MedDataX Logo

Trial Outcomes & Findings for Safety & Efficacy of Peginesatide for Maintenance Treatment of Anemia in Participants With Chronic Kidney Disease on Hemodialysis (NCT NCT00597584)

NCT ID: NCT00597584

Last Updated: 2013-03-08

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

823 participants

Primary outcome timeframe

Baseline to Weeks 29-36

Results posted on

2013-03-08

Participant Flow

Participant milestones

Participant milestones
Measure
Peginesatide
Participants received peginesatide by intravenous (IV) or subcutaneous (SC) injection once every 4 weeks. The starting dose was based on the participant's total weekly epoetin alfa or beta dose during the last week of the Screening Period; the first dose was administered one week after the last epoetin alfa or beta dose. Participants who received epoetin alfa or beta IV at the time of screening received peginesatide IV during the study, and participants who received epoetin alfa or beta SC at the time of screening received peginesatide SC during the study. 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
Participants continued to receive commercially available epoetin alfa or beta by intravenous or subcutaneous injection, at the same starting dose, frequency and route of administration as received during the last week of the Screening Period, with the first study dose of epoetin alfa or beta 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
549
274
Overall Study
COMPLETED
421
211
Overall Study
NOT COMPLETED
128
63

Reasons for withdrawal

Reasons for withdrawal
Measure
Peginesatide
Participants received peginesatide by intravenous (IV) or subcutaneous (SC) injection once every 4 weeks. The starting dose was based on the participant's total weekly epoetin alfa or beta dose during the last week of the Screening Period; the first dose was administered one week after the last epoetin alfa or beta dose. Participants who received epoetin alfa or beta IV at the time of screening received peginesatide IV during the study, and participants who received epoetin alfa or beta SC at the time of screening received peginesatide SC during the study. 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
Participants continued to receive commercially available epoetin alfa or beta by intravenous or subcutaneous injection, at the same starting dose, frequency and route of administration as received during the last week of the Screening Period, with the first study dose of epoetin alfa or beta 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
4
2
Overall Study
Death
53
30
Overall Study
Lack of Efficacy
1
0
Overall Study
Lost to Follow-up
2
4
Overall Study
Physician Decision
3
0
Overall Study
Pregnancy
2
0
Overall Study
Withdrawal by Subject
44
12
Overall Study
Discontinued Dialysis
0
1
Overall Study
Lost ability to consent
1
1
Overall Study
Never dosed
1
0
Overall Study
Relocation
8
6
Overall Study
Renal transplant
9
7

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=542 Participants
Participants received peginesatide by intravenous (IV) or subcutaneous (SC) injection once every 4 weeks. The starting dose was based on the participant's total weekly epoetin alfa or beta dose during the last week of the Screening Period; the first dose was administered one week after the last epoetin alfa or beta dose. Participants who received epoetin alfa or beta IV at the time of screening received peginesatide IV during the study, and participants who received epoetin alfa or beta SC at the time of screening received peginesatide SC during the study. 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
n=273 Participants
Participants continued to receive commercially available epoetin alfa or beta by intravenous or subcutaneous injection, at the same starting dose, frequency and route of administration as received during the last week of the Screening Period, with the first study dose of epoetin alfa or beta 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=815 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
Age, Categorical
Between 18 and 65 years
350 Participants
n=5 Participants
173 Participants
n=7 Participants
523 Participants
n=5 Participants
Age, Categorical
>=65 years
192 Participants
n=5 Participants
100 Participants
n=7 Participants
292 Participants
n=5 Participants
Age Continuous
58.8 years
STANDARD_DEVIATION 14.47 • n=5 Participants
58.6 years
STANDARD_DEVIATION 13.73 • n=7 Participants
58.8 years
STANDARD_DEVIATION 14.22 • n=5 Participants
Sex: Female, Male
Female
211 Participants
n=5 Participants
120 Participants
n=7 Participants
331 Participants
n=5 Participants
Sex: Female, Male
Male
331 Participants
n=5 Participants
153 Participants
n=7 Participants
484 Participants
n=5 Participants

PRIMARY outcome

Timeframe: Baseline to 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=542 Participants
Participants received peginesatide by intravenous (IV) or subcutaneous (SC) injection once every 4 weeks. The starting dose was based on the participant's total weekly epoetin alfa or beta dose during the last week of the Screening Period; the first dose was administered one week after the last epoetin alfa or beta dose. Participants who received epoetin alfa or beta IV at the time of screening received peginesatide IV during the study, and participants who received epoetin alfa or beta SC at the time of screening received peginesatide SC during the study. 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
n=273 Participants
Participants continued to receive commercially available epoetin alfa or beta by intravenous or subcutaneous injection, at the same starting dose, frequency and route of administration as received during the last week of the Screening Period, with the first study dose of epoetin alfa or beta 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=542, 273]
11.20 g/dL
Standard Deviation 0.553
11.21 g/dL
Standard Deviation 0.546
Mean Change in Hemoglobin Between Baseline and the Evaluation Period
Evaluation Period [N=488, 237]
11.13 g/dL
Standard Deviation 1.018
11.05 g/dL
Standard Deviation 0.958
Mean Change in Hemoglobin Between Baseline and the Evaluation Period
Change from Baseline [N=488, 237]
-0.07 g/dL
Standard Deviation 1.009
-0.17 g/dL
Standard Deviation 1.000

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=542 Participants
Participants received peginesatide by intravenous (IV) or subcutaneous (SC) injection once every 4 weeks. The starting dose was based on the participant's total weekly epoetin alfa or beta dose during the last week of the Screening Period; the first dose was administered one week after the last epoetin alfa or beta dose. Participants who received epoetin alfa or beta IV at the time of screening received peginesatide IV during the study, and participants who received epoetin alfa or beta SC at the time of screening received peginesatide SC during the study. 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
n=273 Participants
Participants continued to receive commercially available epoetin alfa or beta by intravenous or subcutaneous injection, at the same starting dose, frequency and route of administration as received during the last week of the Screening Period, with the first study dose of epoetin alfa or beta 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
0.077 percentage of participants
0.099 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=542 Participants
Participants received peginesatide by intravenous (IV) or subcutaneous (SC) injection once every 4 weeks. The starting dose was based on the participant's total weekly epoetin alfa or beta dose during the last week of the Screening Period; the first dose was administered one week after the last epoetin alfa or beta dose. Participants who received epoetin alfa or beta IV at the time of screening received peginesatide IV during the study, and participants who received epoetin alfa or beta SC at the time of screening received peginesatide SC during the study. 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
n=273 Participants
Participants continued to receive commercially available epoetin alfa or beta by intravenous or subcutaneous injection, at the same starting dose, frequency and route of administration as received during the last week of the Screening Period, with the first study dose of epoetin alfa or beta 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)
0.635 percentage of participants
0.659 percentage of participants

Adverse Events

Peginesatide

Serious events: 268 serious events
Other events: 445 other events
Deaths: 0 deaths

Epoetin

Serious events: 141 serious events
Other events: 222 other events
Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure
Peginesatide
n=542 participants at risk
Participants received peginesatide by intravenous (IV) or subcutaneous (SC) injection once every 4 weeks. The starting dose was based on the participant's total weekly epoetin alfa or beta dose during the last week of the Screening Period; the first dose was administered one week after the last epoetin alfa or beta dose. Participants who received epoetin alfa or beta IV at the time of screening received peginesatide IV during the study, and participants who received epoetin alfa or beta SC at the time of screening received peginesatide SC during the study. 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
n=273 participants at risk
Participants continued to receive commercially available epoetin alfa or beta by intravenous or subcutaneous injection, at the same starting dose, frequency and route of administration as received during the last week of the Screening Period, with the first study dose of epoetin alfa or beta 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-small cell lung cancer metastatic
0.18%
1/542
0.00%
0/273
Blood and lymphatic system disorders
Anaemia
0.92%
5/542
1.8%
5/273
Blood and lymphatic system disorders
Coagulopathy
0.37%
2/542
0.37%
1/273
Blood and lymphatic system disorders
Hypoprothrombinaemia
0.00%
0/542
0.37%
1/273
Blood and lymphatic system disorders
Leukocytosis
0.18%
1/542
0.00%
0/273
Blood and lymphatic system disorders
Leukopenia
0.00%
0/542
0.37%
1/273
Blood and lymphatic system disorders
Pancytopenia
0.18%
1/542
0.00%
0/273
Blood and lymphatic system disorders
Thrombocytopenia
0.18%
1/542
0.00%
0/273
Cardiac disorders
Cardiac failure congestive
4.4%
24/542
6.2%
17/273
Cardiac disorders
Acute myocardial infarction
2.0%
11/542
3.3%
9/273
Cardiac disorders
Cardiac arrest
1.5%
8/542
3.3%
9/273
Cardiac disorders
Atrial fibrillation
1.5%
8/542
2.9%
8/273
Cardiac disorders
Coronary artery disease
1.5%
8/542
2.6%
7/273
Cardiac disorders
Myocardial infarction
1.8%
10/542
1.5%
4/273
Cardiac disorders
Angina pectoris
1.3%
7/542
0.73%
2/273
Cardiac disorders
Cardio-respiratory arrest
0.74%
4/542
1.1%
3/273
Cardiac disorders
Bradycardia
0.92%
5/542
0.37%
1/273
Cardiac disorders
Cardiac failure
0.74%
4/542
0.73%
2/273
Cardiac disorders
Angina unstable
0.55%
3/542
0.73%
2/273
Cardiac disorders
Arrhythmia
0.55%
3/542
0.37%
1/273
Cardiac disorders
Sick sinus syndrome
0.18%
1/542
1.1%
3/273
Cardiac disorders
Acute coronary syndrome
0.37%
2/542
0.37%
1/273
Cardiac disorders
Pericarditis
0.18%
1/542
0.73%
2/273
Cardiac disorders
Supraventricular tachycardia
0.37%
2/542
0.37%
1/273
Cardiac disorders
Atrial flutter
0.00%
0/542
0.73%
2/273
Cardiac disorders
Atrial thrombosis
0.18%
1/542
0.37%
1/273
Cardiac disorders
Atrioventricular block complete
0.37%
2/542
0.00%
0/273
Cardiac disorders
Cardiac tamponade
0.37%
2/542
0.00%
0/273
Cardiac disorders
Cardiogenic shock
0.18%
1/542
0.37%
1/273
Cardiac disorders
Myocardial ischaemia
0.18%
1/542
0.37%
1/273
Cardiac disorders
Nodal arrhythmia
0.37%
2/542
0.00%
0/273
Cardiac disorders
Tachycardia
0.00%
0/542
0.73%
2/273
Cardiac disorders
Aortic valve stenosis
0.00%
0/542
0.37%
1/273
Cardiac disorders
Arteriosclerosis coronary artery
0.00%
0/542
0.37%
1/273
Cardiac disorders
Atrial tachycardia
0.18%
1/542
0.00%
0/273
Cardiac disorders
Cardiac failure acute
0.00%
0/542
0.37%
1/273
Cardiac disorders
Cardiomyopathy
0.00%
0/542
0.37%
1/273
Cardiac disorders
Cardiopulmonary failure
0.00%
0/542
0.37%
1/273
Cardiac disorders
Diastolic dysfunction
0.18%
1/542
0.00%
0/273
Cardiac disorders
Dilatation ventricular
0.00%
0/542
0.37%
1/273
Cardiac disorders
Ischaemic cardiomyopathy
0.18%
1/542
0.00%
0/273
Cardiac disorders
Left ventricular dysfunction
0.18%
1/542
0.00%
0/273
Cardiac disorders
Mitral valve disease
0.18%
1/542
0.00%
0/273
Cardiac disorders
Palpitations
0.18%
1/542
0.00%
0/273
Cardiac disorders
Pericardial effusion
0.00%
0/542
0.37%
1/273
Cardiac disorders
Pericarditis uraemic
0.00%
0/542
0.37%
1/273
Cardiac disorders
Sinus tachycardia
0.00%
0/542
0.37%
1/273
Cardiac disorders
Ventricular fibrillation
0.00%
0/542
0.37%
1/273
Cardiac disorders
Ventricular tachycardia
0.18%
1/542
0.00%
0/273
Congenital, familial and genetic disorders
Congenital cystic kidney disease
0.18%
1/542
0.00%
0/273
Endocrine disorders
Hyperparathyroidism
0.37%
2/542
0.00%
0/273
Endocrine disorders
Hyperparathyroidism secondary
0.00%
0/542
0.37%
1/273
Endocrine disorders
Hyperparathyroidism tertiary
0.18%
1/542
0.00%
0/273
Endocrine disorders
Hypothyroidism
0.18%
1/542
0.00%
0/273
Eye disorders
Vision blurred
0.00%
0/542
0.73%
2/273
Gastrointestinal disorders
Gastrointestinal haemorrhage
1.7%
9/542
1.5%
4/273
Gastrointestinal disorders
Gastritis erosive
0.74%
4/542
1.1%
3/273
Gastrointestinal disorders
Gastrooesophageal reflux disease
0.37%
2/542
0.73%
2/273
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
0.55%
3/542
0.37%
1/273
Gastrointestinal disorders
Ascites
0.18%
1/542
0.73%
2/273
Gastrointestinal disorders
Colitis
0.55%
3/542
0.00%
0/273
Gastrointestinal disorders
Diarrhoea
0.37%
2/542
0.37%
1/273
Gastrointestinal disorders
Duodenal ulcer
0.37%
2/542
0.37%
1/273
Gastrointestinal disorders
Gastric ulcer
0.37%
2/542
0.37%
1/273
Gastrointestinal disorders
Gastritis
0.37%
2/542
0.37%
1/273
Gastrointestinal disorders
Appendicitis perforated
0.18%
1/542
0.37%
1/273
Gastrointestinal disorders
Diabetic gastroparesis
0.37%
2/542
0.00%
0/273
Gastrointestinal disorders
Diverticulum
0.18%
1/542
0.37%
1/273
Gastrointestinal disorders
Impaired gastric emptying
0.37%
2/542
0.00%
0/273
Gastrointestinal disorders
Large intestinal ulcer
0.18%
1/542
0.37%
1/273
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
0.37%
2/542
0.00%
0/273
Gastrointestinal disorders
Oesophagitis
0.37%
2/542
0.00%
0/273
Gastrointestinal disorders
Oesophagitis haemorrhagic
0.18%
1/542
0.37%
1/273
Gastrointestinal disorders
Pancreatitis
0.37%
2/542
0.00%
0/273
Gastrointestinal disorders
Pancreatitis acute
0.18%
1/542
0.37%
1/273
Gastrointestinal disorders
Rectal haemorrhage
0.37%
2/542
0.00%
0/273
Gastrointestinal disorders
Vomiting
0.37%
2/542
0.00%
0/273
Gastrointestinal disorders
Abdominal discomfort
0.00%
0/542
0.37%
1/273
Gastrointestinal disorders
Abdominal mass
0.18%
1/542
0.00%
0/273
Gastrointestinal disorders
Abdominal pain
0.00%
0/542
0.37%
1/273
Gastrointestinal disorders
Colitis ischaemic
0.18%
1/542
0.00%
0/273
Gastrointestinal disorders
Colonic polyp
0.18%
1/542
0.00%
0/273
Gastrointestinal disorders
Constipation
0.18%
1/542
0.00%
0/273
Gastrointestinal disorders
Crohn's disease
0.18%
1/542
0.00%
0/273
Gastrointestinal disorders
Diverticulum intestinal haemorrhagic
0.00%
0/542
0.37%
1/273
Gastrointestinal disorders
Duodenal ulcer haemorrhage
0.18%
1/542
0.00%
0/273
Gastrointestinal disorders
Erosive oesophagitis
0.18%
1/542
0.00%
0/273
Gastrointestinal disorders
Gastritis atrophic
0.18%
1/542
0.00%
0/273
Gastrointestinal disorders
Gastroduodenitis
0.18%
1/542
0.00%
0/273
Gastrointestinal disorders
Gastrointestinal necrosis
0.18%
1/542
0.00%
0/273
Gastrointestinal disorders
Gingivitis ulcerative
0.18%
1/542
0.00%
0/273
Gastrointestinal disorders
Haematemesis
0.18%
1/542
0.00%
0/273
Gastrointestinal disorders
Haematochezia
0.00%
0/542
0.37%
1/273
Gastrointestinal disorders
Haemorrhoidal haemorrhage
0.00%
0/542
0.37%
1/273
Gastrointestinal disorders
Hiatus hernia
0.00%
0/542
0.37%
1/273
Gastrointestinal disorders
Inguinal hernia
0.18%
1/542
0.00%
0/273
Gastrointestinal disorders
Intestinal angina
0.18%
1/542
0.00%
0/273
Gastrointestinal disorders
Intestinal haemorrhage
0.00%
0/542
0.37%
1/273
Gastrointestinal disorders
Intestinal obstruction
0.00%
0/542
0.37%
1/273
Gastrointestinal disorders
Mallory-Weiss syndrome
0.18%
1/542
0.00%
0/273
Gastrointestinal disorders
Nausea
0.18%
1/542
0.00%
0/273
Gastrointestinal disorders
Oesophageal achalasia
0.18%
1/542
0.00%
0/273
Gastrointestinal disorders
Oesophageal ulcer
0.18%
1/542
0.00%
0/273
Gastrointestinal disorders
Oesophagitis ulcerative
0.18%
1/542
0.00%
0/273
Gastrointestinal disorders
Peptic ulcer perforation
0.18%
1/542
0.00%
0/273
Gastrointestinal disorders
Peritonitis
0.18%
1/542
0.00%
0/273
Gastrointestinal disorders
Small intestinal haemorrhage
0.00%
0/542
0.37%
1/273
Gastrointestinal disorders
Small intestinal obstruction
0.18%
1/542
0.00%
0/273
Gastrointestinal disorders
Umbilical hernia, obstructive
0.18%
1/542
0.00%
0/273
General disorders
Non-cardiac chest pain
1.8%
10/542
1.5%
4/273
General disorders
Chest pain
1.5%
8/542
1.8%
5/273
General disorders
Pyrexia
0.37%
2/542
1.8%
5/273
General disorders
Death
0.55%
3/542
0.73%
2/273
General disorders
Asthenia
0.55%
3/542
0.37%
1/273
General disorders
Catheter related complication
0.18%
1/542
0.73%
2/273
General disorders
Catheter thrombosis
0.37%
2/542
0.37%
1/273
General disorders
Chills
0.18%
1/542
0.00%
0/273
General disorders
Gait disturbance
0.00%
0/542
0.37%
1/273
General disorders
Generalised oedema
0.00%
0/542
0.37%
1/273
General disorders
Ischaemic ulcer
0.18%
1/542
0.00%
0/273
General disorders
Oedema
0.18%
1/542
0.00%
0/273
General disorders
Sudden cardiac death
0.18%
1/542
0.00%
0/273
General disorders
Systemic inflammatory response syndrome
0.00%
0/542
0.37%
1/273
Hepatobiliary disorders
Cholecystitis acute
0.55%
3/542
0.37%
1/273
Hepatobiliary disorders
Cholecystitis
0.18%
1/542
0.37%
1/273
Hepatobiliary disorders
Cholelithiasis
0.18%
1/542
0.37%
1/273
Hepatobiliary disorders
Bile duct stone
0.18%
1/542
0.00%
0/273
Hepatobiliary disorders
Cholangitis acute
0.18%
1/542
0.00%
0/273
Hepatobiliary disorders
Cholecystitis chronic
0.18%
1/542
0.00%
0/273
Hepatobiliary disorders
Hepatitis
0.18%
1/542
0.00%
0/273
Immune system disorders
Anaphylactic reaction
0.18%
1/542
0.00%
0/273
Immune system disorders
Anaphylactic shock
0.18%
1/542
0.00%
0/273
Immune system disorders
Contrast media allergy
0.18%
1/542
0.00%
0/273
Infections and infestations
Pneumonia
5.7%
31/542
4.4%
12/273
Infections and infestations
Sepsis
3.7%
20/542
4.8%
13/273
Infections and infestations
Cellulitis
3.5%
19/542
1.8%
5/273
Infections and infestations
Gastroenteritis
1.1%
6/542
1.5%
4/273
Infections and infestations
Bacteraemia
1.3%
7/542
0.73%
2/273
Infections and infestations
Urinary tract infection
1.3%
7/542
0.37%
1/273
Infections and infestations
Bronchitis
0.92%
5/542
0.73%
2/273
Infections and infestations
Osteomyelitis
0.74%
4/542
1.1%
3/273
Infections and infestations
Catheter related infection
0.74%
4/542
0.73%
2/273
Infections and infestations
Gangrene
0.74%
4/542
0.73%
2/273
Infections and infestations
Arteriovenous fistula site infection
0.37%
2/542
1.1%
3/273
Infections and infestations
Clostridium difficile colitis
0.92%
5/542
0.00%
0/273
Infections and infestations
Septic shock
0.37%
2/542
1.1%
3/273
Infections and infestations
Bronchopneumonia
0.37%
2/542
0.73%
2/273
Infections and infestations
Localised infection
0.37%
2/542
0.73%
2/273
Infections and infestations
Arteriovenous graft site infection
0.37%
2/542
0.37%
1/273
Infections and infestations
Pneumonia staphylococcal
0.18%
1/542
0.73%
2/273
Infections and infestations
Staphylococcal bacteraemia
0.37%
2/542
0.37%
1/273
Infections and infestations
Staphylococcal sepsis
0.18%
1/542
0.73%
2/273
Infections and infestations
Wound infection staphylococcal
0.18%
1/542
0.73%
2/273
Infections and infestations
Abdominal abscess
0.18%
1/542
0.37%
1/273
Infections and infestations
Abscess
0.37%
2/542
0.00%
0/273
Infections and infestations
Appendicitis
0.00%
0/542
0.73%
2/273
Infections and infestations
Arthritis infective
0.37%
2/542
0.00%
0/273
Infections and infestations
Clostridium difficile sepsis
0.37%
2/542
0.00%
0/273
Infections and infestations
Diabetic foot infection
0.37%
2/542
0.00%
0/273
Infections and infestations
Diverticulitis
0.18%
1/542
0.37%
1/273
Infections and infestations
Empyema
0.37%
2/542
0.00%
0/273
Infections and infestations
Endocarditis
0.18%
1/542
0.37%
1/273
Infections and infestations
Enterococcal sepsis
0.37%
2/542
0.00%
0/273
Infections and infestations
Hepatitis B
0.37%
2/542
0.00%
0/273
Infections and infestations
Influenza
0.37%
2/542
0.00%
0/273
Infections and infestations
Lobar pneumonia
0.18%
1/542
0.37%
1/273
Infections and infestations
Lower respiratory tract infection
0.37%
2/542
0.00%
0/273
Infections and infestations
Necrotising fasciitis
0.18%
1/542
0.37%
1/273
Infections and infestations
Osteomyelitis chronic
0.18%
1/542
0.37%
1/273
Infections and infestations
Pyelonephritis chronic
0.00%
0/542
0.73%
2/273
Infections and infestations
Sepsis syndrome
0.18%
1/542
0.37%
1/273
Infections and infestations
Staphylococcal infection
0.18%
1/542
0.37%
1/273
Infections and infestations
Upper respiratory tract infection
0.18%
1/542
0.37%
1/273
Infections and infestations
Viral upper respiratory tract infection
0.18%
1/542
0.37%
1/273
Infections and infestations
Abscess limb
0.00%
0/542
0.37%
1/273
Infections and infestations
Bacterial sepsis
0.00%
0/542
0.37%
1/273
Infections and infestations
Bronchitis bacterial
0.18%
1/542
0.00%
0/273
Infections and infestations
Cystitis
0.18%
1/542
0.00%
0/273
Infections and infestations
Diabetic gangrene
0.00%
0/542
0.37%
1/273
Infections and infestations
Groin abscess
0.18%
1/542
0.00%
0/273
Infections and infestations
Hepatitis C
0.18%
1/542
0.00%
0/273
Infections and infestations
Herpes zoster
0.00%
0/542
0.37%
1/273
Infections and infestations
Incision site infection
0.18%
1/542
0.00%
0/273
Infections and infestations
Infected skin ulcer
0.00%
0/542
0.37%
1/273
Infections and infestations
Klebsiella bacteraemia
0.18%
1/542
0.00%
0/273
Infections and infestations
Liver abscess
0.18%
1/542
0.00%
0/273
Infections and infestations
Mastoiditis
0.18%
1/542
0.00%
0/273
Infections and infestations
Nasopharyngitis
0.00%
0/542
0.37%
1/273
Infections and infestations
Otitis externa
0.00%
0/542
0.37%
1/273
Infections and infestations
Perinephric abscess
0.18%
1/542
0.00%
0/273
Infections and infestations
Perirectal abscess
0.18%
1/542
0.00%
0/273
Infections and infestations
Pneumonia fungal
0.18%
1/542
0.00%
0/273
Infections and infestations
Post procedural sepsis
0.18%
1/542
0.00%
0/273
Infections and infestations
Postoperative abscess
0.18%
1/542
0.00%
0/273
Infections and infestations
Postoperative wound infection
0.18%
1/542
0.00%
0/273
Infections and infestations
Respiratory tract infection
0.18%
1/542
0.00%
0/273
Infections and infestations
Skin infection
0.00%
0/542
0.37%
1/273
Infections and infestations
Streptococcal bacteraemia
0.18%
1/542
0.00%
0/273
Infections and infestations
Streptococcal sepsis
0.00%
0/542
0.37%
1/273
Infections and infestations
Subcutaneous abscess
0.00%
0/542
0.37%
1/273
Infections and infestations
Tooth abscess
0.00%
0/542
0.37%
1/273
Infections and infestations
Tuberculous pleurisy
0.00%
0/542
0.37%
1/273
Infections and infestations
Viraemia
0.00%
0/542
0.37%
1/273
Infections and infestations
Viral infection
0.18%
1/542
0.00%
0/273
Infections and infestations
Wound sepsis
0.18%
1/542
0.00%
0/273
Injury, poisoning and procedural complications
Arteriovenous fistula thrombosis
1.8%
10/542
2.2%
6/273
Injury, poisoning and procedural complications
Arteriovenous fistula site haemorrhage
0.92%
5/542
0.73%
2/273
Injury, poisoning and procedural complications
Arteriovenous fistula site complication
0.18%
1/542
1.8%
5/273
Injury, poisoning and procedural complications
Arteriovenous graft thrombosis
0.55%
3/542
1.1%
3/273
Injury, poisoning and procedural complications
Arteriovenous graft site haemorrhage
0.74%
4/542
0.37%
1/273
Injury, poisoning and procedural complications
Hip fracture
0.55%
3/542
0.73%
2/273
Injury, poisoning and procedural complications
Vascular graft complication
0.74%
4/542
0.37%
1/273
Injury, poisoning and procedural complications
Femur fracture
0.18%
1/542
1.1%
3/273
Injury, poisoning and procedural complications
Arteriovenous fistula aneurysm
0.55%
3/542
0.00%
0/273
Injury, poisoning and procedural complications
Complications of transplanted kidney
0.55%
3/542
0.00%
0/273
Injury, poisoning and procedural complications
Fall
0.37%
2/542
0.37%
1/273
Injury, poisoning and procedural complications
Pelvic fracture
0.18%
1/542
0.37%
1/273
Injury, poisoning and procedural complications
Post procedural haemorrhage
0.37%
2/542
0.00%
0/273
Injury, poisoning and procedural complications
Procedural hypotension
0.18%
1/542
0.37%
1/273
Injury, poisoning and procedural complications
Subdural haematoma
0.00%
0/542
0.73%
2/273
Injury, poisoning and procedural complications
Therapeutic product contamination
0.37%
2/542
0.00%
0/273
Injury, poisoning and procedural complications
Ankle fracture
0.18%
1/542
0.00%
0/273
Injury, poisoning and procedural complications
Arteriovenous fistula occlusion
0.18%
1/542
0.00%
0/273
Injury, poisoning and procedural complications
Cervical vertebral fracture
0.18%
1/542
0.00%
0/273
Injury, poisoning and procedural complications
Concussion
0.18%
1/542
0.00%
0/273
Injury, poisoning and procedural complications
Delayed recovery from anaesthesia
0.18%
1/542
0.00%
0/273
Injury, poisoning and procedural complications
Drug toxicity
0.18%
1/542
0.00%
0/273
Injury, poisoning and procedural complications
Excoriation
0.00%
0/542
0.37%
1/273
Injury, poisoning and procedural complications
Femoral neck fracture
0.18%
1/542
0.00%
0/273
Injury, poisoning and procedural complications
Fibula fracture
0.18%
1/542
0.00%
0/273
Injury, poisoning and procedural complications
Foot fracture
0.18%
1/542
0.00%
0/273
Injury, poisoning and procedural complications
Graft thrombosis
0.18%
1/542
0.00%
0/273
Injury, poisoning and procedural complications
Humerus fracture
0.00%
0/542
0.37%
1/273
Injury, poisoning and procedural complications
Implantable defibrillator malfunction
0.18%
1/542
0.00%
0/273
Injury, poisoning and procedural complications
Joint injury
0.00%
0/542
0.37%
1/273
Injury, poisoning and procedural complications
Lower limb fracture
0.18%
1/542
0.00%
0/273
Injury, poisoning and procedural complications
Muscle strain
0.18%
1/542
0.00%
0/273
Injury, poisoning and procedural complications
Operative haemorrhage
0.18%
1/542
0.00%
0/273
Injury, poisoning and procedural complications
Patella fracture
0.18%
1/542
0.00%
0/273
Injury, poisoning and procedural complications
Post procedural complication
0.18%
1/542
0.00%
0/273
Injury, poisoning and procedural complications
Postoperative wound complication
0.18%
1/542
0.00%
0/273
Injury, poisoning and procedural complications
Procedural nausea
0.18%
1/542
0.00%
0/273
Injury, poisoning and procedural complications
Procedural vomiting
0.18%
1/542
0.00%
0/273
Injury, poisoning and procedural complications
Renal haematoma
0.00%
0/542
0.37%
1/273
Injury, poisoning and procedural complications
Road traffic accident
0.18%
1/542
0.00%
0/273
Injury, poisoning and procedural complications
Shunt thrombosis
0.18%
1/542
0.00%
0/273
Injury, poisoning and procedural complications
Skin laceration
0.00%
0/542
0.37%
1/273
Injury, poisoning and procedural complications
Stent occlusion
0.18%
1/542
0.00%
0/273
Injury, poisoning and procedural complications
Subcutaneous haematoma
0.18%
1/542
0.00%
0/273
Injury, poisoning and procedural complications
Therapeutic agent toxicity
0.18%
1/542
0.00%
0/273
Injury, poisoning and procedural complications
Thermal burn
0.18%
1/542
0.00%
0/273
Injury, poisoning and procedural complications
Tibia fracture
0.18%
1/542
0.00%
0/273
Injury, poisoning and procedural complications
Transplant failure
0.18%
1/542
0.00%
0/273
Injury, poisoning and procedural complications
Traumatic haematoma
0.18%
1/542
0.00%
0/273
Injury, poisoning and procedural complications
Upper limb fracture
0.00%
0/542
0.37%
1/273
Injury, poisoning and procedural complications
Urinary anastomotic leak
0.18%
1/542
0.00%
0/273
Injury, poisoning and procedural complications
Wrist fracture
0.00%
0/542
0.37%
1/273
Investigations
Blood pressure increased
0.18%
1/542
0.00%
0/273
Investigations
Cardiac enzymes increased
0.18%
1/542
0.00%
0/273
Investigations
Electrocardiogram QT prolonged
0.18%
1/542
0.00%
0/273
Investigations
Weight decreased
0.18%
1/542
0.00%
0/273
Metabolism and nutrition disorders
Hyperkalaemia
4.6%
25/542
2.9%
8/273
Metabolism and nutrition disorders
Fluid overload
3.7%
20/542
3.3%
9/273
Metabolism and nutrition disorders
Hypoglycaemia
1.5%
8/542
2.2%
6/273
Metabolism and nutrition disorders
Diabetic foot
0.74%
4/542
0.37%
1/273
Metabolism and nutrition disorders
Calciphylaxis
0.55%
3/542
0.00%
0/273
Metabolism and nutrition disorders
Diabetes mellitus inadequate control
0.18%
1/542
0.37%
1/273
Metabolism and nutrition disorders
Diabetic ketoacidosis
0.18%
1/542
0.37%
1/273
Metabolism and nutrition disorders
Hypocalcaemia
0.00%
0/542
0.73%
2/273
Metabolism and nutrition disorders
Hypomagnesaemia
0.37%
2/542
0.00%
0/273
Metabolism and nutrition disorders
Malnutrition
0.37%
2/542
0.00%
0/273
Metabolism and nutrition disorders
Acidosis
0.00%
0/542
0.37%
1/273
Metabolism and nutrition disorders
Cachexia
0.00%
0/542
0.37%
1/273
Metabolism and nutrition disorders
Dehydration
0.00%
0/542
0.37%
1/273
Metabolism and nutrition disorders
Diabetes mellitus
0.18%
1/542
0.00%
0/273
Metabolism and nutrition disorders
Fluid retention
0.00%
0/542
0.37%
1/273
Metabolism and nutrition disorders
Hypercalcaemia
0.18%
1/542
0.00%
0/273
Metabolism and nutrition disorders
Hyperglycaemia
0.00%
0/542
0.37%
1/273
Metabolism and nutrition disorders
Hypovolaemia
0.18%
1/542
0.00%
0/273
Metabolism and nutrition disorders
Metabolic acidosis
0.18%
1/542
0.00%
0/273
Metabolism and nutrition disorders
Vitamin B12 deficiency
0.18%
1/542
0.00%
0/273
Musculoskeletal and connective tissue disorders
Back pain
0.37%
2/542
0.37%
1/273
Musculoskeletal and connective tissue disorders
Muscular weakness
0.18%
1/542
0.73%
2/273
Musculoskeletal and connective tissue disorders
Osteoarthritis
0.55%
3/542
0.00%
0/273
Musculoskeletal and connective tissue disorders
Arthralgia
0.00%
0/542
0.37%
1/273
Musculoskeletal and connective tissue disorders
Diabetic amyotrophy
0.00%
0/542
0.37%
1/273
Musculoskeletal and connective tissue disorders
Intervertebral disc degeneration
0.00%
0/542
0.37%
1/273
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
0.18%
1/542
0.00%
0/273
Musculoskeletal and connective tissue disorders
Scleroderma
0.18%
1/542
0.00%
0/273
Musculoskeletal and connective tissue disorders
Spinal column stenosis
0.18%
1/542
0.00%
0/273
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cell carcinoma
0.18%
1/542
0.37%
1/273
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Anal neoplasm
0.18%
1/542
0.00%
0/273
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon neoplasm
0.18%
1/542
0.00%
0/273
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Diffuse large B-cell lymphoma
0.00%
0/542
0.37%
1/273
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic neoplasm malignant
0.00%
0/542
0.37%
1/273
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm
0.18%
1/542
0.00%
0/273
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neuroendocrine tumour
0.18%
1/542
0.00%
0/273
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-small cell lung cancer
0.00%
0/542
0.37%
1/273
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal carcinoma
0.18%
1/542
0.00%
0/273
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma
0.18%
1/542
0.00%
0/273
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic neoplasm
0.18%
1/542
0.00%
0/273
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tongue neoplasm malignant stage unspecified
0.18%
1/542
0.00%
0/273
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Transitional cell carcinoma
0.18%
1/542
0.00%
0/273
Nervous system disorders
Cerebrovascular accident
2.0%
11/542
1.5%
4/273
Nervous system disorders
Syncope
0.92%
5/542
0.73%
2/273
Nervous system disorders
Convulsion
0.55%
3/542
1.1%
3/273
Nervous system disorders
Transient ischaemic attack
0.18%
1/542
1.1%
3/273
Nervous system disorders
Anoxic encephalopathy
0.37%
2/542
0.37%
1/273
Nervous system disorders
Cerebral haemorrhage
0.00%
0/542
0.73%
2/273
Nervous system disorders
Cerebral infarction
0.37%
2/542
0.00%
0/273
Nervous system disorders
Encephalopathy
0.37%
2/542
0.00%
0/273
Nervous system disorders
Ischaemic stroke
0.18%
1/542
0.37%
1/273
Nervous system disorders
Presyncope
0.37%
2/542
0.00%
0/273
Nervous system disorders
Subarachnoid haemorrhage
0.00%
0/542
0.73%
2/273
Nervous system disorders
Brain oedema
0.00%
0/542
0.37%
1/273
Nervous system disorders
Brain stem infarction
0.00%
0/542
0.37%
1/273
Nervous system disorders
Carotid artery stenosis
0.00%
0/542
0.37%
1/273
Nervous system disorders
Cerebral haematoma
0.18%
1/542
0.00%
0/273
Nervous system disorders
Cerebral ischaemia
0.18%
1/542
0.00%
0/273
Nervous system disorders
Coma
0.18%
1/542
0.00%
0/273
Nervous system disorders
Diabetic autonomic neuropathy
0.18%
1/542
0.00%
0/273
Nervous system disorders
Dizziness
0.18%
1/542
0.00%
0/273
Nervous system disorders
Embolic stroke
0.00%
0/542
0.37%
1/273
Nervous system disorders
Facial palsy
0.18%
1/542
0.00%
0/273
Nervous system disorders
Grand mal convulsion
0.18%
1/542
0.00%
0/273
Nervous system disorders
Haemorrhage intracranial
0.00%
0/542
0.37%
1/273
Nervous system disorders
Headache
0.18%
1/542
0.00%
0/273
Nervous system disorders
Hypertensive encephalopathy
0.18%
1/542
0.00%
0/273
Nervous system disorders
Hypoglycaemic encephalopathy
0.00%
0/542
0.37%
1/273
Nervous system disorders
Hypoxic encephalopathy
0.18%
1/542
0.00%
0/273
Nervous system disorders
IIIrd nerve paralysis
0.18%
1/542
0.00%
0/273
Nervous system disorders
Intracranial aneurysm
0.18%
1/542
0.00%
0/273
Nervous system disorders
Myelopathy
0.18%
1/542
0.00%
0/273
Nervous system disorders
Neuropathy peripheral
0.18%
1/542
0.00%
0/273
Nervous system disorders
Neurotoxicity
0.18%
1/542
0.00%
0/273
Nervous system disorders
Parkinson's disease
0.00%
0/542
0.37%
1/273
Nervous system disorders
Radiculopathy
0.00%
0/542
0.37%
1/273
Nervous system disorders
Sensory disturbance
0.00%
0/542
0.37%
1/273
Nervous system disorders
Syncope vasovagal
0.00%
0/542
0.37%
1/273
Nervous system disorders
Tardive dyskinesia
0.18%
1/542
0.00%
0/273
Nervous system disorders
Thrombotic stroke
0.18%
1/542
0.00%
0/273
Pregnancy, puerperium and perinatal conditions
Pregnancy
0.18%
1/542
0.00%
0/273
Psychiatric disorders
Mental status changes
0.92%
5/542
1.1%
3/273
Psychiatric disorders
Acute psychosis
0.18%
1/542
0.00%
0/273
Psychiatric disorders
Depression
0.18%
1/542
0.00%
0/273
Psychiatric disorders
Hallucination
0.18%
1/542
0.00%
0/273
Renal and urinary disorders
Azotaemia
0.37%
2/542
0.37%
1/273
Renal and urinary disorders
Renal failure chronic
0.55%
3/542
0.00%
0/273
Renal and urinary disorders
Haematuria
0.18%
1/542
0.00%
0/273
Renal and urinary disorders
Hydronephrosis
0.18%
1/542
0.00%
0/273
Renal and urinary disorders
Pyuria
0.18%
1/542
0.00%
0/273
Renal and urinary disorders
Renal failure acute
0.18%
1/542
0.00%
0/273
Renal and urinary disorders
Renal haemorrhage
0.18%
1/542
0.00%
0/273
Renal and urinary disorders
Ureteric dilatation
0.18%
1/542
0.00%
0/273
Renal and urinary disorders
Urethral stenosis
0.18%
1/542
0.00%
0/273
Renal and urinary disorders
Urinary retention
0.18%
1/542
0.00%
0/273
Renal and urinary disorders
Urinary tract inflammation
0.18%
1/542
0.00%
0/273
Reproductive system and breast disorders
Benign prostatic hyperplasia
0.18%
1/542
0.00%
0/273
Reproductive system and breast disorders
Penile necrosis
0.00%
0/542
0.37%
1/273
Respiratory, thoracic and mediastinal disorders
Respiratory failure
3.0%
16/542
2.6%
7/273
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
1.5%
8/542
3.3%
9/273
Respiratory, thoracic and mediastinal disorders
Pleural effusion
1.3%
7/542
0.73%
2/273
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
1.1%
6/542
0.00%
0/273
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
0.55%
3/542
1.1%
3/273
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
0.55%
3/542
0.73%
2/273
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
0.55%
3/542
0.37%
1/273
Respiratory, thoracic and mediastinal disorders
Asthma
0.37%
2/542
0.00%
0/273
Respiratory, thoracic and mediastinal disorders
Haemothorax
0.18%
1/542
0.37%
1/273
Respiratory, thoracic and mediastinal disorders
Pneumonitis
0.37%
2/542
0.00%
0/273
Respiratory, thoracic and mediastinal disorders
Respiratory arrest
0.18%
1/542
0.37%
1/273
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema
0.00%
0/542
0.37%
1/273
Respiratory, thoracic and mediastinal disorders
Asphyxia
0.18%
1/542
0.00%
0/273
Respiratory, thoracic and mediastinal disorders
Aspiration
0.00%
0/542
0.37%
1/273
Respiratory, thoracic and mediastinal disorders
Choking
0.18%
1/542
0.00%
0/273
Respiratory, thoracic and mediastinal disorders
Cough
0.00%
0/542
0.37%
1/273
Respiratory, thoracic and mediastinal disorders
Dyspnoea
0.18%
1/542
0.00%
0/273
Respiratory, thoracic and mediastinal disorders
Haemoptysis
0.18%
1/542
0.00%
0/273
Respiratory, thoracic and mediastinal disorders
Hypoxia
0.00%
0/542
0.37%
1/273
Respiratory, thoracic and mediastinal disorders
Pleurisy
0.18%
1/542
0.00%
0/273
Respiratory, thoracic and mediastinal disorders
Pneumothorax
0.00%
0/542
0.37%
1/273
Respiratory, thoracic and mediastinal disorders
Pulmonary cavitation
0.18%
1/542
0.00%
0/273
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
0.18%
1/542
0.00%
0/273
Respiratory, thoracic and mediastinal disorders
Pulmonary mass
0.18%
1/542
0.00%
0/273
Respiratory, thoracic and mediastinal disorders
Respiratory distress
0.00%
0/542
0.37%
1/273
Skin and subcutaneous tissue disorders
Skin ulcer
0.37%
2/542
0.00%
0/273
Skin and subcutaneous tissue disorders
Angioedema
0.18%
1/542
0.00%
0/273
Skin and subcutaneous tissue disorders
Decubitus ulcer
0.00%
0/542
0.37%
1/273
Skin and subcutaneous tissue disorders
Dry gangrene
0.00%
0/542
0.37%
1/273
Skin and subcutaneous tissue disorders
Pruritus
0.18%
1/542
0.00%
0/273
Skin and subcutaneous tissue disorders
Skin haemorrhage
0.18%
1/542
0.00%
0/273
Skin and subcutaneous tissue disorders
Skin necrosis
0.00%
0/542
0.37%
1/273
Vascular disorders
Hypotension
2.0%
11/542
1.1%
3/273
Vascular disorders
Hypertensive crisis
1.5%
8/542
1.5%
4/273
Vascular disorders
Hypertension
0.55%
3/542
1.1%
3/273
Vascular disorders
Deep vein thrombosis
0.74%
4/542
0.37%
1/273
Vascular disorders
Malignant hypertension
0.37%
2/542
1.1%
3/273
Vascular disorders
Arteriosclerosis
0.37%
2/542
0.37%
1/273
Vascular disorders
Peripheral arterial occlusive disease
0.37%
2/542
0.37%
1/273
Vascular disorders
Peripheral ischaemia
0.37%
2/542
0.37%
1/273
Vascular disorders
Peripheral vascular disorder
0.55%
3/542
0.00%
0/273
Vascular disorders
Hypertensive emergency
0.37%
2/542
0.00%
0/273
Vascular disorders
Orthostatic hypotension
0.18%
1/542
0.37%
1/273
Vascular disorders
Shock haemorrhagic
0.18%
1/542
0.37%
1/273
Vascular disorders
Aortic aneurysm
0.18%
1/542
0.00%
0/273
Vascular disorders
Arterial thrombosis
0.18%
1/542
0.00%
0/273
Vascular disorders
Arterial thrombosis limb
0.18%
1/542
0.00%
0/273
Vascular disorders
Circulatory collapse
0.18%
1/542
0.00%
0/273
Vascular disorders
Embolism
0.18%
1/542
0.00%
0/273
Vascular disorders
Extremity necrosis
0.18%
1/542
0.00%
0/273
Vascular disorders
Femoral artery occlusion
0.18%
1/542
0.00%
0/273
Vascular disorders
Haematoma
0.18%
1/542
0.00%
0/273
Vascular disorders
Lymphocele
0.18%
1/542
0.00%
0/273
Vascular disorders
Lymphoedema
0.18%
1/542
0.00%
0/273
Vascular disorders
Shock
0.18%
1/542
0.00%
0/273
Vascular disorders
Steal syndrome
0.00%
0/542
0.37%
1/273
Vascular disorders
Superior vena caval occlusion
0.00%
0/542
0.37%
1/273
Vascular disorders
Vascular pseudoaneurysm
0.18%
1/542
0.00%
0/273

Other adverse events

Other adverse events
Measure
Peginesatide
n=542 participants at risk
Participants received peginesatide by intravenous (IV) or subcutaneous (SC) injection once every 4 weeks. The starting dose was based on the participant's total weekly epoetin alfa or beta dose during the last week of the Screening Period; the first dose was administered one week after the last epoetin alfa or beta dose. Participants who received epoetin alfa or beta IV at the time of screening received peginesatide IV during the study, and participants who received epoetin alfa or beta SC at the time of screening received peginesatide SC during the study. 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
n=273 participants at risk
Participants continued to receive commercially available epoetin alfa or beta by intravenous or subcutaneous injection, at the same starting dose, frequency and route of administration as received during the last week of the Screening Period, with the first study dose of epoetin alfa or beta 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
Nausea
17.7%
96/542
19.8%
54/273
Gastrointestinal disorders
Diarrhoea
16.8%
91/542
17.2%
47/273
Gastrointestinal disorders
Vomiting
13.7%
74/542
13.9%
38/273
Gastrointestinal disorders
Constipation
10.3%
56/542
9.9%
27/273
Gastrointestinal disorders
Abdominal pain
9.4%
51/542
7.7%
21/273
Gastrointestinal disorders
Abdominal pain upper
5.4%
29/542
4.0%
11/273
General disorders
Pyrexia
11.3%
61/542
10.6%
29/273
General disorders
Oedema peripheral
9.8%
53/542
6.6%
18/273
General disorders
Chest pain
7.9%
43/542
5.9%
16/273
General disorders
Asthenia
7.6%
41/542
4.4%
12/273
General disorders
Fatigue
7.2%
39/542
7.7%
21/273
General disorders
Pain
5.5%
30/542
3.7%
10/273
Infections and infestations
Upper respiratory tract infection
9.8%
53/542
8.8%
24/273
Infections and infestations
Nasopharyngitis
8.5%
46/542
8.8%
24/273
Infections and infestations
Urinary tract infection
3.9%
21/542
5.5%
15/273
Injury, poisoning and procedural complications
Arteriovenous fistula site complication
16.6%
90/542
14.7%
40/273
Injury, poisoning and procedural complications
Procedural hypotension
15.1%
82/542
15.8%
43/273
Injury, poisoning and procedural complications
Vascular graft complication
8.5%
46/542
7.0%
19/273
Injury, poisoning and procedural complications
Arteriovenous fistula thrombosis
7.7%
42/542
7.7%
21/273
Injury, poisoning and procedural complications
Procedural hypertension
6.6%
36/542
6.2%
17/273
Injury, poisoning and procedural complications
Arteriovenous graft thrombosis
6.1%
33/542
5.9%
16/273
Injury, poisoning and procedural complications
Arteriovenous fistula site haemorrhage
5.5%
30/542
7.0%
19/273
Injury, poisoning and procedural complications
Fall
5.5%
30/542
4.0%
11/273
Metabolism and nutrition disorders
Hyperkalaemia
7.6%
41/542
5.9%
16/273
Musculoskeletal and connective tissue disorders
Muscle spasms
19.6%
106/542
19.0%
52/273
Musculoskeletal and connective tissue disorders
Arthralgia
11.6%
63/542
9.9%
27/273
Musculoskeletal and connective tissue disorders
Back pain
11.3%
61/542
8.4%
23/273
Musculoskeletal and connective tissue disorders
Pain in extremity
11.3%
61/542
13.2%
36/273
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
6.3%
34/542
5.5%
15/273
Nervous system disorders
Headache
15.9%
86/542
16.8%
46/273
Nervous system disorders
Dizziness
7.9%
43/542
9.2%
25/273
Psychiatric disorders
Insomnia
7.0%
38/542
8.4%
23/273
Psychiatric disorders
Anxiety
5.2%
28/542
8.4%
23/273
Psychiatric disorders
Depression
4.2%
23/542
5.1%
14/273
Respiratory, thoracic and mediastinal disorders
Dyspnoea
17.7%
96/542
18.3%
50/273
Respiratory, thoracic and mediastinal disorders
Cough
12.7%
69/542
12.8%
35/273
Skin and subcutaneous tissue disorders
Pruritus
6.6%
36/542
5.9%
16/273
Vascular disorders
Hypertension
15.5%
84/542
11.4%
31/273
Vascular disorders
Hypotension
13.3%
72/542
15.4%
42/273

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