Study: NCT01176565

Adverse event: Abdominal abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 500 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 500 at risk

Adverse event: Acute myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 500 at risk

Adverse event: Acute respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 500 at risk

Adverse event: Asthenia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 500 at risk

Adverse event: Back pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 500 at risk

Adverse event: Blood creatinine increased
Serious: yes
Organ System: Renal and urinary disorders
Notes: Coded under investigations, also analyzed with renal disorders for safety
Frequency: 1 affected / 500 at risk

Adverse event: Brain herniation
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 500 at risk

Adverse event: Brain oedema
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 500 at risk

Adverse event: CNS ventriculitis
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 500 at risk

Adverse event: Cardiac arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 500 at risk

Adverse event: Cardiac failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 500 at risk

Adverse event: Cardiac failure acute
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 500 at risk

Adverse event: Cardiac failure congestive
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 500 at risk

Adverse event: Cardio-respiratory arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 500 at risk

Adverse event: Cerebral haematoma
Serious: yes
Organ System: Nervous system disorders
Frequency: 6 affected / 500 at risk

Adverse event: Cerebral haemorrhage
Serious: yes
Organ System: Nervous system disorders
Notes: (Meeting SAE criteria)
Frequency: 1 affected / 500 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Nervous system disorders
Frequency: 19 affected / 500 at risk

Adverse event: Cerebrovascular disorder
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 500 at risk

Adverse event: Chest pain
Serious: yes
Organ System: Cardiac disorders
Notes: (Meeting SAE criteria); coded under general disorders, also analyzed with cardiac disorders for safety
Frequency: 2 affected / 500 at risk

Adverse event: Cholecystitis acute
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 500 at risk

Adverse event: Cholecystitis infective
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 500 at risk

Adverse event: Clostridial infection
Serious: yes
Organ System: Infections and infestations
Notes: (Meeting SAE criteria)
Frequency: 1 affected / 500 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Notes: (Meeting SAE criteria)
Frequency: 3 affected / 500 at risk

Adverse event: Cranioplasty
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 2 affected / 500 at risk

Adverse event: Cyst aspiration
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 500 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 500 at risk

Adverse event: Deep vein thrombosis
Serious: yes
Organ System: Vascular disorders
Notes: (Meeting SAE criteria)
Frequency: 4 affected / 500 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 500 at risk

Adverse event: Depression
Serious: yes
Organ System: Psychiatric disorders
Notes: (Meeting SAE criteria)
Frequency: 1 affected / 500 at risk

Adverse event: Embolic stroke
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 500 at risk

Adverse event: Epilepsy
Serious: yes
Organ System: Nervous system disorders
Notes: (Meeting SAE criteria)
Frequency: 1 affected / 500 at risk

Adverse event: Femur fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 500 at risk

Adverse event: Haemorrhage
Serious: yes
Organ System: Vascular disorders
Notes: (Meeting SAE criteria)
Frequency: 2 affected / 500 at risk

Adverse event: Haemorrhage intracranial
Serious: yes
Organ System: Nervous system disorders
Notes: (Meeting SAE criteria)
Frequency: 3 affected / 500 at risk

Adverse event: Blood loss anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: (Meeting SAE criteria)
Frequency: 1 affected / 500 at risk

Adverse event: Hemiplegia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 500 at risk

Adverse event: Hepatic function abnormal
Serious: yes
Organ System: Hepatobiliary disorders
Notes: (Meeting SAE criteria)
Frequency: 1 affected / 500 at risk

Adverse event: Hydrocephalus
Serious: yes
Organ System: Nervous system disorders
Notes: (Meeting SAE criteria)
Frequency: 4 affected / 500 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Cardiac disorders
Notes: (Meeting SAE criteria); coded under general disorders, also analyzed with cardiac disorders for safety
Frequency: 1 affected / 500 at risk

Adverse event: Hypoaesthesia
Serious: yes
Organ System: Nervous system disorders
Notes: (Meeting SAE criteria)
Frequency: 1 affected / 500 at risk

Adverse event: Hyponatraemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: (Meeting SAE criteria)
Frequency: 1 affected / 500 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Cardiac disorders
Notes: (Meeting SAE criteria); coded under vascular disorders, also analyzed with cardiac disorders for safety
Frequency: 1 affected / 500 at risk

Adverse event: Hypoxia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: (Meeting SAE criteria)
Frequency: 1 affected / 500 at risk

Adverse event: Ileus paralytic
Serious: yes
Organ System: Gastrointestinal disorders
Notes: (Meeting SAE criteria)
Frequency: 1 affected / 500 at risk

Adverse event: Ischaemia
Serious: yes
Organ System: Nervous system disorders
Notes: Coded under vascular disorders, also analyzed with brain infarct/nervous disorders for safety
Frequency: 1 affected / 500 at risk

Adverse event: Ischaemic stroke
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 500 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Notes: (Meeting SAE criteria)
Frequency: 2 affected / 500 at risk

Adverse event: Mental impairment
Serious: yes
Organ System: Nervous system disorders
Notes: (Meeting SAE criteria)
Frequency: 1 affected / 500 at risk

Adverse event: Mental status changes
Serious: yes
Organ System: Nervous system disorders
Notes: (Meeting SAE criteria)
Frequency: 2 affected / 500 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Notes: (Meeting SAE criteria)
Frequency: 1 affected / 500 at risk

Adverse event: Neurological decompensation
Serious: yes
Organ System: Nervous system disorders
Notes: (Meeting SAE criteria)
Frequency: 9 affected / 500 at risk

Adverse event: Paraesthesia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 500 at risk

Adverse event: Partial seizures
Serious: yes
Organ System: Nervous system disorders
Notes: (Meeting SAE criteria)
Frequency: 1 affected / 500 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Notes: (Meeting SAE criteria)
Frequency: 5 affected / 500 at risk

Adverse event: Pneumonia aspiration
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: (Meeting SAE criteria)
Frequency: 5 affected / 500 at risk

Adverse event: Pneumothorax traumatic
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 500 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 500 at risk

Adverse event: Pulmonary oedema
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: (Meeting SAE criteria)
Frequency: 1 affected / 500 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Notes: (Meeting SAE criteria)
Frequency: 2 affected / 500 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Notes: (Meeting SAE criteria)
Frequency: 1 affected / 500 at risk

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Notes: (Meeting SAE criteria)
Frequency: 2 affected / 500 at risk

Adverse event: Respiratory distress
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: (Meeting SAE criteria)
Frequency: 1 affected / 500 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: (Meeting SAE criteria)
Frequency: 8 affected / 500 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 500 at risk

Adverse event: Small intestinal obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 500 at risk

Adverse event: Somnolence
Serious: yes
Organ System: Nervous system disorders
Notes: (Meeting SAE criteria)
Frequency: 1 affected / 500 at risk

Adverse event: Stroke in evolution
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 500 at risk

Adverse event: Subdural hygroma
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 500 at risk

Adverse event: Tachycardia
Serious: yes
Organ System: Cardiac disorders
Notes: (Meeting SAE criteria)
Frequency: 1 affected / 500 at risk

Adverse event: Transient ischaemic attack
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 500 at risk

Adverse event: Ureteric obstruction
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 500 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 500 at risk

Adverse event: Activated partial thromboplastin time prolonged
Serious: no
Organ System: Investigations
Frequency: 1 affected / 500 at risk

Adverse event: Acute myocardial infarction
Serious: no
Organ System: Cardiac disorders
Notes: (AE Not meeting SAE criteria)
Frequency: 1 affected / 500 at risk

Adverse event: Acute respiratory distress syndrome
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 500 at risk

Adverse event: Agitation
Serious: no
Organ System: Psychiatric disorders
Frequency: 6 affected / 500 at risk

Adverse event: Alkalosis
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 500 at risk

Adverse event: Amnesia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 500 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 5 affected / 500 at risk

Adverse event: Arteriovenous fistula
Serious: no
Organ System: Vascular disorders
Notes: (AE Not meeting SAE criteria)
Frequency: 1 affected / 500 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 500 at risk

Adverse event: Arthritis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 500 at risk

Adverse event: Atelectasis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 500 at risk

Adverse event: Atrial fibrillation
Serious: no
Organ System: Cardiac disorders
Notes: (AE Not meeting SAE criteria)
Frequency: 2 affected / 500 at risk

Adverse event: Axillary vein thrombosis
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 500 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: (AE Not meeting SAE criteria)
Frequency: 2 affected / 500 at risk

Adverse event: Bacteraemia
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 500 at risk

Adverse event: Blister
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 500 at risk

Adverse event: Blood albumin decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 500 at risk

Adverse event: Blood bilirubin increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 500 at risk

Adverse event: Blood cholesterol increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 500 at risk

Adverse event: Blood creatinine abnormal
Serious: no
Organ System: Renal and urinary disorders
Notes: Coded under investigations, also analyzed with renal disorders for safety
Frequency: 1 affected / 500 at risk

Adverse event: Blood creatinine increased
Serious: no
Organ System: Renal and urinary disorders
Notes: (AE Not meeting SAE criteria) Coded under investigations, also analyzed with renal disorders for safety.
Frequency: 2 affected / 500 at risk

Adverse event: Blood phosphorus decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 500 at risk

Adverse event: Blood potassium decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 500 at risk

Adverse event: Blood pressure decreased
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 500 at risk

Adverse event: Blood pressure diastolic increased
Serious: no
Organ System: Cardiac disorders
Notes: Coded under investigations, also analyzed with cardiac disorders for safety
Frequency: 1 affected / 500 at risk

Adverse event: Blood pressure increased
Serious: no
Organ System: Cardiac disorders
Notes: Coded under investigations, also analyzed with cardiac disorders for safety
Frequency: 1 affected / 500 at risk

Adverse event: Blood urea increased
Serious: no
Organ System: Renal and urinary disorders
Frequency: 3 affected / 500 at risk

Adverse event: Blood urine present
Serious: no
Organ System: Investigations
Frequency: 1 affected / 500 at risk

Adverse event: Body temperature increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 500 at risk

Adverse event: Bradycardia
Serious: no
Organ System: Cardiac disorders
Notes: (AE Not meeting SAE criteria)
Frequency: 5 affected / 500 at risk

Adverse event: Brain oedema
Serious: no
Organ System: Nervous system disorders
Notes: (AE Not meeting SAE criteria)
Frequency: 1 affected / 500 at risk

Adverse event: Brain stem infarction
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 500 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 500 at risk

Adverse event: Catheter site pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 500 at risk

Adverse event: Cellulitis
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 500 at risk

Adverse event: Cerebral haematoma
Serious: no
Organ System: Nervous system disorders
Notes: (AE Not meeting SAE criteria)
Frequency: 1 affected / 500 at risk

Adverse event: Cerebral haemorrhage
Serious: no
Organ System: Nervous system disorders
Notes: (AE Not meeting SAE criteria)
Frequency: 1 affected / 500 at risk

Adverse event: Cerebral infarction
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 500 at risk

Adverse event: Cerebrovascular accident
Serious: no
Organ System: Nervous system disorders
Notes: (AE Not meeting SAE criteria)
Frequency: 4 affected / 500 at risk

Adverse event: Chest pain
Serious: no
Organ System: Cardiac disorders
Notes: (AE Not meeting SAE criteria); coded under general disorders, also analyzed with cardiac disorders for safety
Frequency: 2 affected / 500 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 1 affected / 500 at risk

Adverse event: Cholecystitis
Serious: no
Organ System: Hepatobiliary disorders
Notes: (AE Not meeting SAE criteria)
Frequency: 1 affected / 500 at risk

Adverse event: Clostridial infection
Serious: no
Organ System: Infections and infestations
Notes: (AE Not meeting SAE criteria)
Frequency: 3 affected / 500 at risk

Adverse event: Coma
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 500 at risk

Adverse event: Coma scale abnormal
Serious: no
Organ System: Investigations
Frequency: 1 affected / 500 at risk

Adverse event: Confusional state
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 500 at risk

Adverse event: Consciousness fluctuating
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 500 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 25 affected / 500 at risk

Adverse event: Seizure
Serious: no
Organ System: Nervous system disorders
Notes: (AE Not meeting SAE criteria)
Frequency: 7 affected / 500 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 500 at risk

Adverse event: Craniotomy
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 500 at risk

Adverse event: Deafness unilateral
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 500 at risk

Adverse event: Decubitus ulcer
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 500 at risk

Adverse event: Deep vein thrombosis
Serious: no
Organ System: Vascular disorders
Notes: (AE Not meeting SAE criteria)
Frequency: 5 affected / 500 at risk

Adverse event: Delirium
Serious: no
Organ System: Psychiatric disorders
Frequency: 7 affected / 500 at risk

Adverse event: Depressed level of consciousness
Serious: no
Organ System: Nervous system disorders
Notes: (AE Not meeting SAE criteria)
Frequency: 1 affected / 500 at risk

Adverse event: Dermatitis contact
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 500 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 500 at risk

Adverse event: Diplopia
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 500 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 500 at risk

Adverse event: Drug eruption
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: (AE Not meeting SAE criteria)
Frequency: 1 affected / 500 at risk

Adverse event: Dysmenorrhoea
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 500 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 500 at risk

Adverse event: Dysphagia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 500 at risk

Adverse event: Dysuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 500 at risk

Adverse event: Eczema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 500 at risk

Adverse event: Electrocardiogram ST segment depression
Serious: no
Organ System: Cardiac disorders
Notes: Coded under investigations, also analyzed with cardiac disorders for safety
Frequency: 1 affected / 500 at risk

Adverse event: Electrolyte imbalance
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 500 at risk

Adverse event: Encephalopathy
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 500 at risk

Adverse event: Endotracheal intubation
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 500 at risk

Adverse event: Epilepsy
Serious: no
Organ System: Nervous system disorders
Notes: (AE Not meeting SAE criteria)
Frequency: 1 affected / 500 at risk

Adverse event: Erysipelas
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 500 at risk

Adverse event: Erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 500 at risk

Adverse event: Fall
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: (AE Not meeting SAE criteria)
Frequency: 6 affected / 500 at risk

Adverse event: Flatulence
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 500 at risk

Adverse event: Gastrostomy
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 500 at risk

Adverse event: Erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 500 at risk

Adverse event: Glycosylated haemoglobin increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 500 at risk

Adverse event: Gout
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 500 at risk

Adverse event: Haematemesis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 500 at risk

Adverse event: Haemoglobin decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 500 at risk

Adverse event: Haemorrhage
Serious: no
Organ System: Vascular disorders
Notes: (AE Not meeting SAE criteria)
Frequency: 1 affected / 500 at risk

Adverse event: Haemorrhage intracranial
Serious: no
Organ System: Nervous system disorders
Notes: (AE Not meeting SAE criteria)
Frequency: 3 affected / 500 at risk

Adverse event: Haemorrhage subcutaneous
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 500 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 22 affected / 500 at risk

Adverse event: Hepatic cirrhosis
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 500 at risk

Adverse event: Hepatic enzyme increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 500 at risk

Adverse event: Hepatic function abnormal
Serious: no
Organ System: Hepatobiliary disorders
Notes: (AE Not meeting SAE criteria)
Frequency: 3 affected / 500 at risk

Adverse event: Hydrocephalus
Serious: no
Organ System: Nervous system disorders
Notes: (AE Not meeting SAE criteria)
Frequency: 4 affected / 500 at risk

Adverse event: Hyperchloraemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 500 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 500 at risk

Adverse event: Hyperhomocysteinaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 500 at risk

Adverse event: Hyperkalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: (AE Not meeting SAE criteria)
Frequency: 5 affected / 500 at risk

Adverse event: Hyperlipidaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 6 affected / 500 at risk

Adverse event: Hypernatraemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 11 affected / 500 at risk

Adverse event: Hyperphosphataemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 500 at risk

Adverse event: Hypersensitivity
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 500 at risk

Adverse event: Hypertension
Serious: no
Organ System: Cardiac disorders
Notes: (AE Not meeting SAE criteria); coded under vascular disorders, also analyzed with cardiac disorders for safety
Frequency: 5 affected / 500 at risk

Adverse event: Hypoaesthesia
Serious: no
Organ System: Nervous system disorders
Notes: (AE Not meeting SAE criteria)
Frequency: 1 affected / 500 at risk

Adverse event: Hypocalcaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 10 affected / 500 at risk

Adverse event: Hypoglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 500 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 28 affected / 500 at risk

Adverse event: Hypomagnesaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 500 at risk

Adverse event: Hyponatraemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: (AE Not meeting SAE criteria)
Frequency: 15 affected / 500 at risk

Adverse event: Hypophosphataemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 8 affected / 500 at risk

Adverse event: Hypoproteinaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 500 at risk

Adverse event: Hypotension
Serious: no
Organ System: Cardiac disorders
Notes: (AE Not meeting SAE criteria); coded under vascular disorders, also analyzed with cardiac disorders for safety
Frequency: 3 affected / 500 at risk

Adverse event: Hypoxia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: (AE Not meeting SAE criteria)
Frequency: 2 affected / 500 at risk

Adverse event: IIIrd nerve paralysis
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 500 at risk

Adverse event: Ileus
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 500 at risk

Adverse event: Incontinence
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 500 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 500 at risk

Adverse event: Intracranial aneurysm
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 500 at risk

Adverse event: Intracranial haematoma
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 500 at risk

Adverse event: Intracranial pressure increased
Serious: no
Organ System: Nervous system disorders
Notes: (AE Not meeting SAE criteria)
Frequency: 2 affected / 500 at risk

Adverse event: Intraventricular haemorrhage
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 500 at risk

Adverse event: Laboratory test abnormal
Serious: no
Organ System: Investigations
Frequency: 2 affected / 500 at risk

Adverse event: Skin laceration
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 500 at risk

Adverse event: Leukocytosis
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: (AE Not meeting SAE criteria)
Frequency: 2 affected / 500 at risk

Adverse event: Leukopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 500 at risk

Adverse event: Liver disorder
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 500 at risk

Adverse event: Liver function test abnormal
Serious: no
Organ System: Investigations
Notes: (AE Not meeting SAE criteria)
Frequency: 2 affected / 500 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Infections and infestations
Notes: (AE Not meeting SAE criteria)
Frequency: 12 affected / 500 at risk

Adverse event: Macular oedema
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 500 at risk

Adverse event: Mental impairment
Serious: no
Organ System: Nervous system disorders
Notes: (AE Not meeting SAE criteria)
Frequency: 1 affected / 500 at risk

Adverse event: Mental status changes
Serious: no
Organ System: Nervous system disorders
Notes: (AE Not meeting SAE criteria)
Frequency: 4 affected / 500 at risk

Adverse event: Metabolic acidosis
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 500 at risk

Adverse event: Muscle spasms
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 500 at risk

Adverse event: Muscular weakness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 500 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 500 at risk

Adverse event: Neurological decompensation
Serious: no
Organ System: Nervous system disorders
Notes: (AE Not meeting SAE criteria)
Frequency: 3 affected / 500 at risk

Adverse event: Oral candidiasis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 500 at risk

Adverse event: PO2 decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 500 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 500 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 500 at risk

Adverse event: Partial seizures
Serious: no
Organ System: Nervous system disorders
Notes: (AE Not meeting SAE criteria)
Frequency: 3 affected / 500 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 500 at risk

Adverse event: Phlebitis
Serious: no
Organ System: Vascular disorders
Frequency: 18 affected / 500 at risk

Adverse event: Platelet count decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 500 at risk

Adverse event: Pneumocephalus
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 500 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Infections and infestations
Notes: (AE Not meeting SAE criteria)
Frequency: 11 affected / 500 at risk

Adverse event: Pneumonia aspiration
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: (AE Not meeting SAE criteria)
Frequency: 15 affected / 500 at risk

Adverse event: Polyarthritis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 500 at risk

Adverse event: Post transfusion purpura
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 500 at risk

Adverse event: Presyncope
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 500 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 500 at risk

Adverse event: Pulmonary oedema
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: (AE Not meeting SAE criteria)
Frequency: 1 affected / 500 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: (AE Not meeting SAE criteria)
Frequency: 39 affected / 500 at risk

Adverse event: Rash macular
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 500 at risk

Adverse event: Renal cyst
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 500 at risk

Adverse event: Renal failure
Serious: no
Organ System: Renal and urinary disorders
Notes: (AE Not meeting SAE criteria)
Frequency: 1 affected / 500 at risk

Adverse event: Acute kidney injury
Serious: no
Organ System: Renal and urinary disorders
Notes: (AE Not meeting SAE criteria)
Frequency: 5 affected / 500 at risk

Adverse event: Renal function test abnormal
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 500 at risk

Adverse event: Renal impairment
Serious: no
Organ System: Renal and urinary disorders
Frequency: 3 affected / 500 at risk

Adverse event: Renal injury
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 500 at risk

Adverse event: Respiratory distress
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: (AE Not meeting SAE criteria)
Frequency: 2 affected / 500 at risk

Adverse event: Respiratory failure
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: (AE Not meeting SAE criteria)
Frequency: 3 affected / 500 at risk

Adverse event: Respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 500 at risk

Adverse event: Restlessness
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 500 at risk

Adverse event: Rheumatoid arthritis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 500 at risk

Adverse event: Scleral oedema
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 500 at risk

Adverse event: Seizure like phenomena
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 500 at risk

Adverse event: Sinus bradycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 500 at risk

Adverse event: Sinus tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 500 at risk

Adverse event: Skin fissures
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 500 at risk

Adverse event: Sleep apnoea syndrome
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 500 at risk

Adverse event: Sleep disorder
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 500 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Notes: (AE Not meeting SAE criteria)
Frequency: 2 affected / 500 at risk

Adverse event: Speech disorder
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 500 at risk

Adverse event: Sputum culture positive
Serious: no
Organ System: Investigations
Frequency: 1 affected / 500 at risk

Adverse event: Sputum increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 500 at risk

Adverse event: Surgery
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 500 at risk

Adverse event: Streptococcus test positive
Serious: no
Organ System: Investigations
Frequency: 1 affected / 500 at risk

Adverse event: Stress ulcer
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 500 at risk

Adverse event: Subarachnoid haemorrhage
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 500 at risk

Adverse event: Tachycardia
Serious: no
Organ System: Cardiac disorders
Notes: (AE Not meeting SAE criteria)
Frequency: 7 affected / 500 at risk

Adverse event: Tachypnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 500 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 500 at risk

Adverse event: Superficial vein thrombosis
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 500 at risk

Adverse event: Tongue oedema
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 500 at risk

Adverse event: Troponin I increased
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 500 at risk

Adverse event: Troponin increased
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 500 at risk

Adverse event: Upper gastrointestinal haemorrhage
Serious: no
Organ System: Gastrointestinal disorders
Notes: (AE Not meeting SAE criteria)
Frequency: 4 affected / 500 at risk

Adverse event: Urinary incontinence
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 500 at risk

Adverse event: Urinary retention
Serious: no
Organ System: Renal and urinary disorders
Frequency: 4 affected / 500 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Notes: (AE Not meeting SAE criteria)
Frequency: 24 affected / 500 at risk

Adverse event: Venous thrombosis
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 500 at risk

Adverse event: Ventricular extrasystoles
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 500 at risk

Adverse event: Ventricular hypertrophy
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 500 at risk

Adverse event: Vision blurred
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 500 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 11 affected / 500 at risk

Adverse event: Wheezing
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 500 at risk

Adverse event: White blood cell count increased
Serious: no
Organ System: Investigations
Frequency: 3 affected / 500 at risk

Adverse event: Abscess oral
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 500 at risk

Adverse event: Acute coronary syndrome
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 500 at risk

Adverse event: Acute pulmonary oedema
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 500 at risk

Adverse event: Alcohol withdrawal syndrome
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 500 at risk

Adverse event: Angioedema
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 500 at risk

Adverse event: Angiopathy
Serious: yes
Organ System: Cardiac disorders
Notes: Coded under vascular disorders, also analyzed with cardiac disorders for safety
Frequency: 1 affected / 500 at risk

Adverse event: Aphasia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 500 at risk

Adverse event: Arteriovenous fistula
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 500 at risk

Adverse event: Aspiration
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 500 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 500 at risk

Adverse event: Bladder cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 500 at risk

Adverse event: Bradycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 500 at risk

Adverse event: Brain herniation
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 500 at risk

Adverse event: Brain oedema
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 500 at risk

Adverse event: Breast cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 500 at risk

Adverse event: Cardiac arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 500 at risk

Adverse event: Cardiac failure congestive
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 500 at risk

Adverse event: Cerebral haematoma
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 500 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Nervous system disorders
Frequency: 17 affected / 500 at risk

Adverse event: Cholecystitis
Serious: yes
Organ System: Hepatobiliary disorders
Notes: (Meeting SAE criteria)
Frequency: 1 affected / 500 at risk

Adverse event: Cholecystitis acute
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 500 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 500 at risk

Adverse event: Circulatory collapse
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 500 at risk

Adverse event: Clostridial infection
Serious: yes
Organ System: Infections and infestations
Notes: (Meeting SAE criteria)
Frequency: 1 affected / 500 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Notes: (Meeting SAE criteria)
Frequency: 1 affected / 500 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 500 at risk

Adverse event: Deep vein thrombosis
Serious: yes
Organ System: Vascular disorders
Notes: (Meeting SAE criteria)
Frequency: 3 affected / 500 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 500 at risk

Adverse event: Depressed level of consciousness
Serious: yes
Organ System: Nervous system disorders
Notes: (Meeting SAE criteria)
Frequency: 2 affected / 500 at risk

Adverse event: Depression
Serious: yes
Organ System: Psychiatric disorders
Notes: (Meeting SAE criteria)
Frequency: 1 affected / 500 at risk

Adverse event: Device related infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 500 at risk

Adverse event: Drug eruption
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Notes: (Meeting SAE criteria)
Frequency: 1 affected / 500 at risk

Adverse event: Drug withdrawal syndrome
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 500 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: (Meeting SAE criteria)
Frequency: 1 affected / 500 at risk

Adverse event: Embolic cerebral infarction
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 500 at risk

Adverse event: Enteritis infectious
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 500 at risk

Adverse event: Extradural haematoma
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 500 at risk

Adverse event: Fall
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: (Meeting SAE criteria)
Frequency: 1 affected / 500 at risk

Adverse event: Femoral neck fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 500 at risk

Adverse event: Gastrointestinal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 500 at risk

Adverse event: Haematuria
Serious: yes
Organ System: Renal and urinary disorders
Notes: (Meeting SAE criteria)
Frequency: 1 affected / 500 at risk

Adverse event: Haemorrhage
Serious: yes
Organ System: Vascular disorders
Notes: (Meeting SAE criteria)
Frequency: 1 affected / 500 at risk

Adverse event: Haemorrhage intracranial
Serious: yes
Organ System: Nervous system disorders
Notes: (Meeting SAE criteria)
Frequency: 3 affected / 500 at risk

Adverse event: Haemorrhagic infarction
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 500 at risk

Adverse event: Haemorrhagic stroke
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 500 at risk

Adverse event: Hydrocephalus
Serious: yes
Organ System: Nervous system disorders
Notes: (Meeting SAE criteria)
Frequency: 7 affected / 500 at risk

Adverse event: Hyperkalaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: (Meeting SAE criteria)
Frequency: 1 affected / 500 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Cardiac disorders
Notes: (Meeting SAE criteria); coded under general disorders, also analyzed with cardiac disorders for safety
Frequency: 3 affected / 500 at risk

Adverse event: Hypertensive crisis
Serious: yes
Organ System: Cardiac disorders
Notes: Coded under vascular disorders, also analyzed with cardiac disorders for safety
Frequency: 1 affected / 500 at risk

Adverse event: Hypertensive emergency
Serious: yes
Organ System: Cardiac disorders
Notes: Coded under vascular disorders, also analyzed with cardiac disorders for safety
Frequency: 1 affected / 500 at risk

Adverse event: Hyponatraemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: (Meeting SAE criteria)
Frequency: 1 affected / 500 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Cardiac disorders
Notes: (Meeting SAE criteria); coded under vascular disorders, also analyzed with cardiac disorders for safety
Frequency: 1 affected / 500 at risk

Adverse event: Intracranial pressure increased
Serious: yes
Organ System: Nervous system disorders
Notes: (Meeting SAE criteria)
Frequency: 1 affected / 500 at risk

Adverse event: Ischaemic cerebral infarction
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 500 at risk

Adverse event: Ischaemic stroke
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 500 at risk

Adverse event: Leukocytosis
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: (Meeting SAE criteria)
Frequency: 1 affected / 500 at risk

Adverse event: Liver function test abnormal
Serious: yes
Organ System: Investigations
Notes: (Meeting SAE criteria)
Frequency: 1 affected / 500 at risk

Adverse event: Meningitis
Serious: yes
Organ System: Infections and infestations
Notes: (Meeting SAE criteria)
Frequency: 1 affected / 500 at risk

Adverse event: Mental impairment
Serious: yes
Organ System: Nervous system disorders
Notes: (Meeting SAE criteria)
Frequency: 2 affected / 500 at risk

Adverse event: Metastasis
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 500 at risk

Adverse event: Myocardial ischaemia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 500 at risk

Adverse event: Necrotising colitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 500 at risk

Adverse event: Neurological decompensation
Serious: yes
Organ System: Nervous system disorders
Notes: (Meeting SAE criteria)
Frequency: 18 affected / 500 at risk

Adverse event: Oxygen saturation decreased
Serious: yes
Organ System: Investigations
Notes: (Meeting SAE criteria)
Frequency: 1 affected / 500 at risk

Adverse event: Pancreatitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 500 at risk

Adverse event: Partial seizures
Serious: yes
Organ System: Nervous system disorders
Notes: (Meeting SAE criteria)
Frequency: 1 affected / 500 at risk

Adverse event: Pleural effusion
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: (Meeting SAE criteria)
Frequency: 1 affected / 500 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Notes: (Meeting SAE criteria)
Frequency: 9 affected / 500 at risk

Adverse event: Pneumonia aspiration
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: (Meeting SAE criteria)
Frequency: 9 affected / 500 at risk

Adverse event: Pneumonia staphylococcal
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 500 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 500 at risk

Adverse event: Pulseless electrical activity
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 500 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Notes: (Meeting SAE criteria)
Frequency: 1 affected / 500 at risk

Adverse event: Rectal cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 500 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Notes: (Meeting SAE criteria)
Frequency: 1 affected / 500 at risk

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Notes: (Meeting SAE criteria)
Frequency: 4 affected / 500 at risk

Adverse event: Chronic kidney disease
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 500 at risk

Adverse event: Respiratory arrest
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 500 at risk

Adverse event: Respiratory distress
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: (Meeting SAE criteria)
Frequency: 2 affected / 500 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: (Meeting SAE criteria)
Frequency: 10 affected / 500 at risk

Adverse event: Respiratory rate increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 500 at risk

Adverse event: Schizophrenia
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 500 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 500 at risk

Adverse event: Septic shock
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 500 at risk

Adverse event: Somnolence
Serious: yes
Organ System: Nervous system disorders
Notes: (Meeting SAE criteria)
Frequency: 1 affected / 500 at risk

Adverse event: Stroke in evolution
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 500 at risk

Adverse event: Subdural haematoma
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 500 at risk

Adverse event: Subdural haematoma evacuation
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 500 at risk

Adverse event: Syncope
Serious: yes
Organ System: Nervous system disorders
Notes: (Meeting SAE criteria)
Frequency: 1 affected / 500 at risk

Adverse event: Upper gastrointestinal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Notes: (Meeting SAE criteria)
Frequency: 1 affected / 500 at risk

Adverse event: Ureteric obstruction
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 500 at risk

Adverse event: Urethral stenosis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 500 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Notes: (Meeting SAE criteria)
Frequency: 1 affected / 500 at risk

Adverse event: Urosepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 500 at risk

Adverse event: Abdominal discomfort
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 500 at risk

Adverse event: Abscess limb
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 500 at risk

Adverse event: Acute respiratory failure
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: (AE Not meeting SAE criteria)
Frequency: 1 affected / 500 at risk

Adverse event: Administration site reaction
Serious: no
Organ System: General disorders
Frequency: 1 affected / 500 at risk

Adverse event: Agitation
Serious: no
Organ System: Psychiatric disorders
Frequency: 13 affected / 500 at risk

Adverse event: Altered state of consciousness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 500 at risk

Adverse event: Amnesia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 500 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 9 affected / 500 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 3 affected / 500 at risk

Adverse event: Aortic stenosis
Serious: no
Organ System: Cardiac disorders
Notes: Coded under vascular disorders, also analyzed with cardiac disorders for safety
Frequency: 1 affected / 500 at risk

Adverse event: Arteriosclerosis
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 500 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 500 at risk

Adverse event: Aspiration
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: (AE Not meeting SAE criteria)
Frequency: 2 affected / 500 at risk

Adverse event: Atelectasis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 500 at risk

Adverse event: Atrial fibrillation
Serious: no
Organ System: Cardiac disorders
Notes: (AE Not meeting SAE criteria)
Frequency: 6 affected / 500 at risk

Adverse event: Atrioventricular block complete
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 500 at risk

Adverse event: Atrioventricular block second degree
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 500 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: (AE Not meeting SAE criteria)
Frequency: 3 affected / 500 at risk

Adverse event: Bacteraemia
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 500 at risk

Adverse event: Benign prostatic hyperplasia
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 500 at risk

Adverse event: Blood albumin decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 500 at risk

Adverse event: Blood calcium decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 500 at risk

Adverse event: Blood chloride abnormal
Serious: no
Organ System: Investigations
Frequency: 1 affected / 500 at risk

Adverse event: Blood chloride increased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 500 at risk

Adverse event: Blood creatinine decreased
Serious: no
Organ System: Renal and urinary disorders
Notes: Coded under investigations, also analyzed with renal disorders for safety
Frequency: 1 affected / 500 at risk

Adverse event: Blood creatinine increased
Serious: no
Organ System: Renal and urinary disorders
Notes: (AE Not meeting SAE criteria) Coded under investigations, also analyzed with renal disorders for safety.
Frequency: 6 affected / 500 at risk

Adverse event: Blood lactate dehydrogenase increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 500 at risk

Adverse event: Blood potassium decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 500 at risk

Adverse event: Blood sodium increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 500 at risk

Adverse event: Blood urea decreased
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 500 at risk

Adverse event: Blood urea increased
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 500 at risk

Adverse event: Bradycardia
Serious: no
Organ System: Cardiac disorders
Notes: (AE Not meeting SAE criteria)
Frequency: 1 affected / 500 at risk

Adverse event: Brain oedema
Serious: no
Organ System: Nervous system disorders
Notes: (AE Not meeting SAE criteria)
Frequency: 5 affected / 500 at risk

Adverse event: Breast mass
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 500 at risk

Adverse event: Bundle branch block left
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 500 at risk

Adverse event: C-reactive protein increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 500 at risk

Adverse event: Cardiac failure
Serious: no
Organ System: Cardiac disorders
Notes: (AE Not meeting SAE criteria)
Frequency: 2 affected / 500 at risk

Adverse event: Cardiac failure congestive
Serious: no
Organ System: Cardiac disorders
Notes: (AE Not meeting SAE criteria)
Frequency: 1 affected / 500 at risk

Adverse event: Cardiac murmur
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 500 at risk

Adverse event: Cardiopulmonary failure
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 500 at risk

Adverse event: Cellulitis
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 500 at risk

Adverse event: Cerebral haematoma
Serious: no
Organ System: Nervous system disorders
Notes: (AE Not meeting SAE criteria)
Frequency: 1 affected / 500 at risk

Adverse event: Cerebral haemorrhage
Serious: no
Organ System: Nervous system disorders
Notes: (AE Not meeting SAE criteria)
Frequency: 2 affected / 500 at risk

Adverse event: Cerebral infarction
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 500 at risk

Adverse event: Cerebrovascular accident
Serious: no
Organ System: Nervous system disorders
Notes: (AE Not meeting SAE criteria)
Frequency: 4 affected / 500 at risk

Adverse event: Chest discomfort
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 500 at risk

Adverse event: Chest pain
Serious: no
Organ System: Cardiac disorders
Notes: (AE Not meeting SAE criteria); coded under general disorders, also analyzed with cardiac disorders for safety
Frequency: 3 affected / 500 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 1 affected / 500 at risk

Adverse event: Clostridium difficile colitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 500 at risk

Adverse event: Cognitive disorder
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 500 at risk

Adverse event: Confusional state
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 500 at risk

Adverse event: Consciousness fluctuating
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 500 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 25 affected / 500 at risk

Adverse event: Contusion
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 500 at risk

Adverse event: Seizure
Serious: no
Organ System: Nervous system disorders
Notes: (AE Not meeting SAE criteria)
Frequency: 4 affected / 500 at risk

Adverse event: Dacryocystitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 500 at risk

Adverse event: Decubitus ulcer
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 500 at risk

Adverse event: Deep vein thrombosis
Serious: no
Organ System: Vascular disorders
Notes: (AE Not meeting SAE criteria)
Frequency: 1 affected / 500 at risk

Adverse event: Delirium
Serious: no
Organ System: Psychiatric disorders
Frequency: 8 affected / 500 at risk

Adverse event: Delirium tremens
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 500 at risk

Adverse event: Depressed level of consciousness
Serious: no
Organ System: Nervous system disorders
Notes: (AE Not meeting SAE criteria)
Frequency: 1 affected / 500 at risk

Adverse event: Depressed mood
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 500 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Notes: (AE Not meeting SAE criteria)
Frequency: 3 affected / 500 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 500 at risk

Adverse event: Diastolic dysfunction
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 500 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 500 at risk

Adverse event: Dyslipidaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 500 at risk

Adverse event: Dysphagia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 500 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: (AE Not meeting SAE criteria)
Frequency: 4 affected / 500 at risk

Adverse event: Dysuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 3 affected / 500 at risk

Adverse event: Electrolyte imbalance
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 7 affected / 500 at risk

Adverse event: Encephalopathy
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 500 at risk

Adverse event: Enterocolitis viral
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 500 at risk

Adverse event: Epilepsy
Serious: no
Organ System: Nervous system disorders
Notes: (AE Not meeting SAE criteria)
Frequency: 1 affected / 500 at risk

Adverse event: Epistaxis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 500 at risk

Adverse event: Skin abrasion
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 500 at risk

Adverse event: Extrasystoles
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 500 at risk

Adverse event: Fall
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: (AE Not meeting SAE criteria)
Frequency: 5 affected / 500 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 1 affected / 500 at risk

Adverse event: Hypervolaemia
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 500 at risk

Adverse event: Gastric occult blood positive
Serious: no
Organ System: Investigations
Frequency: 1 affected / 500 at risk

Adverse event: Glomerular filtration rate increased
Serious: no
Organ System: Renal and urinary disorders
Notes: Coded under investigations, also analyzed with renal disorders for safety
Frequency: 1 affected / 500 at risk

Adverse event: Gout
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 500 at risk

Adverse event: Haematemesis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 500 at risk

Adverse event: Haematocrit decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 500 at risk

Adverse event: Haematoma
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 500 at risk

Adverse event: Haematuria
Serious: no
Organ System: Renal and urinary disorders
Notes: (AE Not meeting SAE criteria)
Frequency: 3 affected / 500 at risk

Adverse event: Haemoglobin decreased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 500 at risk

Adverse event: Haemorrhage intracranial
Serious: no
Organ System: Nervous system disorders
Notes: (AE Not meeting SAE criteria)
Frequency: 8 affected / 500 at risk

Adverse event: Blood loss anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: (AE Not meeting SAE criteria)
Frequency: 1 affected / 500 at risk

Adverse event: Hallucination
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 500 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 17 affected / 500 at risk

Adverse event: Hepatic cyst
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 500 at risk

Adverse event: Hepatic enzyme increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 500 at risk

Adverse event: Hepatic function abnormal
Serious: no
Organ System: Hepatobiliary disorders
Notes: (AE Not meeting SAE criteria)
Frequency: 3 affected / 500 at risk

Adverse event: Hepatic steatosis
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 500 at risk

Adverse event: Hydrocephalus
Serious: no
Organ System: Nervous system disorders
Notes: (AE Not meeting SAE criteria)
Frequency: 5 affected / 500 at risk

Adverse event: Hydronephrosis
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 500 at risk

Adverse event: Hyperbilirubinaemia
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 500 at risk

Adverse event: Hypercapnia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 500 at risk

Adverse event: Hyperchloraemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 500 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 7 affected / 500 at risk

Adverse event: Hyperhomocysteinaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 500 at risk

Adverse event: Hyperkalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: (AE Not meeting SAE criteria)
Frequency: 2 affected / 500 at risk

Adverse event: Hyperlipidaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 500 at risk

Adverse event: Hypermagnesaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 500 at risk

Adverse event: Hypernatraemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 10 affected / 500 at risk

Adverse event: Hypersensitivity
Serious: no
Organ System: Immune system disorders
Frequency: 3 affected / 500 at risk

Adverse event: Hypertension
Serious: no
Organ System: Cardiac disorders
Notes: (AE Not meeting SAE criteria); coded under vascular disorders, also analyzed with cardiac disorders for safety
Frequency: 3 affected / 500 at risk

Adverse event: Hypervolaemia
Serious: no
Organ System: Renal and urinary disorders
Notes: Coded under metabolism and nutrition disorders, also analyzed with renal disorders for safety
Frequency: 1 affected / 500 at risk

Adverse event: Hypoalbuminaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 500 at risk

Adverse event: Hypocalcaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 7 affected / 500 at risk

Adverse event: Hypoglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 500 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 38 affected / 500 at risk

Adverse event: Hypomagnesaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 500 at risk

Adverse event: Hyponatraemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: (AE Not meeting SAE criteria)
Frequency: 6 affected / 500 at risk

Adverse event: Hypophosphataemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 9 affected / 500 at risk

Adverse event: Hypotension
Serious: no
Organ System: Cardiac disorders
Notes: (AE Not meeting SAE criteria); coded under vascular disorders, also analyzed with cardiac disorders for safety
Frequency: 6 affected / 500 at risk

Adverse event: Hypovolaemia
Serious: no
Organ System: Renal and urinary disorders
Notes: Coded under metabolism and nutrition disorders, also analyzed with renal disorders for safety
Frequency: 1 affected / 500 at risk

Adverse event: Hypoxia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: (AE Not meeting SAE criteria)
Frequency: 1 affected / 500 at risk

Adverse event: Ileus paralytic
Serious: no
Organ System: Gastrointestinal disorders
Notes: (AE Not meeting SAE criteria)
Frequency: 1 affected / 500 at risk

Adverse event: Incontinence
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 500 at risk

Adverse event: Infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 500 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 500 at risk

Adverse event: Intracranial haematoma
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 500 at risk

Adverse event: Intraventricular haemorrhage
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 500 at risk

Adverse event: Laboratory test abnormal
Serious: no
Organ System: Investigations
Frequency: 1 affected / 500 at risk

Adverse event: Skin laceration
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 500 at risk

Adverse event: Left ventricular hypertrophy
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 500 at risk

Adverse event: Lethargy
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 500 at risk

Adverse event: Leukocytosis
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: (AE Not meeting SAE criteria)
Frequency: 12 affected / 500 at risk

Adverse event: Liver disorder
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 4 affected / 500 at risk

Adverse event: Liver function test abnormal
Serious: no
Organ System: Investigations
Notes: (AE Not meeting SAE criteria)
Frequency: 2 affected / 500 at risk

Adverse event: Loss of consciousness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 500 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Infections and infestations
Notes: (AE Not meeting SAE criteria)
Frequency: 14 affected / 500 at risk

Adverse event: Meningitis
Serious: no
Organ System: Infections and infestations
Notes: (AE Not meeting SAE criteria)
Frequency: 1 affected / 500 at risk

Adverse event: Mental impairment
Serious: no
Organ System: Nervous system disorders
Notes: (AE Not meeting SAE criteria)
Frequency: 2 affected / 500 at risk

Adverse event: Mental status changes
Serious: no
Organ System: Nervous system disorders
Notes: (AE Not meeting SAE criteria)
Frequency: 2 affected / 500 at risk

Adverse event: Monocyte count increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 500 at risk

Adverse event: Musculoskeletal pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 500 at risk

Adverse event: Myocardial infarction
Serious: no
Organ System: Cardiac disorders
Notes: (AE Not meeting SAE criteria)
Frequency: 1 affected / 500 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 500 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 500 at risk

Adverse event: Nephropathy
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 500 at risk

Adverse event: Neurogenic bladder
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 500 at risk

Adverse event: Neurological decompensation
Serious: no
Organ System: Nervous system disorders
Notes: (AE Not meeting SAE criteria)
Frequency: 8 affected / 500 at risk

Adverse event: Neurological symptom
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 500 at risk

Adverse event: Neutrophil count increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 500 at risk

Adverse event: Faecal occult blood positive
Serious: no
Organ System: Investigations
Frequency: 1 affected / 500 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Frequency: 3 affected / 500 at risk

Adverse event: Oliguria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 500 at risk

Adverse event: Ovarian cyst
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 500 at risk

Adverse event: Oxygen saturation decreased
Serious: no
Organ System: Investigations
Notes: (AE Not meeting SAE criteria)
Frequency: 2 affected / 500 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 4 affected / 500 at risk

Adverse event: Phlebitis
Serious: no
Organ System: Vascular disorders
Frequency: 17 affected / 500 at risk

Adverse event: Pleural effusion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: (AE Not meeting SAE criteria)
Frequency: 1 affected / 500 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Infections and infestations
Notes: (AE Not meeting SAE criteria)
Frequency: 18 affected / 500 at risk

Adverse event: Pneumonia aspiration
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: (AE Not meeting SAE criteria)
Frequency: 21 affected / 500 at risk

Adverse event: Pneumonia pneumococcal
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 500 at risk

Adverse event: Pollakiuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 500 at risk

Adverse event: Presyncope
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 500 at risk

Adverse event: Procalcitonin increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 500 at risk

Adverse event: Psychotic disorder
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 500 at risk

Adverse event: Pulmonary congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 500 at risk

Adverse event: Pulmonary oedema
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: (AE Not meeting SAE criteria)
Frequency: 2 affected / 500 at risk

Adverse event: Pyelonephritis chronic
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 500 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: (AE Not meeting SAE criteria)
Frequency: 30 affected / 500 at risk

Adverse event: Renal failure
Serious: no
Organ System: Renal and urinary disorders
Notes: (AE Not meeting SAE criteria)
Frequency: 2 affected / 500 at risk

Adverse event: Acute kidney injury
Serious: no
Organ System: Renal and urinary disorders
Notes: (AE Not meeting SAE criteria)
Frequency: 13 affected / 500 at risk

Adverse event: Renal impairment
Serious: no
Organ System: Renal and urinary disorders
Frequency: 6 affected / 500 at risk

Adverse event: Respiratory distress
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: (AE Not meeting SAE criteria)
Frequency: 1 affected / 500 at risk

Adverse event: Restlessness
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 500 at risk

Adverse event: Retinal degeneration
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 500 at risk

Adverse event: Retinopathy hypertensive
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 500 at risk

Adverse event: Sinus tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 500 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 500 at risk

Adverse event: Skin disorder
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 500 at risk

Adverse event: Sleep apnoea syndrome
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 500 at risk

Adverse event: Sleep disorder
Serious: no
Organ System: Psychiatric disorders
Frequency: 4 affected / 500 at risk

Adverse event: Staphylococcal infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 500 at risk

Adverse event: Stress ulcer
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 500 at risk

Adverse event: Supraventricular tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 500 at risk

Adverse event: Syncope
Serious: no
Organ System: Nervous system disorders
Notes: (AE Not meeting SAE criteria)
Frequency: 1 affected / 500 at risk

Adverse event: Tachycardia
Serious: no
Organ System: Cardiac disorders
Notes: (AE Not meeting SAE criteria)
Frequency: 8 affected / 500 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 500 at risk

Adverse event: Tonsillitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 500 at risk

Adverse event: Tracheobronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 500 at risk

Adverse event: Tremor
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 500 at risk

Adverse event: Troponin I increased
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 500 at risk

Adverse event: Troponin increased
Serious: no
Organ System: Cardiac disorders
Frequency: 6 affected / 500 at risk

Adverse event: Upper gastrointestinal haemorrhage
Serious: no
Organ System: Gastrointestinal disorders
Notes: (AE Not meeting SAE criteria)
Frequency: 1 affected / 500 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 500 at risk

Adverse event: Urinary retention
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 500 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Notes: (AE Not meeting SAE criteria)
Frequency: 20 affected / 500 at risk

Adverse event: Urinary tract infection fungal
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 500 at risk

Adverse event: Urine output decreased
Serious: no
Organ System: Renal and urinary disorders
Frequency: 6 affected / 500 at risk

Adverse event: Urticaria
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 500 at risk

Adverse event: Vasogenic cerebral oedema
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 500 at risk

Adverse event: Vena cava thrombosis
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 500 at risk

Adverse event: Peripheral vein thrombosis
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 500 at risk

Adverse event: Ventricular extrasystoles
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 500 at risk

Adverse event: Ventricular tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 500 at risk

Adverse event: Vertigo
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 500 at risk

Adverse event: Vitamin B12 deficiency
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 500 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 13 affected / 500 at risk

Adverse event: Wheezing
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 500 at risk

Adverse event: White blood cell count increased
Serious: no
Organ System: Investigations
Frequency: 4 affected / 500 at risk