Study: NCT01794793

Adverse event: Cholelithiasis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 9 affected / 337 at risk

Adverse event: Cholecystitis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 5 affected / 337 at risk

Adverse event: COVID-19
Serious: yes
Organ System: Infections and infestations
Frequency: 8 affected / 337 at risk

Adverse event: Cellulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 337 at risk

Adverse event: Febrile neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 337 at risk

Adverse event: Acute myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 337 at risk

Adverse event: Cardiac failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 337 at risk

Adverse event: Coronary artery disease
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 337 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 337 at risk

Adverse event: Angina pectoris
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 337 at risk

Adverse event: Arrhythmia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 337 at risk

Adverse event: Cardiorespiratory arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 337 at risk

Adverse event: Myocardial ischaemia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 337 at risk

Adverse event: Syringomyelia
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 337 at risk

Adverse event: Adrenal insufficiency
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 337 at risk

Adverse event: Hyperadrenocorticism
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 337 at risk

Adverse event: Cataract
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 337 at risk

Adverse event: Abdominal adhesion
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 337 at risk

Adverse event: Abdominal fat apron
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 337 at risk

Adverse event: Anal fistula
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 337 at risk

Adverse event: Enteritis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 337 at risk

Adverse event: Gastrointestinal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 337 at risk

Adverse event: Large Intestin Polyp
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 337 at risk

Adverse event: Pancreatitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 337 at risk

Adverse event: Pancreatitis acute
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 337 at risk

Adverse event: Small intestinal obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 337 at risk

Adverse event: Stasis syndrome
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 337 at risk

Adverse event: Umbelical hernia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 337 at risk

Adverse event: Asthenia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 337 at risk

Adverse event: General physical health deterioration
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 337 at risk

Adverse event: Multiple organ dysfunction syndrome
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 337 at risk

Adverse event: Non-cardiac chest pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 337 at risk

Adverse event: Oedema peripheral
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 337 at risk

Adverse event: Cholangitis chronic
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 337 at risk

Adverse event: Cholecystitis acute
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 337 at risk

Adverse event: Cholecystitis chronic
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 337 at risk

Adverse event: Hydrocholecystitis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 337 at risk

Adverse event: Hyperbilirubinaemia
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 337 at risk

Adverse event: Appendicitis
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 337 at risk

Adverse event: COVID-19 pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 337 at risk

Adverse event: Septic shock
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 337 at risk

Adverse event: Abscess jaw
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 337 at risk

Adverse event: Acute sinusitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 337 at risk

Adverse event: Coronavirus infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 337 at risk

Adverse event: Diarrhoea infectious
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 337 at risk

Adverse event: Endocarditis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 337 at risk

Adverse event: Erysipelas
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 337 at risk

Adverse event: Furuncle
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 337 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 337 at risk

Adverse event: Infected dermal cyst
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 337 at risk

Adverse event: Influenza
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 337 at risk

Adverse event: Meningitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 337 at risk

Adverse event: Peritonitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 337 at risk

Adverse event: Pneunomia pseudomonal
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 337 at risk

Adverse event: Pneumonia viral
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 337 at risk

Adverse event: Post procedural infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 337 at risk

Adverse event: Pyelonephritis acute
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 337 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 337 at risk

Adverse event: Sinusitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 337 at risk

Adverse event: Suspected COVID-19
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 337 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 337 at risk

Adverse event: Viral upper respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 337 at risk

Adverse event: Femur fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 337 at risk

Adverse event: Joint injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 337 at risk

Adverse event: Meniscus injury
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 337 at risk

Adverse event: Poisoning
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 337 at risk

Adverse event: Suture related complication
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 337 at risk

Adverse event: Upper limb fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 337 at risk

Adverse event: Hepatic enzyme increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 337 at risk

Adverse event: Weight decreased
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 337 at risk

Adverse event: Diabetic ketoacidosis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 337 at risk

Adverse event: Hypoglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 337 at risk

Adverse event: Diabetes mellitus
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 337 at risk

Adverse event: Diabetic ketosis
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 337 at risk

Adverse event: Diabetic metabolic decompesation
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 337 at risk

Adverse event: Hyperglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 337 at risk

Adverse event: Hyponatraemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 337 at risk

Adverse event: Back pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 337 at risk

Adverse event: Foot deformity
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 337 at risk

Adverse event: Muscular weakness
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 337 at risk

Adverse event: Neck mass
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 337 at risk

Adverse event: Tendon disorder
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 337 at risk

Adverse event: Adenocarcinoma of colon
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 337 at risk

Adverse event: Colon cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 337 at risk

Adverse event: Leiomyoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 337 at risk

Adverse event: Lung neoplasm
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 337 at risk

Adverse event: Pituitary tumour recurrent
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 337 at risk

Adverse event: Prostate cancer metastatic
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 337 at risk

Adverse event: Thyroid cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 337 at risk

Adverse event: Epilepsy
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 337 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 337 at risk

Adverse event: Dementia
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 337 at risk

Adverse event: Headache
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 337 at risk

Adverse event: Hypoglycaemic coma
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 337 at risk

Adverse event: Hypoglycaemic seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 337 at risk

Adverse event: Myasthenia gravis
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 337 at risk

Adverse event: Transient ischaemic attack
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 337 at risk

Adverse event: Confusional state
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 337 at risk

Adverse event: Depression
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 337 at risk

Adverse event: Mental disorder
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 337 at risk

Adverse event: Mental fatigue
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 337 at risk

Adverse event: Psychiatric decompensation
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 337 at risk

Adverse event: Nephrolithiasis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 337 at risk

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 337 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 337 at risk

Adverse event: Breast pain
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 337 at risk

Adverse event: Heavy menstrual bleeding
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 337 at risk

Adverse event: Intermenstrual bleeding
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 337 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 337 at risk

Adverse event: Acute respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 337 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 337 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 337 at risk

Adverse event: Aortic aneurysm
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 337 at risk

Adverse event: Deep vein thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 337 at risk

Adverse event: Distributive shock
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 337 at risk

Adverse event: Hypertensive emergency
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 337 at risk

Adverse event: Peripheral arterial occlusive disease
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 337 at risk

Adverse event: Peripheral embolism
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 337 at risk

Adverse event: Thrombophlebitis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 337 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 32 affected / 337 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 30 affected / 337 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 25 affected / 337 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 23 affected / 337 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 22 affected / 337 at risk

Adverse event: COVID-19
Serious: no
Organ System: Infections and infestations
Frequency: 20 affected / 337 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 19 affected / 337 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 18 affected / 337 at risk

Adverse event: Diabetes mellitus
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 18 affected / 337 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 17 affected / 337 at risk