Study: NCT01920711

Adverse event: Bronchial carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 2402 at risk

Adverse event: Central nervous system lymphoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 2402 at risk

Adverse event: Cholangiocarcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 2402 at risk

Adverse event: Clear cell renal cell carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 2402 at risk

Adverse event: Colorectal adenoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 2402 at risk

Adverse event: Colon cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 4 affected / 2402 at risk

Adverse event: Colon neoplasm
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 2402 at risk

Adverse event: Colorectal cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 2402 at risk

Adverse event: Diffuse large B-cell lymphoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 2402 at risk

Adverse event: Endometrial adenocarcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 2402 at risk

Adverse event: Endometrial cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 2402 at risk

Adverse event: Fibroma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 2402 at risk

Adverse event: Gallbladder neoplasm
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 2402 at risk

Adverse event: Gastric cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 4 affected / 2402 at risk

Adverse event: Gastric neoplasm
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 2402 at risk

Adverse event: Gastrointestinal neoplasm
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 2402 at risk

Adverse event: Gastrointestinal stromal tumour
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 2402 at risk

Adverse event: Glioblastoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 2402 at risk

Adverse event: Haemangioma of liver
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 2402 at risk

Adverse event: Hepatic cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 2402 at risk

Adverse event: Hepatic cancer metastatic
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 2402 at risk

Adverse event: Hepatic neoplasm
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 2402 at risk

Adverse event: Hepatocellular carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 2402 at risk

Adverse event: Intestinal adenocarcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 2402 at risk

Adverse event: Invasive lobular breast carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 2402 at risk

Adverse event: Laryngeal squamous cell carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 2402 at risk

Adverse event: Leiomyoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 2402 at risk

Adverse event: Lipoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 2402 at risk

Adverse event: Lung adenocarcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 3 affected / 2402 at risk

Adverse event: Lung neoplasm malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 10 affected / 2402 at risk

Adverse event: Lymphoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 2402 at risk

Adverse event: Lymphoproliferative disorder
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 2402 at risk

Adverse event: Malignant melanoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 6 affected / 2402 at risk

Adverse event: Malignant pleural effusion
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 2402 at risk

Adverse event: Mantle cell lymphoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 2402 at risk

Adverse event: Meningioma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 2402 at risk

Adverse event: Metastases to bone
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 2402 at risk

Adverse event: Metastases to liver
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 4 affected / 2402 at risk

Adverse event: Metastases to lung
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 2402 at risk

Adverse event: Metastasis
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 2402 at risk

Adverse event: Metastatic carcinoma of the bladder
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 2402 at risk

Adverse event: Monoclonal gammopathy
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 2402 at risk

Adverse event: Myeloid leukaemia
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 2402 at risk

Adverse event: Myeloproliferative neoplasm
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 2402 at risk

Adverse event: Neoplasm malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 2402 at risk

Adverse event: Neoplasm skin
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 2402 at risk

Adverse event: Non-Hodgkin's lymphoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 2402 at risk

Adverse event: Non-small cell lung cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 2402 at risk

Adverse event: Oesophageal carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 2402 at risk

Adverse event: Oncologic complication
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 2402 at risk

Adverse event: Oral haemangioma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 2402 at risk

Adverse event: Oropharyngeal cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 2402 at risk

Adverse event: Ovarian cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 2402 at risk

Adverse event: Ovarian epithelial cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 2402 at risk

Adverse event: Pancreatic carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 2402 at risk

Adverse event: Papilloma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 2402 at risk

Adverse event: Plasma cell myeloma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 3 affected / 2402 at risk

Adverse event: Prostate cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 8 affected / 2402 at risk

Adverse event: Prostatic adenoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 2402 at risk

Adverse event: Rectal adenocarcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 3 affected / 2402 at risk

Adverse event: Rectal cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 4 affected / 2402 at risk

Adverse event: Rectal neoplasm
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 2402 at risk

Adverse event: Renal cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 2402 at risk

Adverse event: Renal cell carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 2402 at risk

Adverse event: Seborrhoeic keratosis
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 2402 at risk

Adverse event: Small cell lung cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 2402 at risk

Adverse event: Squamous cell carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 8 affected / 2402 at risk

Adverse event: Squamous cell carcinoma of lung
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 2402 at risk

Adverse event: Transitional cell carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 4 affected / 2402 at risk

Adverse event: Transitional cell carcinoma recurrent
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 2402 at risk

Adverse event: Ureteral neoplasm
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 2402 at risk

Adverse event: Ureteric cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 2402 at risk

Adverse event: Uterine cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 2402 at risk

Adverse event: Uterine leiomyoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 2402 at risk

Adverse event: Waldenstrom's macroglobulinaemia
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 2402 at risk

Adverse event: Amyotrophic lateral sclerosis
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 2402 at risk

Adverse event: Aphasia
Serious: yes
Organ System: Nervous system disorders
Frequency: 4 affected / 2402 at risk

Adverse event: Ataxia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 2402 at risk

Adverse event: Brain hypoxia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 2402 at risk

Adverse event: Brain injury
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 2402 at risk

Adverse event: Brain oedema
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 2402 at risk

Adverse event: Brain stem stroke
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 2402 at risk

Adverse event: Carotid artery aneurysm
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 2402 at risk

Adverse event: Carotid artery disease
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 2402 at risk

Adverse event: Carotid artery stenosis
Serious: yes
Organ System: Nervous system disorders
Frequency: 7 affected / 2402 at risk

Adverse event: Carpal tunnel syndrome
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 2402 at risk

Adverse event: Cerebellar haematoma
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 2402 at risk

Adverse event: Cerebellar infarction
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 2402 at risk

Adverse event: Cerebral cyst
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 2402 at risk

Adverse event: Cerebral haemorrhage
Serious: yes
Organ System: Nervous system disorders
Frequency: 6 affected / 2402 at risk

Adverse event: Cerebral infarction
Serious: yes
Organ System: Nervous system disorders
Frequency: 18 affected / 2402 at risk

Adverse event: Cerebral ischaemia
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 2402 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Nervous system disorders
Frequency: 42 affected / 2402 at risk

Adverse event: Cerebrovascular disorder
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 2402 at risk

Adverse event: Cerebrovascular insufficiency
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 2402 at risk

Adverse event: Cervical radiculopathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 2402 at risk

Adverse event: Cervicobrachial syndrome
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 2402 at risk

Adverse event: Cognitive disorder
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 2402 at risk

Adverse event: Coma
Serious: yes
Organ System: Nervous system disorders
Frequency: 4 affected / 2402 at risk

Adverse event: Dementia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 2402 at risk

Adverse event: Dementia Alzheimer's type
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 2402 at risk

Adverse event: Dementia with Lewy bodies
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 2402 at risk

Adverse event: Diabetic ketoacidotic hyperglycaemic coma
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 2402 at risk

Adverse event: Dizziness
Serious: yes
Organ System: Nervous system disorders
Frequency: 11 affected / 2402 at risk

Adverse event: Dysarthria
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 2402 at risk

Adverse event: Embolic stroke
Serious: yes
Organ System: Nervous system disorders
Frequency: 4 affected / 2402 at risk

Adverse event: Encephalopathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 6 affected / 2402 at risk

Adverse event: Epilepsy
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 2402 at risk

Adverse event: Generalised tonic-clonic seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 2402 at risk

Adverse event: Guillain-Barre syndrome
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 2402 at risk

Adverse event: Haemorrhage intracranial
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 2402 at risk

Adverse event: Haemorrhagic cerebral infarction
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 2402 at risk

Adverse event: Haemorrhagic stroke
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 2402 at risk

Adverse event: Haemorrhagic transformation stroke
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 2402 at risk

Adverse event: Headache
Serious: yes
Organ System: Nervous system disorders
Frequency: 10 affected / 2402 at risk

Adverse event: Hemiparesis
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 2402 at risk

Adverse event: Hemiplegia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 2402 at risk

Adverse event: Hepatic encephalopathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 5 affected / 2402 at risk

Adverse event: Hydrocephalus
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 2402 at risk

Adverse event: Hypoxic-ischaemic encephalopathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 2402 at risk

Adverse event: IIIrd nerve paralysis
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 2402 at risk

Adverse event: Intracranial aneurysm
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 2402 at risk

Adverse event: Intracranial haematoma
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 2402 at risk

Adverse event: Intracranial pressure increased
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 2402 at risk

Adverse event: Ischaemic cerebral infarction
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 2402 at risk

Adverse event: Ischaemic stroke
Serious: yes
Organ System: Nervous system disorders
Frequency: 29 affected / 2402 at risk

Adverse event: Lacunar infarction
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 2402 at risk

Adverse event: Lethargy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 2402 at risk

Adverse event: Loss of consciousness
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 2402 at risk

Adverse event: Lumbar radiculopathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 2402 at risk

Adverse event: Metabolic encephalopathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 2402 at risk

Adverse event: Mixed dementia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 2402 at risk

Adverse event: Myoclonus
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 2402 at risk

Adverse event: Normal pressure hydrocephalus
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 2402 at risk

Adverse event: Parkinson's disease
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 2402 at risk

Adverse event: Parkinsonism
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 2402 at risk

Adverse event: Peripheral sensorimotor neuropathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 2402 at risk

Adverse event: Posterior reversible encephalopathy syndrome
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 2402 at risk

Adverse event: Presyncope
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 2402 at risk

Adverse event: Pseudoradicular syndrome
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 2402 at risk

Adverse event: Radiculopathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 2402 at risk

Adverse event: Sciatica
Serious: yes
Organ System: Nervous system disorders
Frequency: 4 affected / 2402 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 2402 at risk

Adverse event: Somnolence
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 2402 at risk

Adverse event: Spinal cord compression
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 2402 at risk

Adverse event: Spinal cord disorder
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 2402 at risk

Adverse event: Status epilepticus
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 2402 at risk

Adverse event: Subarachnoid haemorrhage
Serious: yes
Organ System: Nervous system disorders
Frequency: 4 affected / 2402 at risk

Adverse event: Syncope
Serious: yes
Organ System: Nervous system disorders
Frequency: 57 affected / 2402 at risk

Adverse event: Thalamus haemorrhage
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 2402 at risk

Adverse event: Thrombotic cerebral infarction
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 2402 at risk

Adverse event: Toxic encephalopathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 2402 at risk

Adverse event: Transient ischaemic attack
Serious: yes
Organ System: Nervous system disorders
Frequency: 26 affected / 2402 at risk

Adverse event: Tremor
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 2402 at risk

Adverse event: Vascular dementia
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 2402 at risk

Adverse event: Vascular parkinsonism
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 2402 at risk

Adverse event: Vertebrobasilar insufficiency
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 2402 at risk

Adverse event: Device power source issue
Serious: yes
Organ System: Product Issues
Frequency: 2 affected / 2402 at risk

Adverse event: Device defective
Serious: yes
Organ System: Product Issues
Frequency: 2 affected / 2402 at risk

Adverse event: Device dislocation
Serious: yes
Organ System: Product Issues
Frequency: 2 affected / 2402 at risk

Adverse event: Device failure
Serious: yes
Organ System: Product Issues
Frequency: 1 affected / 2402 at risk

Adverse event: Device leakage
Serious: yes
Organ System: Product Issues
Frequency: 1 affected / 2402 at risk

Adverse event: Device loosening
Serious: yes
Organ System: Product Issues
Frequency: 1 affected / 2402 at risk

Adverse event: Device malfunction
Serious: yes
Organ System: Product Issues
Frequency: 1 affected / 2402 at risk

Adverse event: Device occlusion
Serious: yes
Organ System: Product Issues
Frequency: 1 affected / 2402 at risk

Adverse event: Adjustment disorder
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 2402 at risk

Adverse event: Alcoholism
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 2402 at risk

Adverse event: Anxiety
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 2402 at risk

Adverse event: Anxiety disorder
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 2402 at risk

Adverse event: Behaviour disorder
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 2402 at risk

Adverse event: Completed suicide
Serious: yes
Organ System: Psychiatric disorders
Frequency: 2 affected / 2402 at risk

Adverse event: Confusional state
Serious: yes
Organ System: Psychiatric disorders
Frequency: 7 affected / 2402 at risk

Adverse event: Delirium
Serious: yes
Organ System: Psychiatric disorders
Frequency: 11 affected / 2402 at risk

Adverse event: Delirium febrile
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 2402 at risk

Adverse event: Depression
Serious: yes
Organ System: Psychiatric disorders
Frequency: 7 affected / 2402 at risk

Adverse event: Disorientation
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 2402 at risk

Adverse event: Hallucination
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 2402 at risk

Adverse event: Major depression
Serious: yes
Organ System: Psychiatric disorders
Frequency: 2 affected / 2402 at risk

Adverse event: Mental disorder
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 2402 at risk

Adverse event: Mental status changes
Serious: yes
Organ System: Psychiatric disorders
Frequency: 5 affected / 2402 at risk

Adverse event: Somatic symptom disorder
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 2402 at risk

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 110 affected / 2402 at risk

Adverse event: Azotaemia
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 3 affected / 2402 at risk

Adverse event: Bladder diverticulum
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 2402 at risk

Adverse event: Bladder neck obstruction
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 2402 at risk

Adverse event: Cystocele
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 2402 at risk

Adverse event: Calculus bladder
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 2402 at risk

Adverse event: Calculus urethral
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 2402 at risk

Adverse event: Calculus urinary
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 2402 at risk

Adverse event: Chronic kidney disease
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 14 affected / 2402 at risk

Adverse event: Dysuria
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 2402 at risk

Adverse event: End stage renal disease
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 3 affected / 2402 at risk

Adverse event: Haematuria
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 8 affected / 2402 at risk

Adverse event: Haemorrhage urinary tract
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 2402 at risk

Adverse event: Hydronephrosis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 3 affected / 2402 at risk

Adverse event: Nephrolithiasis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 5 affected / 2402 at risk

Adverse event: Nephropathy toxic
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 3 affected / 2402 at risk

Adverse event: Nephrotic syndrome
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 2402 at risk

Adverse event: Oliguria
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 2402 at risk

Adverse event: Prerenal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 3 affected / 2402 at risk

Adverse event: Proteinuria
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 2402 at risk

Adverse event: Renal artery stenosis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 2402 at risk

Adverse event: Renal cyst
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 2402 at risk

Adverse event: Renal disorder
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 2402 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 29 affected / 2402 at risk

Adverse event: Renal impairment
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 48 affected / 2402 at risk

Adverse event: Renal injury
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 2402 at risk

Adverse event: Renal mass
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 2402 at risk

Adverse event: Renal tubular necrosis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 3 affected / 2402 at risk

Adverse event: Urinary incontinence
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 3 affected / 2402 at risk

Adverse event: Urinary retention
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 8 affected / 2402 at risk

Adverse event: Adenomyosis
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 2402 at risk

Adverse event: Benign prostatic hyperplasia
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 5 affected / 2402 at risk

Adverse event: Breast calcifications
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 2402 at risk

Adverse event: Breast cyst
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 2402 at risk

Adverse event: Cervical dysplasia
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 2402 at risk

Adverse event: Intermenstrual bleeding
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 2402 at risk

Adverse event: Ovarian cyst
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 2402 at risk

Adverse event: Postmenopausal haemorrhage
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 2402 at risk

Adverse event: Prostatic haemorrhage
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 2402 at risk

Adverse event: Prostatic obstruction
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 2402 at risk

Adverse event: Prostatitis
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 2402 at risk

Adverse event: Uterine polyp
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 2402 at risk

Adverse event: Vaginal prolapse
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 2402 at risk

Adverse event: Acute pulmonary oedema
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 14 affected / 2402 at risk

Adverse event: Acute respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 24 affected / 2402 at risk

Adverse event: Aspiration
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 2402 at risk

Adverse event: Asthma
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 10 affected / 2402 at risk

Adverse event: Atelectasis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 2402 at risk

Adverse event: Bronchial obstruction
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 2402 at risk

Adverse event: Bronchiectasis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 2402 at risk

Adverse event: Bronchitis chronic
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 2402 at risk

Adverse event: Bronchospasm
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 2402 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 67 affected / 2402 at risk

Adverse event: Chronic respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 2402 at risk

Adverse event: Cough
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 2402 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 64 affected / 2402 at risk

Adverse event: Dyspnoea at rest
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 2402 at risk

Adverse event: Dyspnoea exertional
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 2402 at risk

Adverse event: Emphysema
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 2402 at risk

Adverse event: Epistaxis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 2402 at risk

Adverse event: Haemoptysis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 2402 at risk

Adverse event: Haemothorax
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 2402 at risk

Adverse event: Hydrothorax
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 2402 at risk

Adverse event: Hypercapnia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 2402 at risk

Adverse event: Hypoventilation
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 2402 at risk

Adverse event: Hypoxia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 2402 at risk

Adverse event: Interstitial lung disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 2402 at risk

Adverse event: Laryngospasm
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 2402 at risk

Adverse event: Lung disorder
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 2402 at risk

Adverse event: Mediastinal mass
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 2402 at risk

Adverse event: Obstructive airways disorder
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 2402 at risk

Adverse event: Orthopnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 2402 at risk

Adverse event: Pharyngeal haemorrhage
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 2402 at risk

Adverse event: Pickwickian syndrome
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 2402 at risk

Adverse event: Pleural effusion
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 15 affected / 2402 at risk

Adverse event: Pleurisy
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 2402 at risk

Adverse event: Pneumonia aspiration
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 11 affected / 2402 at risk

Adverse event: Pneumonitis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 2402 at risk

Adverse event: Pneumothorax
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 2402 at risk

Adverse event: Presbyphonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 2402 at risk

Adverse event: Pulmonary arterial hypertension
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 2402 at risk

Adverse event: Pulmonary congestion
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 2402 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 17 affected / 2402 at risk

Adverse event: Pulmonary hypertension
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 9 affected / 2402 at risk

Adverse event: Pulmonary mass
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 2402 at risk

Adverse event: Pulmonary oedema
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 16 affected / 2402 at risk

Adverse event: Respiratory acidosis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 2402 at risk

Adverse event: Respiratory arrest
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 2402 at risk

Adverse event: Respiratory distress
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 2402 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 32 affected / 2402 at risk

Adverse event: Sleep apnoea syndrome
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 2402 at risk

Adverse event: Vocal cord polyp
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 2402 at risk

Adverse event: Wheezing
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 2402 at risk

Adverse event: Angioedema
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 2402 at risk

Adverse event: Decubitus ulcer
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 2402 at risk

Adverse event: Dermatitis
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 2402 at risk

Adverse event: Dermatitis exfoliative generalised
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 2402 at risk

Adverse event: Diabetic foot
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 2402 at risk

Adverse event: Diabetic wound
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 2402 at risk

Adverse event: Haemorrhage subcutaneous
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 2402 at risk

Adverse event: Neurodermatitis
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 2402 at risk

Adverse event: Purpura
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 2402 at risk

Adverse event: Rash maculo-papular
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 2402 at risk

Adverse event: Rash pruritic
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 2402 at risk

Adverse event: Rhinophyma
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 2402 at risk

Adverse event: Skin ulcer
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 2402 at risk

Adverse event: Urticaria
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 2402 at risk

Adverse event: Living in residential institution
Serious: yes
Organ System: Social circumstances
Frequency: 1 affected / 2402 at risk

Adverse event: Accelerated hypertension
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 2402 at risk

Adverse event: Angiopathy
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 2402 at risk

Adverse event: Aortic aneurysm
Serious: yes
Organ System: Vascular disorders
Frequency: 8 affected / 2402 at risk

Adverse event: Aortic aneurysm rupture
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 2402 at risk

Adverse event: Aortic dissection
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 2402 at risk

Adverse event: Aortic rupture
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 2402 at risk

Adverse event: Aortic stenosis
Serious: yes
Organ System: Vascular disorders
Frequency: 12 affected / 2402 at risk

Adverse event: Arterial occlusive disease
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 2402 at risk

Adverse event: Arteriosclerosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 2402 at risk

Adverse event: Bleeding varicose vein
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 2402 at risk

Adverse event: Blood pressure fluctuation
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 2402 at risk

Adverse event: Circulatory collapse
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 2402 at risk

Adverse event: Deep vein thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 7 affected / 2402 at risk

Adverse event: Essential hypertension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 2402 at risk

Adverse event: Haematoma
Serious: yes
Organ System: Vascular disorders
Frequency: 8 affected / 2402 at risk

Adverse event: Haemorrhage
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 2402 at risk

Adverse event: Haemorrhagic infarction
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 2402 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Vascular disorders
Frequency: 25 affected / 2402 at risk

Adverse event: Hypertensive crisis
Serious: yes
Organ System: Vascular disorders
Frequency: 8 affected / 2402 at risk

Adverse event: Hypertensive emergency
Serious: yes
Organ System: Vascular disorders
Frequency: 3 affected / 2402 at risk

Adverse event: Hypertensive urgency
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 2402 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Vascular disorders
Frequency: 47 affected / 2402 at risk

Adverse event: Hypovolaemic shock
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 2402 at risk

Adverse event: Iliac artery embolism
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 2402 at risk

Adverse event: Intermittent claudication
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 2402 at risk

Adverse event: Ischaemia
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 2402 at risk

Adverse event: Leriche syndrome
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 2402 at risk

Adverse event: Lymphoedema
Serious: yes
Organ System: Vascular disorders
Frequency: 4 affected / 2402 at risk

Adverse event: Orthostatic hypertension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 2402 at risk

Adverse event: Orthostatic hypotension
Serious: yes
Organ System: Vascular disorders
Frequency: 9 affected / 2402 at risk

Adverse event: Peripheral arterial occlusive disease
Serious: yes
Organ System: Vascular disorders
Frequency: 7 affected / 2402 at risk

Adverse event: Peripheral artery occlusion
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 2402 at risk

Adverse event: Peripheral artery stenosis
Serious: yes
Organ System: Vascular disorders
Frequency: 4 affected / 2402 at risk

Adverse event: Peripheral artery thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 2402 at risk

Adverse event: Peripheral embolism
Serious: yes
Organ System: Vascular disorders
Frequency: 3 affected / 2402 at risk

Adverse event: Peripheral ischaemia
Serious: yes
Organ System: Vascular disorders
Frequency: 7 affected / 2402 at risk

Adverse event: Peripheral vascular disorder
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 2402 at risk

Adverse event: Shock
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 2402 at risk

Adverse event: Shock haemorrhagic
Serious: yes
Organ System: Vascular disorders
Frequency: 5 affected / 2402 at risk

Adverse event: Subclavian artery stenosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 2402 at risk

Adverse event: Thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 2402 at risk

Adverse event: Varicose ulceration
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 2402 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 214 affected / 2402 at risk

Adverse event: Angina pectoris
Serious: no
Organ System: Cardiac disorders
Frequency: 82 affected / 2402 at risk

Adverse event: Atrial fibrillation
Serious: no
Organ System: Cardiac disorders
Frequency: 239 affected / 2402 at risk

Adverse event: Bradycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 85 affected / 2402 at risk

Adverse event: Cardiac failure
Serious: no
Organ System: Cardiac disorders
Frequency: 269 affected / 2402 at risk

Adverse event: Palpitations
Serious: no
Organ System: Cardiac disorders
Frequency: 56 affected / 2402 at risk

Adverse event: Vertigo
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 60 affected / 2402 at risk

Adverse event: Cataract
Serious: no
Organ System: Eye disorders
Frequency: 70 affected / 2402 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 54 affected / 2402 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 86 affected / 2402 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 180 affected / 2402 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 87 affected / 2402 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 58 affected / 2402 at risk

Adverse event: Asthenia
Serious: no
Organ System: General disorders
Frequency: 58 affected / 2402 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 107 affected / 2402 at risk

Adverse event: Non-cardiac chest pain
Serious: no
Organ System: General disorders
Frequency: 92 affected / 2402 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Frequency: 183 affected / 2402 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 54 affected / 2402 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 197 affected / 2402 at risk

Adverse event: Cellulitis
Serious: no
Organ System: Infections and infestations
Frequency: 41 affected / 2402 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 109 affected / 2402 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 177 affected / 2402 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Infections and infestations
Frequency: 97 affected / 2402 at risk

Adverse event: Respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 60 affected / 2402 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 139 affected / 2402 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 268 affected / 2402 at risk

Adverse event: Contusion
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 72 affected / 2402 at risk

Adverse event: Fall
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 90 affected / 2402 at risk

Adverse event: Blood creatinine increased
Serious: no
Organ System: Investigations
Frequency: 65 affected / 2402 at risk

Adverse event: Glomerular filtration rate decreased
Serious: no
Organ System: Investigations
Frequency: 93 affected / 2402 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Investigations
Frequency: 82 affected / 2402 at risk

Adverse event: Diabetes mellitus
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 62 affected / 2402 at risk

Adverse event: Gout
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 88 affected / 2402 at risk

Adverse event: Hyperkalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 298 affected / 2402 at risk

Adverse event: Hyperuricaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 75 affected / 2402 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 100 affected / 2402 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 153 affected / 2402 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 170 affected / 2402 at risk

Adverse event: Muscle spasms
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 49 affected / 2402 at risk

Adverse event: Musculoskeletal pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 58 affected / 2402 at risk

Adverse event: Osteoarthritis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 92 affected / 2402 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 75 affected / 2402 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 192 affected / 2402 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 126 affected / 2402 at risk

Adverse event: Syncope
Serious: no
Organ System: Nervous system disorders
Frequency: 62 affected / 2402 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 70 affected / 2402 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 54 affected / 2402 at risk

Adverse event: Acute kidney injury
Serious: no
Organ System: Renal and urinary disorders
Frequency: 65 affected / 2402 at risk

Adverse event: Chronic kidney disease
Serious: no
Organ System: Renal and urinary disorders
Frequency: 50 affected / 2402 at risk

Adverse event: Haematuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 77 affected / 2402 at risk

Adverse event: Renal failure
Serious: no
Organ System: Renal and urinary disorders
Frequency: 108 affected / 2402 at risk

Adverse event: Renal impairment
Serious: no
Organ System: Renal and urinary disorders
Frequency: 331 affected / 2402 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 68 affected / 2402 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 146 affected / 2402 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 236 affected / 2402 at risk

Adverse event: Epistaxis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 71 affected / 2402 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 51 affected / 2402 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 314 affected / 2402 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 379 affected / 2402 at risk

Adverse event: Acquired haemophilia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 4821 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 135 affected / 4821 at risk

Adverse event: Anaemia macrocytic
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 4821 at risk

Adverse event: Anaemia megaloblastic
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 4821 at risk

Adverse event: Anaemia vitamin B12 deficiency
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 4821 at risk

Adverse event: Autoimmune haemolytic anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 4821 at risk

Adverse event: Blood loss anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 9 affected / 4821 at risk

Adverse event: Coagulopathy
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 4821 at risk

Adverse event: Disseminated intravascular coagulation
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 4821 at risk

Adverse event: Hypercoagulation
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 4821 at risk

Adverse event: Hypersplenism
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 4821 at risk

Adverse event: Immune thrombocytopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 4821 at risk

Adverse event: Iron deficiency anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 11 affected / 4821 at risk

Adverse event: Leukocytosis
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 7 affected / 4821 at risk

Adverse event: Leukopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 4821 at risk

Adverse event: Lymphadenitis
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 4821 at risk

Adverse event: Lymphadenopathy
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 4821 at risk

Adverse event: Lymphadenopathy mediastinal
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 4821 at risk

Adverse event: Microcytic anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 4821 at risk

Adverse event: Nephrogenic anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 4821 at risk

Adverse event: Neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 4821 at risk

Adverse event: Normochromic normocytic anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 4821 at risk

Adverse event: Pancytopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 4821 at risk

Adverse event: Splenic infarction
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 4821 at risk

Adverse event: Splenitis
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 4821 at risk

Adverse event: Thrombocytopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 7 affected / 4821 at risk

Adverse event: Thrombocytosis
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 4821 at risk

Adverse event: Acute coronary syndrome
Serious: yes
Organ System: Cardiac disorders
Frequency: 24 affected / 4821 at risk

Adverse event: Acute left ventricular failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 29 affected / 4821 at risk

Adverse event: Acute myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 114 affected / 4821 at risk

Adverse event: Adams-Stokes syndrome
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 4821 at risk

Adverse event: Angina pectoris
Serious: yes
Organ System: Cardiac disorders
Frequency: 92 affected / 4821 at risk

Adverse event: Angina unstable
Serious: yes
Organ System: Cardiac disorders
Frequency: 93 affected / 4821 at risk

Adverse event: Aortic valve disease
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 4821 at risk

Adverse event: Aortic valve incompetence
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 4821 at risk

Adverse event: Aortic valve stenosis
Serious: yes
Organ System: Cardiac disorders
Frequency: 7 affected / 4821 at risk

Adverse event: Arrhythmia
Serious: yes
Organ System: Cardiac disorders
Frequency: 8 affected / 4821 at risk

Adverse event: Arrhythmia supraventricular
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 4821 at risk

Adverse event: Arteriosclerosis coronary artery
Serious: yes
Organ System: Cardiac disorders
Frequency: 8 affected / 4821 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 307 affected / 4821 at risk

Adverse event: Atrial flutter
Serious: yes
Organ System: Cardiac disorders
Frequency: 54 affected / 4821 at risk

Adverse event: Atrial tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 9 affected / 4821 at risk

Adverse event: Atrial thrombosis
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 4821 at risk

Adverse event: Atrioventricular block
Serious: yes
Organ System: Cardiac disorders
Frequency: 10 affected / 4821 at risk

Adverse event: Atrioventricular block complete
Serious: yes
Organ System: Cardiac disorders
Frequency: 19 affected / 4821 at risk

Adverse event: Atrioventricular block first degree
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 4821 at risk

Adverse event: Atrioventricular block second degree
Serious: yes
Organ System: Cardiac disorders
Frequency: 7 affected / 4821 at risk

Adverse event: Bradyarrhythmia
Serious: yes
Organ System: Cardiac disorders
Frequency: 6 affected / 4821 at risk

Adverse event: Bradycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 51 affected / 4821 at risk

Adverse event: Bundle branch block left
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 4821 at risk

Adverse event: Cardiac amyloidosis
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 4821 at risk

Adverse event: Cardiac arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 47 affected / 4821 at risk

Adverse event: Cardiac asthma
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 4821 at risk

Adverse event: Cardiac discomfort
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 4821 at risk

Adverse event: Cardiac failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 720 affected / 4821 at risk

Adverse event: Cardiac failure acute
Serious: yes
Organ System: Cardiac disorders
Frequency: 162 affected / 4821 at risk

Adverse event: Cardiac failure chronic
Serious: yes
Organ System: Cardiac disorders
Frequency: 56 affected / 4821 at risk

Adverse event: Cardiac failure congestive
Serious: yes
Organ System: Cardiac disorders
Frequency: 169 affected / 4821 at risk

Adverse event: Cardiac fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 4821 at risk

Adverse event: Cardiac flutter
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 4821 at risk

Adverse event: Cardiac tamponade
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 4821 at risk

Adverse event: Cardiac valve disease
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 4821 at risk

Adverse event: Cardiac ventricular disorder
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 4821 at risk

Adverse event: Cardio-respiratory arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 28 affected / 4821 at risk

Adverse event: Cardiogenic shock
Serious: yes
Organ System: Cardiac disorders
Frequency: 18 affected / 4821 at risk

Adverse event: Cardiomegaly
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 4821 at risk

Adverse event: Cardiomyopathy
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 4821 at risk

Adverse event: Cardiopulmonary failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 5 affected / 4821 at risk

Adverse event: Cardiorenal syndrome
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 4821 at risk

Adverse event: Cardiovascular disorder
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 4821 at risk

Adverse event: Cardiovascular insufficiency
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 4821 at risk

Adverse event: Chronic left ventricular failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 4821 at risk

Adverse event: Dilated cardiomyopathy
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 4821 at risk

Adverse event: Cor pulmonale
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 4821 at risk

Adverse event: Coronary artery disease
Serious: yes
Organ System: Cardiac disorders
Frequency: 51 affected / 4821 at risk

Adverse event: Coronary artery occlusion
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 4821 at risk

Adverse event: Coronary artery stenosis
Serious: yes
Organ System: Cardiac disorders
Frequency: 7 affected / 4821 at risk

Adverse event: Hypertensive heart disease
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 4821 at risk

Adverse event: Intracardiac mass
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 4821 at risk

Adverse event: Ischaemic cardiomyopathy
Serious: yes
Organ System: Cardiac disorders
Frequency: 5 affected / 4821 at risk

Adverse event: Left ventricular dysfunction
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 4821 at risk

Adverse event: Left ventricular failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 11 affected / 4821 at risk

Adverse event: Microvascular coronary artery disease
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 4821 at risk

Adverse event: Mitral valve calcification
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 4821 at risk

Adverse event: Mitral valve incompetence
Serious: yes
Organ System: Cardiac disorders
Frequency: 15 affected / 4821 at risk

Adverse event: Mitral valve prolapse
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 4821 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 67 affected / 4821 at risk

Adverse event: Myocardial ischaemia
Serious: yes
Organ System: Cardiac disorders
Frequency: 18 affected / 4821 at risk

Adverse event: Myocardial rupture
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 4821 at risk

Adverse event: Myocarditis
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 4821 at risk

Adverse event: Nodal rhythm
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 4821 at risk

Adverse event: Palpitations
Serious: yes
Organ System: Cardiac disorders
Frequency: 7 affected / 4821 at risk

Adverse event: Pericardial effusion
Serious: yes
Organ System: Cardiac disorders
Frequency: 7 affected / 4821 at risk

Adverse event: Pericarditis
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 4821 at risk

Adverse event: Pericarditis constrictive
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 4821 at risk

Adverse event: Pulseless electrical activity
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 4821 at risk

Adverse event: Right ventricular dysfunction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 4821 at risk

Adverse event: Right ventricular failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 4821 at risk

Adverse event: Sinoatrial block
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 4821 at risk

Adverse event: Sinus arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 4821 at risk

Adverse event: Sinus bradycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 9 affected / 4821 at risk

Adverse event: Sinus node dysfunction
Serious: yes
Organ System: Cardiac disorders
Frequency: 30 affected / 4821 at risk

Adverse event: Sinus tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 4821 at risk

Adverse event: Stress cardiomyopathy
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 4821 at risk

Adverse event: Supraventricular extrasystoles
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 4821 at risk

Adverse event: Supraventricular tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 9 affected / 4821 at risk

Adverse event: Systolic dysfunction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 4821 at risk

Adverse event: Tachyarrhythmia
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 4821 at risk

Adverse event: Tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 4821 at risk

Adverse event: Torsade de pointes
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 4821 at risk

Adverse event: Tricuspid valve incompetence
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 4821 at risk

Adverse event: Trifascicular block
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 4821 at risk

Adverse event: Ventricular arrhythmia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 4821 at risk

Adverse event: Ventricular dyssynchrony
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 4821 at risk

Adverse event: Ventricular extrasystoles
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 4821 at risk

Adverse event: Ventricular fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 9 affected / 4821 at risk

Adverse event: Ventricular tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 13 affected / 4821 at risk

Adverse event: Atrial septal defect
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 4821 at risk

Adverse event: Congenital coronary artery malformation
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 4821 at risk

Adverse event: Congenital megaureter
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 4821 at risk

Adverse event: Gastrointestinal arteriovenous malformation
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 2 affected / 4821 at risk

Adverse event: Back pain
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 4821 at risk

Adverse event: Phimosis
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 4821 at risk

Adverse event: Vertebral artery hypoplasia
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 4821 at risk

Adverse event: Deafness unilateral
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 4821 at risk

Adverse event: Sudden hearing loss
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 4821 at risk

Adverse event: Tinnitus
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 4821 at risk

Adverse event: Vertigo
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 9 affected / 4821 at risk

Adverse event: Vertigo positional
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 6 affected / 4821 at risk

Adverse event: Vestibular ischaemia
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 4821 at risk

Adverse event: Goitre
Serious: yes
Organ System: Endocrine disorders
Frequency: 3 affected / 4821 at risk

Adverse event: Hyperadrenocorticism
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 4821 at risk

Adverse event: Hyperparathyroidism
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 4821 at risk

Adverse event: Hyperthyroidism
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 4821 at risk

Adverse event: Hypothyroidism
Serious: yes
Organ System: Endocrine disorders
Frequency: 6 affected / 4821 at risk

Adverse event: Inappropriate antidiuretic hormone secretion
Serious: yes
Organ System: Endocrine disorders
Frequency: 2 affected / 4821 at risk

Adverse event: Parathyroid hyperplasia
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 4821 at risk

Adverse event: Amaurosis fugax
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 4821 at risk

Adverse event: Blindness unilateral
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 4821 at risk

Adverse event: Cataract
Serious: yes
Organ System: Eye disorders
Frequency: 26 affected / 4821 at risk

Adverse event: Cataract diabetic
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 4821 at risk

Adverse event: Conjunctival haemorrhage
Serious: yes
Organ System: Eye disorders
Frequency: 4 affected / 4821 at risk

Adverse event: Entropion
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 4821 at risk

Adverse event: Eye pain
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 4821 at risk

Adverse event: Glaucoma
Serious: yes
Organ System: Eye disorders
Frequency: 3 affected / 4821 at risk

Adverse event: Macular degeneration
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 4821 at risk

Adverse event: Macular fibrosis
Serious: yes
Organ System: Eye disorders
Frequency: 2 affected / 4821 at risk

Adverse event: Maculopathy
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 4821 at risk

Adverse event: Narrow anterior chamber angle
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 4821 at risk

Adverse event: Neovascular age-related macular degeneration
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 4821 at risk

Adverse event: Pterygium
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 4821 at risk

Adverse event: Retinal detachment
Serious: yes
Organ System: Eye disorders
Frequency: 4 affected / 4821 at risk

Adverse event: Retinal haemorrhage
Serious: yes
Organ System: Eye disorders
Frequency: 3 affected / 4821 at risk

Adverse event: Retinal vein occlusion
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 4821 at risk

Adverse event: Vision blurred
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 4821 at risk

Adverse event: Visual acuity reduced
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 4821 at risk

Adverse event: Vitreous haemorrhage
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 4821 at risk

Adverse event: Abdominal distension
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 4821 at risk

Adverse event: Abdominal hernia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 4821 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 14 affected / 4821 at risk

Adverse event: Abdominal pain lower
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 4821 at risk

Adverse event: Abdominal pain upper
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 4821 at risk

Adverse event: Abdominal wall haematoma
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 4821 at risk

Adverse event: Anal fissure
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 4821 at risk

Adverse event: Anal fistula
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 4821 at risk

Adverse event: Anal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 4821 at risk

Adverse event: Anal incontinence
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 4821 at risk

Adverse event: Appendiceal mucocoele
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 4821 at risk

Adverse event: Ascites
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 17 affected / 4821 at risk

Adverse event: Chronic gastritis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 4821 at risk

Adverse event: Colitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 4821 at risk

Adverse event: Colitis ischaemic
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 4821 at risk

Adverse event: Colitis microscopic
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 4821 at risk

Adverse event: Colitis ulcerative
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 4821 at risk

Adverse event: Constipation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 4821 at risk

Adverse event: Crohn's disease
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 4821 at risk

Adverse event: Dental caries
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 4821 at risk

Adverse event: Diabetic gastroenteropathy
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 4821 at risk

Adverse event: Diaphragmatic hernia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 4821 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 27 affected / 4821 at risk

Adverse event: Dieulafoy's vascular malformation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 4821 at risk

Adverse event: Diverticular perforation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 4821 at risk

Adverse event: Diverticulum
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 4821 at risk

Adverse event: Diverticulum intestinal
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 4821 at risk

Adverse event: Diverticulum intestinal haemorrhagic
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 4821 at risk

Adverse event: Duodenal polyp
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 4821 at risk

Adverse event: Duodenal ulcer
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 4821 at risk

Adverse event: Duodenal ulcer haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 4821 at risk

Adverse event: Duodenitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 4821 at risk

Adverse event: Dyspepsia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 4821 at risk

Adverse event: Dysphagia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 4821 at risk

Adverse event: Enteritis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 4821 at risk

Adverse event: Erosive oesophagitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 4821 at risk

Adverse event: Faecaloma
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 4821 at risk

Adverse event: Faeces discoloured
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 4821 at risk

Adverse event: Femoral hernia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 4821 at risk

Adverse event: Gastrointestinal disorder
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 4821 at risk

Adverse event: Gastric haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 4821 at risk

Adverse event: Gastric polyps
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 4821 at risk

Adverse event: Gastric ulcer
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 11 affected / 4821 at risk

Adverse event: Gastric ulcer haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 4821 at risk

Adverse event: Gastritis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 4821 at risk

Adverse event: Gastritis erosive
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 4821 at risk

Adverse event: Gastritis haemorrhagic
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 4821 at risk

Adverse event: Gastrointestinal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 61 affected / 4821 at risk

Adverse event: Gastrointestinal perforation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 4821 at risk

Adverse event: Gastrointestinal polyp haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 4821 at risk

Adverse event: Gastrointestinal ulcer
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 4821 at risk

Adverse event: Gastrointestinal ulcer haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 4821 at risk

Adverse event: Gastrointestinal wall thickening
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 4821 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 4821 at risk

Adverse event: Haematemesis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 4821 at risk

Adverse event: Haematochezia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 4821 at risk

Adverse event: Haemorrhagic erosive gastritis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 4821 at risk

Adverse event: Haemorrhoidal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 4821 at risk

Adverse event: Haemorrhoids
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 4821 at risk

Adverse event: Hiatus hernia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 4821 at risk

Adverse event: Ileus
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 4821 at risk

Adverse event: Ileus paralytic
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 4821 at risk

Adverse event: Impaired gastric emptying
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 4821 at risk

Adverse event: Incarcerated inguinal hernia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 4821 at risk

Adverse event: Incarcerated umbilical hernia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 4821 at risk

Adverse event: Inguinal hernia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 23 affected / 4821 at risk

Adverse event: Inguinal hernia, obstructive
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 4821 at risk

Adverse event: Intestinal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 4821 at risk

Adverse event: Intestinal infarction
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 4821 at risk

Adverse event: Intestinal ischaemia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 4821 at risk

Adverse event: Intestinal obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 4821 at risk

Adverse event: Intestinal perforation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 4821 at risk

Adverse event: Intestinal polyp
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 4821 at risk

Adverse event: Intestinal strangulation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 4821 at risk

Adverse event: Intra-abdominal haematoma
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 4821 at risk

Adverse event: Intra-abdominal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 4821 at risk

Adverse event: Irritable bowel syndrome
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 4821 at risk

Adverse event: Large intestinal obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 4821 at risk

Adverse event: Large intestine perforation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 4821 at risk

Adverse event: Large intestine polyp
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 4821 at risk

Adverse event: Lower gastrointestinal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 4821 at risk

Adverse event: Mallory-Weiss syndrome
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 4821 at risk

Adverse event: Melaena
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 13 affected / 4821 at risk

Adverse event: Mouth haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 4821 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 17 affected / 4821 at risk

Adverse event: Obstructive pancreatitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 4821 at risk

Adverse event: Oesophageal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 4821 at risk

Adverse event: Oesophageal perforation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 4821 at risk

Adverse event: Oesophageal ulcer
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 4821 at risk

Adverse event: Pancreatitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 4821 at risk

Adverse event: Pancreatitis acute
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 14 affected / 4821 at risk

Adverse event: Pancreatitis chronic
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 4821 at risk

Adverse event: Pancreatitis necrotising
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 4821 at risk

Adverse event: Pancreatitis relapsing
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 4821 at risk

Adverse event: Peptic ulcer haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 4821 at risk

Adverse event: Haemoperitoneum
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 4821 at risk

Adverse event: Portal hypertensive gastropathy
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 4821 at risk

Adverse event: Proctitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 4821 at risk

Adverse event: Rectal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 13 affected / 4821 at risk

Adverse event: Anorectal polyp
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 4821 at risk

Adverse event: Rectal prolapse
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 4821 at risk

Adverse event: Retroperitoneal haematoma
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 4821 at risk

Adverse event: Salivary gland calculus
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 4821 at risk

Adverse event: Small intestinal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 4821 at risk

Adverse event: Small intestinal obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 12 affected / 4821 at risk

Adverse event: Subileus
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 4821 at risk

Adverse event: Toothache
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 4821 at risk

Adverse event: Umbilical hernia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 4821 at risk

Adverse event: Upper gastrointestinal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 18 affected / 4821 at risk

Adverse event: Varices oesophageal
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 4821 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 20 affected / 4821 at risk

Adverse event: Adverse drug reaction
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 4821 at risk

Adverse event: Asthenia
Serious: yes
Organ System: General disorders
Frequency: 33 affected / 4821 at risk

Adverse event: Cardiac death
Serious: yes
Organ System: General disorders
Frequency: 9 affected / 4821 at risk

Adverse event: Catheter site haemorrhage
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 4821 at risk

Adverse event: Chest discomfort
Serious: yes
Organ System: General disorders
Frequency: 5 affected / 4821 at risk

Adverse event: Chest pain
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 4821 at risk

Adverse event: Concomitant disease progression
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 4821 at risk

Adverse event: Condition aggravated
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 4821 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 57 affected / 4821 at risk

Adverse event: Immobilisation syndrome
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 4821 at risk

Adverse event: Euthanasia
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 4821 at risk

Adverse event: Fatigue
Serious: yes
Organ System: General disorders
Frequency: 8 affected / 4821 at risk

Adverse event: Gait disturbance
Serious: yes
Organ System: General disorders
Frequency: 6 affected / 4821 at risk

Adverse event: General physical health deterioration
Serious: yes
Organ System: General disorders
Frequency: 14 affected / 4821 at risk

Adverse event: Hyperthermia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 4821 at risk

Adverse event: Ill-defined disorder
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 4821 at risk

Adverse event: Impaired healing
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 4821 at risk

Adverse event: Loss of personal independence in daily activities
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 4821 at risk

Adverse event: Implant site haemorrhage
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 4821 at risk

Adverse event: Incarcerated hernia
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 4821 at risk

Adverse event: Influenza like illness
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 4821 at risk

Adverse event: Lithiasis
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 4821 at risk

Adverse event: Malaise
Serious: yes
Organ System: General disorders
Frequency: 4 affected / 4821 at risk

Adverse event: Mass
Serious: yes
Organ System: General disorders
Frequency: 4 affected / 4821 at risk

Adverse event: Medical device discomfort
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 4821 at risk

Adverse event: Multiple organ dysfunction syndrome
Serious: yes
Organ System: General disorders
Frequency: 17 affected / 4821 at risk

Adverse event: Necrosis
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 4821 at risk

Adverse event: Non-cardiac chest pain
Serious: yes
Organ System: General disorders
Frequency: 79 affected / 4821 at risk

Adverse event: Oedema
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 4821 at risk

Adverse event: Oedema peripheral
Serious: yes
Organ System: General disorders
Frequency: 18 affected / 4821 at risk

Adverse event: Pain
Serious: yes
Organ System: General disorders
Frequency: 4 affected / 4821 at risk

Adverse event: Peripheral swelling
Serious: yes
Organ System: General disorders
Frequency: 4 affected / 4821 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 21 affected / 4821 at risk

Adverse event: Stenosis
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 4821 at risk

Adverse event: Sudden cardiac death
Serious: yes
Organ System: General disorders
Frequency: 31 affected / 4821 at risk

Adverse event: Sudden death
Serious: yes
Organ System: General disorders
Frequency: 43 affected / 4821 at risk

Adverse event: Surgical failure
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 4821 at risk

Adverse event: Swelling
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 4821 at risk

Adverse event: Systemic inflammatory response syndrome
Serious: yes
Organ System: General disorders
Frequency: 6 affected / 4821 at risk

Adverse event: Treatment noncompliance
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 4821 at risk

Adverse event: Ulcer haemorrhage
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 4821 at risk

Adverse event: Unevaluable event
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 4821 at risk

Adverse event: Vascular stent stenosis
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 4821 at risk

Adverse event: Biliary obstruction
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 2 affected / 4821 at risk

Adverse event: Bile duct stenosis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 4821 at risk

Adverse event: Bile duct stone
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 9 affected / 4821 at risk

Adverse event: Biliary colic
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 3 affected / 4821 at risk

Adverse event: Biliary dyskinesia
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 4821 at risk

Adverse event: Cholangitis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 8 affected / 4821 at risk

Adverse event: Cholangitis acute
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 2 affected / 4821 at risk

Adverse event: Cholecystitis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 25 affected / 4821 at risk

Adverse event: Cholecystitis acute
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 17 affected / 4821 at risk

Adverse event: Cholecystitis chronic
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 7 affected / 4821 at risk

Adverse event: Cholelithiasis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 36 affected / 4821 at risk

Adverse event: Cholelithiasis migration
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 4821 at risk

Adverse event: Cholestasis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 2 affected / 4821 at risk

Adverse event: Chronic hepatic failure
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 4821 at risk

Adverse event: Cirrhosis alcoholic
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 4821 at risk

Adverse event: Cryptogenic cirrhosis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 4821 at risk

Adverse event: Gallbladder disorder
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 4821 at risk

Adverse event: Gallbladder rupture
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 2 affected / 4821 at risk

Adverse event: Haemobilia
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 4821 at risk

Adverse event: Hepatic cirrhosis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 10 affected / 4821 at risk

Adverse event: Hepatic cyst
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 11 affected / 4821 at risk

Adverse event: Hepatic failure
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 7 affected / 4821 at risk

Adverse event: Hepatic function abnormal
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 10 affected / 4821 at risk

Adverse event: Hepatic lesion
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 4821 at risk

Adverse event: Hepatic mass
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 4821 at risk

Adverse event: Hepatic steatosis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 20 affected / 4821 at risk

Adverse event: Hepatitis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 4821 at risk

Adverse event: Hepatitis acute
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 2 affected / 4821 at risk

Adverse event: Hepatobiliary disease
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 4821 at risk

Adverse event: Hepatocellular injury
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 3 affected / 4821 at risk

Adverse event: Hepatomegaly
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 2 affected / 4821 at risk

Adverse event: Hepatorenal syndrome
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 3 affected / 4821 at risk

Adverse event: Hepatosplenomegaly
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 4821 at risk

Adverse event: Jaundice
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 13 affected / 4821 at risk

Adverse event: Jaundice cholestatic
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 2 affected / 4821 at risk

Adverse event: Liver disorder
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 5 affected / 4821 at risk

Adverse event: Liver injury
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 4821 at risk

Adverse event: Metabolic dysfunction-associated liver disease
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 3 affected / 4821 at risk

Adverse event: Portal hypertension
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 3 affected / 4821 at risk

Adverse event: Portal vein thrombosis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 4821 at risk

Adverse event: Primary biliary cholangitis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 4821 at risk

Adverse event: Steatohepatitis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 4821 at risk

Adverse event: Anaphylactic reaction
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 4821 at risk

Adverse event: Anaphylactic shock
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 4821 at risk

Adverse event: Drug hypersensitivity
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 4821 at risk

Adverse event: Food allergy
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 4821 at risk

Adverse event: Sarcoidosis
Serious: yes
Organ System: Immune system disorders
Frequency: 2 affected / 4821 at risk

Adverse event: Abdominal sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 4821 at risk

Adverse event: Abdominal wall abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 4821 at risk

Adverse event: Abscess jaw
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 4821 at risk

Adverse event: Abscess limb
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 4821 at risk

Adverse event: Abscess neck
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 4821 at risk

Adverse event: Abscess oral
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 4821 at risk

Adverse event: Acinetobacter bacteraemia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 4821 at risk

Adverse event: Acute endocarditis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 4821 at risk

Adverse event: Amoebiasis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 4821 at risk

Adverse event: Anal abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 4821 at risk

Adverse event: Appendicitis
Serious: yes
Organ System: Infections and infestations
Frequency: 6 affected / 4821 at risk

Adverse event: Arthritis bacterial
Serious: yes
Organ System: Infections and infestations
Frequency: 9 affected / 4821 at risk

Adverse event: Arthritis infective
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 4821 at risk

Adverse event: Aspergillus infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 4821 at risk

Adverse event: Bacteraemia
Serious: yes
Organ System: Infections and infestations
Frequency: 13 affected / 4821 at risk

Adverse event: Bacterial disease carrier
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 4821 at risk

Adverse event: Bacterial infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 4821 at risk

Adverse event: Bacterial rhinitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 4821 at risk

Adverse event: Bacterial sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 4821 at risk

Adverse event: Beta haemolytic streptococcal infection
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 4821 at risk

Adverse event: Biliary sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 4821 at risk

Adverse event: Biliary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 4821 at risk

Adverse event: Bone abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 4821 at risk

Adverse event: Bronchiolitis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 4821 at risk

Adverse event: Bronchitis
Serious: yes
Organ System: Infections and infestations
Frequency: 73 affected / 4821 at risk

Adverse event: Bronchitis viral
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 4821 at risk

Adverse event: Campylobacter infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 4821 at risk

Adverse event: Cellulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 55 affected / 4821 at risk

Adverse event: Chest wall abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 4821 at risk

Adverse event: Cholangitis infective
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 4821 at risk

Adverse event: Chronic sinusitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 4821 at risk

Adverse event: Clostridium colitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 4821 at risk

Adverse event: Clostridium difficile colitis
Serious: yes
Organ System: Infections and infestations
Frequency: 9 affected / 4821 at risk

Adverse event: Clostridium difficile infection
Serious: yes
Organ System: Infections and infestations
Frequency: 5 affected / 4821 at risk

Adverse event: Colonic abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 4821 at risk

Adverse event: Complicated appendicitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 4821 at risk

Adverse event: Cystitis
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 4821 at risk

Adverse event: Cystitis bacterial
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 4821 at risk

Adverse event: Cystitis escherichia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 4821 at risk

Adverse event: Cytomegalovirus infection
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 4821 at risk

Adverse event: Dengue fever
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 4821 at risk

Adverse event: Device related infection
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 4821 at risk

Adverse event: Diabetic foot infection
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 4821 at risk

Adverse event: Diabetic gangrene
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 4821 at risk

Adverse event: Diarrhoea infectious
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 4821 at risk

Adverse event: Diverticulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 12 affected / 4821 at risk

Adverse event: Eczema infected
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 4821 at risk

Adverse event: Embolic pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 4821 at risk

Adverse event: Endocarditis
Serious: yes
Organ System: Infections and infestations
Frequency: 5 affected / 4821 at risk

Adverse event: Enteritis infectious
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 4821 at risk

Adverse event: Enterococcal bacteraemia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 4821 at risk

Adverse event: Enterococcal sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 4821 at risk

Adverse event: Epididymitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 4821 at risk

Adverse event: Epiglottitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 4821 at risk

Adverse event: Erysipelas
Serious: yes
Organ System: Infections and infestations
Frequency: 18 affected / 4821 at risk

Adverse event: Escherichia bacteraemia
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 4821 at risk

Adverse event: Escherichia sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 4821 at risk

Adverse event: Escherichia urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 4821 at risk

Adverse event: Gangrene
Serious: yes
Organ System: Infections and infestations
Frequency: 6 affected / 4821 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 37 affected / 4821 at risk

Adverse event: Gastroenteritis bacterial
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 4821 at risk

Adverse event: Gastroenteritis clostridial
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 4821 at risk

Adverse event: Gastroenteritis norovirus
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 4821 at risk

Adverse event: Gastroenteritis salmonella
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 4821 at risk

Adverse event: Gastroenteritis viral
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 4821 at risk

Adverse event: Gastrointestinal viral infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 4821 at risk

Adverse event: Genital herpes zoster
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 4821 at risk

Adverse event: Haematoma infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 4821 at risk

Adverse event: Helicobacter infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 4821 at risk

Adverse event: Hepatitis E
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 4821 at risk

Adverse event: Herpes zoster
Serious: yes
Organ System: Infections and infestations
Frequency: 6 affected / 4821 at risk

Adverse event: Hordeolum
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 4821 at risk

Adverse event: Human anaplasmosis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 4821 at risk

Adverse event: Infected skin ulcer
Serious: yes
Organ System: Infections and infestations
Frequency: 6 affected / 4821 at risk

Adverse event: Infection
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 4821 at risk

Adverse event: Infectious pleural effusion
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 4821 at risk

Adverse event: Infective exacerbation of bronchiectasis
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 4821 at risk

Adverse event: Infective exacerbation of chronic obstructive airways disease
Serious: yes
Organ System: Infections and infestations
Frequency: 5 affected / 4821 at risk

Adverse event: Influenza
Serious: yes
Organ System: Infections and infestations
Frequency: 27 affected / 4821 at risk

Adverse event: Intervertebral discitis
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 4821 at risk

Adverse event: Intestinal sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 4821 at risk

Adverse event: Intracranial infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 4821 at risk

Adverse event: Klebsiella sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 4821 at risk

Adverse event: Labyrinthitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 4821 at risk

Adverse event: Laryngitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 4821 at risk

Adverse event: Liver abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 4821 at risk

Adverse event: Localised infection
Serious: yes
Organ System: Infections and infestations
Frequency: 9 affected / 4821 at risk

Adverse event: Lower respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 23 affected / 4821 at risk

Adverse event: Lower respiratory tract infection viral
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 4821 at risk

Adverse event: Lung abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 4821 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 23 affected / 4821 at risk

Adverse event: Lymphangitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 4821 at risk

Adverse event: Mediastinitis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 4821 at risk

Adverse event: Medical device site infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 4821 at risk

Adverse event: Meningitis enterococcal
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 4821 at risk

Adverse event: Nasopharyngitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 4821 at risk

Adverse event: Necrotising fasciitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 4821 at risk

Adverse event: Nosocomial infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 4821 at risk

Adverse event: Oesophageal candidiasis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 4821 at risk

Adverse event: Ophthalmic herpes zoster
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 4821 at risk

Adverse event: Oral candidiasis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 4821 at risk

Adverse event: Oral herpes
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 4821 at risk

Adverse event: Orchitis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 4821 at risk

Adverse event: Osteomyelitis
Serious: yes
Organ System: Infections and infestations
Frequency: 10 affected / 4821 at risk

Adverse event: Otitis media
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 4821 at risk

Adverse event: Pelvic abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 4821 at risk

Adverse event: Periodontitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 4821 at risk

Adverse event: Peritonitis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 4821 at risk

Adverse event: Peritonitis bacterial
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 4821 at risk

Adverse event: Pharyngitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 4821 at risk

Adverse event: Pneumococcal sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 4821 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 340 affected / 4821 at risk

Adverse event: Pneumonia bacterial
Serious: yes
Organ System: Infections and infestations
Frequency: 9 affected / 4821 at risk

Adverse event: Pneumonia influenzal
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 4821 at risk

Adverse event: Pneumonia mycoplasmal
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 4821 at risk

Adverse event: Pneumonia pneumococcal
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 4821 at risk

Adverse event: Pneumonia respiratory syncytial viral
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 4821 at risk

Adverse event: Pneumonia streptococcal
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 4821 at risk

Adverse event: Pneumonia viral
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 4821 at risk

Adverse event: Post procedural infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 4821 at risk

Adverse event: Postoperative wound infection
Serious: yes
Organ System: Infections and infestations
Frequency: 6 affected / 4821 at risk

Adverse event: Pseudomembranous colitis
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 4821 at risk

Adverse event: Pulmonary sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 4821 at risk

Adverse event: Pulmonary tuberculosis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 4821 at risk

Adverse event: Pyelonephritis
Serious: yes
Organ System: Infections and infestations
Frequency: 6 affected / 4821 at risk

Adverse event: Pyelonephritis acute
Serious: yes
Organ System: Infections and infestations
Frequency: 7 affected / 4821 at risk

Adverse event: Pyelonephritis chronic
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 4821 at risk

Adverse event: Rectal abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 4821 at risk

Adverse event: Renal abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 4821 at risk

Adverse event: Respiratory moniliasis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 4821 at risk

Adverse event: Respiratory syncytial virus bronchitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 4821 at risk

Adverse event: Respiratory syncytial virus infection
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 4821 at risk

Adverse event: Respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 40 affected / 4821 at risk

Adverse event: Respiratory tract infection bacterial
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 4821 at risk

Adverse event: Respiratory tract infection viral
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 4821 at risk

Adverse event: Salmonellosis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 4821 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 71 affected / 4821 at risk

Adverse event: Septic encephalopathy
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 4821 at risk

Adverse event: Septic necrosis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 4821 at risk

Adverse event: Septic shock
Serious: yes
Organ System: Infections and infestations
Frequency: 37 affected / 4821 at risk

Adverse event: Severe acute respiratory syndrome
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 4821 at risk

Adverse event: Shunt infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 4821 at risk

Adverse event: Skin bacterial infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 4821 at risk

Adverse event: Skin infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 4821 at risk

Adverse event: Soft tissue infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 4821 at risk

Adverse event: Staphylococcal bacteraemia
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 4821 at risk

Adverse event: Staphylococcal infection
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 4821 at risk

Adverse event: Staphylococcal sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 4821 at risk

Adverse event: Streptococcal bacteraemia
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 4821 at risk

Adverse event: Streptococcal sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 4821 at risk

Adverse event: Syphilis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 4821 at risk

Adverse event: Tooth abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 4821 at risk

Adverse event: Tracheobronchitis
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 4821 at risk

Adverse event: Tuberculosis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 4821 at risk

Adverse event: Tuberculous pleurisy
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 4821 at risk

Adverse event: Tubo-ovarian abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 4821 at risk

Adverse event: Upper respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 11 affected / 4821 at risk

Adverse event: Urethritis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 4821 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 122 affected / 4821 at risk

Adverse event: Urosepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 25 affected / 4821 at risk

Adverse event: Vestibular neuronitis
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 4821 at risk

Adverse event: Viral infection
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 4821 at risk

Adverse event: Viral upper respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 4821 at risk

Adverse event: Wound abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 4821 at risk

Adverse event: Wound infection
Serious: yes
Organ System: Infections and infestations
Frequency: 5 affected / 4821 at risk

Adverse event: Abdominal injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 4821 at risk

Adverse event: Accident
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 4821 at risk

Adverse event: Accidental overdose
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 4821 at risk

Adverse event: Acetabulum fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 4821 at risk

Adverse event: Alcohol poisoning
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 4821 at risk

Adverse event: Anaemia postoperative
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 4821 at risk

Adverse event: Anastomotic leak
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 4821 at risk

Adverse event: Anastomotic ulcer
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 4821 at risk

Adverse event: Animal bite
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 4821 at risk

Adverse event: Ankle fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 11 affected / 4821 at risk

Adverse event: Vascular graft occlusion
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 4821 at risk

Adverse event: Arteriovenous fistula thrombosis
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 4821 at risk

Adverse event: Avulsion fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 4821 at risk

Adverse event: Bone contusion
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 4821 at risk

Adverse event: Brain herniation
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 4821 at risk

Adverse event: Carbon monoxide poisoning
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 4821 at risk

Adverse event: Cardiac function disturbance postoperative
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 4821 at risk

Adverse event: Cervical vertebral fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 4821 at risk

Adverse event: Chest injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 4821 at risk

Adverse event: Clavicle fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 4821 at risk

Adverse event: Comminuted fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 4821 at risk

Adverse event: Complications of transplanted kidney
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 4821 at risk

Adverse event: Concussion
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 4821 at risk

Adverse event: Contusion
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 7 affected / 4821 at risk

Adverse event: Coronary bypass stenosis
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 4821 at risk

Adverse event: Craniocerebral injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 7 affected / 4821 at risk

Adverse event: Cystitis radiation
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 4821 at risk

Adverse event: Extra dose administered
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 4821 at risk

Adverse event: Extradural haematoma
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 4821 at risk

Adverse event: Eye injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 4821 at risk

Adverse event: Craniofacial fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 4821 at risk

Adverse event: Fall
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 59 affected / 4821 at risk

Adverse event: Femoral neck fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 13 affected / 4821 at risk

Adverse event: Femur fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 31 affected / 4821 at risk

Adverse event: Foot fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 4821 at risk

Adverse event: Fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 4821 at risk

Adverse event: Fractured coccyx
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 4821 at risk

Adverse event: Gastrointestinal stoma complication
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 4821 at risk

Adverse event: Hand fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 4821 at risk

Adverse event: Head injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 11 affected / 4821 at risk

Adverse event: Hip fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 27 affected / 4821 at risk

Adverse event: Humerus fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 12 affected / 4821 at risk

Adverse event: Hypobarism
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 4821 at risk

Adverse event: Incision site haematoma
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 4821 at risk

Adverse event: Incisional hernia
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 4821 at risk

Adverse event: Injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 4821 at risk

Adverse event: Joint dislocation
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 5 affected / 4821 at risk

Adverse event: Ligament injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 4821 at risk

Adverse event: Ligament sprain
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 4821 at risk

Adverse event: Limb crushing injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 4821 at risk

Adverse event: Limb injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 5 affected / 4821 at risk

Adverse event: Lower limb fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 4821 at risk

Adverse event: Lumbar vertebral fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 5 affected / 4821 at risk

Adverse event: Meniscus injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 4821 at risk

Adverse event: Multiple injuries
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 4821 at risk

Adverse event: Muscle strain
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 4821 at risk

Adverse event: Nerve root injury cervical
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 4821 at risk

Adverse event: Overdose
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 6 affected / 4821 at risk

Adverse event: Patella fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 4821 at risk

Adverse event: Pelvic fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 4821 at risk

Adverse event: Periprosthetic fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 4821 at risk

Adverse event: Post procedural complication
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 4821 at risk

Adverse event: Post procedural haematoma
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 4821 at risk

Adverse event: Post procedural haemorrhage
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 4821 at risk

Adverse event: Post procedural myocardial infarction
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 4821 at risk

Adverse event: Traumatic pain
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 4821 at risk

Adverse event: Post procedural hypotension
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 4821 at risk

Adverse event: Postoperative respiratory failure
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 4821 at risk

Adverse event: Postoperative wound complication
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 4821 at risk

Adverse event: Procedural pneumothorax
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 4821 at risk

Adverse event: Procedural vomiting
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 4821 at risk

Adverse event: Pelvic fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 4821 at risk

Adverse event: Radiation proctitis
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 4821 at risk

Adverse event: Radius fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 8 affected / 4821 at risk

Adverse event: Respiratory fume inhalation disorder
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 4821 at risk

Adverse event: Rib fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 17 affected / 4821 at risk

Adverse event: Road traffic accident
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 4821 at risk

Adverse event: Scapula fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 4821 at risk

Adverse event: Sedation complication
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 4821 at risk

Adverse event: Skin abrasion
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 4821 at risk

Adverse event: Skin laceration
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 8 affected / 4821 at risk

Adverse event: Compression fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 11 affected / 4821 at risk

Adverse event: Spinal fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 8 affected / 4821 at risk

Adverse event: Splenic rupture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 4821 at risk

Adverse event: Stomal hernia
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 4821 at risk

Adverse event: Subdural haematoma
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 15 affected / 4821 at risk

Adverse event: Subdural haemorrhage
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 4821 at risk

Adverse event: Tendon rupture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 4821 at risk

Adverse event: Thoracic vertebral fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 4821 at risk

Adverse event: Tibia fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 4 affected / 4821 at risk

Adverse event: Toxicity to various agents
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 10 affected / 4821 at risk

Adverse event: Traumatic haematoma
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 4821 at risk

Adverse event: Traumatic haemothorax
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 4821 at risk

Adverse event: Traumatic intracranial haemorrhage
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 4821 at risk

Adverse event: Traumatic liver injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 4821 at risk

Adverse event: Ulna fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 4821 at risk

Adverse event: Upper limb fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 4 affected / 4821 at risk

Adverse event: Vascular graft occlusion
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 4821 at risk

Adverse event: Vascular pseudoaneurysm
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 4 affected / 4821 at risk

Adverse event: Vascular pseudoaneurysm ruptured
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 4821 at risk

Adverse event: Wound
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 4821 at risk

Adverse event: Wound complication
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 4821 at risk

Adverse event: Alanine aminotransferase increased
Serious: yes
Organ System: Investigations
Frequency: 4 affected / 4821 at risk

Adverse event: Anticoagulation drug level above therapeutic
Serious: yes
Organ System: Investigations
Frequency: 6 affected / 4821 at risk

Adverse event: Aspartate aminotransferase increased
Serious: yes
Organ System: Investigations
Frequency: 6 affected / 4821 at risk

Adverse event: Bleeding time abnormal
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 4821 at risk

Adverse event: Blood alkaline phosphatase increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 4821 at risk

Adverse event: Blood bilirubin increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 4821 at risk

Adverse event: Blood creatine phosphokinase increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 4821 at risk

Adverse event: Blood creatinine increased
Serious: yes
Organ System: Investigations
Frequency: 5 affected / 4821 at risk

Adverse event: Blood glucose abnormal
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 4821 at risk

Adverse event: Blood glucose decreased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 4821 at risk

Adverse event: Blood glucose fluctuation
Serious: yes
Organ System: Investigations
Frequency: 2 affected / 4821 at risk

Adverse event: Blood glucose increased
Serious: yes
Organ System: Investigations
Frequency: 3 affected / 4821 at risk

Adverse event: Blood osmolarity decreased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 4821 at risk

Adverse event: Blood pressure decreased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 4821 at risk

Adverse event: Blood pressure increased
Serious: yes
Organ System: Investigations
Frequency: 3 affected / 4821 at risk

Adverse event: Blood sodium decreased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 4821 at risk

Adverse event: Blood urea increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 4821 at risk

Adverse event: Brain natriuretic peptide increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 4821 at risk

Adverse event: Cardiac output decreased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 4821 at risk

Adverse event: Coagulation time prolonged
Serious: yes
Organ System: Investigations
Frequency: 2 affected / 4821 at risk

Adverse event: Electrocardiogram QT prolonged
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 4821 at risk

Adverse event: Electrocardiogram repolarisation abnormality
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 4821 at risk

Adverse event: General physical condition abnormal
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 4821 at risk

Adverse event: Glomerular filtration rate decreased
Serious: yes
Organ System: Investigations
Frequency: 3 affected / 4821 at risk

Adverse event: Haemoglobin decreased
Serious: yes
Organ System: Investigations
Frequency: 3 affected / 4821 at risk

Adverse event: Heart rate decreased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 4821 at risk

Adverse event: Heart rate irregular
Serious: yes
Organ System: Investigations
Frequency: 2 affected / 4821 at risk

Adverse event: Hepatic enzyme increased
Serious: yes
Organ System: Investigations
Frequency: 13 affected / 4821 at risk

Adverse event: Inflammatory marker increased
Serious: yes
Organ System: Investigations
Frequency: 2 affected / 4821 at risk

Adverse event: Influenza virus test positive
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 4821 at risk

Adverse event: International normalised ratio increased
Serious: yes
Organ System: Investigations
Frequency: 5 affected / 4821 at risk

Adverse event: Lipase increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 4821 at risk

Adverse event: Myocardial necrosis marker increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 4821 at risk

Adverse event: Platelet count decreased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 4821 at risk

Adverse event: Precancerous cells present
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 4821 at risk

Adverse event: Prostatic specific antigen increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 4821 at risk

Adverse event: Pulse absent
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 4821 at risk

Adverse event: Respiratory rate increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 4821 at risk

Adverse event: Transaminases increased
Serious: yes
Organ System: Investigations
Frequency: 3 affected / 4821 at risk

Adverse event: Troponin I increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 4821 at risk

Adverse event: Troponin T increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 4821 at risk

Adverse event: Troponin increased
Serious: yes
Organ System: Investigations
Frequency: 4 affected / 4821 at risk

Adverse event: Urine output decreased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 4821 at risk

Adverse event: Ventilation/perfusion scan abnormal
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 4821 at risk

Adverse event: Visual field tests abnormal
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 4821 at risk

Adverse event: Weight decreased
Serious: yes
Organ System: Investigations
Frequency: 2 affected / 4821 at risk

Adverse event: Cachexia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 4821 at risk

Adverse event: Metabolic syndrome
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 4821 at risk

Adverse event: Decreased appetite
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 4821 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 44 affected / 4821 at risk

Adverse event: Diabetes mellitus
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 17 affected / 4821 at risk

Adverse event: Diabetes mellitus inadequate control
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 7 affected / 4821 at risk

Adverse event: Diabetic complication
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 4821 at risk

Adverse event: Diabetic ketoacidosis
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 4821 at risk

Adverse event: Diabetic metabolic decompensation
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 12 affected / 4821 at risk

Adverse event: Electrolyte imbalance
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 4821 at risk

Adverse event: Failure to thrive
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 4821 at risk

Adverse event: Hypervolaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 16 affected / 4821 at risk

Adverse event: Fluid retention
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 4821 at risk

Adverse event: Folate deficiency
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 4821 at risk

Adverse event: Gout
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 16 affected / 4821 at risk

Adverse event: Haemochromatosis
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 4821 at risk

Adverse event: Hyperammonaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 4821 at risk

Adverse event: Hypercalcaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 4821 at risk

Adverse event: Hypercholesterolaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 4821 at risk

Adverse event: Hyperglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 26 affected / 4821 at risk

Adverse event: Hyperglycaemic hyperosmolar nonketotic syndrome
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 4821 at risk

Adverse event: Hyperkalaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 61 affected / 4821 at risk

Adverse event: Hypernatraemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 4821 at risk

Adverse event: Hyperuricaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 4821 at risk

Adverse event: Hypoalbuminaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 4821 at risk

Adverse event: Hypocalcaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 4821 at risk

Adverse event: Hypoglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 26 affected / 4821 at risk

Adverse event: Hypokalaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 22 affected / 4821 at risk

Adverse event: Hypomagnesaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 4821 at risk

Adverse event: Hyponatraemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 34 affected / 4821 at risk

Adverse event: Hypoosmolar state
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 4821 at risk

Adverse event: Hypophosphataemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 4821 at risk

Adverse event: Hypovolaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 4821 at risk

Adverse event: Iron deficiency
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 4821 at risk

Adverse event: Ketoacidosis
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 4821 at risk

Adverse event: Lactic acidosis
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 4821 at risk

Adverse event: Malnutrition
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 4821 at risk

Adverse event: Marasmus
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 4821 at risk

Adverse event: Metabolic acidosis
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 6 affected / 4821 at risk

Adverse event: Type 2 diabetes mellitus
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 13 affected / 4821 at risk

Adverse event: Foot deformity
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 4821 at risk

Adverse event: Arthralgia
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 11 affected / 4821 at risk

Adverse event: Arthritis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 8 affected / 4821 at risk

Adverse event: Back pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 22 affected / 4821 at risk

Adverse event: Bursitis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 4821 at risk

Adverse event: CREST syndrome
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 4821 at risk

Adverse event: Chest wall haematoma
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 4821 at risk

Adverse event: Chondrocalcinosis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 4821 at risk

Adverse event: Costochondritis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 4821 at risk

Adverse event: Dactylitis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 4821 at risk

Adverse event: Dupuytren's contracture
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 4821 at risk

Adverse event: Exostosis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 4821 at risk

Adverse event: Fibromyalgia
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 4821 at risk

Adverse event: Flank pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 4821 at risk

Adverse event: Foot deformity
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 4821 at risk

Adverse event: Gouty arthritis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 4821 at risk

Adverse event: Haemarthrosis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 4821 at risk

Adverse event: Intervertebral disc degeneration
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 4821 at risk

Adverse event: Intervertebral disc disorder
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 4821 at risk

Adverse event: Intervertebral disc protrusion
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 14 affected / 4821 at risk

Adverse event: Joint effusion
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 4821 at risk

Adverse event: Kyphosis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 4821 at risk

Adverse event: Lumbar spinal stenosis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 9 affected / 4821 at risk

Adverse event: Mobility decreased
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 4821 at risk

Adverse event: Muscle spasms
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 4821 at risk

Adverse event: Muscular weakness
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 7 affected / 4821 at risk

Adverse event: Musculoskeletal chest pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 4821 at risk

Adverse event: Musculoskeletal pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 4821 at risk

Adverse event: Myalgia
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 4821 at risk

Adverse event: Myositis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 4821 at risk

Adverse event: Extraskeletal ossification
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 4821 at risk

Adverse event: Neck pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 4821 at risk

Adverse event: Osteitis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 4821 at risk

Adverse event: Osteitis deformans
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 4821 at risk

Adverse event: Osteoarthritis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 59 affected / 4821 at risk

Adverse event: Osteochondrosis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 4821 at risk

Adverse event: Osteonecrosis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 4821 at risk

Adverse event: Osteoporosis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 4821 at risk

Adverse event: Pain in extremity
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 8 affected / 4821 at risk

Adverse event: Pathological fracture
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 4821 at risk

Adverse event: Periarthritis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 4821 at risk

Adverse event: Periostitis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 4821 at risk

Adverse event: Polymyalgia rheumatica
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 4821 at risk

Adverse event: Pseudarthrosis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 4821 at risk

Adverse event: Rheumatoid arthritis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 4821 at risk

Adverse event: Rotator cuff syndrome
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 9 affected / 4821 at risk

Adverse event: Scleroderma
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 4821 at risk

Adverse event: Spinal osteoarthritis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 10 affected / 4821 at risk

Adverse event: Spinal pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 9 affected / 4821 at risk

Adverse event: Spinal stenosis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 11 affected / 4821 at risk

Adverse event: Spondylolisthesis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 4821 at risk

Adverse event: Synovial cyst
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 4821 at risk

Adverse event: Tenosynovitis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 4821 at risk

Adverse event: Acute lymphocytic leukaemia
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 4821 at risk

Adverse event: Acute myeloid leukaemia
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 4821 at risk

Adverse event: Acute promyelocytic leukaemia
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 4821 at risk

Adverse event: Adenocarcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 3 affected / 4821 at risk

Adverse event: Adenocarcinoma gastric
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 4 affected / 4821 at risk

Adverse event: Adenocarcinoma of colon
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 7 affected / 4821 at risk

Adverse event: Anal cancer stage 0
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 4821 at risk

Adverse event: B-cell lymphoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 4821 at risk

Adverse event: Basal cell carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 22 affected / 4821 at risk

Adverse event: Benign gastrointestinal neoplasm
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 4821 at risk

Adverse event: Benign lung neoplasm
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 4821 at risk

Adverse event: Benign pancreatic neoplasm
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 4821 at risk

Adverse event: Bile duct cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 4 affected / 4821 at risk

Adverse event: Bladder cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 7 affected / 4821 at risk

Adverse event: Bladder neoplasm
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 4 affected / 4821 at risk

Adverse event: Bladder transitional cell carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 4821 at risk

Adverse event: Bone cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 4821 at risk

Adverse event: Bowen's disease
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 4821 at risk

Adverse event: Brain neoplasm
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 4821 at risk

Adverse event: Brain neoplasm malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 4821 at risk

Adverse event: Breast angiosarcoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 4821 at risk

Adverse event: Breast cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 14 affected / 4821 at risk

Adverse event: Breast neoplasm
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 4821 at risk

Adverse event: Bronchial carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 5 affected / 4821 at risk

Adverse event: Carcinoma in situ of skin
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 4821 at risk

Adverse event: Central nervous system lymphoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 4821 at risk

Adverse event: Cholangiocarcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 4821 at risk

Adverse event: Chronic lymphocytic leukaemia
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 4821 at risk

Adverse event: Chronic myeloid leukaemia
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 4821 at risk

Adverse event: Clear cell renal cell carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 4821 at risk

Adverse event: Colorectal adenoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 4821 at risk

Adverse event: Colon cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 9 affected / 4821 at risk

Adverse event: Colon cancer metastatic
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 4821 at risk

Adverse event: Colon neoplasm
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 4821 at risk

Adverse event: Colorectal cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 4821 at risk

Adverse event: Diffuse large B-cell lymphoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 4821 at risk

Adverse event: Endometrial adenocarcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 3 affected / 4821 at risk

Adverse event: Endometrial cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 3 affected / 4821 at risk

Adverse event: Fibroma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 4821 at risk

Adverse event: Gallbladder cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 4821 at risk

Adverse event: Gallbladder neoplasm
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 4821 at risk

Adverse event: Gastric cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 7 affected / 4821 at risk

Adverse event: Gastric neoplasm
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 4821 at risk

Adverse event: Gastrointestinal carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 4821 at risk

Adverse event: Gastrointestinal neoplasm
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 4821 at risk

Adverse event: Gastrointestinal stromal tumour
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 4821 at risk

Adverse event: Gastrointestinal tract adenoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 4821 at risk

Adverse event: Glioblastoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 4821 at risk

Adverse event: Haemangioma of liver
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 4821 at risk

Adverse event: Hepatic cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 3 affected / 4821 at risk

Adverse event: Hepatic cancer metastatic
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 4821 at risk

Adverse event: Hepatic neoplasm
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 4821 at risk

Adverse event: Hepatocellular carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 7 affected / 4821 at risk

Adverse event: Hormone-refractory prostate cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 4821 at risk

Adverse event: Intestinal adenocarcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 4821 at risk

Adverse event: Invasive breast carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 4821 at risk

Adverse event: Invasive lobular breast carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 4821 at risk

Adverse event: Invasive papillary breast carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 4821 at risk

Adverse event: Kaposi's sarcoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 4821 at risk

Adverse event: Laryngeal cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 4821 at risk

Adverse event: Laryngeal squamous cell carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 4821 at risk

Adverse event: Leiomyoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 4821 at risk

Adverse event: Lip and/or oral cavity cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 4821 at risk

Adverse event: Lip squamous cell carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 4821 at risk

Adverse event: Lipoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 5 affected / 4821 at risk

Adverse event: Lung adenocarcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 4 affected / 4821 at risk

Adverse event: Lung cancer metastatic
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 4821 at risk

Adverse event: Lung carcinoma cell type unspecified stage II
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 4821 at risk

Adverse event: Lung neoplasm
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 4821 at risk

Adverse event: Lung neoplasm malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 18 affected / 4821 at risk

Adverse event: Lymphoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 3 affected / 4821 at risk

Adverse event: Lymphoproliferative disorder
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 4821 at risk

Adverse event: Malignant mediastinal neoplasm
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 4821 at risk

Adverse event: Malignant melanoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 13 affected / 4821 at risk

Adverse event: Malignant neoplasm of unknown primary site
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 4821 at risk

Adverse event: Malignant pleural effusion
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 4821 at risk

Adverse event: Mantle cell lymphoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 4821 at risk

Adverse event: Mediastinum neoplasm
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 4821 at risk

Adverse event: Meningioma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 4821 at risk

Adverse event: Mesothelioma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 4821 at risk

Adverse event: Metastases to bone
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 3 affected / 4821 at risk

Adverse event: Metastases to central nervous system
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 4821 at risk

Adverse event: Metastases to liver
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 7 affected / 4821 at risk

Adverse event: Metastases to lung
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 3 affected / 4821 at risk

Adverse event: Metastases to lymph nodes
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 4821 at risk

Adverse event: Metastasis
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 4821 at risk

Adverse event: Metastatic carcinoma of the bladder
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 4821 at risk

Adverse event: Metastatic lymphoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 4821 at risk

Adverse event: Metastatic malignant melanoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 4821 at risk

Adverse event: Metastatic squamous cell carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 4821 at risk

Adverse event: Monoclonal gammopathy
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 3 affected / 4821 at risk

Adverse event: Myelodysplastic syndrome
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 4821 at risk

Adverse event: Myeloid leukaemia
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 4821 at risk

Adverse event: Myeloproliferative neoplasm
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 4821 at risk

Adverse event: Neoplasm malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 3 affected / 4821 at risk

Adverse event: Neoplasm skin
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 4821 at risk

Adverse event: Non-Hodgkin's lymphoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 4821 at risk

Adverse event: Non-small cell lung cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 4821 at risk

Adverse event: Oesophageal adenocarcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 4821 at risk

Adverse event: Oesophageal carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 4821 at risk

Adverse event: Oncologic complication
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 4821 at risk

Adverse event: Oral haemangioma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 4821 at risk

Adverse event: Oropharyngeal cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 4821 at risk

Adverse event: Oropharyngeal squamous cell carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 4821 at risk

Adverse event: Ovarian cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 4821 at risk

Adverse event: Ovarian epithelial cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 4821 at risk

Adverse event: Pancreatic carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 6 affected / 4821 at risk

Adverse event: Pancreatic neoplasm
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 4821 at risk

Adverse event: Papillary thyroid cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 4821 at risk

Adverse event: Papilloma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 4821 at risk

Adverse event: Parathyroid tumour benign
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 4821 at risk

Adverse event: Penile cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 4821 at risk

Adverse event: Plasma cell myeloma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 3 affected / 4821 at risk

Adverse event: Prostate cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 15 affected / 4821 at risk

Adverse event: Prostate cancer metastatic
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 4821 at risk

Adverse event: Prostatic adenoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 4821 at risk

Adverse event: Rectal adenocarcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 5 affected / 4821 at risk

Adverse event: Rectal cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 10 affected / 4821 at risk

Adverse event: Rectal cancer metastatic
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 4821 at risk

Adverse event: Rectal cancer recurrent
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 4821 at risk

Adverse event: Rectal neoplasm
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 4821 at risk

Adverse event: Renal cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 4821 at risk

Adverse event: Renal cell carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 3 affected / 4821 at risk

Adverse event: Renal neoplasm
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 4821 at risk

Adverse event: Sarcoma uterus
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 4821 at risk

Adverse event: Schwannoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 4821 at risk

Adverse event: Seborrhoeic keratosis
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 4821 at risk

Adverse event: Skin cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 4821 at risk

Adverse event: Skin neoplasm bleeding
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 4821 at risk

Adverse event: Small cell lung cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 4 affected / 4821 at risk

Adverse event: Squamous cell carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 14 affected / 4821 at risk

Adverse event: Squamous cell carcinoma of lung
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 5 affected / 4821 at risk

Adverse event: Transitional cell carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 4 affected / 4821 at risk

Adverse event: Transitional cell carcinoma recurrent
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 4821 at risk

Adverse event: Tumour compression
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 4821 at risk

Adverse event: Tumour embolism
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 4821 at risk

Adverse event: Tumour haemorrhage
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 4821 at risk

Adverse event: Ureteral neoplasm
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 4821 at risk

Adverse event: Ureteric cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 4821 at risk

Adverse event: Uterine cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 4821 at risk

Adverse event: Uterine leiomyoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 4821 at risk

Adverse event: Vaginal adenocarcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 4821 at risk

Adverse event: Vaginal cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 4821 at risk

Adverse event: Waldenstrom's macroglobulinaemia
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 4821 at risk

Adverse event: Altered state of consciousness
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 4821 at risk

Adverse event: Amyotrophic lateral sclerosis
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 4821 at risk

Adverse event: Aphasia
Serious: yes
Organ System: Nervous system disorders
Frequency: 5 affected / 4821 at risk

Adverse event: Ataxia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 4821 at risk

Adverse event: Brain hypoxia
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 4821 at risk

Adverse event: Brain injury
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 4821 at risk

Adverse event: Brain oedema
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 4821 at risk

Adverse event: Brain stem stroke
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 4821 at risk

Adverse event: Carotid artery aneurysm
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 4821 at risk

Adverse event: Carotid artery disease
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 4821 at risk

Adverse event: Carotid artery stenosis
Serious: yes
Organ System: Nervous system disorders
Frequency: 16 affected / 4821 at risk

Adverse event: Carpal tunnel syndrome
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 4821 at risk

Adverse event: Central nervous system lesion
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 4821 at risk

Adverse event: Cerebellar haematoma
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 4821 at risk

Adverse event: Cerebellar infarction
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 4821 at risk

Adverse event: Cerebellar ischaemia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 4821 at risk

Adverse event: Cerebral arteriosclerosis
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 4821 at risk

Adverse event: Cerebral artery embolism
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 4821 at risk

Adverse event: Cerebral cyst
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 4821 at risk

Adverse event: Cerebral haemorrhage
Serious: yes
Organ System: Nervous system disorders
Frequency: 11 affected / 4821 at risk

Adverse event: Cerebral infarction
Serious: yes
Organ System: Nervous system disorders
Frequency: 35 affected / 4821 at risk

Adverse event: Cerebral ischaemia
Serious: yes
Organ System: Nervous system disorders
Frequency: 6 affected / 4821 at risk

Adverse event: Cerebral thrombosis
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 4821 at risk

Adverse event: Cerebrospinal fluid leakage
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 4821 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Nervous system disorders
Frequency: 81 affected / 4821 at risk

Adverse event: Cerebrovascular disorder
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 4821 at risk

Adverse event: Cerebrovascular insufficiency
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 4821 at risk

Adverse event: Cervical radiculopathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 4821 at risk

Adverse event: Cervicobrachial syndrome
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 4821 at risk

Adverse event: Cognitive disorder
Serious: yes
Organ System: Nervous system disorders
Frequency: 9 affected / 4821 at risk

Adverse event: Coma
Serious: yes
Organ System: Nervous system disorders
Frequency: 5 affected / 4821 at risk

Adverse event: Dementia
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 4821 at risk

Adverse event: Dementia Alzheimer's type
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 4821 at risk

Adverse event: Dementia with Lewy bodies
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 4821 at risk

Adverse event: Depressed level of consciousness
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 4821 at risk

Adverse event: Diabetic ketoacidotic hyperglycaemic coma
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 4821 at risk

Adverse event: Diabetic neuropathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 4821 at risk

Adverse event: Dizziness
Serious: yes
Organ System: Nervous system disorders
Frequency: 28 affected / 4821 at risk

Adverse event: Dysarthria
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 4821 at risk

Adverse event: Embolic stroke
Serious: yes
Organ System: Nervous system disorders
Frequency: 9 affected / 4821 at risk

Adverse event: Encephalopathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 7 affected / 4821 at risk

Adverse event: Epilepsy
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 4821 at risk

Adverse event: Facial paralysis
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 4821 at risk

Adverse event: Generalised tonic-clonic seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 4821 at risk

Adverse event: Guillain-Barre syndrome
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 4821 at risk

Adverse event: Haemorrhage intracranial
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 4821 at risk

Adverse event: Haemorrhagic cerebral infarction
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 4821 at risk

Adverse event: Haemorrhagic stroke
Serious: yes
Organ System: Nervous system disorders
Frequency: 6 affected / 4821 at risk

Adverse event: Haemorrhagic transformation stroke
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 4821 at risk

Adverse event: Headache
Serious: yes
Organ System: Nervous system disorders
Frequency: 13 affected / 4821 at risk

Adverse event: Hemiparesis
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 4821 at risk

Adverse event: Hemiplegia
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 4821 at risk

Adverse event: Hepatic encephalopathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 6 affected / 4821 at risk

Adverse event: Hydrocephalus
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 4821 at risk

Adverse event: Hypoaesthesia
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 4821 at risk

Adverse event: Hypoglycaemic coma
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 4821 at risk

Adverse event: Hypoxic-ischaemic encephalopathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 4821 at risk

Adverse event: IIIrd nerve paralysis
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 4821 at risk

Adverse event: Intracranial aneurysm
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 4821 at risk

Adverse event: Intracranial haematoma
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 4821 at risk

Adverse event: Intracranial pressure increased
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 4821 at risk

Adverse event: Ischaemic cerebral infarction
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 4821 at risk

Adverse event: Ischaemic stroke
Serious: yes
Organ System: Nervous system disorders
Frequency: 61 affected / 4821 at risk

Adverse event: Lacunar infarction
Serious: yes
Organ System: Nervous system disorders
Frequency: 6 affected / 4821 at risk

Adverse event: Lacunar stroke
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 4821 at risk

Adverse event: Lethargy
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 4821 at risk

Adverse event: Loss of consciousness
Serious: yes
Organ System: Nervous system disorders
Frequency: 6 affected / 4821 at risk

Adverse event: Lumbar radiculopathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 4821 at risk

Adverse event: Lumbosacral radiculopathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 4821 at risk

Adverse event: Metabolic encephalopathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 9 affected / 4821 at risk

Adverse event: Migraine
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 4821 at risk

Adverse event: Mixed dementia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 4821 at risk

Adverse event: Motor dysfunction
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 4821 at risk

Adverse event: Movement disorder
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 4821 at risk

Adverse event: Multiple system atrophy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 4821 at risk

Adverse event: Myasthenia gravis
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 4821 at risk

Adverse event: Myasthenic syndrome
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 4821 at risk

Adverse event: Myelopathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 4821 at risk

Adverse event: Myoclonus
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 4821 at risk

Adverse event: Nervous system disorder
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 4821 at risk

Adverse event: Neuralgia
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 4821 at risk

Adverse event: Neuropathy peripheral
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 4821 at risk

Adverse event: Normal pressure hydrocephalus
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 4821 at risk

Adverse event: Parkinson's disease
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 4821 at risk

Adverse event: Parkinsonism
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 4821 at risk

Adverse event: Peripheral sensorimotor neuropathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 4821 at risk

Adverse event: Polyneuropathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 4821 at risk

Adverse event: Post herpetic neuralgia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 4821 at risk

Adverse event: Post stroke epilepsy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 4821 at risk

Adverse event: Posterior reversible encephalopathy syndrome
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 4821 at risk

Adverse event: Presyncope
Serious: yes
Organ System: Nervous system disorders
Frequency: 6 affected / 4821 at risk

Adverse event: Pseudoradicular syndrome
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 4821 at risk

Adverse event: Radiculopathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 4 affected / 4821 at risk

Adverse event: Resting tremor
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 4821 at risk

Adverse event: Sciatica
Serious: yes
Organ System: Nervous system disorders
Frequency: 8 affected / 4821 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 8 affected / 4821 at risk

Adverse event: Sensory disturbance
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 4821 at risk

Adverse event: Somnolence
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 4821 at risk

Adverse event: Speech disorder
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 4821 at risk

Adverse event: Spinal cord compression
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 4821 at risk

Adverse event: Spinal cord disorder
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 4821 at risk

Adverse event: Spondylitic myelopathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 4821 at risk

Adverse event: Status epilepticus
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 4821 at risk

Adverse event: Stroke in evolution
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 4821 at risk

Adverse event: Subarachnoid haemorrhage
Serious: yes
Organ System: Nervous system disorders
Frequency: 7 affected / 4821 at risk

Adverse event: Syncope
Serious: yes
Organ System: Nervous system disorders
Frequency: 98 affected / 4821 at risk

Adverse event: Thalamus haemorrhage
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 4821 at risk

Adverse event: Thrombotic cerebral infarction
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 4821 at risk

Adverse event: Thrombotic stroke
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 4821 at risk

Adverse event: Toxic encephalopathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 4821 at risk

Adverse event: Transient ischaemic attack
Serious: yes
Organ System: Nervous system disorders
Frequency: 60 affected / 4821 at risk

Adverse event: Tremor
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 4821 at risk

Adverse event: Trigeminal neuralgia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 4821 at risk

Adverse event: Unresponsive to stimuli
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 4821 at risk

Adverse event: Uraemic encephalopathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 4821 at risk

Adverse event: VIth nerve paresis
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 4821 at risk

Adverse event: Vascular dementia
Serious: yes
Organ System: Nervous system disorders
Frequency: 4 affected / 4821 at risk

Adverse event: Vascular parkinsonism
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 4821 at risk

Adverse event: Vertebrobasilar insufficiency
Serious: yes
Organ System: Nervous system disorders
Frequency: 6 affected / 4821 at risk

Adverse event: Vertigo CNS origin
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 4821 at risk

Adverse event: Device power source issue
Serious: yes
Organ System: Product Issues
Frequency: 3 affected / 4821 at risk

Adverse event: Device breakage
Serious: yes
Organ System: Product Issues
Frequency: 1 affected / 4821 at risk

Adverse event: Device physical property issue
Serious: yes
Organ System: Product Issues
Frequency: 1 affected / 4821 at risk

Adverse event: Device defective
Serious: yes
Organ System: Product Issues
Frequency: 2 affected / 4821 at risk

Adverse event: Device dislocation
Serious: yes
Organ System: Product Issues
Frequency: 4 affected / 4821 at risk

Adverse event: Device failure
Serious: yes
Organ System: Product Issues
Frequency: 1 affected / 4821 at risk

Adverse event: Device leakage
Serious: yes
Organ System: Product Issues
Frequency: 1 affected / 4821 at risk

Adverse event: Device loosening
Serious: yes
Organ System: Product Issues
Frequency: 1 affected / 4821 at risk

Adverse event: Device malfunction
Serious: yes
Organ System: Product Issues
Frequency: 2 affected / 4821 at risk

Adverse event: Device occlusion
Serious: yes
Organ System: Product Issues
Frequency: 1 affected / 4821 at risk

Adverse event: Lead dislodgement
Serious: yes
Organ System: Product Issues
Frequency: 1 affected / 4821 at risk

Adverse event: Acute stress disorder
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 4821 at risk

Adverse event: Adjustment disorder
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 4821 at risk

Adverse event: Adjustment disorder with mixed anxiety and depressed mood
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 4821 at risk

Adverse event: Agitation
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 4821 at risk

Adverse event: Alcoholism
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 4821 at risk

Adverse event: Anxiety
Serious: yes
Organ System: Psychiatric disorders
Frequency: 3 affected / 4821 at risk

Adverse event: Anxiety disorder
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 4821 at risk

Adverse event: Behaviour disorder
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 4821 at risk

Adverse event: Completed suicide
Serious: yes
Organ System: Psychiatric disorders
Frequency: 6 affected / 4821 at risk

Adverse event: Confusional state
Serious: yes
Organ System: Psychiatric disorders
Frequency: 13 affected / 4821 at risk

Adverse event: Delirium
Serious: yes
Organ System: Psychiatric disorders
Frequency: 18 affected / 4821 at risk

Adverse event: Delirium febrile
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 4821 at risk

Adverse event: Delusion
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 4821 at risk

Adverse event: Depressed mood
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 4821 at risk

Adverse event: Depression
Serious: yes
Organ System: Psychiatric disorders
Frequency: 13 affected / 4821 at risk

Adverse event: Disorientation
Serious: yes
Organ System: Psychiatric disorders
Frequency: 2 affected / 4821 at risk

Adverse event: Hallucination
Serious: yes
Organ System: Psychiatric disorders
Frequency: 3 affected / 4821 at risk

Adverse event: Major depression
Serious: yes
Organ System: Psychiatric disorders
Frequency: 3 affected / 4821 at risk

Adverse event: Mental disorder
Serious: yes
Organ System: Psychiatric disorders
Frequency: 2 affected / 4821 at risk

Adverse event: Mental disorder due to a general medical condition
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 4821 at risk

Adverse event: Mental status changes
Serious: yes
Organ System: Psychiatric disorders
Frequency: 8 affected / 4821 at risk

Adverse event: Organic brain syndrome
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 4821 at risk

Adverse event: Paranoia
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 4821 at risk

Adverse event: Personality disorder
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 4821 at risk

Adverse event: Somatic symptom disorder
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 4821 at risk

Adverse event: Suicidal ideation
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 4821 at risk

Adverse event: Suicide attempt
Serious: yes
Organ System: Psychiatric disorders
Frequency: 2 affected / 4821 at risk

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 200 affected / 4821 at risk

Adverse event: Anuria
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 4821 at risk

Adverse event: Azotaemia
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 6 affected / 4821 at risk

Adverse event: Bladder diverticulum
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 4821 at risk

Adverse event: Bladder neck obstruction
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 4821 at risk

Adverse event: Cystocele
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 4821 at risk

Adverse event: Calculus bladder
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 4821 at risk

Adverse event: Calculus urethral
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 4821 at risk

Adverse event: Calculus urinary
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 4821 at risk

Adverse event: Chronic kidney disease
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 27 affected / 4821 at risk

Adverse event: Dysuria
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 4821 at risk

Adverse event: End stage renal disease
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 6 affected / 4821 at risk

Adverse event: Glomerulonephritis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 4821 at risk

Adverse event: Glomerulonephropathy
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 4821 at risk

Adverse event: Haematuria
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 13 affected / 4821 at risk

Adverse event: Haemorrhage urinary tract
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 4821 at risk

Adverse event: Hydronephrosis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 5 affected / 4821 at risk

Adverse event: Nephrolithiasis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 8 affected / 4821 at risk

Adverse event: Nephropathy toxic
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 3 affected / 4821 at risk

Adverse event: Nephrotic syndrome
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 4821 at risk

Adverse event: Oliguria
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 4821 at risk

Adverse event: Prerenal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 4 affected / 4821 at risk

Adverse event: Proteinuria
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 4821 at risk

Adverse event: Renal artery stenosis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 4821 at risk

Adverse event: Renal colic
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 4821 at risk

Adverse event: Renal cyst
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 4821 at risk

Adverse event: Renal disorder
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 4821 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 60 affected / 4821 at risk

Adverse event: Renal impairment
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 72 affected / 4821 at risk

Adverse event: Renal infarct
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 3 affected / 4821 at risk