Study: NCT00566501

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 570 at risk

Adverse event: Angina pectoris
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 570 at risk

Adverse event: Bradycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 570 at risk

Adverse event: Cardiac failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 570 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 570 at risk

Adverse event: Ventricular tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 570 at risk

Adverse event: Hydrocele
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 570 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 570 at risk

Adverse event: Duodenal ulcer perforation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 570 at risk

Adverse event: Gastrointestinal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 570 at risk

Adverse event: Haematochezia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 570 at risk

Adverse event: Ileus paralytic
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 570 at risk

Adverse event: Oesophageal ulcer
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 570 at risk

Adverse event: Pancreatic mass
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 570 at risk

Adverse event: Upper gastrointestinal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 570 at risk

Adverse event: Asthenia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 570 at risk

Adverse event: Chest pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 570 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 570 at risk

Adverse event: Gait disturbance
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 570 at risk

Adverse event: Non-cardiac chest pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 570 at risk

Adverse event: Abdominal abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 570 at risk

Adverse event: Cellulitis staphylococcal
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 570 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 570 at risk

Adverse event: Lower respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 570 at risk

Adverse event: Orchitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 570 at risk

Adverse event: Peritonillar abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 570 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 6 affected / 570 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 570 at risk

Adverse event: Tuberculosis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 570 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 8 affected / 570 at risk

Adverse event: Concussion
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 570 at risk

Adverse event: Device lead damage
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 570 at risk

Adverse event: Fall
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 7 affected / 570 at risk

Adverse event: Femoral neck fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 570 at risk

Adverse event: Femur fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 570 at risk

Adverse event: Head injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 570 at risk

Adverse event: Hip fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 570 at risk

Adverse event: Skin laceration
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 570 at risk

Adverse event: Lumbar vertebral fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 570 at risk

Adverse event: Road traffic accident
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 570 at risk

Adverse event: Skin laceration
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 570 at risk

Adverse event: Subdural haematoma
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 570 at risk

Adverse event: Thoracic vertebral fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 570 at risk

Adverse event: Upper limb fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 570 at risk

Adverse event: Electrocardiogram QT prolonged
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 570 at risk

Adverse event: Weight decreased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 570 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 570 at risk

Adverse event: Hypokalaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 570 at risk

Adverse event: Osteoarthritis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 570 at risk

Adverse event: Breast cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 570 at risk

Adverse event: Lung carcinoma cell type unspecified stage IV
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 570 at risk

Adverse event: Lung neoplasm
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 570 at risk

Adverse event: Metastases to liver
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 570 at risk

Adverse event: Metastasis
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 570 at risk

Adverse event: Rectal cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 570 at risk

Adverse event: Cerebral atrophy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 570 at risk

Adverse event: Cerebral haemorrhage
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 570 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Nervous system disorders
Frequency: 5 affected / 570 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 570 at risk

Adverse event: Dementia Alzheimers type
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 570 at risk

Adverse event: Dizziness
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 570 at risk

Adverse event: Encephalopathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 570 at risk

Adverse event: Hemiparesis
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 570 at risk

Adverse event: Hydrocephalus
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 570 at risk

Adverse event: Presyncope
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 570 at risk

Adverse event: Sciatica
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 570 at risk

Adverse event: Syncope
Serious: yes
Organ System: Nervous system disorders
Frequency: 6 affected / 570 at risk

Adverse event: Transient ischaemic attack
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 570 at risk

Adverse event: Unresponsive to stimuli
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 570 at risk

Adverse event: Aggression
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 570 at risk

Adverse event: Poriomania
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 570 at risk

Adverse event: Restlessness
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 570 at risk

Adverse event: Calculus bladder
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 570 at risk

Adverse event: Haematuria
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 570 at risk

Adverse event: Nephrolithiasis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 570 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 570 at risk

Adverse event: Urinary retention
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 570 at risk

Adverse event: Benign prostatic hyperplasia
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 2 affected / 570 at risk

Adverse event: Prostatomegaly
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 570 at risk

Adverse event: Choking
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 570 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 570 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 570 at risk

Adverse event: Lung disorder
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 570 at risk

Adverse event: Pleural effusion
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 570 at risk

Adverse event: Deep vein thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 570 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 570 at risk

Adverse event: Lung neoplasm malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 570 at risk

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 570 at risk

Adverse event: Cardio-rspiratory arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 570 at risk

Adverse event: Subdural haemorrhage
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 570 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Investigations
Frequency: 58 affected / 570 at risk

Adverse event: Fall
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 54 affected / 570 at risk

Adverse event: Agitation
Serious: no
Organ System: Psychiatric disorders
Frequency: 33 affected / 570 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Renal and urinary disorders
Frequency: 33 affected / 570 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 20 affected / 570 at risk

Adverse event: Aggression
Serious: no
Organ System: Psychiatric disorders
Frequency: 29 affected / 570 at risk

Adverse event: Nausea
Serious: no
Organ System: General disorders
Frequency: 12 affected / 570 at risk

Adverse event: Insomnia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 18 affected / 570 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 18 affected / 570 at risk

Adverse event: Syncope
Serious: no
Organ System: Nervous system disorders
Frequency: 19 affected / 570 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 15 affected / 570 at risk

Adverse event: Weight increased
Serious: no
Organ System: Investigations
Frequency: 15 affected / 570 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 14 affected / 570 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 570 at risk

Adverse event: Urinary incontinence
Serious: no
Organ System: Renal and urinary disorders
Frequency: 12 affected / 570 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 11 affected / 570 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Frequency: 13 affected / 570 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Frequency: 15 affected / 570 at risk

Adverse event: Asthenia
Serious: no
Organ System: General disorders
Frequency: 6 affected / 570 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 570 at risk

Adverse event: Hypercholesterolaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 10 affected / 570 at risk

Adverse event: Contusion
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 9 affected / 570 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 7 affected / 570 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 12 affected / 570 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 570 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 7 affected / 570 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 570 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 570 at risk

Adverse event: Haematuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 7 affected / 570 at risk

Adverse event: Acute myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 332 at risk

Adverse event: Arrhythmia supraventricular
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 332 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 332 at risk

Adverse event: Cardiac failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 332 at risk

Adverse event: Encephalocele
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 332 at risk

Adverse event: Meningocele
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 332 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 332 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 332 at risk

Adverse event: Gastric ulcer
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 332 at risk

Adverse event: Haematemesis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 332 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 332 at risk

Adverse event: Asthenia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 332 at risk

Adverse event: Multiple organ dysfunction syndrome
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 332 at risk

Adverse event: Sudden death
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 332 at risk

Adverse event: Cholecystitis acute
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 332 at risk

Adverse event: Hepatic cirrhosis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 332 at risk

Adverse event: Bronchitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 332 at risk

Adverse event: Liver abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 332 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 332 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 332 at risk

Adverse event: Respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 332 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 332 at risk

Adverse event: Device dislocation
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 332 at risk

Adverse event: Fall
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 332 at risk

Adverse event: Hip fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 332 at risk

Adverse event: Skin laceration
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 332 at risk

Adverse event: Radius fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 332 at risk

Adverse event: Subdural haematoma
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 332 at risk

Adverse event: Upper limb fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 332 at risk

Adverse event: Lipase increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 332 at risk

Adverse event: Decreased appetite
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 332 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 332 at risk

Adverse event: Gout
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 332 at risk

Adverse event: Muscle rigidity
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 332 at risk

Adverse event: Malignant melanoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 332 at risk

Adverse event: Metastases to spine
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 332 at risk

Adverse event: Prostate cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 332 at risk

Adverse event: Prostate cancer stage II
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 332 at risk

Adverse event: Bradykinesia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 332 at risk

Adverse event: Cerebral haemorrhage
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 332 at risk

Adverse event: Cerebral infarction
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 332 at risk

Adverse event: Cerebrospinal fistula
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 332 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 332 at risk

Adverse event: Dizziness
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 332 at risk

Adverse event: Epilepsy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 332 at risk

Adverse event: Headache
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 332 at risk

Adverse event: Hemiplegia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 332 at risk

Adverse event: Ischaemic cerebral infarction
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 332 at risk

Adverse event: Lacunar infarction
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 332 at risk

Adverse event: Status epilepticus
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 332 at risk

Adverse event: Syncope
Serious: yes
Organ System: Nervous system disorders
Frequency: 6 affected / 332 at risk

Adverse event: Transient ischaemic attack
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 332 at risk

Adverse event: Aggression
Serious: yes
Organ System: Psychiatric disorders
Frequency: 3 affected / 332 at risk

Adverse event: Agitation
Serious: yes
Organ System: Psychiatric disorders
Frequency: 2 affected / 332 at risk

Adverse event: Anxiety
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 332 at risk

Adverse event: Hallucination
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 332 at risk

Adverse event: Insomnia
Serious: yes
Organ System: Psychiatric disorders
Frequency: 3 affected / 332 at risk

Adverse event: Mental status change
Serious: yes
Organ System: Psychiatric disorders
Frequency: 4 affected / 332 at risk

Adverse event: Psychotic disorder
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 332 at risk

Adverse event: Restlessness
Serious: yes
Organ System: Psychiatric disorders
Frequency: 2 affected / 332 at risk

Adverse event: Haematuria
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 332 at risk

Adverse event: Neurogenic bladder
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 332 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 332 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 332 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 332 at risk

Adverse event: Lung neoplasm malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 332 at risk

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 332 at risk

Adverse event: Hyponatraemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 332 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Investigations
Frequency: 43 affected / 332 at risk

Adverse event: Fall
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 25 affected / 332 at risk

Adverse event: Agitation
Serious: no
Organ System: Psychiatric disorders
Frequency: 28 affected / 332 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Renal and urinary disorders
Frequency: 20 affected / 332 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 19 affected / 332 at risk

Adverse event: Aggression
Serious: no
Organ System: Psychiatric disorders
Frequency: 23 affected / 332 at risk

Adverse event: Nausea
Serious: no
Organ System: General disorders
Frequency: 20 affected / 332 at risk

Adverse event: Insomnia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 15 affected / 332 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 10 affected / 332 at risk

Adverse event: Syncope
Serious: no
Organ System: Nervous system disorders
Frequency: 9 affected / 332 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 12 affected / 332 at risk

Adverse event: Weight increased
Serious: no
Organ System: Investigations
Frequency: 12 affected / 332 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 11 affected / 332 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 15 affected / 332 at risk

Adverse event: Urinary incontinence
Serious: no
Organ System: Renal and urinary disorders
Frequency: 11 affected / 332 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 11 affected / 332 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Frequency: 7 affected / 332 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Frequency: 5 affected / 332 at risk

Adverse event: Asthenia
Serious: no
Organ System: General disorders
Frequency: 12 affected / 332 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 12 affected / 332 at risk

Adverse event: Hypercholesterolaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 7 affected / 332 at risk

Adverse event: Contusion
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 7 affected / 332 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 8 affected / 332 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 332 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 332 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 7 affected / 332 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 9 affected / 332 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 332 at risk

Adverse event: Haematuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 7 affected / 332 at risk