
Nervous system disorders
Spinal cord compression
0.00%
0/524
0.37%
1/269
Nervous system disorders
Spinal cord infarction
0.19%
1/524
0.00%
0/269
Nervous system disorders
Status epilepticus
0.19%
1/524
0.00%
0/269
Nervous system disorders
Thalamus haemorrhage
0.19%
1/524
0.00%
0/269
Psychiatric disorders
Mental status changes
1.5%
8/524
3.0%
8/269
Psychiatric disorders
Delirium
0.38%
2/524
0.74%
2/269
Psychiatric disorders
Bipolar disorder
0.19%
1/524
0.00%
0/269
Psychiatric disorders
Confusional state
0.00%
0/524
0.37%
1/269
Psychiatric disorders
Depression suicidal
0.19%
1/524
0.00%
0/269
Psychiatric disorders
Homicidal ideation
0.19%
1/524
0.00%
0/269
Psychiatric disorders
Schizophrenia, paranoid type
0.19%
1/524
0.00%
0/269
Psychiatric disorders
Suicidal ideation
0.19%
1/524
0.00%
0/269
Renal and urinary disorders
Renal failure chronic
0.76%
4/524
0.37%
1/269
Renal and urinary disorders
Azotaemia
0.57%
3/524
0.37%
1/269
Renal and urinary disorders
Bladder perforation
0.19%
1/524
0.00%
0/269
Renal and urinary disorders
Hydronephrosis
0.19%
1/524
0.00%
0/269
Renal and urinary disorders
Nephrosclerosis
0.00%
0/524
0.37%
1/269
Renal and urinary disorders
Obstructive uropathy
0.19%
1/524
0.00%
0/269
Renal and urinary disorders
Renal cyst
0.19%
1/524
0.00%
0/269
Renal and urinary disorders
Renal failure
0.19%
1/524
0.00%
0/269
Renal and urinary disorders
Ureteric dilatation
0.00%
0/524
0.37%
1/269
Renal and urinary disorders
Urinary bladder haemorrhage
0.19%
1/524
0.00%
0/269
Reproductive system and breast disorders
Prostatitis
0.38%
2/524
0.00%
0/269
Reproductive system and breast disorders
Breast calcifications
0.19%
1/524
0.00%
0/269
Respiratory, thoracic and mediastinal disorders
Respiratory failure
3.1%
16/524
1.9%
5/269
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
2.9%
15/524
1.9%
5/269
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
1.5%
8/524
2.2%
6/269
Respiratory, thoracic and mediastinal disorders
Dyspnoea
1.9%
10/524
1.5%
4/269
Respiratory, thoracic and mediastinal disorders
Pleural effusion
0.95%
5/524
1.9%
5/269
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
1.1%
6/524
1.1%
3/269
Respiratory, thoracic and mediastinal disorders
Asthma
0.76%
4/524
0.37%
1/269
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
0.76%
4/524
0.37%
1/269
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema
0.38%
2/524
0.74%
2/269
Respiratory, thoracic and mediastinal disorders
Respiratory distress
0.38%
2/524
0.74%
2/269
Respiratory, thoracic and mediastinal disorders
Hypoxia
0.19%
1/524
0.74%
2/269
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
0.57%
3/524
0.00%
0/269
Respiratory, thoracic and mediastinal disorders
Haemoptysis
0.38%
2/524
0.00%
0/269
Respiratory, thoracic and mediastinal disorders
Respiratory arrest
0.38%
2/524
0.00%
0/269
Respiratory, thoracic and mediastinal disorders
Aspiration
0.19%
1/524
0.00%
0/269
Respiratory, thoracic and mediastinal disorders
Bronchospasm
0.19%
1/524
0.00%
0/269
Respiratory, thoracic and mediastinal disorders
Cough
0.00%
0/524
0.37%
1/269
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
0.19%
1/524
0.00%
0/269
Respiratory, thoracic and mediastinal disorders
Emphysema
0.19%
1/524
0.00%
0/269
Respiratory, thoracic and mediastinal disorders
Hiccups
0.19%
1/524
0.00%
0/269
Respiratory, thoracic and mediastinal disorders
Laryngeal stenosis
0.19%
1/524
0.00%
0/269
Respiratory, thoracic and mediastinal disorders
Lung infiltration
0.19%
1/524
0.00%
0/269
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
0.00%
0/524
0.37%
1/269
Respiratory, thoracic and mediastinal disorders
Pneumonitis
0.19%
1/524
0.00%
0/269
Respiratory, thoracic and mediastinal disorders
Pneumothorax
0.00%
0/524
0.37%
1/269
Respiratory, thoracic and mediastinal disorders
Pulmonary congestion
0.19%
1/524
0.00%
0/269
Respiratory, thoracic and mediastinal disorders
Respiratory acidosis
0.19%
1/524
0.00%
0/269
Respiratory, thoracic and mediastinal disorders
Restrictive pulmonary disease
0.19%
1/524
0.00%
0/269
Skin and subcutaneous tissue disorders
Decubitus ulcer
0.19%
1/524
0.74%
2/269
Skin and subcutaneous tissue disorders
Skin ulcer
0.19%
1/524
0.74%
2/269
Skin and subcutaneous tissue disorders
Panniculitis
0.38%
2/524
0.00%
0/269
Skin and subcutaneous tissue disorders
Diabetic ulcer
0.19%
1/524
0.00%
0/269
Skin and subcutaneous tissue disorders
Eczema
0.19%
1/524
0.00%
0/269
Skin and subcutaneous tissue disorders
Skin necrosis
0.19%
1/524
0.00%
0/269
Vascular disorders
Hypotension
3.6%
19/524
2.6%
7/269
Vascular disorders
Hypertension
2.3%
12/524
1.9%
5/269
Vascular disorders
Hypertensive crisis
1.3%
7/524
2.6%
7/269
Vascular disorders
Peripheral vascular disorder
0.76%
4/524
1.5%
4/269
Vascular disorders
Accelerated hypertension
0.57%
3/524
0.37%
1/269
Vascular disorders
Peripheral ischaemia
0.57%
3/524
0.37%
1/269
Vascular disorders
Steal syndrome
0.38%
2/524
0.74%
2/269
Vascular disorders
Deep vein thrombosis
0.19%
1/524
0.74%
2/269
Vascular disorders
Vascular pseudoaneurysm
0.38%
2/524
0.37%
1/269
Vascular disorders
Arteriosclerosis
0.19%
1/524
0.37%
1/269
Vascular disorders
Hypertensive emergency
0.19%
1/524
0.37%
1/269
Vascular disorders
Malignant hypertension
0.38%
2/524
0.00%
0/269
Vascular disorders
Peripheral arterial occlusive disease
0.38%
2/524
0.00%
0/269
Vascular disorders
Vena cava thrombosis
0.38%
2/524
0.00%
0/269
Vascular disorders
Arterial disorder
0.00%
0/524
0.37%
1/269
Vascular disorders
Arterial occlusive disease
0.00%
0/524
0.37%
1/269
Vascular disorders
Essential hypertension
0.19%
1/524
0.00%
0/269
Vascular disorders
Femoral arterial stenosis
0.00%
0/524
0.37%
1/269
Vascular disorders
Haematoma
0.19%
1/524
0.00%
0/269
Vascular disorders
Haemorrhage
0.00%
0/524
0.37%
1/269
Vascular disorders
Jugular vein thrombosis
0.00%
0/524
0.37%
1/269
Vascular disorders
Varicose vein
0.00%
0/524
0.37%
1/269
Vascular disorders
Venous stenosis
0.19%
1/524
0.00%
0/269

Other adverse events

Other adverse events
Measure
Peginesatide
n=524 participants at risk
Participants received peginesatide by intravenous injection once every 4 weeks. The starting dose was based on the participant's total weekly epoetin alfa dose during the last week of the Screening Period; the first dose was administered one week after the last epoetin alfa dose. The dose was adjusted to maintain hemoglobin levels in a target range of 10.0-12.0 grams per deciliter (g/dL) and ± 1.5 g/dL from baseline during the Titration and Evaluation Periods, and 10.0-12.0 g/dL during the Long-Term Safety and Efficacy Period.
Epoetin Alfa
n=269 participants at risk
Participants continued to receive commercially available epoetin alfa by intravenous injection, at the same starting dose and frequency as received during the last week of the Screening Period, with the first study dose of epoetin alfa administered after randomization at Week 0. The dose was adjusted to maintain hemoglobin levels in a target range of 10.0-12.0 g/dL and ± 1.5 g/dL from baseline during the Titration and Evaluation Periods, and 10.0-12.0 g/dL during the Long-Term Safety and Efficacy Period.
Gastrointestinal disorders
Diarrhoea
18.7%
98/524
13.0%
35/269
Gastrointestinal disorders
Nausea
17.0%
89/524
19.0%
51/269
Gastrointestinal disorders
Vomiting
16.4%
86/524
11.9%
32/269
Gastrointestinal disorders
Constipation
7.1%
37/524
12.3%
33/269
Gastrointestinal disorders
Abdominal pain
5.9%
31/524
7.4%
20/269
Gastrointestinal disorders
Abdominal pain upper
5.2%
27/524
4.8%
13/269
Gastrointestinal disorders
Gastrooesophageal reflux disease
3.2%
17/524
7.4%
20/269
Gastrointestinal disorders
Haemorrhoids
1.3%
7/524
5.2%
14/269
General disorders
Pyrexia
11.8%
62/524
14.5%
39/269
General disorders
Oedema peripheral
8.6%
45/524
8.6%
23/269
General disorders
Asthenia
7.8%
41/524
5.9%
16/269
General disorders
Fatigue
6.3%
33/524
7.4%
20/269
General disorders
Pain
4.6%
24/524
5.6%
15/269
General disorders
Chills
3.8%
20/524
5.9%
16/269
Infections and infestations
Upper respiratory tract infection
11.6%
61/524
14.9%
40/269
Infections and infestations
Urinary tract infection
7.6%
40/524
9.7%
26/269
Infections and infestations
Nasopharyngitis
7.1%
37/524
9.3%
25/269
Infections and infestations
Bronchitis
6.7%
35/524
4.5%
12/269
Infections and infestations
Sinusitis
5.2%
27/524
4.8%
13/269
Injury, poisoning and procedural complications
Arteriovenous fistula site complication
14.7%
77/524
16.0%
43/269
Injury, poisoning and procedural complications
Arteriovenous graft thrombosis
8.0%
42/524
8.9%
24/269
Injury, poisoning and procedural complications
Vascular graft complication
7.4%
39/524
8.9%
24/269
Injury, poisoning and procedural complications
Arteriovenous fistula thrombosis
7.3%
38/524
5.6%
15/269
Injury, poisoning and procedural complications
Fall
7.3%
38/524
5.6%
15/269
Injury, poisoning and procedural complications
Procedural hypotension
6.3%
33/524
8.6%
23/269
Injury, poisoning and procedural complications
Arteriovenous fistula site haemorrhage
5.9%
31/524
2.6%
7/269
Metabolism and nutrition disorders
Hyperkalaemia
6.1%
32/524
9.3%
25/269
Metabolism and nutrition disorders
Fluid overload
3.8%
20/524
6.3%
17/269
Musculoskeletal and connective tissue disorders
Muscle spasms
10.9%
57/524
14.9%
40/269
Musculoskeletal and connective tissue disorders
Pain in extremity
10.3%
54/524
11.9%
32/269
Musculoskeletal and connective tissue disorders
Back pain
9.7%
51/524
13.0%
35/269
Musculoskeletal and connective tissue disorders
Arthralgia
9.4%
49/524
9.3%
25/269
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
5.0%
26/524
7.4%
20/269
Nervous system disorders
Headache
14.1%
74/524
14.9%
40/269
Nervous system disorders
Dizziness
10.5%
55/524
12.3%
33/269
Psychiatric disorders
Insomnia
6.5%
34/524
7.4%
20/269
Psychiatric disorders
Anxiety
5.9%
31/524
5.6%
15/269
Respiratory, thoracic and mediastinal disorders
Cough
19.3%
101/524
19.3%
52/269
Respiratory, thoracic and mediastinal disorders
Dyspnoea
17.0%
89/524
19.0%
51/269
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
4.4%
23/524
5.6%
15/269
Skin and subcutaneous tissue disorders
Pruritus
5.2%
27/524
5.9%
16/269
Vascular disorders
Hypotension
9.4%
49/524
10.0%
27/269
Vascular disorders
Hypertension
8.2%
43/524
8.6%
23/269

Additional Information

Vice President, Clinical Development

Affymax

Phone: 650-812-8700

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