Study: NCT02676466

Adverse event: Acute coronary syndrome
Serious: yes
Organ System: Cardiac disorders
Notes: ANY SAE
Frequency: 1 affected / 109 at risk

Adverse event: Arthritis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: ANY SAE
Frequency: 3 affected / 109 at risk

Adverse event: Back pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: ANY SAE
Frequency: 2 affected / 109 at risk

Adverse event: Angina pectoris
Serious: yes
Organ System: Cardiac disorders
Notes: ANY SAE
Frequency: 3 affected / 109 at risk

Adverse event: Large intestinal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Notes: ANY SAE
Frequency: 1 affected / 109 at risk

Adverse event: Oesophageal obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Notes: ANY SAE
Frequency: 1 affected / 109 at risk

Adverse event: Fall
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: ANY SAE
Frequency: 1 affected / 109 at risk

Adverse event: Fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: ANY SAE
Frequency: 3 affected / 109 at risk

Adverse event: GASTROINTESTINAL DISORDERS - OTHER, SPECIFY
Serious: yes
Organ System: Gastrointestinal disorders
Notes: ANY SAE
Frequency: 1 affected / 109 at risk

Adverse event: Haematoma
Serious: yes
Organ System: Vascular disorders
Notes: ANY SAE
Frequency: 1 affected / 109 at risk

Adverse event: Hyperglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: ANY SAE
Frequency: 1 affected / 109 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Vascular disorders
Notes: ANY SAE
Frequency: 1 affected / 109 at risk

Adverse event: Joint range of motion decreased
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: ANY SAE
Frequency: 1 affected / 109 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Notes: ANY SAE
Frequency: 2 affected / 109 at risk

Adverse event: NEOPLASMS BENIGN, MALIGNANT AND UNSPECIFIED (INCL CYSTS AND POLYPS) - OTHER, SPECIFY
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: ANY SAE
Frequency: 1 affected / 109 at risk

Adverse event: Non-cardiac chest pain
Serious: yes
Organ System: General disorders
Notes: ANY SAE
Frequency: 1 affected / 109 at risk

Adverse event: ORTHOPEDIC NEUROLOGIC
Serious: yes
Organ System: Nervous system disorders
Notes: ANY SAE
Frequency: 1 affected / 109 at risk

Adverse event: Pain in extremity
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: ANY SAE
Frequency: 1 affected / 109 at risk

Adverse event: Pain of skin
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Notes: ANY SAE
Frequency: 1 affected / 109 at risk

Adverse event: Sinus bradycardia
Serious: yes
Organ System: Cardiac disorders
Notes: ANY SAE
Frequency: 1 affected / 109 at risk

Adverse event: SKIN AND SUBCUTANEOUS TISSUE DISORDERS - OTHER, SPECIFY
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Notes: ANY SAE
Frequency: 1 affected / 109 at risk

Adverse event: Skin infection
Serious: yes
Organ System: Infections and infestations
Notes: ANY SAE
Frequency: 1 affected / 109 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Nervous system disorders
Notes: ANY SAE
Frequency: 2 affected / 109 at risk

Adverse event: SURGICAL AND MEDICAL PROCEDURES - OTHER, SPECIFY
Serious: yes
Organ System: Surgical and medical procedures
Notes: ANY SAE
Frequency: 1 affected / 109 at risk

Adverse event: Syncope
Serious: yes
Organ System: Nervous system disorders
Notes: ANY SAE
Frequency: 1 affected / 109 at risk

Adverse event: Embolism
Serious: yes
Organ System: Vascular disorders
Notes: ANY SAE
Frequency: 1 affected / 109 at risk

Adverse event: Upper respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Notes: ANY SAE
Frequency: 1 affected / 109 at risk

Adverse event: Acute coronary syndrome
Serious: yes
Organ System: Cardiac disorders
Notes: INPATIENT HOSP
Frequency: 1 affected / 109 at risk

Adverse event: Arthritis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: INPATIENT HOSP
Frequency: 3 affected / 109 at risk

Adverse event: Back pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: INPATIENT HOSP
Frequency: 2 affected / 109 at risk

Adverse event: Angina pectoris
Serious: yes
Organ System: Cardiac disorders
Notes: INPATIENT HOSP
Frequency: 3 affected / 109 at risk

Adverse event: Large intestinal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Notes: INPATIENT HOSP
Frequency: 1 affected / 109 at risk

Adverse event: Oesophageal obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Notes: INPATIENT HOSP
Frequency: 1 affected / 109 at risk

Adverse event: Fall
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: INPATIENT HOSP
Frequency: 1 affected / 109 at risk

Adverse event: Fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: INPATIENT HOSP
Frequency: 3 affected / 109 at risk

Adverse event: GASTROINTESTINAL DISORDERS - OTHER, SPECIFY
Serious: yes
Organ System: Gastrointestinal disorders
Notes: INPATIENT HOSP
Frequency: 1 affected / 109 at risk

Adverse event: Haematoma
Serious: yes
Organ System: Vascular disorders
Notes: INPATIENT HOSP
Frequency: 1 affected / 109 at risk

Adverse event: Hyperglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: INPATIENT HOSP
Frequency: 1 affected / 109 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Vascular disorders
Notes: INPATIENT HOSP
Frequency: 1 affected / 109 at risk

Adverse event: Joint range of motion decreased
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: INPATIENT HOSP
Frequency: 1 affected / 109 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Notes: INPATIENT HOSP
Frequency: 2 affected / 109 at risk

Adverse event: NEOPLASMS BENIGN, MALIGNANT AND UNSPECIFIED (INCL CYSTS AND POLYPS) - OTHER, SPECIFY
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: INPATIENT HOSP
Frequency: 1 affected / 109 at risk

Adverse event: Non-cardiac chest pain
Serious: yes
Organ System: General disorders
Notes: INPATIENT HOSP
Frequency: 1 affected / 109 at risk

Adverse event: ORTHOPEDIC NEUROLOGIC
Serious: yes
Organ System: Nervous system disorders
Notes: INPATIENT HOSP
Frequency: 1 affected / 109 at risk

Adverse event: Pain in extremity
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: INPATIENT HOSP
Frequency: 1 affected / 109 at risk

Adverse event: Pain of skin
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Notes: INPATIENT HOSP
Frequency: 1 affected / 109 at risk

Adverse event: Sinus bradycardia
Serious: yes
Organ System: Cardiac disorders
Notes: INPATIENT HOSP
Frequency: 1 affected / 109 at risk

Adverse event: SKIN AND SUBCUTANEOUS TISSUE DISORDERS - OTHER, SPECIFY
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Notes: INPATIENT HOSP
Frequency: 1 affected / 109 at risk

Adverse event: Skin infection
Serious: yes
Organ System: Infections and infestations
Notes: INPATIENT HOSP
Frequency: 1 affected / 109 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Nervous system disorders
Notes: INPATIENT HOSP
Frequency: 2 affected / 109 at risk

Adverse event: SURGICAL AND MEDICAL PROCEDURES - OTHER, SPECIFY
Serious: yes
Organ System: Surgical and medical procedures
Notes: INPATIENT HOSP
Frequency: 1 affected / 109 at risk

Adverse event: Syncope
Serious: yes
Organ System: Nervous system disorders
Notes: INPATIENT HOSP
Frequency: 1 affected / 109 at risk

Adverse event: Embolism
Serious: yes
Organ System: Vascular disorders
Notes: INPATIENT HOSP
Frequency: 1 affected / 109 at risk

Adverse event: Upper respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Notes: INPATIENT HOSP
Frequency: 1 affected / 109 at risk

Adverse event: NON-SERIOUS AES - Any Adverse Event
Serious: no
Organ System: General disorders
Notes: Any Adverse Event
Frequency: 73 affected / 109 at risk

Adverse event: NON-SERIOUS AES - Cough
Serious: no
Organ System: General disorders
Notes: Cough
Frequency: 4 affected / 109 at risk

Adverse event: NON-SERIOUS AES - Dizziness/Presyncope
Serious: no
Organ System: General disorders
Notes: Dizziness/Presyncope
Frequency: 1 affected / 109 at risk

Adverse event: NON-SERIOUS AES - Fall (mechanical)
Serious: no
Organ System: General disorders
Notes: Fall (mechanical)
Frequency: 10 affected / 109 at risk

Adverse event: NON-SERIOUS AES - Fatigue
Serious: no
Organ System: General disorders
Notes: Fatigue
Frequency: 2 affected / 109 at risk

Adverse event: NON-SERIOUS AES - GI Upset
Serious: no
Organ System: General disorders
Notes: GI Upset
Frequency: 7 affected / 109 at risk

Adverse event: NON-SERIOUS AES - Hyperglycemia
Serious: no
Organ System: General disorders
Notes: Hyperglycemia
Frequency: 1 affected / 109 at risk

Adverse event: NON-SERIOUS AES - Hypotension
Serious: no
Organ System: General disorders
Notes: Hypotension
Frequency: 6 affected / 109 at risk

Adverse event: NON-SERIOUS AES - Other
Serious: no
Organ System: General disorders
Notes: Other
Frequency: 69 affected / 109 at risk

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Notes: ANY SAE
Frequency: 1 affected / 71 at risk

Adverse event: Aortic valve disease
Serious: yes
Organ System: Cardiac disorders
Notes: ANY SAE
Frequency: 1 affected / 71 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Notes: ANY SAE
Frequency: 1 affected / 71 at risk

Adverse event: Cardiac arrest
Serious: yes
Organ System: Cardiac disorders
Notes: ANY SAE
Frequency: 1 affected / 71 at risk

Adverse event: CARDIAC DISORDERS - OTHER, SPECIFY
Serious: yes
Organ System: Cardiac disorders
Notes: ANY SAE
Frequency: 1 affected / 71 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: ANY SAE
Frequency: 1 affected / 71 at risk

Adverse event: Fall
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: ANY SAE
Frequency: 1 affected / 71 at risk

Adverse event: Cardiac failure
Serious: yes
Organ System: Cardiac disorders
Notes: ANY SAE
Frequency: 2 affected / 71 at risk

Adverse event: Hepatic failure
Serious: yes
Organ System: Hepatobiliary disorders
Notes: ANY SAE
Frequency: 1 affected / 71 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Notes: ANY SAE
Frequency: 1 affected / 71 at risk

Adverse event: NEOPLASMS BENIGN, MALIGNANT AND UNSPECIFIED (INCL CYSTS AND POLYPS) - OTHER, SPECIFY
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: ANY SAE
Frequency: 1 affected / 71 at risk

Adverse event: Non-cardiac chest pain
Serious: yes
Organ System: General disorders
Notes: ANY SAE
Frequency: 2 affected / 71 at risk

Adverse event: RENAL AND URINARY DISORDERS - OTHER, SPECIFY
Serious: yes
Organ System: Renal and urinary disorders
Notes: ANY SAE
Frequency: 1 affected / 71 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: ANY SAE
Frequency: 1 affected / 71 at risk

Adverse event: Sinus node dysfunction
Serious: yes
Organ System: Cardiac disorders
Notes: ANY SAE
Frequency: 1 affected / 71 at risk

Adverse event: SURGICAL AND MEDICAL PROCEDURES - OTHER, SPECIFY
Serious: yes
Organ System: Surgical and medical procedures
Notes: ANY SAE
Frequency: 1 affected / 71 at risk

Adverse event: SURGICAL AND MEDICAL PROCEDURES, OTHER, LEFT KNEE REPLACEMENT
Serious: yes
Organ System: Surgical and medical procedures
Notes: ANY SAE
Frequency: 1 affected / 71 at risk

Adverse event: Syncope
Serious: yes
Organ System: Nervous system disorders
Notes: ANY SAE
Frequency: 1 affected / 71 at risk

Adverse event: Transient ischaemic attack
Serious: yes
Organ System: Nervous system disorders
Notes: ANY SAE
Frequency: 1 affected / 71 at risk

Adverse event: Tremor
Serious: yes
Organ System: Nervous system disorders
Notes: ANY SAE
Frequency: 1 affected / 71 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Notes: ANY SAE
Frequency: 1 affected / 71 at risk

Adverse event: Urinary tract obstruction
Serious: yes
Organ System: Renal and urinary disorders
Notes: ANY SAE
Frequency: 1 affected / 71 at risk

Adverse event: Cardiac arrest
Serious: yes
Organ System: Cardiac disorders
Notes: DEATH
Frequency: 1 affected / 71 at risk

Adverse event: Cardiac failure
Serious: yes
Organ System: Cardiac disorders
Notes: DEATH
Frequency: 1 affected / 71 at risk

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Notes: INPATIENT HOSP
Frequency: 1 affected / 71 at risk

Adverse event: Aortic valve disease
Serious: yes
Organ System: Cardiac disorders
Notes: INPATIENT HOSP
Frequency: 1 affected / 71 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Notes: INPATIENT HOSP
Frequency: 1 affected / 71 at risk

Adverse event: CARDIAC DISORDERS - OTHER, SPECIFY
Serious: yes
Organ System: Cardiac disorders
Notes: INPATIENT HOSP
Frequency: 1 affected / 71 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: INPATIENT HOSP
Frequency: 1 affected / 71 at risk

Adverse event: Fall
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: INPATIENT HOSP
Frequency: 1 affected / 71 at risk

Adverse event: Cardiac failure
Serious: yes
Organ System: Cardiac disorders
Notes: INPATIENT HOSP
Frequency: 1 affected / 71 at risk

Adverse event: Hepatic failure
Serious: yes
Organ System: Hepatobiliary disorders
Notes: INPATIENT HOSP
Frequency: 1 affected / 71 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Notes: INPATIENT HOSP
Frequency: 1 affected / 71 at risk

Adverse event: NEOPLASMS BENIGN, MALIGNANT AND UNSPECIFIED (INCL CYSTS AND POLYPS) - OTHER, SPECIFY
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: INPATIENT HOSP
Frequency: 1 affected / 71 at risk

Adverse event: Non-cardiac chest pain
Serious: yes
Organ System: General disorders
Notes: INPATIENT HOSP
Frequency: 2 affected / 71 at risk

Adverse event: RENAL AND URINARY DISORDERS - OTHER, SPECIFY
Serious: yes
Organ System: Renal and urinary disorders
Notes: INPATIENT HOSP
Frequency: 1 affected / 71 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: INPATIENT HOSP
Frequency: 1 affected / 71 at risk

Adverse event: Sinus node dysfunction
Serious: yes
Organ System: Cardiac disorders
Notes: INPATIENT HOSP
Frequency: 1 affected / 71 at risk

Adverse event: SURGICAL AND MEDICAL PROCEDURES - OTHER, SPECIFY
Serious: yes
Organ System: Surgical and medical procedures
Notes: INPATIENT HOSP
Frequency: 1 affected / 71 at risk

Adverse event: SURGICAL AND MEDICAL PROCEDURES, OTHER, LEFT KNEE REPLACEMENT
Serious: yes
Organ System: Surgical and medical procedures
Notes: INPATIENT HOSP
Frequency: 1 affected / 71 at risk

Adverse event: Syncope
Serious: yes
Organ System: Nervous system disorders
Notes: INPATIENT HOSP
Frequency: 1 affected / 71 at risk

Adverse event: Transient ischaemic attack
Serious: yes
Organ System: Nervous system disorders
Notes: INPATIENT HOSP
Frequency: 1 affected / 71 at risk

Adverse event: Tremor
Serious: yes
Organ System: Nervous system disorders
Notes: INPATIENT HOSP
Frequency: 1 affected / 71 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Notes: INPATIENT HOSP
Frequency: 1 affected / 71 at risk

Adverse event: Urinary tract obstruction
Serious: yes
Organ System: Renal and urinary disorders
Notes: INPATIENT HOSP
Frequency: 1 affected / 71 at risk

Adverse event: NON-SERIOUS AES - Any Adverse Event
Serious: no
Organ System: General disorders
Notes: Any Adverse Event
Frequency: 46 affected / 71 at risk

Adverse event: NON-SERIOUS AES - Atrial Fibrillation
Serious: no
Organ System: General disorders
Notes: Atrial Fibrillation
Frequency: 2 affected / 71 at risk

Adverse event: NON-SERIOUS AES - Cough
Serious: no
Organ System: General disorders
Notes: Cough
Frequency: 3 affected / 71 at risk

Adverse event: NON-SERIOUS AES - Dizziness/Presyncope
Serious: no
Organ System: General disorders
Notes: Dizziness/Presyncope
Frequency: 1 affected / 71 at risk

Adverse event: NON-SERIOUS AES - Fall (mechanical)
Serious: no
Organ System: General disorders
Notes: Fall (mechanical)
Frequency: 7 affected / 71 at risk

Adverse event: NON-SERIOUS AES - Fatigue
Serious: no
Organ System: General disorders
Notes: Fatigue
Frequency: 3 affected / 71 at risk

Adverse event: NON-SERIOUS AES - GI Upset
Serious: no
Organ System: General disorders
Notes: GI Upset
Frequency: 5 affected / 71 at risk

Adverse event: NON-SERIOUS AES - Hyperglycemia
Serious: no
Organ System: General disorders
Notes: Hyperglycemia
Frequency: 1 affected / 71 at risk

Adverse event: NON-SERIOUS AES - Drop in hemoglobin
Serious: no
Organ System: General disorders
Notes: Drop in hemoglobin
Frequency: 1 affected / 71 at risk

Adverse event: NON-SERIOUS AES - Hypotension
Serious: no
Organ System: General disorders
Notes: Hypotension
Frequency: 2 affected / 71 at risk

Adverse event: NON-SERIOUS AES - Drop in eGFR
Serious: no
Organ System: General disorders
Notes: Drop in eGFR
Frequency: 1 affected / 71 at risk

Adverse event: NON-SERIOUS AES - Other
Serious: no
Organ System: General disorders
Notes: Other
Frequency: 40 affected / 71 at risk

Adverse event: Back pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: ANY SAE
Frequency: 1 affected / 26 at risk

Adverse event: Dizziness
Serious: yes
Organ System: Nervous system disorders
Notes: ANY SAE
Frequency: 1 affected / 26 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Notes: ANY SAE
Frequency: 1 affected / 26 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Notes: DEATH
Frequency: 1 affected / 26 at risk

Adverse event: Back pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: INPATIENT HOSP
Frequency: 1 affected / 26 at risk

Adverse event: Dizziness
Serious: yes
Organ System: Nervous system disorders
Notes: INPATIENT HOSP
Frequency: 1 affected / 26 at risk

Adverse event: NON-SERIOUS AES - Any Adverse Event
Serious: no
Organ System: General disorders
Notes: Any Adverse Event
Frequency: 22 affected / 26 at risk

Adverse event: NON-SERIOUS AES - Dizziness/Presyncope
Serious: no
Organ System: General disorders
Notes: Dizziness/Presyncope
Frequency: 6 affected / 26 at risk

Adverse event: NON-SERIOUS AES - Fall (mechanical)
Serious: no
Organ System: General disorders
Notes: Fall (mechanical)
Frequency: 1 affected / 26 at risk

Adverse event: NON-SERIOUS AES - Fatigue
Serious: no
Organ System: General disorders
Notes: Fatigue
Frequency: 2 affected / 26 at risk

Adverse event: NON-SERIOUS AES - GI Upset
Serious: no
Organ System: General disorders
Notes: GI Upset
Frequency: 1 affected / 26 at risk

Adverse event: NON-SERIOUS AES - Hyperkalemia
Serious: no
Organ System: General disorders
Notes: Hyperkalemia
Frequency: 1 affected / 26 at risk

Adverse event: NON-SERIOUS AES - Hypotension
Serious: no
Organ System: General disorders
Notes: Hypotension
Frequency: 1 affected / 26 at risk

Adverse event: NON-SERIOUS AES - Drop in eGFR
Serious: no
Organ System: General disorders
Notes: Drop in eGFR
Frequency: 2 affected / 26 at risk

Adverse event: NON-SERIOUS AES - Other
Serious: no
Organ System: General disorders
Notes: Other
Frequency: 20 affected / 26 at risk

Adverse event: Amnesia
Serious: yes
Organ System: Nervous system disorders
Notes: ANY SAE
Frequency: 1 affected / 17 at risk

Adverse event: Arthritis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: ANY SAE
Frequency: 1 affected / 17 at risk

Adverse event: SURGICAL AND MEDICAL PROCEDURES - OTHER, SPECIFY
Serious: yes
Organ System: Surgical and medical procedures
Notes: ANY SAE
Frequency: 1 affected / 17 at risk

Adverse event: Urinary tract obstruction
Serious: yes
Organ System: Renal and urinary disorders
Notes: ANY SAE
Frequency: 1 affected / 17 at risk

Adverse event: Amnesia
Serious: yes
Organ System: Nervous system disorders
Notes: INPATIENT HOSP
Frequency: 1 affected / 17 at risk

Adverse event: Arthritis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: INPATIENT HOSP
Frequency: 1 affected / 17 at risk

Adverse event: SURGICAL AND MEDICAL PROCEDURES - OTHER, SPECIFY
Serious: yes
Organ System: Surgical and medical procedures
Notes: INPATIENT HOSP
Frequency: 1 affected / 17 at risk

Adverse event: Urinary tract obstruction
Serious: yes
Organ System: Renal and urinary disorders
Notes: INPATIENT HOSP
Frequency: 1 affected / 17 at risk

Adverse event: NON-SERIOUS AES - Any Adverse Event
Serious: no
Organ System: General disorders
Notes: Any Adverse Event
Frequency: 16 affected / 17 at risk

Adverse event: NON-SERIOUS AES - Cough
Serious: no
Organ System: General disorders
Notes: Cough
Frequency: 2 affected / 17 at risk

Adverse event: NON-SERIOUS AES - Dizziness/Presyncope
Serious: no
Organ System: General disorders
Notes: Dizziness/Presyncope
Frequency: 4 affected / 17 at risk

Adverse event: NON-SERIOUS AES - Fall (mechanical)
Serious: no
Organ System: General disorders
Notes: Fall (mechanical)
Frequency: 3 affected / 17 at risk

Adverse event: NON-SERIOUS AES - GI Upset
Serious: no
Organ System: General disorders
Notes: GI Upset
Frequency: 1 affected / 17 at risk

Adverse event: NON-SERIOUS AES - Hyperkalemia
Serious: no
Organ System: General disorders
Notes: Hyperkalemia
Frequency: 1 affected / 17 at risk

Adverse event: NON-SERIOUS AES - Drop in eGFR
Serious: no
Organ System: General disorders
Notes: Drop in eGFR
Frequency: 3 affected / 17 at risk

Adverse event: NON-SERIOUS AES - Other
Serious: no
Organ System: General disorders
Notes: Other
Frequency: 15 affected / 17 at risk

Adverse event: Bronchitis
Serious: yes
Organ System: Infections and infestations
Notes: ANY SAE
Frequency: 2 affected / 26 at risk

Adverse event: Fall
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: ANY SAE
Frequency: 1 affected / 26 at risk

Adverse event: Fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: ANY SAE
Frequency: 1 affected / 26 at risk

Adverse event: NEOPLASMS BENIGN, MALIGNANT AND UNSPECIFIED (INCL CYSTS AND POLYPS) - OTHER, SPECIFY
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: ANY SAE
Frequency: 1 affected / 26 at risk

Adverse event: Peripheral motor neuropathy
Serious: yes
Organ System: Nervous system disorders
Notes: ANY SAE
Frequency: 1 affected / 26 at risk

Adverse event: Nephrolithiasis
Serious: yes
Organ System: Renal and urinary disorders
Notes: ANY SAE
Frequency: 1 affected / 26 at risk

Adverse event: SURGICAL AND MEDICAL PROCEDURES - OTHER, SPECIFY
Serious: yes
Organ System: Surgical and medical procedures
Notes: ANY SAE
Frequency: 2 affected / 26 at risk

Adverse event: Embolism
Serious: yes
Organ System: Vascular disorders
Notes: ANY SAE
Frequency: 1 affected / 26 at risk

Adverse event: Bronchitis
Serious: yes
Organ System: Infections and infestations
Notes: INPATIENT HOSP
Frequency: 2 affected / 26 at risk

Adverse event: Fall
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: INPATIENT HOSP
Frequency: 1 affected / 26 at risk

Adverse event: Fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: INPATIENT HOSP
Frequency: 1 affected / 26 at risk

Adverse event: Peripheral motor neuropathy
Serious: yes
Organ System: Nervous system disorders
Notes: INPATIENT HOSP
Frequency: 1 affected / 26 at risk

Adverse event: Nephrolithiasis
Serious: yes
Organ System: Renal and urinary disorders
Notes: INPATIENT HOSP
Frequency: 1 affected / 26 at risk

Adverse event: SURGICAL AND MEDICAL PROCEDURES - OTHER, SPECIFY
Serious: yes
Organ System: Surgical and medical procedures
Notes: INPATIENT HOSP
Frequency: 2 affected / 26 at risk

Adverse event: Embolism
Serious: yes
Organ System: Vascular disorders
Notes: INPATIENT HOSP
Frequency: 1 affected / 26 at risk

Adverse event: NEOPLASMS BENIGN, MALIGNANT AND UNSPECIFIED (INCL CYSTS AND POLYPS) - OTHER, SPECIFY
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: OTHER SERIOUS EVENT
Frequency: 1 affected / 26 at risk

Adverse event: NON-SERIOUS AES - Any Adverse Event
Serious: no
Organ System: General disorders
Notes: Any Adverse Event
Frequency: 20 affected / 26 at risk

Adverse event: NON-SERIOUS AES - Cough
Serious: no
Organ System: General disorders
Notes: Cough
Frequency: 3 affected / 26 at risk

Adverse event: NON-SERIOUS AES - Dizziness/Presyncope
Serious: no
Organ System: General disorders
Notes: Dizziness/Presyncope
Frequency: 5 affected / 26 at risk

Adverse event: NON-SERIOUS AES - Fall (mechanical)
Serious: no
Organ System: General disorders
Notes: Fall (mechanical)
Frequency: 2 affected / 26 at risk

Adverse event: NON-SERIOUS AES - Fatigue
Serious: no
Organ System: General disorders
Notes: Fatigue
Frequency: 2 affected / 26 at risk

Adverse event: NON-SERIOUS AES - GI Upset
Serious: no
Organ System: General disorders
Notes: GI Upset
Frequency: 3 affected / 26 at risk

Adverse event: NON-SERIOUS AES - Drop in eGFR
Serious: no
Organ System: General disorders
Notes: Drop in eGFR
Frequency: 1 affected / 26 at risk

Adverse event: NON-SERIOUS AES - Other
Serious: no
Organ System: General disorders
Notes: Other
Frequency: 19 affected / 26 at risk

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Notes: ANY SAE
Frequency: 1 affected / 13 at risk

Adverse event: Large intestinal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Notes: ANY SAE
Frequency: 1 affected / 13 at risk

Adverse event: RENAL AND URINARY DISORDERS - OTHER, SPECIFY
Serious: yes
Organ System: Renal and urinary disorders
Notes: ANY SAE
Frequency: 1 affected / 13 at risk

Adverse event: Small intestinal obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Notes: ANY SAE
Frequency: 1 affected / 13 at risk

Adverse event: Urinary tract obstruction
Serious: yes
Organ System: Renal and urinary disorders
Notes: ANY SAE
Frequency: 1 affected / 13 at risk

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Notes: INPATIENT HOSP
Frequency: 1 affected / 13 at risk

Adverse event: Large intestinal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Notes: INPATIENT HOSP
Frequency: 1 affected / 13 at risk

Adverse event: RENAL AND URINARY DISORDERS - OTHER, SPECIFY
Serious: yes
Organ System: Renal and urinary disorders
Notes: INPATIENT HOSP
Frequency: 1 affected / 13 at risk

Adverse event: Small intestinal obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Notes: INPATIENT HOSP
Frequency: 1 affected / 13 at risk

Adverse event: Urinary tract obstruction
Serious: yes
Organ System: Renal and urinary disorders
Notes: INPATIENT HOSP
Frequency: 1 affected / 13 at risk

Adverse event: NON-SERIOUS AES - Any Adverse Event
Serious: no
Organ System: General disorders
Notes: Any Adverse Event
Frequency: 12 affected / 13 at risk

Adverse event: NON-SERIOUS AES - Cough
Serious: no
Organ System: General disorders
Notes: Cough
Frequency: 1 affected / 13 at risk

Adverse event: NON-SERIOUS AES - Dizziness/Presyncope
Serious: no
Organ System: General disorders
Notes: Dizziness/Presyncope
Frequency: 2 affected / 13 at risk

Adverse event: NON-SERIOUS AES - Fall (mechanical)
Serious: no
Organ System: General disorders
Notes: Fall (mechanical)
Frequency: 4 affected / 13 at risk

Adverse event: NON-SERIOUS AES - Fatigue
Serious: no
Organ System: General disorders
Notes: Fatigue
Frequency: 1 affected / 13 at risk

Adverse event: NON-SERIOUS AES - GI Upset
Serious: no
Organ System: General disorders
Notes: GI Upset
Frequency: 1 affected / 13 at risk

Adverse event: NON-SERIOUS AES - Drop in eGFR
Serious: no
Organ System: General disorders
Notes: Drop in eGFR
Frequency: 2 affected / 13 at risk

Adverse event: NON-SERIOUS AES - Other
Serious: no
Organ System: General disorders
Notes: Other
Frequency: 10 affected / 13 at risk

Adverse event: Hip fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: ANY SAE
Frequency: 1 affected / 13 at risk

Adverse event: Haemorrhage intracranial
Serious: yes
Organ System: Nervous system disorders
Notes: ANY SAE
Frequency: 1 affected / 13 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Nervous system disorders
Notes: ANY SAE
Frequency: 1 affected / 13 at risk

Adverse event: Hip fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: INPATIENT HOSP
Frequency: 1 affected / 13 at risk

Adverse event: Haemorrhage intracranial
Serious: yes
Organ System: Nervous system disorders
Notes: INPATIENT HOSP
Frequency: 1 affected / 13 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Nervous system disorders
Notes: INPATIENT HOSP
Frequency: 1 affected / 13 at risk

Adverse event: NON-SERIOUS AES - Any Adverse Event
Serious: no
Organ System: General disorders
Notes: Any Adverse Event
Frequency: 10 affected / 13 at risk

Adverse event: NON-SERIOUS AES - Dizziness/Presyncope
Serious: no
Organ System: General disorders
Notes: Dizziness/Presyncope
Frequency: 5 affected / 13 at risk

Adverse event: NON-SERIOUS AES - Drop in eGFR
Serious: no
Organ System: General disorders
Notes: Drop in eGFR
Frequency: 1 affected / 13 at risk

Adverse event: NON-SERIOUS AES - Other
Serious: no
Organ System: General disorders
Notes: Other
Frequency: 7 affected / 13 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Notes: ANY SAE
Frequency: 1 affected / 14 at risk

Adverse event: Cough
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: ANY SAE
Frequency: 1 affected / 14 at risk

Adverse event: Dizziness
Serious: yes
Organ System: Nervous system disorders
Notes: ANY SAE
Frequency: 1 affected / 14 at risk

Adverse event: Hip fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: ANY SAE
Frequency: 1 affected / 14 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Notes: ANY SAE
Frequency: 1 affected / 14 at risk

Adverse event: Non-cardiac chest pain
Serious: yes
Organ System: General disorders
Notes: ANY SAE
Frequency: 1 affected / 14 at risk

Adverse event: SURGICAL AND MEDICAL PROCEDURES - OTHER, SPECIFY
Serious: yes
Organ System: Surgical and medical procedures
Notes: ANY SAE
Frequency: 1 affected / 14 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Notes: INPATIENT HOSP
Frequency: 1 affected / 14 at risk

Adverse event: Cough
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: INPATIENT HOSP
Frequency: 1 affected / 14 at risk

Adverse event: Dizziness
Serious: yes
Organ System: Nervous system disorders
Notes: INPATIENT HOSP
Frequency: 1 affected / 14 at risk

Adverse event: Hip fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: INPATIENT HOSP
Frequency: 1 affected / 14 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Notes: INPATIENT HOSP
Frequency: 1 affected / 14 at risk

Adverse event: Non-cardiac chest pain
Serious: yes
Organ System: General disorders
Notes: INPATIENT HOSP
Frequency: 1 affected / 14 at risk

Adverse event: SURGICAL AND MEDICAL PROCEDURES - OTHER, SPECIFY
Serious: yes
Organ System: Surgical and medical procedures
Notes: INPATIENT HOSP
Frequency: 1 affected / 14 at risk

Adverse event: NON-SERIOUS AES - Any Adverse Event
Serious: no
Organ System: General disorders
Notes: Any Adverse Event
Frequency: 11 affected / 14 at risk

Adverse event: NON-SERIOUS AES - Cough
Serious: no
Organ System: General disorders
Notes: Cough
Frequency: 2 affected / 14 at risk

Adverse event: NON-SERIOUS AES - Dizziness/Presyncope
Serious: no
Organ System: General disorders
Notes: Dizziness/Presyncope
Frequency: 2 affected / 14 at risk

Adverse event: NON-SERIOUS AES - Fall (mechanical)
Serious: no
Organ System: General disorders
Notes: Fall (mechanical)
Frequency: 2 affected / 14 at risk

Adverse event: NON-SERIOUS AES - Fatigue
Serious: no
Organ System: General disorders
Notes: Fatigue
Frequency: 2 affected / 14 at risk

Adverse event: NON-SERIOUS AES - GI Upset
Serious: no
Organ System: General disorders
Notes: GI Upset
Frequency: 2 affected / 14 at risk

Adverse event: NON-SERIOUS AES - Hyperkalemia
Serious: no
Organ System: General disorders
Notes: Hyperkalemia
Frequency: 1 affected / 14 at risk

Adverse event: NON-SERIOUS AES - Drop in eGFR
Serious: no
Organ System: General disorders
Notes: Drop in eGFR
Frequency: 1 affected / 14 at risk

Adverse event: NON-SERIOUS AES - Other
Serious: no
Organ System: General disorders
Notes: Other
Frequency: 11 affected / 14 at risk