Study: NCT02275780

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 383 at risk

Adverse event: Supraventricular tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 383 at risk

Adverse event: Anal fistula
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 383 at risk

Adverse event: Anal skin tags
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 383 at risk

Adverse event: Colitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 383 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 383 at risk

Adverse event: Pancreatitis acute
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 383 at risk

Adverse event: Pancreatitis necrotising
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 383 at risk

Adverse event: Umbilical hernia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 383 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 383 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 383 at risk

Adverse event: Bile duct stone
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 383 at risk

Adverse event: Cholecystitis acute
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 383 at risk

Adverse event: Abdominal abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 383 at risk

Adverse event: Acute hepatitis C
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 383 at risk

Adverse event: Anal abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 383 at risk

Adverse event: Appendicitis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 383 at risk

Adverse event: Cellulitis staphylococcal
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 383 at risk

Adverse event: Chronic hepatitis C
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 383 at risk

Adverse event: Fournier's gangrene
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 383 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 383 at risk

Adverse event: Keratouveitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 383 at risk

Adverse event: Neurosyphilis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 383 at risk

Adverse event: Parotitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 383 at risk

Adverse event: Perirectal abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 383 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 383 at risk

Adverse event: Ankle fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 383 at risk

Adverse event: Carbon monoxide poisoning
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 383 at risk

Adverse event: Craniofacial fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 383 at risk

Adverse event: Femur fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 383 at risk

Adverse event: Wrist fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 383 at risk

Adverse event: Hypovolaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 383 at risk

Adverse event: Bone lesion
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 383 at risk

Adverse event: Intervertebral disc protrusion
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 383 at risk

Adverse event: Muscular weakness
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 383 at risk

Adverse event: Rhabdomyolysis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 383 at risk

Adverse event: Angiosarcoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 383 at risk

Adverse event: Benign salivary gland neoplasm
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 383 at risk

Adverse event: Bladder cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 383 at risk

Adverse event: Prostate cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 383 at risk

Adverse event: Squamous cell carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 383 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 383 at risk

Adverse event: Hemiparesis
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 383 at risk

Adverse event: Hypoaesthesia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 383 at risk

Adverse event: Post abortion haemorrhage
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 383 at risk

Adverse event: Device dislocation
Serious: yes
Organ System: Product Issues
Frequency: 1 affected / 383 at risk

Adverse event: Depression
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 383 at risk

Adverse event: Drug dependence
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 383 at risk

Adverse event: Psychotic disorder
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 383 at risk

Adverse event: Substance-induced mood disorder
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 383 at risk

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 383 at risk

Adverse event: Acute pulmonary oedema
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 383 at risk

Adverse event: Asthma
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 383 at risk

Adverse event: Angioedema
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 383 at risk

Adverse event: Seborrhoeic dermatitis
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 383 at risk

Adverse event: Drug abuser
Serious: yes
Organ System: Social circumstances
Frequency: 1 affected / 383 at risk

Adverse event: Deep vein thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 383 at risk

Adverse event: Femoral artery aneurysm
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 383 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 20 affected / 383 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 27 affected / 383 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 72 affected / 383 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 52 affected / 383 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 20 affected / 383 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 38 affected / 383 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 21 affected / 383 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 31 affected / 383 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 22 affected / 383 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 24 affected / 383 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 61 affected / 383 at risk

Adverse event: Syphilis
Serious: no
Organ System: Infections and infestations
Frequency: 29 affected / 383 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 64 affected / 383 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 26 affected / 383 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 37 affected / 383 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 25 affected / 383 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 63 affected / 383 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 27 affected / 383 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 38 affected / 383 at risk

Adverse event: Febrile neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 383 at risk

Adverse event: Neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 383 at risk

Adverse event: Vertigo
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 383 at risk

Adverse event: Abdominal distension
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 383 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 383 at risk

Adverse event: Anal fistula
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 383 at risk

Adverse event: Gastritis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 383 at risk

Adverse event: Inguinal hernia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 383 at risk

Adverse event: Non-cardiac chest pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 383 at risk

Adverse event: Oedema peripheral
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 383 at risk

Adverse event: Cholecystitis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 383 at risk

Adverse event: Cholelithiasis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 383 at risk

Adverse event: Abscess limb
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 383 at risk

Adverse event: Acute sinusitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 383 at risk

Adverse event: Appendicitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 383 at risk

Adverse event: Atypical pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 383 at risk

Adverse event: Bronchitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 383 at risk

Adverse event: Cellulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 383 at risk

Adverse event: Gastroenteritis shigella
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 383 at risk

Adverse event: Herpes oesophagitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 383 at risk

Adverse event: Influenza
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 383 at risk

Adverse event: Meningitis tuberculous
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 383 at risk

Adverse event: Orchitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 383 at risk

Adverse event: Pharyngitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 383 at risk

Adverse event: Pilonidal disease
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 383 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 383 at risk

Adverse event: Pneumonia klebsiella
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 383 at risk

Adverse event: Post procedural infection
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 383 at risk

Adverse event: Rectal abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 383 at risk

Adverse event: Scrotal abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 383 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 383 at risk

Adverse event: Tonsillitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 383 at risk

Adverse event: Tuberculosis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 383 at risk

Adverse event: Tuberculosis of central nervous system
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 383 at risk

Adverse event: Accidental overdose
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 383 at risk

Adverse event: Animal bite
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 383 at risk

Adverse event: Exposure to toxic agent
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 383 at risk

Adverse event: Femoral neck fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 383 at risk

Adverse event: Ligament rupture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 383 at risk

Adverse event: Post procedural haemorrhage
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 383 at risk

Adverse event: Rectal injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 383 at risk

Adverse event: Subdural haematoma
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 383 at risk

Adverse event: Traumatic intracranial haemorrhage
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 383 at risk

Adverse event: Hyponatraemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 383 at risk

Adverse event: Back pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 383 at risk

Adverse event: Osteoarthritis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 383 at risk

Adverse event: Rhabdomyolysis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 383 at risk

Adverse event: Anal squamous cell carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 383 at risk

Adverse event: B-cell lymphoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 383 at risk

Adverse event: Malignant melanoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 383 at risk

Adverse event: Pancreatic carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 383 at risk

Adverse event: Rectal cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 383 at risk

Adverse event: Squamous cell carcinoma of skin
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 383 at risk

Adverse event: Aphasia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 383 at risk

Adverse event: Bell's palsy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 383 at risk

Adverse event: Osmotic demyelination syndrome
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 383 at risk

Adverse event: Syncope
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 383 at risk

Adverse event: Device dislocation
Serious: yes
Organ System: Product Issues
Frequency: 1 affected / 383 at risk

Adverse event: Depression
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 383 at risk

Adverse event: Major depression
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 383 at risk

Adverse event: Schizoaffective disorder depressive type
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 383 at risk

Adverse event: Nephrolithiasis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 383 at risk

Adverse event: Prostatitis
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 383 at risk

Adverse event: Bronchospasm
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 383 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 383 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 383 at risk

Adverse event: Stridor
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 383 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 383 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 20 affected / 383 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 15 affected / 383 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 100 affected / 383 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 54 affected / 383 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 12 affected / 383 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 28 affected / 383 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 10 affected / 383 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 37 affected / 383 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 23 affected / 383 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 16 affected / 383 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 61 affected / 383 at risk

Adverse event: Syphilis
Serious: no
Organ System: Infections and infestations
Frequency: 39 affected / 383 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 40 affected / 383 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 22 affected / 383 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 13 affected / 383 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 24 affected / 383 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 59 affected / 383 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 23 affected / 383 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 14 affected / 383 at risk