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Safety and Efficacy of Peginesatide for the Treatment of Anemia in Participants With Chronic Renal Failure Not on Dialysis (PEARL 2)

This study has been completed.
Sponsor:
Collaborator:
Takeda
Information provided by (Responsible Party):
Affymax
ClinicalTrials.gov Identifier:
NCT00598442
First received: January 10, 2008
Last updated: February 6, 2013
Last verified: February 2013
Results First Received: April 26, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Chronic Renal Failure
Chronic Kidney Disease
Anemia
Interventions: Drug: peginesatide
Drug: Darbepoetin alfa

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Peginesatide 0.025 mg/kg Participants received peginesatide by subcutaneous injection once every 4 weeks. The starting dose was 0.025 milligram per kilogram (mg/kg) and was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 grams per deciliter (g/dL).
Peginesatide 0.04 mg/kg Participants received peginesatide by subcutaneous injection once every 4 weeks. The starting dose was 0.04 mg/kg and was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 g/dL.
Darbepoetin Alfa Participants received darbepoetin alfa by subcutaneous injection once every 2 weeks, as prescribed. The starting dose was 0.75 microgram per kilogram (mcg/kg) and was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 g/dL.

Participant Flow:   Overall Study
    Peginesatide 0.025 mg/kg     Peginesatide 0.04 mg/kg     Darbepoetin Alfa  
STARTED     167     163     163  
COMPLETED     124     124     139  
NOT COMPLETED     43     39     24  
Adverse Event                 3                 0                 0  
Death                 19                 11                 11  
Lost to Follow-up                 4                 3                 3  
Physician Decision                 2                 1                 1  
Withdrawal by Subject                 8                 16                 6  
Noncompliance                 0                 2                 1  
Relocation                 1                 4                 0  
Renal transplant                 0                 0                 1  
Site closed by sponsor                 5                 2                 1  
Started dialysis                 1                 0                 0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Peginesatide 0.025 mg/kg Participants received peginesatide by subcutaneous injection once every 4 weeks. The starting dose was 0.025 milligram per kilogram (mg/kg) and was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 grams per deciliter (g/dL).
Peginesatide 0.04 mg/kg Participants received peginesatide by subcutaneous injection once every 4 weeks. The starting dose was 0.04 mg/kg and was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 g/dL.
Darbepoetin Alfa Participants received darbepoetin alfa by subcutaneous injection once every 2 weeks, as prescribed. The starting dose was 0.75 microgram per kilogram (mcg/kg) and was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 g/dL.
Total Total of all reporting groups

Baseline Measures
    Peginesatide 0.025 mg/kg     Peginesatide 0.04 mg/kg     Darbepoetin Alfa     Total  
Number of Participants  
[units: participants]
  167     163     163     493  
Age  
[units: participants]
       
<=18 years     0     0     0     0  
Between 18 and 65 years     63     57     62     182  
>=65 years     104     106     101     311  
Age  
[units: years]
Mean ± Standard Deviation
  68.1  ± 12.93     68.3  ± 13.53     67.2  ± 15.03     67.9  ± 13.83  
Gender  
[units: participants]
       
Female     93     96     99     288  
Male     74     67     64     205  



  Outcome Measures
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1.  Primary:   Mean Change in Hemoglobin Between Baseline and the Evaluation Period   [ Time Frame: Baseline and Weeks 25-36 ]

2.  Secondary:   Proportion of Participants Who Received Red Blood Cell (RBC) Transfusions During the Correction and Evaluation Periods   [ Time Frame: Weeks 0 to 36 ]

3.  Secondary:   Proportion of Participants Achieving Hemoglobin Response During the Correction and Evaluation Periods   [ Time Frame: Weeks 0 to 36 ]


  Serious Adverse Events
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Time Frame No text entered.
Additional Description No text entered.

Reporting Groups
  Description
Peginesatide 0.025 mg/kg Participants received peginesatide by subcutaneous injection once every 4 weeks. The starting dose was 0.025 milligram per kilogram (mg/kg) and was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 grams per deciliter (g/dL).
Peginesatide 0.04 mg/kg Participants received peginesatide by subcutaneous injection once every 4 weeks. The starting dose was 0.04 mg/kg and was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 g/dL.
Darbepoetin Alfa Participants received darbepoetin alfa by subcutaneous injection once every 2 weeks, as prescribed. The starting dose was 0.75 microgram per kilogram (mcg/kg) and was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 g/dL.

Serious Adverse Events
    Peginesatide 0.025 mg/kg     Peginesatide 0.04 mg/kg     Darbepoetin Alfa  
Total, serious adverse events        
# participants affected / at risk     86/167 (51.50%)     80/163 (49.08%)     70/163 (42.94%)  
Blood and lymphatic system disorders        
Anaemia † 1      
# participants affected / at risk     7/167 (4.19%)     6/163 (3.68%)     4/163 (2.45%)  
Haemorrhagic anaemia † 1      
# participants affected / at risk     1/167 (0.60%)     0/163 (0.00%)     0/163 (0.00%)  
Heparin-induced thrombocytopenia † 1      
# participants affected / at risk     1/167 (0.60%)     0/163 (0.00%)     0/163 (0.00%)  
Leukocytosis † 1      
# participants affected / at risk     0/167 (0.00%)     1/163 (0.61%)     0/163 (0.00%)  
Pancytopenia † 1      
# participants affected / at risk     0/167 (0.00%)     1/163 (0.61%)     0/163 (0.00%)  
Thrombocytopenia † 1      
# participants affected / at risk     0/167 (0.00%)     1/163 (0.61%)     0/163 (0.00%)  
Cardiac disorders        
Cardiac failure congestive † 1      
# participants affected / at risk     7/167 (4.19%)     18/163 (11.04%)     12/163 (7.36%)  
Acute myocardial infarction † 1      
# participants affected / at risk     5/167 (2.99%)     4/163 (2.45%)     2/163 (1.23%)  
Atrial fibrillation † 1      
# participants affected / at risk     1/167 (0.60%)     5/163 (3.07%)     4/163 (2.45%)  
Cardiac arrest † 1      
# participants affected / at risk     5/167 (2.99%)     2/163 (1.23%)     3/163 (1.84%)  
Myocardial infarction † 1      
# participants affected / at risk     4/167 (2.40%)     2/163 (1.23%)     4/163 (2.45%)  
Bradycardia † 1      
# participants affected / at risk     4/167 (2.40%)     5/163 (3.07%)     0/163 (0.00%)  
Coronary artery disease † 1      
# participants affected / at risk     2/167 (1.20%)     1/163 (0.61%)     3/163 (1.84%)  
Angina pectoris † 1      
# participants affected / at risk     1/167 (0.60%)     3/163 (1.84%)     1/163 (0.61%)  
Angina unstable † 1      
# participants affected / at risk     3/167 (1.80%)     2/163 (1.23%)     0/163 (0.00%)  
Cardiac failure † 1      
# participants affected / at risk     2/167 (1.20%)     2/163 (1.23%)     1/163 (0.61%)  
Acute coronary syndrome † 1      
# participants affected / at risk     1/167 (0.60%)     2/163 (1.23%)     0/163 (0.00%)  
Coronary artery occlusion † 1      
# participants affected / at risk     2/167 (1.20%)     1/163 (0.61%)     0/163 (0.00%)  
Sick sinus syndrome † 1      
# participants affected / at risk     1/167 (0.60%)     2/163 (1.23%)     0/163 (0.00%)  
Cardiomyopathy † 1      
# participants affected / at risk     1/167 (0.60%)     0/163 (0.00%)     1/163 (0.61%)  
Ischaemic cardiomyopathy † 1      
# participants affected / at risk     1/167 (0.60%)     1/163 (0.61%)     0/163 (0.00%)  
Tachycardia † 1      
# participants affected / at risk     1/167 (0.60%)     0/163 (0.00%)     1/163 (0.61%)  
Aortic valve stenosis † 1      
# participants affected / at risk     0/167 (0.00%)     1/163 (0.61%)     0/163 (0.00%)  
Arrhythmia † 1      
# participants affected / at risk     0/167 (0.00%)     0/163 (0.00%)     1/163 (0.61%)  
Arteriosclerosis coronary artery † 1      
# participants affected / at risk     0/167 (0.00%)     1/163 (0.61%)     0/163 (0.00%)  
Atrial flutter † 1      
# participants affected / at risk     0/167 (0.00%)     1/163 (0.61%)     0/163 (0.00%)  
Atrioventricular block † 1      
# participants affected / at risk     0/167 (0.00%)     0/163 (0.00%)     1/163 (0.61%)  
Atrioventricular block complete † 1      
# participants affected / at risk     0/167 (0.00%)     1/163 (0.61%)     0/163 (0.00%)  
Atrioventricular block second degree † 1      
# participants affected / at risk     0/167 (0.00%)     1/163 (0.61%)     0/163 (0.00%)  
Cardio-respiratory arrest † 1      
# participants affected / at risk     0/167 (0.00%)     0/163 (0.00%)     1/163 (0.61%)  
Cardiogenic shock † 1      
# participants affected / at risk     0/167 (0.00%)     0/163 (0.00%)     1/163 (0.61%)  
Cardiomegaly † 1      
# participants affected / at risk     0/167 (0.00%)     0/163 (0.00%)     1/163 (0.61%)  
Cor pulmonale † 1      
# participants affected / at risk     1/167 (0.60%)     0/163 (0.00%)     0/163 (0.00%)  
Intracardiac thrombus † 1      
# participants affected / at risk     0/167 (0.00%)     0/163 (0.00%)     1/163 (0.61%)  
Myocardial ischaemia † 1      
# participants affected / at risk     0/167 (0.00%)     1/163 (0.61%)     0/163 (0.00%)  
Palpitations † 1      
# participants affected / at risk     0/167 (0.00%)     1/163 (0.61%)     0/163 (0.00%)  
Pericardial effusion † 1      
# participants affected / at risk     0/167 (0.00%)     0/163 (0.00%)     1/163 (0.61%)  
Pericarditis † 1      
# participants affected / at risk     1/167 (0.60%)     0/163 (0.00%)     0/163 (0.00%)  
Supraventricular tachycardia † 1      
# participants affected / at risk     0/167 (0.00%)     1/163 (0.61%)     0/163 (0.00%)  
Congenital, familial and genetic disorders        
Gastrointestinal angiodysplasia † 1      
# participants affected / at risk     0/167 (0.00%)     0/163 (0.00%)     1/163 (0.61%)  
Vitello-intestinal duct remnant † 1      
# participants affected / at risk     1/167 (0.60%)     0/163 (0.00%)     0/163 (0.00%)  
Endocrine disorders        
Hyperthyroidism † 1      
# participants affected / at risk     0/167 (0.00%)     1/163 (0.61%)     0/163 (0.00%)  
Hypothyroidism † 1      
# participants affected / at risk     0/167 (0.00%)     1/163 (0.61%)     0/163 (0.00%)  
Eye disorders        
Cataract † 1      
# participants affected / at risk     0/167 (0.00%)     1/163 (0.61%)     0/163 (0.00%)  
Gastrointestinal disorders        
Gastrointestinal haemorrhage † 1      
# participants affected / at risk     2/167 (1.20%)     5/163 (3.07%)     2/163 (1.23%)  
Pancreatitis acute † 1      
# participants affected / at risk     2/167 (1.20%)     2/163 (1.23%)     0/163 (0.00%)  
Pancreatitis † 1      
# participants affected / at risk     1/167 (0.60%)     2/163 (1.23%)     0/163 (0.00%)  
Rectal haemorrhage † 1      
# participants affected / at risk     3/167 (1.80%)     0/163 (0.00%)     0/163 (0.00%)  
Abdominal pain † 1      
# participants affected / at risk     0/167 (0.00%)     1/163 (0.61%)     1/163 (0.61%)  
Haematemesis † 1      
# participants affected / at risk     1/167 (0.60%)     1/163 (0.61%)     0/163 (0.00%)  
Lower gastrointestinal haemorrhage † 1      
# participants affected / at risk     2/167 (1.20%)     0/163 (0.00%)     0/163 (0.00%)  
Retroperitoneal haematoma † 1      
# participants affected / at risk     0/167 (0.00%)     0/163 (0.00%)     2/163 (1.23%)  
Small intestinal obstruction † 1      
# participants affected / at risk     1/167 (0.60%)     1/163 (0.61%)     0/163 (0.00%)  
Vomiting † 1      
# participants affected / at risk     0/167 (0.00%)     1/163 (0.61%)     1/163 (0.61%)  
Abdominal pain upper † 1      
# participants affected / at risk     1/167 (0.60%)     0/163 (0.00%)     0/163 (0.00%)  
Alcoholic pancreatitis † 1      
# participants affected / at risk     0/167 (0.00%)     0/163 (0.00%)     1/163 (0.61%)  
Ascites † 1      
# participants affected / at risk     0/167 (0.00%)     1/163 (0.61%)     0/163 (0.00%)  
Caecitis † 1      
# participants affected / at risk     1/167 (0.60%)     0/163 (0.00%)     0/163 (0.00%)  
Colitis † 1      
# participants affected / at risk     1/167 (0.60%)     0/163 (0.00%)     0/163 (0.00%)  
Colonic pseudo-obstruction † 1      
# participants affected / at risk     0/167 (0.00%)     1/163 (0.61%)     0/163 (0.00%)  
Constipation † 1      
# participants affected / at risk     0/167 (0.00%)     1/163 (0.61%)     0/163 (0.00%)  
Diabetic gastroparesis † 1      
# participants affected / at risk     0/167 (0.00%)     1/163 (0.61%)     0/163 (0.00%)  
Diarrhoea † 1      
# participants affected / at risk     0/167 (0.00%)     1/163 (0.61%)     0/163 (0.00%)  
Diverticular perforation † 1      
# participants affected / at risk     1/167 (0.60%)     0/163 (0.00%)     0/163 (0.00%)  
Diverticulum intestinal haemorrhagic † 1      
# participants affected / at risk     0/167 (0.00%)     1/163 (0.61%)     0/163 (0.00%)  
Duodenal ulcer haemorrhage † 1      
# participants affected / at risk     0/167 (0.00%)     1/163 (0.61%)     0/163 (0.00%)  
Dyspepsia † 1      
# participants affected / at risk     0/167 (0.00%)     0/163 (0.00%)     1/163 (0.61%)  
Gastric hypomotility † 1      
# participants affected / at risk     0/167 (0.00%)     1/163 (0.61%)     0/163 (0.00%)  
Gastritis erosive † 1      
# participants affected / at risk     0/167 (0.00%)     1/163 (0.61%)     0/163 (0.00%)  
Gastritis haemorrhagic † 1      
# participants affected / at risk     0/167 (0.00%)     1/163 (0.61%)     0/163 (0.00%)  
Gastroduodenal ulcer † 1      
# participants affected / at risk     1/167 (0.60%)     0/163 (0.00%)     0/163 (0.00%)  
Gastrointestinal pain † 1      
# participants affected / at risk     0/167 (0.00%)     1/163 (0.61%)     0/163 (0.00%)  
Gastrooesophageal reflux disease † 1      
# participants affected / at risk     0/167 (0.00%)     0/163 (0.00%)     1/163 (0.61%)  
Haematochezia † 1      
# participants affected / at risk     0/167 (0.00%)     0/163 (0.00%)     1/163 (0.61%)  
Impaired gastric emptying † 1      
# participants affected / at risk     0/167 (0.00%)     0/163 (0.00%)     1/163 (0.61%)  
Intestinal mass † 1      
# participants affected / at risk     1/167 (0.60%)     0/163 (0.00%)     0/163 (0.00%)  
Large intestinal haemorrhage † 1      
# participants affected / at risk     1/167 (0.60%)     0/163 (0.00%)     0/163 (0.00%)  
Large intestine perforation † 1      
# participants affected / at risk     1/167 (0.60%)     0/163 (0.00%)     0/163 (0.00%)  
Nausea † 1      
# participants affected / at risk     0/167 (0.00%)     1/163 (0.61%)     0/163 (0.00%)  
Peritonitis † 1      
# participants affected / at risk     0/167 (0.00%)     1/163 (0.61%)     0/163 (0.00%)  
Umbilical hernia, obstructive † 1      
# participants affected / at risk     0/167 (0.00%)     1/163 (0.61%)     0/163 (0.00%)  
Uraemic gastropathy † 1      
# participants affected / at risk     0/167 (0.00%)     0/163 (0.00%)     1/163 (0.61%)  
Volvulus † 1      
# participants affected / at risk     1/167 (0.60%)     0/163 (0.00%)     0/163 (0.00%)  
General disorders        
Non-cardiac chest pain † 1      
# participants affected / at risk     2/167 (1.20%)     4/163 (2.45%)     1/163 (0.61%)  
Pyrexia † 1      
# participants affected / at risk     1/167 (0.60%)     1/163 (0.61%)     2/163 (1.23%)  
Generalised oedema † 1      
# participants affected / at risk     1/167 (0.60%)     2/163 (1.23%)     0/163 (0.00%)  
Asthenia † 1      
# participants affected / at risk     2/167 (1.20%)     0/163 (0.00%)     0/163 (0.00%)  
Chest pain † 1      
# participants affected / at risk     0/167 (0.00%)     1/163 (0.61%)     1/163 (0.61%)  
Multi-organ failure † 1      
# participants affected / at risk     2/167 (1.20%)     0/163 (0.00%)     0/163 (0.00%)  
Brain death † 1      
# participants affected / at risk     0/167 (0.00%)     1/163 (0.61%)     0/163 (0.00%)  
Cyst † 1      
# participants affected / at risk     1/167 (0.60%)     0/163 (0.00%)     0/163 (0.00%)  
Fatigue † 1      
# participants affected / at risk     1/167 (0.60%)     0/163 (0.00%)     0/163 (0.00%)  
General physical health deterioration † 1      
# participants affected / at risk     1/167 (0.60%)     0/163 (0.00%)     0/163 (0.00%)  
Hypothermia † 1      
# participants affected / at risk     1/167 (0.60%)     0/163 (0.00%)     0/163 (0.00%)  
Local swelling † 1      
# participants affected / at risk     0/167 (0.00%)     0/163 (0.00%)     1/163 (0.61%)  
Oedema peripheral † 1      
# participants affected / at risk     0/167 (0.00%)     1/163 (0.61%)     0/163 (0.00%)  
Pain † 1      
# participants affected / at risk     0/167 (0.00%)     1/163 (0.61%)     0/163 (0.00%)  
Sudden death † 1      
# participants affected / at risk     1/167 (0.60%)     0/163 (0.00%)     0/163 (0.00%)  
Hepatobiliary disorders        
Cholelithiasis † 1      
# participants affected / at risk     0/167 (0.00%)     3/163 (1.84%)     1/163 (0.61%)  
Cholecystitis † 1      
# participants affected / at risk     0/167 (0.00%)     2/163 (1.23%)     0/163 (0.00%)  
Bile duct stone † 1      
# participants affected / at risk     0/167 (0.00%)     1/163 (0.61%)     0/163 (0.00%)  
Cholangitis † 1      
# participants affected / at risk     0/167 (0.00%)     1/163 (0.61%)     0/163 (0.00%)  
Cholecystitis acute † 1      
# participants affected / at risk     1/167 (0.60%)     0/163 (0.00%)     0/163 (0.00%)  
Cholecystitis chronic † 1      
# participants affected / at risk     0/167 (0.00%)     1/163 (0.61%)     0/163 (0.00%)  
Hepatic failure † 1      
# participants affected / at risk     1/167 (0.60%)     0/163 (0.00%)     0/163 (0.00%)  
Hepatic ischaemia † 1      
# participants affected / at risk     1/167 (0.60%)     0/163 (0.00%)     0/163 (0.00%)  
Jaundice † 1      
# participants affected / at risk     0/167 (0.00%)     1/163 (0.61%)     0/163 (0.00%)  
Liver disorder † 1      
# participants affected / at risk     1/167 (0.60%)     0/163 (0.00%)     0/163 (0.00%)  
Immune system disorders        
Transplant rejection † 1      
# participants affected / at risk     1/167 (0.60%)     0/163 (0.00%)     0/163 (0.00%)  
Infections and infestations        
Pneumonia † 1      
# participants affected / at risk     4/167 (2.40%)     11/163 (6.75%)     5/163 (3.07%)  
Urinary tract infection † 1      
# participants affected / at risk     5/167 (2.99%)     5/163 (3.07%)     1/163 (0.61%)  
Cellulitis † 1      
# participants affected / at risk     4/167 (2.40%)     2/163 (1.23%)     3/163 (1.84%)  
Lobar pneumonia † 1      
# participants affected / at risk     3/167 (1.80%)     2/163 (1.23%)     0/163 (0.00%)  
Sepsis † 1      
# participants affected / at risk     0/167 (0.00%)     3/163 (1.84%)     2/163 (1.23%)  
Gastroenteritis † 1      
# participants affected / at risk     1/167 (0.60%)     2/163 (1.23%)     1/163 (0.61%)  
Osteomyelitis † 1      
# participants affected / at risk     1/167 (0.60%)     2/163 (1.23%)     1/163 (0.61%)  
Bacteraemia † 1      
# participants affected / at risk     0/167 (0.00%)     2/163 (1.23%)     1/163 (0.61%)  
Wound infection † 1      
# participants affected / at risk     2/167 (1.20%)     1/163 (0.61%)     0/163 (0.00%)  
Gangrene † 1      
# participants affected / at risk     1/167 (0.60%)     1/163 (0.61%)     0/163 (0.00%)  
Gastroenteritis viral † 1      
# participants affected / at risk     0/167 (0.00%)     2/163 (1.23%)     0/163 (0.00%)  
Localised infection † 1      
# participants affected / at risk     0/167 (0.00%)     2/163 (1.23%)     0/163 (0.00%)  
Staphylococcal infection † 1      
# participants affected / at risk     0/167 (0.00%)     1/163 (0.61%)     1/163 (0.61%)  
Urinary tract infection bacterial † 1      
# participants affected / at risk     0/167 (0.00%)     1/163 (0.61%)     1/163 (0.61%)  
Abdominal sepsis † 1      
# participants affected / at risk     1/167 (0.60%)     0/163 (0.00%)     0/163 (0.00%)  
Arthritis bacterial † 1      
# participants affected / at risk     1/167 (0.60%)     0/163 (0.00%)     0/163 (0.00%)  
Bacterial pyelonephritis † 1      
# participants affected / at risk     0/167 (0.00%)     1/163 (0.61%)     0/163 (0.00%)  
Bronchitis † 1      
# participants affected / at risk     0/167 (0.00%)     1/163 (0.61%)     0/163 (0.00%)  
Bronchopneumonia † 1      
# participants affected / at risk     0/167 (0.00%)     0/163 (0.00%)     1/163 (0.61%)  
Cellulitis of male external genital organ † 1      
# participants affected / at risk     0/167 (0.00%)     1/163 (0.61%)     0/163 (0.00%)  
Clostridium difficile colitis † 1      
# participants affected / at risk     0/167 (0.00%)     0/163 (0.00%)     1/163 (0.61%)  
Clostridium difficile sepsis † 1      
# participants affected / at risk     1/167 (0.60%)     0/163 (0.00%)     0/163 (0.00%)  
Device related infection † 1      
# participants affected / at risk     1/167 (0.60%)     0/163 (0.00%)     0/163 (0.00%)  
Diabetic foot infection † 1      
# participants affected / at risk     0/167 (0.00%)     1/163 (0.61%)     0/163 (0.00%)  
Diabetic gangrene † 1      
# participants affected / at risk     1/167 (0.60%)     0/163 (0.00%)     0/163 (0.00%)  
Diverticulitis † 1      
# participants affected / at risk     0/167 (0.00%)     1/163 (0.61%)     0/163 (0.00%)  
Herpes zoster † 1      
# participants affected / at risk     0/167 (0.00%)     1/163 (0.61%)     0/163 (0.00%)  
Labyrinthitis † 1      
# participants affected / at risk     0/167 (0.00%)     0/163 (0.00%)     1/163 (0.61%)  
Necrotising fasciitis † 1      
# participants affected / at risk     1/167 (0.60%)     0/163 (0.00%)     0/163 (0.00%)  
Osteomyelitis bacterial † 1      
# participants affected / at risk     0/167 (0.00%)     1/163 (0.61%)     0/163 (0.00%)  
Perihepatic abscess † 1      
# participants affected / at risk     0/167 (0.00%)     1/163 (0.61%)     0/163 (0.00%)  
Perineal abscess † 1      
# participants affected / at risk     1/167 (0.60%)     0/163 (0.00%)     0/163 (0.00%)  
Pneumonia cryptococcal † 1      
# participants affected / at risk     0/167 (0.00%)     1/163 (0.61%)     0/163 (0.00%)  
Pyelonephritis † 1      
# participants affected / at risk     0/167 (0.00%)     0/163 (0.00%)     1/163 (0.61%)  
Pyelonephritis acute † 1      
# participants affected / at risk     0/167 (0.00%)     1/163 (0.61%)     0/163 (0.00%)  
Septic shock † 1      
# participants affected / at risk     0/167 (0.00%)     1/163 (0.61%)     0/163 (0.00%)  
Staphylococcal bacteraemia † 1      
# participants affected / at risk     0/167 (0.00%)     1/163 (0.61%)     0/163 (0.00%)  
Staphylococcal sepsis † 1      
# participants affected / at risk     1/167 (0.60%)     0/163 (0.00%)     0/163 (0.00%)  
Streptococcal bacteraemia † 1      
# participants affected / at risk     0/167 (0.00%)     1/163 (0.61%)     0/163 (0.00%)  
Subcutaneous abscess † 1      
# participants affected / at risk     1/167 (0.60%)     0/163 (0.00%)     0/163 (0.00%)  
Urinary tract infection enterococcal † 1      
# participants affected / at risk     0/167 (0.00%)     1/163 (0.61%)     0/163 (0.00%)  
Urinary tract infection pseudomonal † 1      
# participants affected / at risk     1/167 (0.60%)     0/163 (0.00%)     0/163 (0.00%)  
Injury, poisoning and procedural complications        
Hip fracture † 1      
# participants affected / at risk     0/167 (0.00%)     2/163 (1.23%)     1/163 (0.61%)  
Scapula fracture † 1      
# participants affected / at risk     0/167 (0.00%)     2/163 (1.23%)     0/163 (0.00%)  
Skin laceration † 1      
# participants affected / at risk     0/167 (0.00%)     0/163 (0.00%)     2/163 (1.23%)  
Subdural haematoma † 1      
# participants affected / at risk     0/167 (0.00%)     1/163 (0.61%)     1/163 (0.61%)  
Avulsion fracture † 1      
# participants affected / at risk     0/167 (0.00%)     1/163 (0.61%)     0/163 (0.00%)  
Clavicle fracture † 1      
# participants affected / at risk     0/167 (0.00%)     1/163 (0.61%)     0/163 (0.00%)  
Complications of transplanted kidney † 1      
# participants affected / at risk     0/167 (0.00%)     0/163 (0.00%)     1/163 (0.61%)  
Concussion † 1      
# participants affected / at risk     0/167 (0.00%)     1/163 (0.61%)     0/163 (0.00%)  
Drug toxicity † 1      
# participants affected / at risk     0/167 (0.00%)     1/163 (0.61%)     0/163 (0.00%)  
Facial bones fracture † 1      
# participants affected / at risk     0/167 (0.00%)     1/163 (0.61%)     0/163 (0.00%)  
Fall † 1      
# participants affected / at risk     0/167 (0.00%)     1/163 (0.61%)     0/163 (0.00%)  
Femoral neck fracture † 1      
# participants affected / at risk     1/167 (0.60%)     0/163 (0.00%)     0/163 (0.00%)  
Femur fracture † 1      
# participants affected / at risk     1/167 (0.60%)     0/163 (0.00%)     0/163 (0.00%)  
Hand fracture † 1      
# participants affected / at risk     0/167 (0.00%)     1/163 (0.61%)     0/163 (0.00%)  
Head injury † 1      
# participants affected / at risk     0/167 (0.00%)     0/163 (0.00%)     1/163 (0.61%)  
Multiple injuries † 1      
# participants affected / at risk     0/167 (0.00%)     1/163 (0.61%)     0/163 (0.00%)  
Perirenal haematoma † 1      
# participants affected / at risk     0/167 (0.00%)     0/163 (0.00%)     1/163 (0.61%)  
Procedural pain † 1      
# participants affected / at risk     0/167 (0.00%)     1/163 (0.61%)     0/163 (0.00%)  
Rib fracture † 1      
# participants affected / at risk     0/167 (0.00%)     1/163 (0.61%)     0/163 (0.00%)  
Seroma † 1      
# participants affected / at risk     0/167 (0.00%)     0/163 (0.00%)     1/163 (0.61%)  
Spinal compression fracture † 1      
# participants affected / at risk     0/167 (0.00%)     0/163 (0.00%)     1/163 (0.61%)  
Wound † 1      
# participants affected / at risk     0/167 (0.00%)     1/163 (0.61%)     0/163 (0.00%)  
Wound dehiscence † 1      
# participants affected / at risk     1/167 (0.60%)     0/163 (0.00%)     0/163 (0.00%)  
Investigations        
Anticoagulation drug level above therapeutic † 1      
# participants affected / at risk     0/167 (0.00%)     1/163 (0.61%)     0/163 (0.00%)  
Coagulation time prolonged † 1      
# participants affected / at risk     0/167 (0.00%)     1/163 (0.61%)     0/163 (0.00%)  
Ejection fraction decreased † 1      
# participants affected / at risk     1/167 (0.60%)     0/163 (0.00%)     0/163 (0.00%)  
Metabolism and nutrition disorders        
Hypoglycaemia † 1      
# participants affected / at risk     1/167 (0.60%)     6/163 (3.68%)     6/163 (3.68%)  
Hyperkalaemia † 1      
# participants affected / at risk     6/167 (3.59%)     2/163 (1.23%)     4/163 (2.45%)  
Dehydration † 1      
# participants affected / at risk     3/167 (1.80%)     4/163 (2.45%)     0/163 (0.00%)  
Diabetic ketoacidosis † 1      
# participants affected / at risk     2/167 (1.20%)     1/163 (0.61%)     2/163 (1.23%)  
Fluid overload † 1      
# participants affected / at risk     1/167 (0.60%)     1/163 (0.61%)     2/163 (1.23%)  
Diabetes mellitus inadequate control † 1      
# participants affected / at risk     1/167 (0.60%)     2/163 (1.23%)     0/163 (0.00%)  
Metabolic acidosis † 1      
# participants affected / at risk     0/167 (0.00%)     1/163 (0.61%)     1/163 (0.61%)  
Diabetes mellitus † 1      
# participants affected / at risk     0/167 (0.00%)     1/163 (0.61%)     0/163 (0.00%)  
Diabetic foot † 1      
# participants affected / at risk     0/167 (0.00%)     1/163 (0.61%)     0/163 (0.00%)  
Failure to thrive † 1      
# participants affected / at risk     0/167 (0.00%)     1/163 (0.61%)     0/163 (0.00%)  
Fluid retention † 1      
# participants affected / at risk     0/167 (0.00%)     1/163 (0.61%)     0/163 (0.00%)  
Gout † 1      
# participants affected / at risk     0/167 (0.00%)     0/163 (0.00%)     1/163 (0.61%)  
Hyperglycaemia † 1      
# participants affected / at risk     0/167 (0.00%)     0/163 (0.00%)     1/163 (0.61%)  
Hyperuricaemia † 1      
# participants affected / at risk     1/167 (0.60%)     0/163 (0.00%)     0/163 (0.00%)  
Hypervolaemia † 1      
# participants affected / at risk     0/167 (0.00%)     1/163 (0.61%)     0/163 (0.00%)  
Hyponatraemia † 1      
# participants affected / at risk     0/167 (0.00%)     1/163 (0.61%)     0/163 (0.00%)  
Hypovolaemia † 1      
# participants affected / at risk     0/167 (0.00%)     1/163 (0.61%)     0/163 (0.00%)  
Ketoacidosis † 1      
# participants affected / at risk     0/167 (0.00%)     1/163 (0.61%)     0/163 (0.00%)  
Neuroglycopenia † 1      
# participants affected / at risk     0/167 (0.00%)     0/163 (0.00%)     1/163 (0.61%)  
Musculoskeletal and connective tissue disorders        
Back pain † 1      
# participants affected / at risk     2/167 (1.20%)     2/163 (1.23%)     0/163 (0.00%)  
Diabetic amyotrophy † 1      
# participants affected / at risk     1/167 (0.60%)     0/163 (0.00%)     0/163 (0.00%)  
Intervertebral disc protrusion † 1      
# participants affected / at risk     0/167 (0.00%)     1/163 (0.61%)     0/163 (0.00%)  
Lumbar spinal stenosis † 1      
# participants affected / at risk     0/167 (0.00%)     0/163 (0.00%)     1/163 (0.61%)  
Musculoskeletal chest pain † 1      
# participants affected / at risk     1/167 (0.60%)     0/163 (0.00%)     0/163 (0.00%)  
Musculoskeletal stiffness † 1      
# participants affected / at risk     0/167 (0.00%)     0/163 (0.00%)     1/163 (0.61%)  
Osteoarthritis † 1      
# participants affected / at risk     0/167 (0.00%)     1/163 (0.61%)     0/163 (0.00%)  
Osteolysis † 1      
# participants affected / at risk     0/167 (0.00%)     0/163 (0.00%)     1/163 (0.61%)  
Pain in extremity † 1      
# participants affected / at risk     0/167 (0.00%)     1/163 (0.61%)     0/163 (0.00%)  
Rhabdomyolysis † 1      
# participants affected / at risk     0/167 (0.00%)     1/163 (0.61%)     0/163 (0.00%)  
Spinal column stenosis † 1      
# participants affected / at risk     0/167 (0.00%)     1/163 (0.61%)     0/163 (0.00%)  
Neoplasms benign, malignant and unspecified (incl cysts and polyps)        
Colon cancer † 1      
# participants affected / at risk     1/167 (0.60%)     0/163 (0.00%)     1/163 (0.61%)  
Acute myeloid leukaemia † 1      
# participants affected / at risk     1/167 (0.60%)     0/163 (0.00%)     0/163 (0.00%)  
Breast cancer metastatic † 1      
# participants affected / at risk     0/167 (0.00%)     1/163 (0.61%)     0/163 (0.00%)  
Colon cancer metastatic † 1      
# participants affected / at risk     1/167 (0.60%)     0/163 (0.00%)     0/163 (0.00%)  
Lung cancer metastatic † 1      
# participants affected / at risk     0/167 (0.00%)     1/163 (0.61%)     0/163 (0.00%)  
Lung squamous cell carcinoma stage unspecified † 1      
# participants affected / at risk     0/167 (0.00%)     0/163 (0.00%)     1/163 (0.61%)  
Seborrhoeic keratosis † 1      
# participants affected / at risk     1/167 (0.60%)     0/163 (0.00%)     0/163 (0.00%)  
Transitional cell carcinoma † 1      
# participants affected / at risk     1/167 (0.60%)     0/163 (0.00%)     0/163 (0.00%)  
Nervous system disorders        
Syncope † 1      
# participants affected / at risk     1/167 (0.60%)     3/163 (1.84%)     1/163 (0.61%)  
Cerebrovascular accident † 1      
# participants affected / at risk     3/167 (1.80%)     1/163 (0.61%)     0/163 (0.00%)  
Transient ischaemic attack † 1      
# participants affected / at risk     0/167 (0.00%)     1/163 (0.61%)     3/163 (1.84%)  
Headache † 1      
# participants affected / at risk     1/167 (0.60%)     0/163 (0.00%)     1/163 (0.61%)  
Lacunar infarction † 1      
# participants affected / at risk     1/167 (0.60%)     1/163 (0.61%)     0/163 (0.00%)  
Presyncope † 1      
# participants affected / at risk     0/167 (0.00%)     2/163 (1.23%)     0/163 (0.00%)  
Carotid artery stenosis † 1      
# participants affected / at risk     0/167 (0.00%)     1/163 (0.61%)     0/163 (0.00%)  
Cerebral haemorrhage † 1      
# participants affected / at risk     0/167 (0.00%)     0/163 (0.00%)     1/163 (0.61%)  
Cerebral infarction † 1      
# participants affected / at risk     0/167 (0.00%)     1/163 (0.61%)     0/163 (0.00%)  
Convulsion † 1      
# participants affected / at risk     1/167 (0.60%)     0/163 (0.00%)     0/163 (0.00%)  
Dizziness † 1      
# participants affected / at risk     0/167 (0.00%)     1/163 (0.61%)     0/163 (0.00%)  
Encephalopathy † 1      
# participants affected / at risk     0/167 (0.00%)     1/163 (0.61%)     0/163 (0.00%)  
Grand mal convulsion † 1      
# participants affected / at risk     0/167 (0.00%)     1/163 (0.61%)     0/163 (0.00%)  
Hypoxic encephalopathy † 1      
# participants affected / at risk     1/167 (0.60%)     0/163 (0.00%)     0/163 (0.00%)  
Migraine † 1      
# participants affected / at risk     0/167 (0.00%)     1/163 (0.61%)     0/163 (0.00%)  
Neuropathy peripheral † 1      
# participants affected / at risk     0/167 (0.00%)     1/163 (0.61%)     0/163 (0.00%)  
Subarachnoid haemorrhage † 1      
# participants affected / at risk     0/167 (0.00%)     0/163 (0.00%)     1/163 (0.61%)  
Tremor † 1      
# participants affected / at risk     0/167 (0.00%)     1/163 (0.61%)     0/163 (0.00%)  
Uraemic encephalopathy † 1      
# participants affected / at risk     1/167 (0.60%)     0/163 (0.00%)     0/163 (0.00%)  
Vocal cord paralysis † 1      
# participants affected / at risk     1/167 (0.60%)     0/163 (0.00%)     0/163 (0.00%)  
Psychiatric disorders        
Mental status changes † 1      
# participants affected / at risk     1/167 (0.60%)     1/163 (0.61%)     3/163 (1.84%)  
Suicide attempt † 1      
# participants affected / at risk     1/167 (0.60%)     0/163 (0.00%)     1/163 (0.61%)  
Agitation † 1      
# participants affected / at risk     0/167 (0.00%)     0/163 (0.00%)     1/163 (0.61%)  
Depression † 1      
# participants affected / at risk     0/167 (0.00%)     1/163 (0.61%)     0/163 (0.00%)  
Hallucination † 1      
# participants affected / at risk     0/167 (0.00%)     0/163 (0.00%)     1/163 (0.61%)  
Psychotic disorder † 1      
# participants affected / at risk     1/167 (0.60%)     0/163 (0.00%)     0/163 (0.00%)  
Schizoaffective disorder † 1      
# participants affected / at risk     0/167 (0.00%)     1/163 (0.61%)     0/163 (0.00%)  
Substance abuse † 1      
# participants affected / at risk     0/167 (0.00%)     1/163 (0.61%)     0/163 (0.00%)  
Renal and urinary disorders        
Renal failure acute † 1      
# participants affected / at risk     11/167 (6.59%)     11/163 (6.75%)     5/163 (3.07%)  
Renal failure chronic † 1      
# participants affected / at risk     10/167 (5.99%)     6/163 (3.68%)     8/163 (4.91%)  
Renal failure † 1      
# participants affected / at risk     2/167 (1.20%)     2/163 (1.23%)     1/163 (0.61%)  
Azotaemia † 1      
# participants affected / at risk     2/167 (1.20%)     1/163 (0.61%)     1/163 (0.61%)  
Renal impairment † 1      
# participants affected / at risk     0/167 (0.00%)     1/163 (0.61%)     1/163 (0.61%)  
Acute prerenal failure † 1      
# participants affected / at risk     0/167 (0.00%)     1/163 (0.61%)     0/163 (0.00%)  
Glomerulonephritis chronic † 1      
# participants affected / at risk     1/167 (0.60%)     0/163 (0.00%)     0/163 (0.00%)  
Obstructive uropathy † 1      
# participants affected / at risk     0/167 (0.00%)     0/163 (0.00%)     1/163 (0.61%)  
Renal pain † 1      
# participants affected / at risk     0/167 (0.00%)     1/163 (0.61%)     0/163 (0.00%)  
Urinary retention † 1      
# participants affected / at risk     1/167 (0.60%)     0/163 (0.00%)     0/163 (0.00%)  
Respiratory, thoracic and mediastinal disorders        
Chronic obstructive pulmonary disease † 1      
# participants affected / at risk     0/167 (0.00%)     1/163 (0.61%)     3/163 (1.84%)  
Pleural effusion † 1      
# participants affected / at risk     1/167 (0.60%)     1/163 (0.61%)     2/163 (1.23%)  
Pneumonia aspiration † 1      
# participants affected / at risk     2/167 (1.20%)     1/163 (0.61%)     1/163 (0.61%)  
Respiratory arrest † 1      
# participants affected / at risk     2/167 (1.20%)     2/163 (1.23%)     0/163 (0.00%)  
Dyspnoea † 1      
# participants affected / at risk     2/167 (1.20%)     0/163 (0.00%)     1/163 (0.61%)  
Pulmonary oedema † 1      
# participants affected / at risk     3/167 (1.80%)     0/163 (0.00%)     0/163 (0.00%)  
Respiratory failure † 1      
# participants affected / at risk     2/167 (1.20%)     0/163 (0.00%)     1/163 (0.61%)  
Acute respiratory failure † 1      
# participants affected / at risk     0/167 (0.00%)     1/163 (0.61%)     1/163 (0.61%)  
Asthma † 1      
# participants affected / at risk     0/167 (0.00%)     1/163 (0.61%)     1/163 (0.61%)  
Pulmonary congestion † 1      
# participants affected / at risk     0/167 (0.00%)     0/163 (0.00%)     2/163 (1.23%)  
Pulmonary embolism † 1      
# participants affected / at risk     1/167 (0.60%)     1/163 (0.61%)     0/163 (0.00%)  
Bronchitis chronic † 1      
# participants affected / at risk     0/167 (0.00%)     1/163 (0.61%)     0/163 (0.00%)  
Epistaxis † 1      
# participants affected / at risk     0/167 (0.00%)     1/163 (0.61%)     0/163 (0.00%)  
Hypoxia † 1      
# participants affected / at risk     0/167 (0.00%)     0/163 (0.00%)     1/163 (0.61%)  
Pulmonary cavitation † 1      
# participants affected / at risk     0/167 (0.00%)     0/163 (0.00%)     1/163 (0.61%)  
Pulmonary fibrosis † 1      
# participants affected / at risk     1/167 (0.60%)     0/163 (0.00%)     0/163 (0.00%)  
Skin and subcutaneous tissue disorders        
Skin ulcer † 1      
# participants affected / at risk     2/167 (1.20%)     0/163 (0.00%)     0/163 (0.00%)  
Diabetic ulcer † 1      
# participants affected / at risk     0/167 (0.00%)     1/163 (0.61%)     0/163 (0.00%)  
Exfoliative rash † 1      
# participants affected / at risk     1/167 (0.60%)     0/163 (0.00%)     0/163 (0.00%)  
Leukocytoclastic vasculitis † 1      
# participants affected / at risk     0/167 (0.00%)     1/163 (0.61%)     0/163 (0.00%)  
Stasis dermatitis † 1      
# participants affected / at risk     0/167 (0.00%)     0/163 (0.00%)     1/163 (0.61%)  
Vascular disorders        
Hypotension † 1      
# participants affected / at risk     1/167 (0.60%)     1/163 (0.61%)     4/163 (2.45%)  
Hypertensive crisis † 1      
# participants affected / at risk     3/167 (1.80%)     2/163 (1.23%)     0/163 (0.00%)  
Deep vein thrombosis † 1      
# participants affected / at risk     0/167 (0.00%)     3/163 (1.84%)     1/163 (0.61%)  
Hypertension † 1      
# participants affected / at risk     2/167 (1.20%)     1/163 (0.61%)     1/163 (0.61%)  
Aortic aneurysm † 1      
# participants affected / at risk     2/167 (1.20%)     0/163 (0.00%)     1/163 (0.61%)  
Hypertensive emergency † 1      
# participants affected / at risk     1/167 (0.60%)     2/163 (1.23%)     0/163 (0.00%)  
Haematoma † 1      
# participants affected / at risk     0/167 (0.00%)     2/163 (1.23%)     0/163 (0.00%)  
Accelerated hypertension † 1      
# participants affected / at risk     1/167 (0.60%)     0/163 (0.00%)     0/163 (0.00%)  
Angiopathy † 1      
# participants affected / at risk     1/167 (0.60%)     0/163 (0.00%)     0/163 (0.00%)  
Aortic aneurysm rupture † 1      
# participants affected / at risk     1/167 (0.60%)     0/163 (0.00%)     0/163 (0.00%)  
Aortic stenosis † 1      
# participants affected / at risk     1/167 (0.60%)     0/163 (0.00%)     0/163 (0.00%)  
Arterial occlusive disease † 1      
# participants affected / at risk     0/167 (0.00%)     1/163 (0.61%)     0/163 (0.00%)  
Cardiovascular insufficiency † 1      
# participants affected / at risk     0/167 (0.00%)     1/163 (0.61%)     0/163 (0.00%)  
Malignant hypertension † 1      
# participants affected / at risk     0/167 (0.00%)     1/163 (0.61%)     0/163 (0.00%)  
Orthostatic hypotension † 1      
# participants affected / at risk     1/167 (0.60%)     0/163 (0.00%)     0/163 (0.00%)  
Peripheral ischaemia † 1      
# participants affected / at risk     1/167 (0.60%)     0/163 (0.00%)     0/163 (0.00%)  
Peripheral vascular disorder † 1      
# participants affected / at risk     0/167 (0.00%)     0/163 (0.00%)     1/163 (0.61%)  
Vascular pseudoaneurysm † 1      
# participants affected / at risk     1/167 (0.60%)     0/163 (0.00%)     0/163 (0.00%)  
Events were collected by systematic assessment
1 Term from vocabulary, MedDRA (11.0)




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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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