Trial Outcomes & Findings for Safety & Efficacy of Peginesatide for the Treatment of Anemia in Participants With Chronic Renal Failure Not on Dialysis (NCT NCT00598273)
NCT ID: NCT00598273
Last Updated: 2013-02-12
Results Overview
The baseline hemoglobin value is defined as the mean of three hemoglobin values: the two most recent hemoglobin values taken prior to the day of randomization and the value obtained on the day of randomization. The mean hemoglobin during the Evaluation Period for each participant is calculated as the mean of the available hemoglobin values during Study Weeks 25 through 36.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
490 participants
Primary outcome timeframe
Baseline and Weeks 25-36
Results posted on
2013-02-12
Participant Flow
Participant milestones
| Measure |
Peginesatide 0.025 mg/kg
Participants received peginesatide by subcutaneous injection once every 4 weeks. The starting dose was 0.025 milligram per kilogram (mg/kg) and was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 grams per deciliter (g/dL).
|
Peginesatide 0.04 mg/kg
Participants received peginesatide by subcutaneous injection once every 4 weeks. The starting dose was 0.04 mg/kg and was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 g/dL.
|
Darbepoetin Alfa
Participants received a starting dose of 0.75 microgram per kilogram (mcg/kg) administered by subcutaneous injection once every 2 weeks, as prescribed. The dose was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 g/dL.
|
|---|---|---|---|
|
Overall Study
STARTED
|
161
|
165
|
164
|
|
Overall Study
COMPLETED
|
120
|
127
|
125
|
|
Overall Study
NOT COMPLETED
|
41
|
38
|
39
|
Reasons for withdrawal
| Measure |
Peginesatide 0.025 mg/kg
Participants received peginesatide by subcutaneous injection once every 4 weeks. The starting dose was 0.025 milligram per kilogram (mg/kg) and was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 grams per deciliter (g/dL).
|
Peginesatide 0.04 mg/kg
Participants received peginesatide by subcutaneous injection once every 4 weeks. The starting dose was 0.04 mg/kg and was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 g/dL.
|
Darbepoetin Alfa
Participants received a starting dose of 0.75 microgram per kilogram (mcg/kg) administered by subcutaneous injection once every 2 weeks, as prescribed. The dose was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 g/dL.
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
4
|
5
|
2
|
|
Overall Study
Death
|
6
|
12
|
8
|
|
Overall Study
Lost to Follow-up
|
8
|
3
|
5
|
|
Overall Study
Physician Decision
|
0
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
12
|
10
|
10
|
|
Overall Study
Noncompliance
|
3
|
2
|
3
|
|
Overall Study
Relocation
|
0
|
2
|
4
|
|
Overall Study
Renal transplant
|
1
|
0
|
1
|
|
Overall Study
Site elected to close
|
1
|
0
|
0
|
|
Overall Study
Started dialysis
|
6
|
4
|
5
|
Baseline Characteristics
Safety & Efficacy of Peginesatide for the Treatment of Anemia in Participants With Chronic Renal Failure Not on Dialysis
Baseline characteristics by cohort
| Measure |
Peginesatide 0.025 mg/kg
n=161 Participants
Participants received peginesatide by subcutaneous injection once every 4 weeks. The starting dose was 0.025 milligram per kilogram (mg/kg) and was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 grams per deciliter (g/dL).
|
Peginesatide 0.04 mg/kg
n=165 Participants
Participants received peginesatide by subcutaneous injection once every 4 weeks. The starting dose was 0.04 mg/kg and was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 g/dL.
|
Darbepoetin Alfa
n=164 Participants
Participants received a starting dose of 0.75 microgram per kilogram (mcg/kg) administered by subcutaneous injection once every 2 weeks, as prescribed. The dose was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 g/dL.
|
Total
n=490 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
|
0 Participants
n=483 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
70 Participants
n=93 Participants
|
63 Participants
n=4 Participants
|
65 Participants
n=27 Participants
|
198 Participants
n=483 Participants
|
|
Age, Categorical
>=65 years
|
91 Participants
n=93 Participants
|
102 Participants
n=4 Participants
|
99 Participants
n=27 Participants
|
292 Participants
n=483 Participants
|
|
Age Continuous
|
67.1 years
STANDARD_DEVIATION 13.51 • n=93 Participants
|
67.1 years
STANDARD_DEVIATION 12.73 • n=4 Participants
|
66.4 years
STANDARD_DEVIATION 14.25 • n=27 Participants
|
66.9 years
STANDARD_DEVIATION 13.49 • n=483 Participants
|
|
Sex: Female, Male
Female
|
93 Participants
n=93 Participants
|
84 Participants
n=4 Participants
|
102 Participants
n=27 Participants
|
279 Participants
n=483 Participants
|
|
Sex: Female, Male
Male
|
68 Participants
n=93 Participants
|
81 Participants
n=4 Participants
|
62 Participants
n=27 Participants
|
211 Participants
n=483 Participants
|
PRIMARY outcome
Timeframe: Baseline and Weeks 25-36Population: Full Analysis Population: All randomized participants who received at least one dose of study medication
The baseline hemoglobin value is defined as the mean of three hemoglobin values: the two most recent hemoglobin values taken prior to the day of randomization and the value obtained on the day of randomization. The mean hemoglobin during the Evaluation Period for each participant is calculated as the mean of the available hemoglobin values during Study Weeks 25 through 36.
Outcome measures
| Measure |
Peginesatide 0.025 mg/kg
n=161 Participants
Participants received peginesatide by subcutaneous injection once every 4 weeks. The starting dose was 0.025 milligram per kilogram (mg/kg) and was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 grams per deciliter (g/dL).
|
Peginesatide 0.04 mg/kg
n=165 Participants
Participants received peginesatide by subcutaneous injection once every 4 weeks. The starting dose was 0.04 mg/kg and was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 g/dL.
|
Darbepoetin Alfa
n=164 Participants
Participants received a starting dose of 0.75 microgram per kilogram (mcg/kg) administered by subcutaneous injection once every 2 weeks, as prescribed. The dose was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 g/dL.
|
|---|---|---|---|
|
Mean Change in Hemoglobin Between Baseline and the Evaluation Period
Baseline [N=161, 165, 164]
|
10.05 g/dL
Standard Deviation 0.623
|
9.95 g/dL
Standard Deviation 0.685
|
10.05 g/dL
Standard Deviation 0.638
|
|
Mean Change in Hemoglobin Between Baseline and the Evaluation Period
Evaluation Period [N=141, 151, 151]
|
11.47 g/dL
Standard Deviation 0.731
|
11.61 g/dL
Standard Deviation 0.856
|
11.47 g/dL
Standard Deviation 0.747
|
|
Mean Change in Hemoglobin Between Baseline and the Evaluation Period
Change from Baseline [N=141, 151, 151]
|
1.39 g/dL
Standard Deviation 0.866
|
1.64 g/dL
Standard Deviation 0.965
|
1.37 g/dL
Standard Deviation 0.861
|
SECONDARY outcome
Timeframe: Weeks 0 to 36Population: Full Analysis Population: All randomized participants who received at least one dose of study medication
Outcome measures
| Measure |
Peginesatide 0.025 mg/kg
n=161 Participants
Participants received peginesatide by subcutaneous injection once every 4 weeks. The starting dose was 0.025 milligram per kilogram (mg/kg) and was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 grams per deciliter (g/dL).
|
Peginesatide 0.04 mg/kg
n=165 Participants
Participants received peginesatide by subcutaneous injection once every 4 weeks. The starting dose was 0.04 mg/kg and was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 g/dL.
|
Darbepoetin Alfa
n=164 Participants
Participants received a starting dose of 0.75 microgram per kilogram (mcg/kg) administered by subcutaneous injection once every 2 weeks, as prescribed. The dose was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 g/dL.
|
|---|---|---|---|
|
Proportion of Participants Who Receive Red Blood Cell (RBC) Transfusions During the Correction and Evaluation Periods
|
0.062 percentage of participants
|
0.073 percentage of participants
|
0.049 percentage of participants
|
SECONDARY outcome
Timeframe: Weeks 0 to 36Population: Full Analysis Population: All randomized participants who received at least one dose of study medication
A hemoglobin response is defined as hemoglobin increase of ≥ 1.0 gram per deciliter (g/dL) above baseline and a hemoglobin ≥ 11.0 g/dL without RBC transfusion during the previous 8 weeks.
Outcome measures
| Measure |
Peginesatide 0.025 mg/kg
n=161 Participants
Participants received peginesatide by subcutaneous injection once every 4 weeks. The starting dose was 0.025 milligram per kilogram (mg/kg) and was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 grams per deciliter (g/dL).
|
Peginesatide 0.04 mg/kg
n=165 Participants
Participants received peginesatide by subcutaneous injection once every 4 weeks. The starting dose was 0.04 mg/kg and was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 g/dL.
|
Darbepoetin Alfa
n=164 Participants
Participants received a starting dose of 0.75 microgram per kilogram (mcg/kg) administered by subcutaneous injection once every 2 weeks, as prescribed. The dose was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 g/dL.
|
|---|---|---|---|
|
Proportion of Participants Achieving Hemoglobin Response During the Correction and Evaluation Periods.
|
0.932 percentage of participants
|
0.939 percentage of participants
|
0.939 percentage of participants
|
Adverse Events
Peginesatide 0.025 mg/kg
Serious events: 77 serious events
Other events: 124 other events
Deaths: 0 deaths
Peginesatide 0.04 mg/kg
Serious events: 75 serious events
Other events: 123 other events
Deaths: 0 deaths
Darbepoetin Alfa
Serious events: 71 serious events
Other events: 116 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Peginesatide 0.025 mg/kg
n=161 participants at risk
Participants received peginesatide by subcutaneous injection once every 4 weeks. The starting dose was 0.025 milligram per kilogram (mg/kg) and was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 grams per deciliter (g/dL).
|
Peginesatide 0.04 mg/kg
n=165 participants at risk
Participants received peginesatide by subcutaneous injection once every 4 weeks. The starting dose was 0.04 mg/kg and was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 g/dL.
|
Darbepoetin Alfa
n=164 participants at risk
Participants received a starting dose of 0.75 microgram per kilogram (mcg/kg) administered by subcutaneous injection once every 2 weeks, as prescribed. The dose was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 g/dL.
|
|---|---|---|---|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/161
|
1.2%
2/165
|
0.00%
0/164
|
|
Renal and urinary disorders
Acute prerenal failure
|
0.62%
1/161
|
0.00%
0/165
|
0.00%
0/164
|
|
Renal and urinary disorders
Cystitis erosive
|
0.00%
0/161
|
0.00%
0/165
|
0.61%
1/164
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.62%
1/161
|
0.00%
0/165
|
0.00%
0/164
|
|
Renal and urinary disorders
Neurogenic bladder
|
0.62%
1/161
|
0.00%
0/165
|
0.00%
0/164
|
|
Renal and urinary disorders
Obstructive uropathy
|
0.62%
1/161
|
0.00%
0/165
|
0.00%
0/164
|
|
Renal and urinary disorders
Urethral stenosis
|
0.00%
0/161
|
0.00%
0/165
|
0.61%
1/164
|
|
Blood and lymphatic system disorders
Anaemia
|
3.1%
5/161
|
3.0%
5/165
|
0.61%
1/164
|
|
Blood and lymphatic system disorders
Haemorrhagic anaemia
|
0.62%
1/161
|
0.61%
1/165
|
0.00%
0/164
|
|
Blood and lymphatic system disorders
Coagulopathy
|
0.00%
0/161
|
0.00%
0/165
|
0.61%
1/164
|
|
Blood and lymphatic system disorders
Heparin-induced thrombocytopenia
|
0.00%
0/161
|
0.00%
0/165
|
0.61%
1/164
|
|
Blood and lymphatic system disorders
Normochromic normocytic anaemia
|
0.62%
1/161
|
0.00%
0/165
|
0.00%
0/164
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/161
|
0.61%
1/165
|
0.00%
0/164
|
|
Cardiac disorders
Cardiac failure congestive
|
9.3%
15/161
|
9.7%
16/165
|
8.5%
14/164
|
|
Cardiac disorders
Atrial fibrillation
|
1.9%
3/161
|
4.2%
7/165
|
1.8%
3/164
|
|
Cardiac disorders
Myocardial infarction
|
0.62%
1/161
|
3.6%
6/165
|
2.4%
4/164
|
|
Cardiac disorders
Acute myocardial infarction
|
2.5%
4/161
|
1.8%
3/165
|
0.61%
1/164
|
|
Cardiac disorders
Bradycardia
|
0.62%
1/161
|
1.2%
2/165
|
2.4%
4/164
|
|
Cardiac disorders
Coronary artery disease
|
1.2%
2/161
|
1.2%
2/165
|
1.8%
3/164
|
|
Cardiac disorders
Angina pectoris
|
1.2%
2/161
|
0.61%
1/165
|
1.2%
2/164
|
|
Cardiac disorders
Cardiac arrest
|
1.2%
2/161
|
1.2%
2/165
|
0.61%
1/164
|
|
Cardiac disorders
Cardio-respiratory arrest
|
1.2%
2/161
|
0.61%
1/165
|
0.61%
1/164
|
|
Cardiac disorders
Acute coronary syndrome
|
0.62%
1/161
|
0.00%
0/165
|
0.61%
1/164
|
|
Cardiac disorders
Sick sinus syndrome
|
0.62%
1/161
|
0.61%
1/165
|
0.00%
0/164
|
|
Cardiac disorders
Angina unstable
|
0.62%
1/161
|
0.00%
0/165
|
0.00%
0/164
|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/161
|
0.61%
1/165
|
0.00%
0/164
|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/161
|
0.61%
1/165
|
0.00%
0/164
|
|
Cardiac disorders
Atrioventricular block complete
|
0.00%
0/161
|
0.00%
0/165
|
0.61%
1/164
|
|
Cardiac disorders
Atrioventricular block first degree
|
0.00%
0/161
|
0.61%
1/165
|
0.00%
0/164
|
|
Cardiac disorders
Atrioventricular block second degree
|
0.00%
0/161
|
0.00%
0/165
|
0.61%
1/164
|
|
Cardiac disorders
Cardiac disorder
|
0.00%
0/161
|
0.61%
1/165
|
0.00%
0/164
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/161
|
0.00%
0/165
|
0.61%
1/164
|
|
Cardiac disorders
Coronary artery stenosis
|
0.00%
0/161
|
0.61%
1/165
|
0.00%
0/164
|
|
Cardiac disorders
Hypertensive cardiomyopathy
|
0.62%
1/161
|
0.00%
0/165
|
0.00%
0/164
|
|
Cardiac disorders
Ischaemic cardiomyopathy
|
0.00%
0/161
|
0.00%
0/165
|
0.61%
1/164
|
|
Cardiac disorders
Nodal arrhythmia
|
0.00%
0/161
|
0.61%
1/165
|
0.00%
0/164
|
|
Cardiac disorders
Pericardial effusion
|
0.62%
1/161
|
0.00%
0/165
|
0.00%
0/164
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/161
|
0.61%
1/165
|
0.00%
0/164
|
|
Cardiac disorders
Supraventricular extrasystoles
|
0.00%
0/161
|
0.61%
1/165
|
0.00%
0/164
|
|
Cardiac disorders
Tachyarrhythmia
|
0.00%
0/161
|
0.61%
1/165
|
0.00%
0/164
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/161
|
0.61%
1/165
|
0.00%
0/164
|
|
Cardiac disorders
Ventricular fibrillation
|
0.00%
0/161
|
0.61%
1/165
|
0.00%
0/164
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/161
|
0.61%
1/165
|
0.61%
1/164
|
|
Endocrine disorders
Adrenal insufficiency
|
0.00%
0/161
|
0.00%
0/165
|
0.61%
1/164
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
2.5%
4/161
|
2.4%
4/165
|
0.00%
0/164
|
|
Gastrointestinal disorders
Diarrhoea
|
0.62%
1/161
|
1.2%
2/165
|
0.61%
1/164
|
|
Gastrointestinal disorders
Abdominal pain
|
1.2%
2/161
|
0.61%
1/165
|
0.00%
0/164
|
|
Gastrointestinal disorders
Diverticulum
|
0.62%
1/161
|
0.00%
0/165
|
0.61%
1/164
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/161
|
0.00%
0/165
|
1.2%
2/164
|
|
Gastrointestinal disorders
Ileus
|
0.62%
1/161
|
0.00%
0/165
|
0.61%
1/164
|
|
Gastrointestinal disorders
Nausea
|
0.62%
1/161
|
0.00%
0/165
|
0.61%
1/164
|
|
Gastrointestinal disorders
Peritonitis
|
1.2%
2/161
|
0.00%
0/165
|
0.00%
0/164
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.62%
1/161
|
0.00%
0/165
|
0.61%
1/164
|
|
Gastrointestinal disorders
Vomiting
|
0.62%
1/161
|
0.00%
0/165
|
0.61%
1/164
|
|
Gastrointestinal disorders
Abdominal wall haematoma
|
0.62%
1/161
|
0.00%
0/165
|
0.00%
0/164
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/161
|
0.61%
1/165
|
0.00%
0/164
|
|
Gastrointestinal disorders
Diverticular perforation
|
0.00%
0/161
|
0.00%
0/165
|
0.61%
1/164
|
|
Gastrointestinal disorders
Diverticulum intestinal haemorrhagic
|
0.00%
0/161
|
0.00%
0/165
|
0.61%
1/164
|
|
Gastrointestinal disorders
Duodenitis
|
0.62%
1/161
|
0.00%
0/165
|
0.00%
0/164
|
|
Gastrointestinal disorders
Enterocolitis haemorrhagic
|
0.00%
0/161
|
0.00%
0/165
|
0.61%
1/164
|
|
Gastrointestinal disorders
Enterocutaneous fistula
|
0.62%
1/161
|
0.00%
0/165
|
0.00%
0/164
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.00%
0/161
|
0.61%
1/165
|
0.00%
0/164
|
|
Gastrointestinal disorders
Gastric varices haemorrhage
|
0.62%
1/161
|
0.00%
0/165
|
0.00%
0/164
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/161
|
0.00%
0/165
|
0.61%
1/164
|
|
Gastrointestinal disorders
Haematemesis
|
0.00%
0/161
|
0.00%
0/165
|
0.61%
1/164
|
|
Gastrointestinal disorders
Haemorrhagic ascites
|
0.62%
1/161
|
0.00%
0/165
|
0.00%
0/164
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
0.00%
0/161
|
0.00%
0/165
|
0.61%
1/164
|
|
Gastrointestinal disorders
Oesophagitis
|
0.62%
1/161
|
0.00%
0/165
|
0.00%
0/164
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/161
|
0.00%
0/165
|
0.61%
1/164
|
|
Gastrointestinal disorders
Peritoneal haemorrhage
|
0.62%
1/161
|
0.00%
0/165
|
0.00%
0/164
|
|
Gastrointestinal disorders
Rectal fissure
|
0.00%
0/161
|
0.00%
0/165
|
0.61%
1/164
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/161
|
0.61%
1/165
|
0.00%
0/164
|
|
Gastrointestinal disorders
Retroperitoneal haemorrhage
|
0.62%
1/161
|
0.00%
0/165
|
0.00%
0/164
|
|
General disorders
Chest pain
|
1.9%
3/161
|
0.00%
0/165
|
1.8%
3/164
|
|
General disorders
Asthenia
|
1.2%
2/161
|
1.8%
3/165
|
0.00%
0/164
|
|
General disorders
Non-cardiac chest pain
|
0.62%
1/161
|
0.61%
1/165
|
1.2%
2/164
|
|
General disorders
Death
|
0.62%
1/161
|
0.61%
1/165
|
0.00%
0/164
|
|
General disorders
Generalised oedema
|
0.62%
1/161
|
0.00%
0/165
|
0.00%
0/164
|
|
General disorders
Sudden cardiac death
|
0.00%
0/161
|
0.61%
1/165
|
0.00%
0/164
|
|
General disorders
Systemic inflammatory response syndrome
|
0.00%
0/161
|
0.00%
0/165
|
0.61%
1/164
|
|
Hepatobiliary disorders
Cholecystitis
|
1.2%
2/161
|
0.00%
0/165
|
1.2%
2/164
|
|
Hepatobiliary disorders
Cholelithiasis
|
1.2%
2/161
|
0.00%
0/165
|
1.2%
2/164
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.62%
1/161
|
0.00%
0/165
|
0.00%
0/164
|
|
Hepatobiliary disorders
Chronic hepatic failure
|
0.62%
1/161
|
0.00%
0/165
|
0.00%
0/164
|
|
Infections and infestations
Pneumonia
|
6.2%
10/161
|
4.8%
8/165
|
5.5%
9/164
|
|
Infections and infestations
Urinary tract infection
|
3.1%
5/161
|
5.5%
9/165
|
4.3%
7/164
|
|
Infections and infestations
Cellulitis
|
3.7%
6/161
|
3.0%
5/165
|
1.8%
3/164
|
|
Infections and infestations
Sepsis
|
2.5%
4/161
|
0.61%
1/165
|
1.8%
3/164
|
|
Infections and infestations
Osteomyelitis
|
0.00%
0/161
|
3.0%
5/165
|
0.61%
1/164
|
|
Infections and infestations
Bacteraemia
|
1.2%
2/161
|
0.61%
1/165
|
0.00%
0/164
|
|
Infections and infestations
Catheter sepsis
|
1.2%
2/161
|
0.00%
0/165
|
0.61%
1/164
|
|
Infections and infestations
Gastroenteritis
|
0.62%
1/161
|
0.00%
0/165
|
1.2%
2/164
|
|
Infections and infestations
Septic shock
|
0.62%
1/161
|
1.2%
2/165
|
0.00%
0/164
|
|
Infections and infestations
Upper respiratory tract infection
|
0.62%
1/161
|
1.2%
2/165
|
0.00%
0/164
|
|
Infections and infestations
Bronchitis
|
0.00%
0/161
|
0.61%
1/165
|
0.61%
1/164
|
|
Infections and infestations
Catheter related infection
|
0.00%
0/161
|
1.2%
2/165
|
0.00%
0/164
|
|
Infections and infestations
Clostridium difficile colitis
|
0.62%
1/161
|
0.61%
1/165
|
0.00%
0/164
|
|
Infections and infestations
Diverticulitis
|
0.62%
1/161
|
0.00%
0/165
|
0.61%
1/164
|
|
Infections and infestations
Endocarditis bacterial
|
0.00%
0/161
|
0.61%
1/165
|
0.61%
1/164
|
|
Infections and infestations
Infected skin ulcer
|
0.00%
0/161
|
0.61%
1/165
|
0.61%
1/164
|
|
Infections and infestations
Staphylococcal bacteraemia
|
0.00%
0/161
|
0.61%
1/165
|
0.61%
1/164
|
|
Infections and infestations
Urosepsis
|
0.62%
1/161
|
0.00%
0/165
|
0.61%
1/164
|
|
Infections and infestations
Wound infection staphylococcal
|
0.62%
1/161
|
0.61%
1/165
|
0.00%
0/164
|
|
Infections and infestations
Abscess limb
|
0.00%
0/161
|
0.61%
1/165
|
0.00%
0/164
|
|
Infections and infestations
Arthritis bacterial
|
0.00%
0/161
|
0.61%
1/165
|
0.00%
0/164
|
|
Infections and infestations
Bacterial sepsis
|
0.00%
0/161
|
0.61%
1/165
|
0.00%
0/164
|
|
Infections and infestations
Carbuncle
|
0.62%
1/161
|
0.00%
0/165
|
0.00%
0/164
|
|
Infections and infestations
Catheter site cellulitis
|
0.00%
0/161
|
0.00%
0/165
|
0.61%
1/164
|
|
Infections and infestations
Endocarditis enterococcal
|
0.00%
0/161
|
0.00%
0/165
|
0.61%
1/164
|
|
Infections and infestations
Escherichia urinary tract infection
|
0.00%
0/161
|
0.00%
0/165
|
0.61%
1/164
|
|
Infections and infestations
Fungaemia
|
0.62%
1/161
|
0.00%
0/165
|
0.00%
0/164
|
|
Infections and infestations
Gangrene
|
0.00%
0/161
|
0.61%
1/165
|
0.00%
0/164
|
|
Infections and infestations
Herpes zoster
|
0.62%
1/161
|
0.00%
0/165
|
0.00%
0/164
|
|
Infections and infestations
Influenza
|
0.00%
0/161
|
0.00%
0/165
|
0.61%
1/164
|
|
Infections and infestations
Labyrinthitis
|
0.00%
0/161
|
0.00%
0/165
|
0.61%
1/164
|
|
Infections and infestations
Lobar pneumonia
|
0.00%
0/161
|
0.61%
1/165
|
0.00%
0/164
|
|
Infections and infestations
Peritonitis bacterial
|
0.62%
1/161
|
0.00%
0/165
|
0.00%
0/164
|
|
Infections and infestations
Pneumonia necrotising
|
0.00%
0/161
|
0.61%
1/165
|
0.00%
0/164
|
|
Infections and infestations
Pneumonia staphylococcal
|
0.62%
1/161
|
0.00%
0/165
|
0.00%
0/164
|
|
Infections and infestations
Pseudomembranous colitis
|
0.00%
0/161
|
0.00%
0/165
|
0.61%
1/164
|
|
Infections and infestations
Pseudomonas infection
|
0.00%
0/161
|
0.61%
1/165
|
0.00%
0/164
|
|
Infections and infestations
Streptococcal bacteraemia
|
0.62%
1/161
|
0.00%
0/165
|
0.00%
0/164
|
|
Infections and infestations
Subcutaneous abscess
|
0.00%
0/161
|
0.61%
1/165
|
0.00%
0/164
|
|
Infections and infestations
Viral infection
|
0.62%
1/161
|
0.00%
0/165
|
0.00%
0/164
|
|
Infections and infestations
Vulval abscess
|
0.62%
1/161
|
0.00%
0/165
|
0.00%
0/164
|
|
Injury, poisoning and procedural complications
Fall
|
1.2%
2/161
|
0.00%
0/165
|
0.61%
1/164
|
|
Injury, poisoning and procedural complications
Arteriovenous fistula thrombosis
|
0.00%
0/161
|
1.2%
2/165
|
0.00%
0/164
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
1.2%
2/161
|
0.00%
0/165
|
0.00%
0/164
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.62%
1/161
|
0.61%
1/165
|
0.00%
0/164
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.62%
1/161
|
0.61%
1/165
|
0.00%
0/164
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
1.2%
2/161
|
0.00%
0/165
|
0.00%
0/164
|
|
Injury, poisoning and procedural complications
Anaemia postoperative
|
0.62%
1/161
|
0.00%
0/165
|
0.00%
0/164
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.62%
1/161
|
0.00%
0/165
|
0.00%
0/164
|
|
Injury, poisoning and procedural complications
Arteriovenous fistula site complication
|
0.00%
0/161
|
0.61%
1/165
|
0.00%
0/164
|
|
Injury, poisoning and procedural complications
Arteriovenous fistula site haemorrhage
|
0.00%
0/161
|
0.00%
0/165
|
0.61%
1/164
|
|
Injury, poisoning and procedural complications
Arteriovenous graft thrombosis
|
0.62%
1/161
|
0.00%
0/165
|
0.00%
0/164
|
|
Injury, poisoning and procedural complications
Cardiac pacemaker malfunction
|
0.62%
1/161
|
0.00%
0/165
|
0.00%
0/164
|
|
Injury, poisoning and procedural complications
Contrast media reaction
|
0.00%
0/161
|
0.61%
1/165
|
0.00%
0/164
|
|
Injury, poisoning and procedural complications
Drug toxicity
|
0.62%
1/161
|
0.00%
0/165
|
0.00%
0/164
|
|
Injury, poisoning and procedural complications
Fibula fracture
|
0.62%
1/161
|
0.00%
0/165
|
0.00%
0/164
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.00%
0/161
|
0.00%
0/165
|
0.61%
1/164
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.00%
0/161
|
0.61%
1/165
|
0.00%
0/164
|
|
Injury, poisoning and procedural complications
Intentional overdose
|
0.00%
0/161
|
0.61%
1/165
|
0.00%
0/164
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.00%
0/161
|
0.00%
0/165
|
0.61%
1/164
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/161
|
0.61%
1/165
|
0.00%
0/164
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.62%
1/161
|
0.00%
0/165
|
0.00%
0/164
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.00%
0/161
|
0.61%
1/165
|
0.00%
0/164
|
|
Injury, poisoning and procedural complications
Traumatic haematoma
|
0.00%
0/161
|
0.61%
1/165
|
0.00%
0/164
|
|
Injury, poisoning and procedural complications
Urinary retention postoperative
|
0.62%
1/161
|
0.00%
0/165
|
0.00%
0/164
|
|
Investigations
Blood glucose increased
|
0.00%
0/161
|
0.61%
1/165
|
0.00%
0/164
|
|
Investigations
Cardiac enzymes increased
|
0.00%
0/161
|
0.00%
0/165
|
0.61%
1/164
|
|
Investigations
Electrocardiogram change
|
0.00%
0/161
|
0.00%
0/165
|
0.61%
1/164
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
2.5%
4/161
|
4.2%
7/165
|
0.61%
1/164
|
|
Metabolism and nutrition disorders
Dehydration
|
1.2%
2/161
|
2.4%
4/165
|
3.0%
5/164
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
1.2%
2/161
|
1.8%
3/165
|
3.0%
5/164
|
|
Metabolism and nutrition disorders
Fluid overload
|
0.62%
1/161
|
1.8%
3/165
|
1.2%
2/164
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.62%
1/161
|
0.00%
0/165
|
1.8%
3/164
|
|
Metabolism and nutrition disorders
Diabetes mellitus inadequate control
|
0.00%
0/161
|
0.61%
1/165
|
0.61%
1/164
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.62%
1/161
|
0.61%
1/165
|
0.00%
0/164
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
0.00%
0/161
|
1.2%
2/165
|
0.00%
0/164
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.62%
1/161
|
0.00%
0/165
|
0.61%
1/164
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/161
|
0.00%
0/165
|
0.61%
1/164
|
|
Metabolism and nutrition disorders
Diabetic foot
|
0.62%
1/161
|
0.00%
0/165
|
0.00%
0/164
|
|
Metabolism and nutrition disorders
Electrolyte imbalance
|
0.00%
0/161
|
0.61%
1/165
|
0.00%
0/164
|
|
Metabolism and nutrition disorders
Failure to thrive
|
0.62%
1/161
|
0.00%
0/165
|
0.00%
0/164
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
0.00%
0/161
|
0.00%
0/165
|
0.61%
1/164
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.2%
2/161
|
0.61%
1/165
|
0.00%
0/164
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/161
|
1.8%
3/165
|
0.00%
0/164
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.62%
1/161
|
0.00%
0/165
|
0.61%
1/164
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/161
|
0.61%
1/165
|
0.00%
0/164
|
|
Musculoskeletal and connective tissue disorders
Arthropathy
|
0.00%
0/161
|
0.61%
1/165
|
0.00%
0/164
|
|
Musculoskeletal and connective tissue disorders
Chondrocalcinosis pyrophosphate
|
0.00%
0/161
|
0.00%
0/165
|
0.61%
1/164
|
|
Musculoskeletal and connective tissue disorders
Haemarthrosis
|
0.62%
1/161
|
0.00%
0/165
|
0.00%
0/164
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/161
|
0.00%
0/165
|
0.61%
1/164
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.62%
1/161
|
0.00%
0/165
|
0.00%
0/164
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cell carcinoma
|
0.00%
0/161
|
1.2%
2/165
|
0.00%
0/164
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Endometrial cancer
|
0.00%
0/161
|
0.61%
1/165
|
0.00%
0/164
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer
|
0.00%
0/161
|
0.00%
0/165
|
0.61%
1/164
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Liposarcoma
|
0.62%
1/161
|
0.00%
0/165
|
0.00%
0/164
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung squamous cell carcinoma stage unspecified
|
0.00%
0/161
|
0.61%
1/165
|
0.00%
0/164
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic gastric cancer
|
0.00%
0/161
|
0.00%
0/165
|
0.61%
1/164
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic squamous cell carcinoma
|
0.62%
1/161
|
0.00%
0/165
|
0.00%
0/164
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Multiple myeloma
|
0.00%
0/161
|
0.00%
0/165
|
0.61%
1/164
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Transitional cell carcinoma
|
0.62%
1/161
|
0.00%
0/165
|
0.00%
0/164
|
|
Nervous system disorders
Syncope
|
1.2%
2/161
|
1.2%
2/165
|
0.61%
1/164
|
|
Nervous system disorders
Dizziness
|
0.62%
1/161
|
0.61%
1/165
|
0.00%
0/164
|
|
Nervous system disorders
Anoxic encephalopathy
|
0.00%
0/161
|
0.00%
0/165
|
0.61%
1/164
|
|
Nervous system disorders
Carotid artery occlusion
|
0.00%
0/161
|
0.00%
0/165
|
0.61%
1/164
|
|
Nervous system disorders
Carotid artery stenosis
|
0.00%
0/161
|
0.61%
1/165
|
0.00%
0/164
|
|
Nervous system disorders
Cerebral infarction
|
0.62%
1/161
|
0.00%
0/165
|
0.00%
0/164
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/161
|
0.61%
1/165
|
0.00%
0/164
|
|
Nervous system disorders
Convulsion
|
0.62%
1/161
|
0.00%
0/165
|
0.00%
0/164
|
|
Nervous system disorders
Dementia
|
0.62%
1/161
|
0.00%
0/165
|
0.00%
0/164
|
|
Nervous system disorders
Dizziness postural
|
0.62%
1/161
|
0.00%
0/165
|
0.00%
0/164
|
|
Nervous system disorders
Embolic stroke
|
0.62%
1/161
|
0.00%
0/165
|
0.00%
0/164
|
|
Nervous system disorders
Haemorrhagic stroke
|
0.00%
0/161
|
0.00%
0/165
|
0.61%
1/164
|
|
Nervous system disorders
Hypertensive encephalopathy
|
0.00%
0/161
|
0.00%
0/165
|
0.61%
1/164
|
|
Nervous system disorders
Lacunar infarction
|
0.00%
0/161
|
0.61%
1/165
|
0.00%
0/164
|
|
Nervous system disorders
Syncope vasovagal
|
0.62%
1/161
|
0.00%
0/165
|
0.00%
0/164
|
|
Nervous system disorders
Transient ischaemic attack
|
0.62%
1/161
|
0.00%
0/165
|
0.00%
0/164
|
|
Psychiatric disorders
Mental status changes
|
1.9%
3/161
|
0.00%
0/165
|
0.00%
0/164
|
|
Renal and urinary disorders
Renal failure acute
|
13.0%
21/161
|
7.9%
13/165
|
5.5%
9/164
|
|
Renal and urinary disorders
Renal failure chronic
|
7.5%
12/161
|
1.8%
3/165
|
4.9%
8/164
|
|
Renal and urinary disorders
Azotaemia
|
2.5%
4/161
|
1.8%
3/165
|
3.7%
6/164
|
|
Renal and urinary disorders
Renal failure
|
3.1%
5/161
|
2.4%
4/165
|
2.4%
4/164
|
|
Renal and urinary disorders
Haematuria
|
0.62%
1/161
|
1.2%
2/165
|
0.61%
1/164
|
|
Renal and urinary disorders
Nephrotic syndrome
|
0.62%
1/161
|
0.00%
0/165
|
1.2%
2/164
|
|
Renal and urinary disorders
Renal impairment
|
0.00%
0/161
|
0.61%
1/165
|
0.61%
1/164
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
2.5%
4/161
|
0.61%
1/165
|
1.2%
2/164
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/161
|
1.8%
3/165
|
1.2%
2/164
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
1.2%
2/161
|
0.61%
1/165
|
1.2%
2/164
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
1.2%
2/161
|
1.8%
3/165
|
0.00%
0/164
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.62%
1/161
|
1.2%
2/165
|
0.00%
0/164
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
1.9%
3/161
|
0.00%
0/165
|
0.00%
0/164
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/161
|
0.00%
0/165
|
1.2%
2/164
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
1.2%
2/161
|
0.00%
0/165
|
0.00%
0/164
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/161
|
1.2%
2/165
|
0.00%
0/164
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.00%
0/161
|
0.61%
1/165
|
0.00%
0/164
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.62%
1/161
|
0.00%
0/165
|
0.00%
0/164
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/161
|
0.00%
0/165
|
0.61%
1/164
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/161
|
0.61%
1/165
|
0.00%
0/164
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary mass
|
0.00%
0/161
|
0.61%
1/165
|
0.00%
0/164
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory arrest
|
0.00%
0/161
|
0.00%
0/165
|
0.61%
1/164
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.00%
0/161
|
0.61%
1/165
|
0.61%
1/164
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
0.00%
0/161
|
0.61%
1/165
|
0.00%
0/164
|
|
Vascular disorders
Hypertension
|
1.9%
3/161
|
3.0%
5/165
|
3.0%
5/164
|
|
Vascular disorders
Hypertensive crisis
|
0.62%
1/161
|
0.61%
1/165
|
1.2%
2/164
|
|
Vascular disorders
Hypotension
|
1.2%
2/161
|
0.61%
1/165
|
0.61%
1/164
|
|
Vascular disorders
Peripheral vascular disorder
|
0.62%
1/161
|
0.00%
0/165
|
1.2%
2/164
|
|
Vascular disorders
Aortic aneurysm
|
0.62%
1/161
|
0.00%
0/165
|
0.61%
1/164
|
|
Vascular disorders
Hypertensive emergency
|
1.2%
2/161
|
0.00%
0/165
|
0.00%
0/164
|
|
Vascular disorders
Malignant hypertension
|
0.62%
1/161
|
0.00%
0/165
|
0.61%
1/164
|
|
Vascular disorders
Aortic stenosis
|
0.00%
0/161
|
0.61%
1/165
|
0.00%
0/164
|
|
Vascular disorders
Arteriosclerosis
|
0.62%
1/161
|
0.00%
0/165
|
0.00%
0/164
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/161
|
0.61%
1/165
|
0.00%
0/164
|
|
Vascular disorders
Hypovolaemic shock
|
0.62%
1/161
|
0.00%
0/165
|
0.00%
0/164
|
|
Vascular disorders
Intermittent claudication
|
0.00%
0/161
|
0.61%
1/165
|
0.00%
0/164
|
|
Vascular disorders
Lymphoedema
|
0.62%
1/161
|
0.00%
0/165
|
0.00%
0/164
|
|
Vascular disorders
Orthostatic hypotension
|
0.62%
1/161
|
0.00%
0/165
|
0.00%
0/164
|
|
Vascular disorders
Peripheral artery dissection
|
0.00%
0/161
|
0.00%
0/165
|
0.61%
1/164
|
|
Vascular disorders
Steal syndrome
|
0.00%
0/161
|
0.00%
0/165
|
0.61%
1/164
|
Other adverse events
| Measure |
Peginesatide 0.025 mg/kg
n=161 participants at risk
Participants received peginesatide by subcutaneous injection once every 4 weeks. The starting dose was 0.025 milligram per kilogram (mg/kg) and was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 grams per deciliter (g/dL).
|
Peginesatide 0.04 mg/kg
n=165 participants at risk
Participants received peginesatide by subcutaneous injection once every 4 weeks. The starting dose was 0.04 mg/kg and was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 g/dL.
|
Darbepoetin Alfa
n=164 participants at risk
Participants received a starting dose of 0.75 microgram per kilogram (mcg/kg) administered by subcutaneous injection once every 2 weeks, as prescribed. The dose was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 g/dL.
|
|---|---|---|---|
|
Endocrine disorders
Hyperparathyroidism secondary
|
8.1%
13/161
|
2.4%
4/165
|
3.7%
6/164
|
|
Gastrointestinal disorders
Nausea
|
16.8%
27/161
|
9.1%
15/165
|
13.4%
22/164
|
|
Gastrointestinal disorders
Vomiting
|
14.3%
23/161
|
6.1%
10/165
|
9.1%
15/164
|
|
Gastrointestinal disorders
Diarrhoea
|
13.7%
22/161
|
10.3%
17/165
|
13.4%
22/164
|
|
Gastrointestinal disorders
Constipation
|
12.4%
20/161
|
9.1%
15/165
|
9.8%
16/164
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
6.8%
11/161
|
6.7%
11/165
|
4.9%
8/164
|
|
Gastrointestinal disorders
Abdominal pain
|
5.6%
9/161
|
3.6%
6/165
|
2.4%
4/164
|
|
General disorders
Oedema peripheral
|
19.3%
31/161
|
16.4%
27/165
|
11.0%
18/164
|
|
General disorders
Fatigue
|
9.3%
15/161
|
4.2%
7/165
|
9.1%
15/164
|
|
General disorders
Pyrexia
|
6.8%
11/161
|
3.6%
6/165
|
3.7%
6/164
|
|
General disorders
Oedema
|
4.3%
7/161
|
6.7%
11/165
|
1.8%
3/164
|
|
Infections and infestations
Urinary tract infection
|
13.7%
22/161
|
14.5%
24/165
|
14.6%
24/164
|
|
Infections and infestations
Nasopharyngitis
|
9.3%
15/161
|
10.9%
18/165
|
6.7%
11/164
|
|
Infections and infestations
Upper respiratory tract infection
|
9.3%
15/161
|
10.3%
17/165
|
9.1%
15/164
|
|
Infections and infestations
Bronchitis
|
5.6%
9/161
|
3.0%
5/165
|
4.3%
7/164
|
|
Infections and infestations
Cellulitis
|
5.0%
8/161
|
5.5%
9/165
|
1.8%
3/164
|
|
Infections and infestations
Influenza
|
5.0%
8/161
|
5.5%
9/165
|
2.4%
4/164
|
|
Injury, poisoning and procedural complications
Contusion
|
7.5%
12/161
|
4.8%
8/165
|
3.7%
6/164
|
|
Injury, poisoning and procedural complications
Fall
|
7.5%
12/161
|
9.1%
15/165
|
4.9%
8/164
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
19.9%
32/161
|
13.3%
22/165
|
16.5%
27/164
|
|
Metabolism and nutrition disorders
Hyperphosphataemia
|
13.7%
22/161
|
4.8%
8/165
|
6.7%
11/164
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
6.8%
11/161
|
4.2%
7/165
|
7.9%
13/164
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
6.2%
10/161
|
4.8%
8/165
|
6.7%
11/164
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
5.0%
8/161
|
6.7%
11/165
|
2.4%
4/164
|
|
Metabolism and nutrition disorders
Gout
|
4.3%
7/161
|
5.5%
9/165
|
4.3%
7/164
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
13.0%
21/161
|
9.1%
15/165
|
7.3%
12/164
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
11.8%
19/161
|
11.5%
19/165
|
8.5%
14/164
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
9.9%
16/161
|
10.3%
17/165
|
7.3%
12/164
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
9.9%
16/161
|
10.3%
17/165
|
10.4%
17/164
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
5.0%
8/161
|
6.7%
11/165
|
3.0%
5/164
|
|
Nervous system disorders
Headache
|
9.3%
15/161
|
7.3%
12/165
|
7.9%
13/164
|
|
Nervous system disorders
Dizziness
|
8.7%
14/161
|
11.5%
19/165
|
14.6%
24/164
|
|
Psychiatric disorders
Insomnia
|
6.8%
11/161
|
4.8%
8/165
|
6.7%
11/164
|
|
Psychiatric disorders
Anxiety
|
5.6%
9/161
|
7.3%
12/165
|
4.3%
7/164
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
14.3%
23/161
|
8.5%
14/165
|
4.9%
8/164
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
10.6%
17/161
|
8.5%
14/165
|
7.9%
13/164
|
|
Skin and subcutaneous tissue disorders
Rash
|
10.6%
17/161
|
5.5%
9/165
|
4.9%
8/164
|
|
Vascular disorders
Hypertension
|
14.9%
24/161
|
9.7%
16/165
|
10.4%
17/164
|
|
Vascular disorders
Hypotension
|
4.3%
7/161
|
6.1%
10/165
|
9.8%
16/164
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The first publication of the primary safety and efficacy results will include data from all appropriate study sites. Either after the first multicenter publication, or following 36 months after the completion of the study, Investigators are free to publish; such publications may not contain Sponsor Confidential Information and may be subject to Sponsor review 60 days prior to submission for publication.
- Publication restrictions are in place
Restriction type: OTHER