Study: NCT01897532

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 121 affected / 3485 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 41 affected / 3485 at risk

Adverse event: Cellulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 38 affected / 3485 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 33 affected / 3485 at risk

Adverse event: Bronchitis
Serious: yes
Organ System: Infections and infestations
Frequency: 17 affected / 3485 at risk

Adverse event: Osteomyelitis
Serious: yes
Organ System: Infections and infestations
Frequency: 14 affected / 3485 at risk

Adverse event: Septic shock
Serious: yes
Organ System: Infections and infestations
Frequency: 12 affected / 3485 at risk

Adverse event: Gangrene
Serious: yes
Organ System: Infections and infestations
Frequency: 14 affected / 3485 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 9 affected / 3485 at risk

Adverse event: Localised infection
Serious: yes
Organ System: Infections and infestations
Frequency: 7 affected / 3485 at risk

Adverse event: Pyelonephritis
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 3485 at risk

Adverse event: Urosepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 7 affected / 3485 at risk

Adverse event: Respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 7 affected / 3485 at risk

Adverse event: Diabetic foot infection
Serious: yes
Organ System: Infections and infestations
Frequency: 6 affected / 3485 at risk

Adverse event: Influenza
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 3485 at risk

Adverse event: Pyelonephritis acute
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 3485 at risk

Adverse event: Erysipelas
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 3485 at risk

Adverse event: Infected skin ulcer
Serious: yes
Organ System: Infections and infestations
Frequency: 6 affected / 3485 at risk

Adverse event: Lower respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 3485 at risk

Adverse event: Abscess limb
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 3485 at risk

Adverse event: Device related infection
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 3485 at risk

Adverse event: Peritonitis
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 3485 at risk

Adverse event: Upper respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 3485 at risk

Adverse event: Bacteraemia
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 3485 at risk

Adverse event: Necrotising fasciitis
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 3485 at risk

Adverse event: Postoperative wound infection
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 3485 at risk

Adverse event: Anal abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 3485 at risk

Adverse event: Catheter site infection
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 3485 at risk

Adverse event: Diabetic gangrene
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 3485 at risk

Adverse event: Diverticulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 3485 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3485 at risk

Adverse event: Post procedural infection
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 3485 at risk

Adverse event: Subcutaneous abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 3485 at risk

Adverse event: Appendicitis
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 3485 at risk

Adverse event: Arthritis bacterial
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 3485 at risk

Adverse event: Clostridium difficile colitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3485 at risk

Adverse event: Endocarditis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 3485 at risk

Adverse event: Escherichia sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3485 at risk

Adverse event: Infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3485 at risk

Adverse event: Pneumonia bacterial
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3485 at risk

Adverse event: Pulmonary sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3485 at risk

Adverse event: Soft tissue infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3485 at risk

Adverse event: Bacterial infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3485 at risk

Adverse event: Carbuncle
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3485 at risk

Adverse event: Cholecystitis infective
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 3485 at risk

Adverse event: Device related sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3485 at risk

Adverse event: Escherichia urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3485 at risk

Adverse event: Osteomyelitis chronic
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3485 at risk

Adverse event: Paronychia
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 3485 at risk

Adverse event: Periodontitis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 3485 at risk

Adverse event: Staphylococcal infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3485 at risk

Adverse event: Staphylococcal sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3485 at risk

Adverse event: Urinary tract infection fungal
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3485 at risk

Adverse event: Wound infection
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 3485 at risk

Adverse event: Abdominal abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3485 at risk

Adverse event: Bacterial pyelonephritis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3485 at risk

Adverse event: Bacterial sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3485 at risk

Adverse event: Blebitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3485 at risk

Adverse event: Bursitis infective
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3485 at risk

Adverse event: Chikungunya virus infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3485 at risk

Adverse event: Chronic sinusitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3485 at risk

Adverse event: Clostridium colitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3485 at risk

Adverse event: Cytomegalovirus infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3485 at risk

Adverse event: Dengue fever
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3485 at risk

Adverse event: Gastroenteritis shigella
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3485 at risk

Adverse event: Gastrointestinal viral infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3485 at risk

Adverse event: Graft infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3485 at risk

Adverse event: Groin abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3485 at risk

Adverse event: Hepatitis C
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3485 at risk

Adverse event: Hepatitis infectious mononucleosis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3485 at risk

Adverse event: Histoplasmosis cutaneous
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3485 at risk

Adverse event: Infected cyst
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3485 at risk

Adverse event: Infective exacerbation of chronic obstructive airways disease
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3485 at risk

Adverse event: Intestinal sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3485 at risk

Adverse event: Laryngitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3485 at risk

Adverse event: Liver abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3485 at risk

Adverse event: Lyme disease
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3485 at risk

Adverse event: Mediastinitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3485 at risk

Adverse event: Medical device site cellulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3485 at risk

Adverse event: Meningitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3485 at risk

Adverse event: Myiasis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3485 at risk

Adverse event: Neutropenic sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3485 at risk

Adverse event: Nosocomial infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3485 at risk

Adverse event: Osteomyelitis viral
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3485 at risk

Adverse event: Otitis externa
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3485 at risk

Adverse event: Otitis media
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3485 at risk

Adverse event: Pelvic abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3485 at risk

Adverse event: Perineal abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3485 at risk

Adverse event: Peritonitis bacterial
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3485 at risk

Adverse event: Pneumonia chlamydial
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3485 at risk

Adverse event: Pulpitis dental
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3485 at risk

Adverse event: Pyelonephritis chronic
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3485 at risk

Adverse event: Renal abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3485 at risk

Adverse event: Respiratory tract infection viral
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3485 at risk

Adverse event: Skin infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3485 at risk

Adverse event: Spinal cord abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3485 at risk

Adverse event: Systemic infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3485 at risk

Adverse event: Tooth infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3485 at risk

Adverse event: Tuberculosis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3485 at risk

Adverse event: Urinary tract infection bacterial
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3485 at risk

Adverse event: Basal cell carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 14 affected / 3485 at risk

Adverse event: Prostate cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 8 affected / 3485 at risk

Adverse event: Squamous cell carcinoma of skin
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 9 affected / 3485 at risk

Adverse event: Lung neoplasm malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 5 affected / 3485 at risk

Adverse event: Colon cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 7 affected / 3485 at risk

Adverse event: Breast cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 4 affected / 3485 at risk

Adverse event: Adenocarcinoma of colon
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 4 affected / 3485 at risk

Adverse event: Bladder cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 3 affected / 3485 at risk

Adverse event: Bladder transitional cell carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 3485 at risk

Adverse event: Hepatic cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 3 affected / 3485 at risk

Adverse event: Invasive ductal breast carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 3 affected / 3485 at risk

Adverse event: Lung adenocarcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 3485 at risk

Adverse event: Myelodysplastic syndrome
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 3 affected / 3485 at risk

Adverse event: Plasma cell myeloma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 3485 at risk

Adverse event: Renal cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 3485 at risk

Adverse event: Transitional cell carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 3 affected / 3485 at risk

Adverse event: Bowen's disease
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 3485 at risk

Adverse event: Colorectal adenoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 3485 at risk

Adverse event: Hepatocellular carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 3485 at risk

Adverse event: Metastases to bone
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 3485 at risk

Adverse event: Metastases to liver
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 3 affected / 3485 at risk

Adverse event: Non-Hodgkin's lymphoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 3 affected / 3485 at risk

Adverse event: Rectal adenocarcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 3485 at risk

Adverse event: Adenocarcinoma gastric
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 3485 at risk

Adverse event: Adenocarcinoma pancreas
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 3485 at risk

Adverse event: Benign breast neoplasm
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 3485 at risk

Adverse event: Benign ovarian tumour
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 3485 at risk

Adverse event: Malignant melanoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 3485 at risk

Adverse event: Mediastinum neoplasm
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 3485 at risk

Adverse event: Plasmacytoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 3485 at risk

Adverse event: Rectal cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 3485 at risk

Adverse event: Renal neoplasm
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 3485 at risk

Adverse event: Small cell lung cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 3485 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 / 3485 at risk

Adverse event: Acute monocytic leukaemia
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 3485 at risk

Adverse event: Acute myeloid leukaemia
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 3485 at risk

Adverse event: Acute promyelocytic leukaemia
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 3485 at risk

Adverse event: Basosquamous carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 3485 at risk

Adverse event: Bladder neoplasm
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 3485 at risk

Adverse event: Bronchial carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 3485 at risk

Adverse event: Cancer pain
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 3485 at risk

Adverse event: Carcinoma in situ of penis
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 3485 at risk

Adverse event: Cardiac myxoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 3485 at risk

Adverse event: Cervix carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 3485 at risk

Adverse event: Chest wall tumour
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 3485 at risk

Adverse event: Cholesteatoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 3485 at risk

Adverse event: Chronic lymphocytic leukaemia
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 3485 at risk

Adverse event: Colon neoplasm
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 3485 at risk

Adverse event: Endometrial adenocarcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 3485 at risk

Adverse event: Gastric cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 3485 at risk

Adverse event: Gastrointestinal cancer metastatic
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 3485 at risk

Adverse event: Gastrointestinal neoplasm
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 3485 at risk

Adverse event: Hepatic neoplasm
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 3485 at risk

Adverse event: Hodgkin's disease
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 3485 at risk

Adverse event: Leiomyosarcoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 3485 at risk

Adverse event: Lip neoplasm malignant stage unspecified
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 3485 at risk

Adverse event: Lung adenocarcinoma stage 0
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 3485 at risk

Adverse event: Lymphoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 3485 at risk

Adverse event: Malignant anorectal neoplasm
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 3485 at risk

Adverse event: Malignant melanoma stage 0
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 3485 at risk

Adverse event: Malignant pleural effusion
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 3485 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 / 3485 at risk

Adverse event: Cystadenocarcinoma pancreas
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 3485 at risk

Adverse event: Naevoid melanoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 3485 at risk

Adverse event: Neoplasm skin
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 3485 at risk

Adverse event: Oesophageal carcinoma recurrent
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 3485 at risk

Adverse event: Papillary renal cell carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 3485 at risk

Adverse event: Papillary thyroid cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 3485 at risk

Adverse event: Colorectal adenoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 3485 at risk

Adverse event: Renal cell carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 3485 at risk

Adverse event: Uterine leiomyoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 3485 at risk

Adverse event: Vulval cancer stage 0
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 3485 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 17 affected / 3485 at risk

Adverse event: Lymphadenopathy
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 3485 at risk

Adverse event: Thrombocytopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 3485 at risk

Adverse event: Autoimmune haemolytic anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 3485 at risk

Adverse event: Immune thrombocytopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 3485 at risk

Adverse event: Leukocytosis
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 3485 at risk

Adverse event: Pancytopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 3485 at risk

Adverse event: Anaemia macrocytic
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 3485 at risk

Adverse event: Anaemia of malignant disease
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 3485 at risk

Adverse event: Hypochromic anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 3485 at risk

Adverse event: Iron deficiency anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 3485 at risk

Adverse event: Overlap syndrome
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 3485 at risk

Adverse event: Goitre
Serious: yes
Organ System: Endocrine disorders
Frequency: 2 affected / 3485 at risk

Adverse event: Adrenal insufficiency
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 3485 at risk

Adverse event: Adrenal mass
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 3485 at risk

Adverse event: Hypothyroidism
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 3485 at risk

Adverse event: Hypoglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 38 affected / 3485 at risk

Adverse event: Hyperkalaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 19 affected / 3485 at risk

Adverse event: Hyperglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 22 affected / 3485 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 6 affected / 3485 at risk

Adverse event: Diabetes mellitus inadequate control
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 10 affected / 3485 at risk

Adverse event: Diabetes mellitus
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 7 affected / 3485 at risk

Adverse event: Hypervolaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 11 affected / 3485 at risk

Adverse event: Diabetic metabolic decompensation
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 3485 at risk

Adverse event: Hyponatraemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 3485 at risk

Adverse event: Metabolic acidosis
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 3485 at risk

Adverse event: Diabetic ketoacidosis
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 3485 at risk

Adverse event: Electrolyte imbalance
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 3485 at risk

Adverse event: Hypokalaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 3485 at risk

Adverse event: Gout
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 3485 at risk

Adverse event: Hyperlipasaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 3485 at risk

Adverse event: Hypovolaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 3485 at risk

Adverse event: Lactic acidosis
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 3485 at risk

Adverse event: Fluid retention
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 3485 at risk

Adverse event: Hypercalcaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 3485 at risk

Adverse event: Acquired mixed hyperlipidaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 3485 at risk

Adverse event: Diabetes with hyperosmolarity
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 3485 at risk

Adverse event: Hypernatraemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 3485 at risk

Adverse event: Hyperosmolar state
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 3485 at risk

Adverse event: Hyperuricaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 3485 at risk

Adverse event: Hypophagia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 3485 at risk

Adverse event: Obesity
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 3485 at risk

Adverse event: Delirium
Serious: yes
Organ System: Psychiatric disorders
Frequency: 4 affected / 3485 at risk

Adverse event: Major depression
Serious: yes
Organ System: Psychiatric disorders
Frequency: 3 affected / 3485 at risk

Adverse event: Mental status changes
Serious: yes
Organ System: Psychiatric disorders
Frequency: 3 affected / 3485 at risk

Adverse event: Depression
Serious: yes
Organ System: Psychiatric disorders
Frequency: 3 affected / 3485 at risk

Adverse event: Anxiety
Serious: yes
Organ System: Psychiatric disorders
Frequency: 2 affected / 3485 at risk

Adverse event: Confusional state
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 3485 at risk

Adverse event: Hallucination, visual
Serious: yes
Organ System: Psychiatric disorders
Frequency: 2 affected / 3485 at risk

Adverse event: Acute stress disorder
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 3485 at risk

Adverse event: Completed suicide
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 3485 at risk

Adverse event: Drug use disorder
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 3485 at risk

Adverse event: Insomnia
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 3485 at risk

Adverse event: Irritability
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 3485 at risk

Adverse event: Mood disorder due to a general medical condition
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 3485 at risk

Adverse event: Psychotic disorder
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 3485 at risk

Adverse event: Suicidal ideation
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 3485 at risk

Adverse event: Ischaemic stroke
Serious: yes
Organ System: Nervous system disorders
Frequency: 49 affected / 3485 at risk

Adverse event: Syncope
Serious: yes
Organ System: Nervous system disorders
Frequency: 25 affected / 3485 at risk

Adverse event: Transient ischaemic attack
Serious: yes
Organ System: Nervous system disorders
Frequency: 9 affected / 3485 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Nervous system disorders
Frequency: 12 affected / 3485 at risk

Adverse event: Haemorrhagic stroke
Serious: yes
Organ System: Nervous system disorders
Frequency: 8 affected / 3485 at risk

Adverse event: Dementia
Serious: yes
Organ System: Nervous system disorders
Frequency: 6 affected / 3485 at risk

Adverse event: Diabetic neuropathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 5 affected / 3485 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 6 affected / 3485 at risk

Adverse event: Cerebral infarction
Serious: yes
Organ System: Nervous system disorders
Frequency: 8 affected / 3485 at risk

Adverse event: Presyncope
Serious: yes
Organ System: Nervous system disorders
Frequency: 7 affected / 3485 at risk

Adverse event: Carotid artery stenosis
Serious: yes
Organ System: Nervous system disorders
Frequency: 6 affected / 3485 at risk

Adverse event: Cerebral ischaemia
Serious: yes
Organ System: Nervous system disorders
Frequency: 4 affected / 3485 at risk

Adverse event: Facial paralysis
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 3485 at risk

Adverse event: Headache
Serious: yes
Organ System: Nervous system disorders
Frequency: 4 affected / 3485 at risk

Adverse event: Loss of consciousness
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 3485 at risk

Adverse event: Encephalopathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 3485 at risk

Adverse event: Haemorrhage intracranial
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 3485 at risk

Adverse event: Hemiparesis
Serious: yes
Organ System: Nervous system disorders
Frequency: 4 affected / 3485 at risk

Adverse event: Myelopathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 3485 at risk

Adverse event: Altered state of consciousness
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 3485 at risk

Adverse event: Cerebral haemorrhage
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 3485 at risk

Adverse event: Diabetic coma
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 3485 at risk

Adverse event: Epilepsy
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 3485 at risk

Adverse event: Hypertensive encephalopathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 3485 at risk

Adverse event: Lacunar infarction
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 3485 at risk

Adverse event: Basal ganglia infarction
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 3485 at risk

Adverse event: Brain oedema
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 3485 at risk

Adverse event: Brain stem infarction
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 3485 at risk

Adverse event: Carotid artery occlusion
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 3485 at risk

Adverse event: Cerebrovascular disorder
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 3485 at risk

Adverse event: Dementia with Lewy bodies
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 3485 at risk

Adverse event: Embolic stroke
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 3485 at risk

Adverse event: Facial nerve disorder
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 3485 at risk

Adverse event: Hypoglycaemic coma
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 3485 at risk

Adverse event: Hypoxic-ischaemic encephalopathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 3485 at risk

Adverse event: Ischaemic cerebral infarction
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 3485 at risk

Adverse event: Lumbar radiculopathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 3485 at risk

Adverse event: Parkinson's disease
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 3485 at risk

Adverse event: Thrombotic stroke
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 3485 at risk

Adverse event: Vertebrobasilar insufficiency
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 3485 at risk

Adverse event: Brain injury
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 3485 at risk

Adverse event: Carotid arteriosclerosis
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 3485 at risk

Adverse event: Carotid artery dissection
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 3485 at risk

Adverse event: Central nervous system lesion
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 3485 at risk

Adverse event: Cerebral haematoma
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 3485 at risk

Adverse event: Cerebral small vessel ischaemic disease
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 3485 at risk

Adverse event: Cerebrospinal fluid leakage
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 3485 at risk

Adverse event: Cervicobrachial syndrome
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 3485 at risk

Adverse event: Coma
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 3485 at risk

Adverse event: Complex regional pain syndrome
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 3485 at risk

Adverse event: Generalised tonic-clonic seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 3485 at risk

Adverse event: Hepatic encephalopathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 3485 at risk

Adverse event: Incoherent
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 3485 at risk

Adverse event: Intraventricular haemorrhage
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 3485 at risk

Adverse event: Myasthenia gravis
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 3485 at risk

Adverse event: Parkinsonism
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 3485 at risk

Adverse event: Peripheral sensory neuropathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 3485 at risk

Adverse event: Polyneuropathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 3485 at risk

Adverse event: Spinal claudication
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 3485 at risk

Adverse event: Thalamic infarction
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 3485 at risk

Adverse event: Tremor
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 3485 at risk

Adverse event: Uraemic encephalopathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 3485 at risk

Adverse event: Vascular headache
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 3485 at risk

Adverse event: VIth nerve paralysis
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 3485 at risk

Adverse event: Wernicke's encephalopathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 3485 at risk

Adverse event: Cataract
Serious: yes
Organ System: Eye disorders
Frequency: 13 affected / 3485 at risk

Adverse event: Glaucoma
Serious: yes
Organ System: Eye disorders
Frequency: 9 affected / 3485 at risk

Adverse event: Vitreous haemorrhage
Serious: yes
Organ System: Eye disorders
Frequency: 5 affected / 3485 at risk

Adverse event: Retinal detachment
Serious: yes
Organ System: Eye disorders
Frequency: 5 affected / 3485 at risk

Adverse event: Diabetic retinopathy
Serious: yes
Organ System: Eye disorders
Frequency: 4 affected / 3485 at risk

Adverse event: Macular hole
Serious: yes
Organ System: Eye disorders
Frequency: 2 affected / 3485 at risk

Adverse event: Retinal vein occlusion
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 3485 at risk

Adverse event: Ulcerative keratitis
Serious: yes
Organ System: Eye disorders
Frequency: 2 affected / 3485 at risk

Adverse event: Diplopia
Serious: yes
Organ System: Eye disorders
Frequency: 2 affected / 3485 at risk

Adverse event: Macular degeneration
Serious: yes
Organ System: Eye disorders
Frequency: 2 affected / 3485 at risk

Adverse event: Angle closure glaucoma
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 3485 at risk

Adverse event: Macular fibrosis
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 3485 at risk

Adverse event: Neovascular age-related macular degeneration
Serious: yes
Organ System: Eye disorders
Frequency: 2 affected / 3485 at risk

Adverse event: Retinal haemorrhage
Serious: yes
Organ System: Eye disorders
Frequency: 2 affected / 3485 at risk

Adverse event: Acquired corneal dystrophy
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 3485 at risk

Adverse event: Amaurosis fugax
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 3485 at risk

Adverse event: Hyalosis asteroid
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 3485 at risk

Adverse event: Open angle glaucoma
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 3485 at risk

Adverse event: Retinal degeneration
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 3485 at risk

Adverse event: Uveitis
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 3485 at risk

Adverse event: Vitreous haematoma
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 3485 at risk

Adverse event: Deafness neurosensory
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 3 affected / 3485 at risk

Adverse event: Vertigo
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 4 affected / 3485 at risk

Adverse event: Deafness
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 2 affected / 3485 at risk

Adverse event: Deafness bilateral
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 2 affected / 3485 at risk

Adverse event: Tinnitus
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 3 affected / 3485 at risk

Adverse event: Vertigo positional
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 3485 at risk

Adverse event: Sudden hearing loss
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 3485 at risk

Adverse event: Cardiac failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 104 affected / 3485 at risk

Adverse event: Cardiac failure congestive
Serious: yes
Organ System: Cardiac disorders
Frequency: 98 affected / 3485 at risk

Adverse event: Angina unstable
Serious: yes
Organ System: Cardiac disorders
Frequency: 70 affected / 3485 at risk

Adverse event: Acute myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 59 affected / 3485 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 54 affected / 3485 at risk

Adverse event: Angina pectoris
Serious: yes
Organ System: Cardiac disorders
Frequency: 25 affected / 3485 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 26 affected / 3485 at risk

Adverse event: Coronary artery disease
Serious: yes
Organ System: Cardiac disorders
Frequency: 21 affected / 3485 at risk

Adverse event: Cardiac failure chronic
Serious: yes
Organ System: Cardiac disorders
Frequency: 20 affected / 3485 at risk

Adverse event: Cardiac arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 17 affected / 3485 at risk

Adverse event: Myocardial ischaemia
Serious: yes
Organ System: Cardiac disorders
Frequency: 12 affected / 3485 at risk

Adverse event: Acute coronary syndrome
Serious: yes
Organ System: Cardiac disorders
Frequency: 18 affected / 3485 at risk

Adverse event: Left ventricular failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 12 affected / 3485 at risk

Adverse event: Atrial flutter
Serious: yes
Organ System: Cardiac disorders
Frequency: 11 affected / 3485 at risk

Adverse event: Cardiogenic shock
Serious: yes
Organ System: Cardiac disorders
Frequency: 12 affected / 3485 at risk

Adverse event: Atrioventricular block complete
Serious: yes
Organ System: Cardiac disorders
Frequency: 10 affected / 3485 at risk

Adverse event: Cardiac failure acute
Serious: yes
Organ System: Cardiac disorders
Frequency: 7 affected / 3485 at risk

Adverse event: Cardio-respiratory arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 8 affected / 3485 at risk

Adverse event: Coronary artery stenosis
Serious: yes
Organ System: Cardiac disorders
Frequency: 8 affected / 3485 at risk

Adverse event: Bradycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 6 affected / 3485 at risk

Adverse event: Sinus node dysfunction
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 3485 at risk

Adverse event: Acute left ventricular failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 8 affected / 3485 at risk

Adverse event: Atrioventricular block second degree
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 3485 at risk

Adverse event: Coronary artery occlusion
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 3485 at risk

Adverse event: Arteriosclerosis coronary artery
Serious: yes
Organ System: Cardiac disorders
Frequency: 6 affected / 3485 at risk

Adverse event: Atrioventricular block
Serious: yes
Organ System: Cardiac disorders
Frequency: 5 affected / 3485 at risk

Adverse event: Ischaemic cardiomyopathy
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 3485 at risk

Adverse event: Ventricular tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 3485 at risk

Adverse event: Cardiomyopathy
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 3485 at risk

Adverse event: Cardiopulmonary failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 3485 at risk

Adverse event: Ventricular fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 3485 at risk

Adverse event: Arrhythmia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 3485 at risk

Adverse event: Cardiovascular insufficiency
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 3485 at risk

Adverse event: Sinus bradycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 3485 at risk

Adverse event: Supraventricular tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 3485 at risk

Adverse event: Ventricular arrhythmia
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 3485 at risk

Adverse event: Aortic valve incompetence
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 3485 at risk

Adverse event: Bundle branch block left
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 3485 at risk

Adverse event: Cardiomegaly
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 3485 at risk

Adverse event: Diastolic dysfunction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 3485 at risk

Adverse event: Myocardial fibrosis
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 3485 at risk

Adverse event: Silent myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 3485 at risk

Adverse event: Sinus tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 3485 at risk

Adverse event: Systolic dysfunction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 3485 at risk

Adverse event: Adams-Stokes syndrome
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 3485 at risk

Adverse event: Arrhythmia supraventricular
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 3485 at risk

Adverse event: Atrioventricular block first degree
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 3485 at risk

Adverse event: Cardiomyopathy acute
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 3485 at risk

Adverse event: Cardiorenal syndrome
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 3485 at risk

Adverse event: Cardiovascular disorder
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 3485 at risk

Adverse event: Chordae tendinae rupture
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 3485 at risk

Adverse event: Chronic left ventricular failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 3485 at risk

Adverse event: Cardiac ventricular thrombosis
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 3485 at risk

Adverse event: Left ventricular dysfunction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 3485 at risk

Adverse event: Mitral valve disease
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 3485 at risk

Adverse event: Myocardial necrosis
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 3485 at risk

Adverse event: Myocarditis
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 3485 at risk

Adverse event: Paroxysmal atrioventricular block
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 3485 at risk

Adverse event: Pericarditis
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 3485 at risk

Adverse event: Sinus arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 3485 at risk

Adverse event: Tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 3485 at risk

Adverse event: Ventricular extrasystoles
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 3485 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Vascular disorders
Frequency: 18 affected / 3485 at risk

Adverse event: Hypertensive crisis
Serious: yes
Organ System: Vascular disorders
Frequency: 20 affected / 3485 at risk

Adverse event: Peripheral arterial occlusive disease
Serious: yes
Organ System: Vascular disorders
Frequency: 17 affected / 3485 at risk

Adverse event: Deep vein thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 14 affected / 3485 at risk

Adverse event: Peripheral artery occlusion
Serious: yes
Organ System: Vascular disorders
Frequency: 12 affected / 3485 at risk

Adverse event: Peripheral ischaemia
Serious: yes
Organ System: Vascular disorders
Frequency: 11 affected / 3485 at risk

Adverse event: Aortic stenosis
Serious: yes
Organ System: Vascular disorders
Frequency: 5 affected / 3485 at risk

Adverse event: Peripheral vascular disorder
Serious: yes
Organ System: Vascular disorders
Frequency: 7 affected / 3485 at risk

Adverse event: Extremity necrosis
Serious: yes
Organ System: Vascular disorders
Frequency: 9 affected / 3485 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Vascular disorders
Frequency: 7 affected / 3485 at risk

Adverse event: Peripheral artery stenosis
Serious: yes
Organ System: Vascular disorders
Frequency: 4 affected / 3485 at risk

Adverse event: Aortic aneurysm
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 3485 at risk

Adverse event: Hypovolaemic shock
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 3485 at risk

Adverse event: Peripheral vein thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 3485 at risk

Adverse event: Arteriosclerosis
Serious: yes
Organ System: Vascular disorders
Frequency: 3 affected / 3485 at risk

Adverse event: Hypertensive emergency
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 3485 at risk

Adverse event: Circulatory collapse
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 3485 at risk

Adverse event: Accelerated hypertension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 3485 at risk

Adverse event: Angiopathy
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 3485 at risk

Adverse event: Diabetic macroangiopathy
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 3485 at risk

Adverse event: Dry gangrene
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 3485 at risk

Adverse event: Haematoma
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 3485 at risk

Adverse event: Peripheral embolism
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 3485 at risk

Adverse event: Thrombophlebitis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 3485 at risk

Adverse event: Aortic aneurysm rupture
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 3485 at risk

Adverse event: Aortic thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 3485 at risk

Adverse event: Arteriovenous fistula
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 3485 at risk

Adverse event: Distributive shock
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 3485 at risk

Adverse event: Embolism
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 3485 at risk

Adverse event: Orthostatic hypertension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 3485 at risk

Adverse event: Shock
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 3485 at risk

Adverse event: Systolic hypertension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 3485 at risk

Adverse event: Vascular insufficiency
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 3485 at risk

Adverse event: Vein rupture
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 3485 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 28 affected / 3485 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 16 affected / 3485 at risk

Adverse event: Pulmonary oedema
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 13 affected / 3485 at risk

Adverse event: Acute pulmonary oedema
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 15 affected / 3485 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 14 affected / 3485 at risk

Adverse event: Pulmonary hypertension
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 14 affected / 3485 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 12 affected / 3485 at risk

Adverse event: Acute respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 11 affected / 3485 at risk

Adverse event: Pleural effusion
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 11 affected / 3485 at risk

Adverse event: Asthma
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 3485 at risk

Adverse event: Dyspnoea exertional
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 3485 at risk

Adverse event: Pulmonary fibrosis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 3485 at risk

Adverse event: Hypoxia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 3485 at risk

Adverse event: Epistaxis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 3485 at risk

Adverse event: Pulmonary mass
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 3485 at risk

Adverse event: Respiratory arrest
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 3485 at risk

Adverse event: Haemoptysis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 3485 at risk

Adverse event: Pneumonia aspiration
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 3485 at risk

Adverse event: Respiratory distress
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 3485 at risk

Adverse event: Sleep apnoea syndrome
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 3485 at risk

Adverse event: Chronic respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 3485 at risk

Adverse event: Cough
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 3485 at risk

Adverse event: Lung disorder
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 3485 at risk

Adverse event: Pneumothorax
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 3485 at risk

Adverse event: Pulmonary congestion
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 3485 at risk

Adverse event: Bronchitis chronic
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 3485 at risk

Adverse event: Bronchospasm
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 3485 at risk

Adverse event: Paraneoplastic pleural effusion
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 3485 at risk

Adverse event: Pleural thickening
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 3485 at risk

Adverse event: Restrictive pulmonary disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 3485 at risk

Adverse event: Sinus polyp
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 3485 at risk

Adverse event: Vocal cord cyst
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 3485 at risk

Adverse event: Vocal cord disorder
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 3485 at risk

Adverse event: Gastrointestinal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 11 affected / 3485 at risk

Adverse event: Gastritis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 3485 at risk

Adverse event: Upper gastrointestinal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 3485 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 3485 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 3485 at risk

Adverse event: Pancreatitis acute
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 3485 at risk

Adverse event: Inguinal hernia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 3485 at risk

Adverse event: Pancreatitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 3485 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 3485 at risk

Adverse event: Constipation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 3485 at risk

Adverse event: Pancreatitis chronic
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 3485 at risk

Adverse event: Abdominal hernia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 3485 at risk

Adverse event: Large intestine polyp
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 3485 at risk

Adverse event: Lower gastrointestinal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 3485 at risk

Adverse event: Intestinal obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 3485 at risk

Adverse event: Colitis ischaemic
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3485 at risk

Adverse event: Gastric ulcer
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 3485 at risk

Adverse event: Chronic gastritis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3485 at risk

Adverse event: Haematochezia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 3485 at risk

Adverse event: Rectal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 3485 at risk

Adverse event: Small intestinal obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 3485 at risk

Adverse event: Duodenal ulcer
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 3485 at risk

Adverse event: Duodenitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 3485 at risk

Adverse event: Haemorrhoids
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3485 at risk

Adverse event: Hiatus hernia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 3485 at risk

Adverse event: Pancreatic cyst
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 3485 at risk

Adverse event: Umbilical hernia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 3485 at risk

Adverse event: Abdominal wall haematoma
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3485 at risk

Adverse event: Ascites
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3485 at risk

Adverse event: Diverticulum intestinal
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3485 at risk

Adverse event: Dysphagia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 3485 at risk

Adverse event: Enterocolitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3485 at risk

Adverse event: Gastric haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3485 at risk

Adverse event: Gastric polyps
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3485 at risk

Adverse event: Gastrointestinal necrosis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3485 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3485 at risk

Adverse event: Ileus
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3485 at risk

Adverse event: Incarcerated inguinal hernia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3485 at risk

Adverse event: Intestinal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3485 at risk

Adverse event: Intestinal perforation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 3485 at risk

Adverse event: Irritable bowel syndrome
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3485 at risk

Adverse event: Mesenteric artery thrombosis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3485 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3485 at risk

Adverse event: Obstructive pancreatitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3485 at risk

Adverse event: Peptic ulcer
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 3485 at risk

Adverse event: Abdominal pain upper
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3485 at risk

Adverse event: Anal fistula
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3485 at risk

Adverse event: Anorectal polyp
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3485 at risk

Adverse event: Diabetic gastroparesis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3485 at risk

Adverse event: Diverticulum
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3485 at risk

Adverse event: Gastric ulcer perforation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3485 at risk

Adverse event: Gastroduodenal ulcer
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3485 at risk

Adverse event: Gastrointestinal obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3485 at risk

Adverse event: Gastrointestinal perforation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3485 at risk

Adverse event: Intestinal polyp
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3485 at risk

Adverse event: Lip ulceration
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3485 at risk

Adverse event: Mesenteric haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3485 at risk

Adverse event: Oesophageal varices haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3485 at risk

Adverse event: Oesophagitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3485 at risk

Adverse event: Peritoneal adhesions
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3485 at risk

Adverse event: Anorectal polyp
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3485 at risk

Adverse event: Strangulated umbilical hernia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3485 at risk

Adverse event: Vomiting projectile
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3485 at risk

Adverse event: Cholelithiasis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 9 affected / 3485 at risk

Adverse event: Cholecystitis acute
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 7 affected / 3485 at risk

Adverse event: Cholecystitis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 3 affected / 3485 at risk

Adverse event: Hepatic cirrhosis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 2 affected / 3485 at risk

Adverse event: Hepatic failure
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 2 affected / 3485 at risk

Adverse event: Bile duct stone
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 2 affected / 3485 at risk

Adverse event: Cholangitis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 2 affected / 3485 at risk

Adverse event: Cholecystitis chronic
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 3485 at risk

Adverse event: Biliary tract disorder
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 3485 at risk

Adverse event: Cholangitis acute
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 3485 at risk

Adverse event: Cirrhosis alcoholic
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 3485 at risk

Adverse event: Ischaemic hepatitis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 3485 at risk

Adverse event: Diabetic foot
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 24 affected / 3485 at risk

Adverse event: Skin ulcer
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 10 affected / 3485 at risk

Adverse event: Angioedema
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 3485 at risk

Adverse event: Ischaemic skin ulcer
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 3485 at risk

Adverse event: Stasis dermatitis
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 3485 at risk

Adverse event: Ecchymosis
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 3485 at risk

Adverse event: Necrobiosis lipoidica diabeticorum
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 3485 at risk

Adverse event: Neurodermatitis
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 3485 at risk

Adverse event: Rash maculo-papular
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 3485 at risk

Adverse event: Osteoarthritis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 17 affected / 3485 at risk

Adverse event: Musculoskeletal chest pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 6 affected / 3485 at risk

Adverse event: Intervertebral disc protrusion
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 3485 at risk

Adverse event: Lumbar spinal stenosis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 3485 at risk

Adverse event: Rhabdomyolysis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 3485 at risk

Adverse event: Spinal osteoarthritis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 3485 at risk

Adverse event: Arthritis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 3485 at risk

Adverse event: Back pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 3485 at risk

Adverse event: Spinal stenosis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 3485 at risk

Adverse event: Intervertebral disc disorder
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 3485 at risk

Adverse event: Musculoskeletal pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 3485 at risk

Adverse event: Pain in extremity
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 3485 at risk

Adverse event: Polymyalgia rheumatica
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 3485 at risk

Adverse event: Spinal pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 3485 at risk

Adverse event: Spondylolisthesis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 3485 at risk

Adverse event: Arthralgia
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 3485 at risk

Adverse event: Neuropathic arthropathy
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 3485 at risk

Adverse event: Osteitis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 3485 at risk

Adverse event: Plantar fasciitis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 3485 at risk

Adverse event: Ankylosing spondylitis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 3485 at risk

Adverse event: Arthritis reactive
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 3485 at risk

Adverse event: Bone pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 3485 at risk

Adverse event: Exostosis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 3485 at risk

Adverse event: Intervertebral disc degeneration
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 3485 at risk

Adverse event: Muscle haemorrhage
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 3485 at risk

Adverse event: Muscle spasms
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 3485 at risk

Adverse event: Myopathy toxic
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 3485 at risk

Adverse event: Neck pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 3485 at risk

Adverse event: Osteochondrosis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 3485 at risk

Adverse event: Synovial cyst
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 3485 at risk

Adverse event: Systemic lupus erythematosus
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 3485 at risk

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 100 affected / 3485 at risk

Adverse event: End stage renal disease
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 45 affected / 3485 at risk

Adverse event: Chronic kidney disease
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 32 affected / 3485 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 31 affected / 3485 at risk

Adverse event: Renal impairment
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 27 affected / 3485 at risk

Adverse event: Diabetic nephropathy
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 7 affected / 3485 at risk

Adverse event: Nephrolithiasis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 7 affected / 3485 at risk

Adverse event: Urinary retention
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 6 affected / 3485 at risk

Adverse event: Haematuria
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 4 affected / 3485 at risk

Adverse event: Nephrotic syndrome
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 3485 at risk

Adverse event: Azotaemia
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 6 affected / 3485 at risk

Adverse event: Nephropathy
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 4 affected / 3485 at risk

Adverse event: Hydronephrosis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 3485 at risk

Adverse event: Ureterolithiasis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 3485 at risk

Adverse event: Urinary tract obstruction
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 3485 at risk

Adverse event: Nephropathy toxic
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 3485 at risk

Adverse event: Renal artery stenosis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 3485 at risk

Adverse event: Renal colic
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 3485 at risk

Adverse event: Renal mass
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 3485 at risk

Adverse event: Anuria
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 3485 at risk

Adverse event: Cystocele
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 3485 at risk

Adverse event: Dysuria
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 3485 at risk

Adverse event: Hypertensive nephropathy
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 3485 at risk

Adverse event: Mesangioproliferative glomerulonephritis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 3485 at risk

Adverse event: Oliguria
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 3485 at risk

Adverse event: Proteinuria
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 3485 at risk

Adverse event: Renal disorder
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 3485 at risk

Adverse event: Renal tubular necrosis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 3485 at risk

Adverse event: Tubulointerstitial nephritis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 3485 at risk

Adverse event: Urinary incontinence
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 3485 at risk

Adverse event: Benign prostatic hyperplasia
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 8 affected / 3485 at risk

Adverse event: Uterine polyp
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 2 affected / 3485 at risk

Adverse event: Cervical polyp
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 3485 at risk

Adverse event: Cystocele
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 3485 at risk

Adverse event: Endometrial hypertrophy
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 3485 at risk

Adverse event: Vaginal haemorrhage
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 3485 at risk

Adverse event: Vaginal leukoplakia
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 3485 at risk

Adverse event: Lymphatic malformation
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 3485 at risk

Adverse event: Dermoid cyst
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 3485 at risk

Adverse event: Gastrointestinal arteriovenous malformation
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 3485 at risk

Adverse event: Hypertrophic cardiomyopathy
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 3485 at risk

Adverse event: Keratosis follicular
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 3485 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 23 affected / 3485 at risk

Adverse event: Non-cardiac chest pain
Serious: yes
Organ System: General disorders
Frequency: 15 affected / 3485 at risk

Adverse event: Sudden death
Serious: yes
Organ System: General disorders
Frequency: 20 affected / 3485 at risk

Adverse event: Cardiac death
Serious: yes
Organ System: General disorders
Frequency: 5 affected / 3485 at risk

Adverse event: Asthenia
Serious: yes
Organ System: General disorders
Frequency: 8 affected / 3485 at risk

Adverse event: Chest pain
Serious: yes
Organ System: General disorders
Frequency: 4 affected / 3485 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 3485 at risk

Adverse event: Multiple organ dysfunction syndrome
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 3485 at risk

Adverse event: Generalised oedema
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 3485 at risk

Adverse event: Oedema peripheral
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 3485 at risk

Adverse event: Sudden cardiac death
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 3485 at risk

Adverse event: Chest discomfort
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 3485 at risk

Adverse event: Vascular stent stenosis
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 3485 at risk

Adverse event: Chronic fatigue syndrome
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 3485 at risk

Adverse event: Fatigue
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 3485 at risk

Adverse event: Impaired healing
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 3485 at risk

Adverse event: Injection site haematoma
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 3485 at risk

Adverse event: Malaise
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 3485 at risk

Adverse event: Peripheral swelling
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 3485 at risk

Adverse event: Strangulated hernia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 3485 at risk

Adverse event: Glomerular filtration rate decreased
Serious: yes
Organ System: Investigations
Frequency: 30 affected / 3485 at risk

Adverse event: Lipase increased
Serious: yes
Organ System: Investigations
Frequency: 5 affected / 3485 at risk

Adverse event: Blood creatinine increased
Serious: yes
Organ System: Investigations
Frequency: 3 affected / 3485 at risk

Adverse event: Blood pressure increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 3485 at risk

Adverse event: Glycosylated haemoglobin increased
Serious: yes
Organ System: Investigations
Frequency: 2 affected / 3485 at risk

Adverse event: Troponin increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 3485 at risk

Adverse event: Alanine aminotransferase increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 3485 at risk

Adverse event: Aspartate aminotransferase increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 3485 at risk

Adverse event: Bronchial aspiration procedure
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 3485 at risk

Adverse event: Creatinine renal clearance decreased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 3485 at risk

Adverse event: Electrocardiogram QT prolonged
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 3485 at risk

Adverse event: International normalised ratio increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 3485 at risk

Adverse event: Liver function test abnormal
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 3485 at risk

Adverse event: Prostatic specific antigen increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 3485 at risk

Adverse event: Staphylococcus test positive
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 3485 at risk

Adverse event: Urine output decreased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 3485 at risk

Adverse event: Fall
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 25 affected / 3485 at risk

Adverse event: Femur fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 6 affected / 3485 at risk

Adverse event: Hip fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 7 affected / 3485 at risk

Adverse event: Limb injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 5 affected / 3485 at risk

Adverse event: Road traffic accident
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 7 affected / 3485 at risk

Adverse event: Contusion
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 3485 at risk

Adverse event: Tibia fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 3485 at risk

Adverse event: Humerus fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 3485 at risk

Adverse event: Rib fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 3485 at risk

Adverse event: Subdural haematoma
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 3485 at risk

Adverse event: Femoral neck fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 3485 at risk

Adverse event: Head injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 3485 at risk

Adverse event: Craniofacial fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 3485 at risk

Adverse event: Foot fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 3485 at risk

Adverse event: Lower limb fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 3485 at risk

Adverse event: Patella fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 3485 at risk

Adverse event: Pelvic fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 3485 at risk

Adverse event: Tendon rupture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 3485 at risk

Adverse event: Wound dehiscence
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 3485 at risk

Adverse event: Craniocerebral injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 3485 at risk

Adverse event: Overdose
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 3485 at risk

Adverse event: Upper limb fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 3485 at risk

Adverse event: Arteriovenous fistula site complication
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 3485 at risk

Adverse event: Back injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 3485 at risk

Adverse event: Fibula fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 3485 at risk

Adverse event: Hyphaema
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 3485 at risk

Adverse event: Joint dislocation
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 3485 at risk

Adverse event: Post procedural haemorrhage
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 3485 at risk

Adverse event: Subarachnoid haemorrhage
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 3485 at risk

Adverse event: Bone contusion
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 3485 at risk

Adverse event: Brain contusion
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 3485 at risk

Adverse event: Burns second degree
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 3485 at risk

Adverse event: Carbon monoxide poisoning
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 3485 at risk

Adverse event: Cervical vertebral fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 3485 at risk

Adverse event: Chest injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 3485 at risk

Adverse event: Hand fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 3485 at risk

Adverse event: Myocardial injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 3485 at risk

Adverse event: Incomplete spinal fusion
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 3485 at risk

Adverse event: Injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 3485 at risk

Adverse event: Jaw fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 3485 at risk

Adverse event: Skin laceration
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 3485 at risk

Adverse event: Lumbar vertebral fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 3485 at risk

Adverse event: Multiple injuries
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 3485 at risk

Adverse event: Muscle injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 3485 at risk

Adverse event: Muscle strain
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 3485 at risk

Adverse event: Periprocedural myocardial infarction
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 3485 at risk

Adverse event: Periprosthetic fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 3485 at risk

Adverse event: Post procedural complication
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 3485 at risk

Adverse event: Procedural hypotension
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 3485 at risk

Adverse event: Procedural intestinal perforation
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 3485 at risk

Adverse event: Scar
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 3485 at risk

Adverse event: Skeletal injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 3485 at risk

Adverse event: Spinal fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 3485 at risk

Adverse event: Splenic rupture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 3485 at risk

Adverse event: Stoma site polyp
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 3485 at risk

Adverse event: Subdural haemorrhage
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 3485 at risk

Adverse event: Traumatic liver injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 3485 at risk

Adverse event: Ulna fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 3485 at risk

Adverse event: VIth nerve injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 3485 at risk

Adverse event: Wound
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 3485 at risk

Adverse event: Wound necrosis
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 3485 at risk

Adverse event: Coronary revascularisation
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 3485 at risk

Adverse event: Peripheral endarterectomy
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 3485 at risk

Adverse event: Device malfunction
Serious: yes
Organ System: Product Issues
Frequency: 2 affected / 3485 at risk

Adverse event: Device failure
Serious: yes
Organ System: Product Issues
Frequency: 1 affected / 3485 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 162 affected / 3485 at risk

Adverse event: Hypoglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1003 affected / 3485 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 240 affected / 3485 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 232 affected / 3485 at risk

Adverse event: Glomerular filtration rate decreased
Serious: no
Organ System: Investigations
Frequency: 200 affected / 3485 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 99 affected / 3494 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 30 affected / 3494 at risk

Adverse event: Cellulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 22 affected / 3494 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 18 affected / 3494 at risk

Adverse event: Bronchitis
Serious: yes
Organ System: Infections and infestations
Frequency: 8 affected / 3494 at risk

Adverse event: Osteomyelitis
Serious: yes
Organ System: Infections and infestations
Frequency: 11 affected / 3494 at risk

Adverse event: Septic shock
Serious: yes
Organ System: Infections and infestations
Frequency: 13 affected / 3494 at risk

Adverse event: Gangrene
Serious: yes
Organ System: Infections and infestations
Frequency: 10 affected / 3494 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 11 affected / 3494 at risk

Adverse event: Localised infection
Serious: yes
Organ System: Infections and infestations
Frequency: 10 affected / 3494 at risk

Adverse event: Pyelonephritis
Serious: yes
Organ System: Infections and infestations
Frequency: 14 affected / 3494 at risk

Adverse event: Urosepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 5 affected / 3494 at risk

Adverse event: Respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 3494 at risk

Adverse event: Diabetic foot infection
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 3494 at risk

Adverse event: Influenza
Serious: yes
Organ System: Infections and infestations
Frequency: 7 affected / 3494 at risk

Adverse event: Pyelonephritis acute
Serious: yes
Organ System: Infections and infestations
Frequency: 6 affected / 3494 at risk

Adverse event: Erysipelas
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 3494 at risk

Adverse event: Infected skin ulcer
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3494 at risk

Adverse event: Lower respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 3494 at risk

Adverse event: Abscess limb
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 3494 at risk

Adverse event: Device related infection
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 3494 at risk

Adverse event: Peritonitis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 3494 at risk

Adverse event: Upper respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 3494 at risk

Adverse event: Bacteraemia
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 3494 at risk

Adverse event: Necrotising fasciitis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 3494 at risk

Adverse event: Postoperative wound infection
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 3494 at risk

Adverse event: Catheter site infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3494 at risk

Adverse event: Diabetic gangrene
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3494 at risk

Adverse event: Diverticulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 3494 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 3494 at risk

Adverse event: Post procedural infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3494 at risk

Adverse event: Arthritis bacterial
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3494 at risk

Adverse event: Clostridium difficile colitis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 3494 at risk

Adverse event: Endocarditis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3494 at risk

Adverse event: Escherichia sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 3494 at risk

Adverse event: Infection
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 3494 at risk

Adverse event: Pneumonia bacterial
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 3494 at risk

Adverse event: Pulmonary sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 3494 at risk

Adverse event: Soft tissue infection
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 3494 at risk

Adverse event: Bacterial infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3494 at risk

Adverse event: Carbuncle
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3494 at risk

Adverse event: Device related sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3494 at risk

Adverse event: Escherichia urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3494 at risk

Adverse event: Gastroenteritis viral
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 3494 at risk

Adverse event: Herpes zoster
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 3494 at risk

Adverse event: Intervertebral discitis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 3494 at risk

Adverse event: Osteomyelitis chronic
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3494 at risk

Adverse event: Scrotal abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 3494 at risk

Adverse event: Staphylococcal infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3494 at risk

Adverse event: Staphylococcal sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3494 at risk

Adverse event: Urinary tract infection fungal
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3494 at risk

Adverse event: Abdominal sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3494 at risk

Adverse event: Abdominal wall abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3494 at risk

Adverse event: Clostridium difficile infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3494 at risk

Adverse event: Disseminated tuberculosis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3494 at risk

Adverse event: Endocarditis bacterial
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3494 at risk

Adverse event: Enteritis infectious
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3494 at risk

Adverse event: Epididymitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3494 at risk

Adverse event: Escherichia bacteraemia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3494 at risk

Adverse event: Fungal peritonitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3494 at risk

Adverse event: Gastroenteritis norovirus
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3494 at risk

Adverse event: Gastrointestinal bacterial infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3494 at risk

Adverse event: Gastrointestinal infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3494 at risk

Adverse event: H1N1 influenza
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3494 at risk

Adverse event: Histoplasmosis disseminated
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3494 at risk

Adverse event: Infected dermal cyst
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3494 at risk

Adverse event: Large intestine infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3494 at risk

Adverse event: Injection site abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3494 at risk

Adverse event: Klebsiella bacteraemia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3494 at risk

Adverse event: Klebsiella infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3494 at risk

Adverse event: Klebsiella sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3494 at risk

Adverse event: Leptospirosis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3494 at risk

Adverse event: Meningitis viral
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3494 at risk

Adverse event: Mycoplasma infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3494 at risk

Adverse event: Oral candidiasis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3494 at risk

Adverse event: Orchitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3494 at risk

Adverse event: Peritonsillar abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3494 at risk

Adverse event: Pneumonia klebsiella
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3494 at risk

Adverse event: Pneumonia legionella
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3494 at risk

Adverse event: Pneumonia pneumococcal
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3494 at risk

Adverse event: Pseudomembranous colitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3494 at risk

Adverse event: Pseudomonas infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3494 at risk

Adverse event: Scrub typhus
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3494 at risk

Adverse event: Sialoadenitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3494 at risk

Adverse event: Streptococcal bacteraemia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3494 at risk

Adverse event: Tonsillitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3494 at risk

Adverse event: Tracheobronchitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3494 at risk

Adverse event: Urinary tract infection pseudomonal
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3494 at risk

Adverse event: Viraemia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3494 at risk

Adverse event: Viral tonsillitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3494 at risk

Adverse event: Basal cell carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 14 affected / 3494 at risk

Adverse event: Prostate cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 9 affected / 3494 at risk

Adverse event: Squamous cell carcinoma of skin
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 8 affected / 3494 at risk

Adverse event: Lung neoplasm malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 7 affected / 3494 at risk

Adverse event: Colon cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 3494 at risk

Adverse event: Breast cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 3494 at risk

Adverse event: Adenocarcinoma of colon
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 3494 at risk

Adverse event: Bladder cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 3494 at risk

Adverse event: Bladder transitional cell carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 3494 at risk

Adverse event: Hepatic cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 3494 at risk

Adverse event: Invasive ductal breast carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 3494 at risk

Adverse event: Lung adenocarcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 3 affected / 3494 at risk

Adverse event: Myelodysplastic syndrome
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 3494 at risk

Adverse event: Plasma cell myeloma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 3494 at risk

Adverse event: Renal cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 3 affected / 3494 at risk

Adverse event: Transitional cell carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 3494 at risk

Adverse event: Bowen's disease
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 3494 at risk

Adverse event: Colorectal adenoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 3494 at risk

Adverse event: Hepatocellular carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 3494 at risk

Adverse event: Metastases to bone
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 3494 at risk

Adverse event: Rectal adenocarcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 3494 at risk

Adverse event: Adenocarcinoma gastric
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 3494 at risk

Adverse event: Benign breast neoplasm
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 3494 at risk

Adverse event: Lung neoplasm
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 3494 at risk

Adverse event: Malignant melanoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 3494 at risk

Adverse event: Mediastinum neoplasm
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 3494 at risk

Adverse event: Meningioma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 3494 at risk

Adverse event: Pancreatic carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 3494 at risk

Adverse event: Plasmacytoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 3494 at risk

Adverse event: Prostate cancer metastatic
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 3494 at risk

Adverse event: Rectal cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 3494 at risk

Adverse event: Renal neoplasm
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 3494 at risk

Adverse event: Small cell lung cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 3494 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 / 3494 at risk

Adverse event: Basosquamous carcinoma of skin
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 3494 at risk

Adverse event: Brain neoplasm
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 3494 at risk

Adverse event: Cardiac neoplasm unspecified
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 3494 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 / 3494 at risk

Adverse event: Endometrial cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 3494 at risk

Adverse event: Gallbladder cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 3494 at risk

Adverse event: Gastric adenoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 3494 at risk

Adverse event: Intraductal proliferative breast lesion
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 3494 at risk

Adverse event: Laryngeal cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 3494 at risk

Adverse event: Lung cancer metastatic
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 3494 at risk

Adverse event: Metastases to lung
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 3494 at risk

Adverse event: Metastases to spine
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 3494 at risk

Adverse event: Metastatic malignant melanoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 3494 at risk

Adverse event: Myeloproliferative neoplasm
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 3494 at risk

Adverse event: Neuroendocrine tumour
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 3494 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 / 3494 at risk

Adverse event: Oesophageal adenocarcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 3494 at risk

Adverse event: Oesophageal carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 3494 at risk

Adverse event: Pancreatic carcinoma metastatic
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 3494 at risk

Adverse event: Pancreatic neoplasm
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 3494 at risk

Adverse event: Penile squamous cell carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 3494 at risk

Adverse event: Prostatic adenoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 3494 at risk

Adverse event: Schwannoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 3494 at risk

Adverse event: Sebaceous adenoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 3494 at risk

Adverse event: Testis cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 3494 at risk

Adverse event: Tongue cancer recurrent
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 3494 at risk

Adverse event: Tongue neoplasm malignant stage unspecified
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 3494 at risk

Adverse event: Transitional cell cancer of the renal pelvis and ureter
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 3494 at risk

Adverse event: Tumour of ampulla of Vater
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 3494 at risk

Adverse event: Vulval cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 3494 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 19 affected / 3494 at risk

Adverse event: Lymphadenopathy
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 3494 at risk

Adverse event: Thrombocytopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Autoimmune haemolytic anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Blood loss anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 3494 at risk

Adverse event: Immune thrombocytopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Leukocytosis
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Eosinophilia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Febrile neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Lymphadenitis
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Nephrogenic anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Hypersensitivity
Serious: yes
Organ System: Immune system disorders
Frequency: 2 affected / 3494 at risk

Adverse event: Drug hypersensitivity
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Goitre
Serious: yes
Organ System: Endocrine disorders
Frequency: 2 affected / 3494 at risk

Adverse event: Hyperthyroidism
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Thyroid mass
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Hypoglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 28 affected / 3494 at risk

Adverse event: Hyperkalaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 16 affected / 3494 at risk

Adverse event: Hyperglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 12 affected / 3494 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 11 affected / 3494 at risk

Adverse event: Diabetes mellitus inadequate control
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 7 affected / 3494 at risk

Adverse event: Diabetes mellitus
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 9 affected / 3494 at risk

Adverse event: Hypervolaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 3494 at risk

Adverse event: Diabetic metabolic decompensation
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 10 affected / 3494 at risk

Adverse event: Hyponatraemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 6 affected / 3494 at risk

Adverse event: Metabolic acidosis
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 7 affected / 3494 at risk

Adverse event: Diabetic ketoacidosis
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 3494 at risk

Adverse event: Electrolyte imbalance
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 3494 at risk

Adverse event: Hypokalaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 3494 at risk

Adverse event: Type 2 diabetes mellitus
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 3494 at risk

Adverse event: Gout
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 3494 at risk

Adverse event: Hyperlipasaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 3494 at risk

Adverse event: Lactic acidosis
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 3494 at risk

Adverse event: Fluid retention
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Hypercalcaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Hypocalcaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 3494 at risk

Adverse event: Abnormal loss of weight
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Decreased appetite
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Failure to thrive
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Fluid imbalance
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Hyperphosphataemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Hypertriglyceridaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Vitamin D deficiency
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Delirium
Serious: yes
Organ System: Psychiatric disorders
Frequency: 4 affected / 3494 at risk

Adverse event: Major depression
Serious: yes
Organ System: Psychiatric disorders
Frequency: 2 affected / 3494 at risk

Adverse event: Mental status changes
Serious: yes
Organ System: Psychiatric disorders
Frequency: 2 affected / 3494 at risk

Adverse event: Depression
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Anxiety
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Confusional state
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Adjustment disorder
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Affect lability
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Ischaemic stroke
Serious: yes
Organ System: Nervous system disorders
Frequency: 61 affected / 3494 at risk

Adverse event: Syncope
Serious: yes
Organ System: Nervous system disorders
Frequency: 15 affected / 3494 at risk

Adverse event: Transient ischaemic attack
Serious: yes
Organ System: Nervous system disorders
Frequency: 27 affected / 3494 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Nervous system disorders
Frequency: 10 affected / 3494 at risk

Adverse event: Haemorrhagic stroke
Serious: yes
Organ System: Nervous system disorders
Frequency: 10 affected / 3494 at risk

Adverse event: Dementia
Serious: yes
Organ System: Nervous system disorders
Frequency: 8 affected / 3494 at risk

Adverse event: Diabetic neuropathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 7 affected / 3494 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 5 affected / 3494 at risk

Adverse event: Cerebral infarction
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 3494 at risk

Adverse event: Presyncope
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 3494 at risk

Adverse event: Carotid artery stenosis
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 3494 at risk

Adverse event: Cerebral ischaemia
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 3494 at risk

Adverse event: Facial paralysis
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 3494 at risk

Adverse event: Headache
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Loss of consciousness
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 3494 at risk

Adverse event: Dizziness
Serious: yes
Organ System: Nervous system disorders
Frequency: 4 affected / 3494 at risk

Adverse event: Encephalopathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 3494 at risk

Adverse event: Haemorrhage intracranial
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 3494 at risk

Adverse event: Myelopathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Altered state of consciousness
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 3494 at risk

Adverse event: Cerebral haemorrhage
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 3494 at risk

Adverse event: Diabetic coma
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 3494 at risk

Adverse event: Epilepsy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Hypertensive encephalopathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 3494 at risk

Adverse event: Lacunar infarction
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Brain oedema
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Brain stem infarction
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Embolic stroke
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Facial nerve disorder
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Hemiplegia
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 3494 at risk

Adverse event: Hypoglycaemic coma
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Hypoxic-ischaemic encephalopathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Intracranial aneurysm
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 3494 at risk

Adverse event: Ischaemic cerebral infarction
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Lumbar radiculopathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Neuropathy peripheral
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 3494 at risk

Adverse event: Parkinson's disease
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Partial seizures
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 3494 at risk

Adverse event: Sciatica
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 3494 at risk

Adverse event: Thrombotic stroke
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Vertebrobasilar insufficiency
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Carotid sinus syndrome
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Carpal tunnel syndrome
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Cervical radiculopathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Dyskinesia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Intracranial pressure increased
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Lacunar stroke
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Metabolic encephalopathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Multiple sclerosis
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Neuritis cranial
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Neuroglycopenia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Paraesthesia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Post stroke seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Spinal cord compression
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Spinal epidural haematoma
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Cataract
Serious: yes
Organ System: Eye disorders
Frequency: 11 affected / 3494 at risk

Adverse event: Glaucoma
Serious: yes
Organ System: Eye disorders
Frequency: 6 affected / 3494 at risk

Adverse event: Vitreous haemorrhage
Serious: yes
Organ System: Eye disorders
Frequency: 6 affected / 3494 at risk

Adverse event: Retinal detachment
Serious: yes
Organ System: Eye disorders
Frequency: 4 affected / 3494 at risk

Adverse event: Diabetic retinopathy
Serious: yes
Organ System: Eye disorders
Frequency: 3 affected / 3494 at risk

Adverse event: Macular hole
Serious: yes
Organ System: Eye disorders
Frequency: 4 affected / 3494 at risk

Adverse event: Retinal vein occlusion
Serious: yes
Organ System: Eye disorders
Frequency: 3 affected / 3494 at risk

Adverse event: Ulcerative keratitis
Serious: yes
Organ System: Eye disorders
Frequency: 2 affected / 3494 at risk

Adverse event: Diplopia
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Macular degeneration
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Angle closure glaucoma
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Macular fibrosis
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Amaurosis
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Blindness
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Blindness unilateral
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Cataract cortical
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Corneal decompensation
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Cystoid macular oedema
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Diabetic retinal oedema
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Dry age-related macular degeneration
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Macular oedema
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Optic ischaemic neuropathy
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Retinal artery embolism
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Retinal artery occlusion
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Retinopathy
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Deafness neurosensory
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 4 affected / 3494 at risk

Adverse event: Vertigo
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 3 affected / 3494 at risk

Adverse event: Deafness
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Deafness bilateral
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Deafness unilateral
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 2 affected / 3494 at risk

Adverse event: Hypoacusis
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 2 affected / 3494 at risk

Adverse event: Vertigo positional
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Conductive deafness
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Cardiac failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 104 affected / 3494 at risk

Adverse event: Cardiac failure congestive
Serious: yes
Organ System: Cardiac disorders
Frequency: 77 affected / 3494 at risk

Adverse event: Angina unstable
Serious: yes
Organ System: Cardiac disorders
Frequency: 77 affected / 3494 at risk

Adverse event: Acute myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 78 affected / 3494 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 47 affected / 3494 at risk

Adverse event: Angina pectoris
Serious: yes
Organ System: Cardiac disorders
Frequency: 42 affected / 3494 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 34 affected / 3494 at risk

Adverse event: Coronary artery disease
Serious: yes
Organ System: Cardiac disorders
Frequency: 26 affected / 3494 at risk

Adverse event: Cardiac failure chronic
Serious: yes
Organ System: Cardiac disorders
Frequency: 24 affected / 3494 at risk

Adverse event: Cardiac arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 25 affected / 3494 at risk

Adverse event: Myocardial ischaemia
Serious: yes
Organ System: Cardiac disorders
Frequency: 20 affected / 3494 at risk

Adverse event: Acute coronary syndrome
Serious: yes
Organ System: Cardiac disorders
Frequency: 12 affected / 3494 at risk

Adverse event: Left ventricular failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 13 affected / 3494 at risk

Adverse event: Atrial flutter
Serious: yes
Organ System: Cardiac disorders
Frequency: 13 affected / 3494 at risk

Adverse event: Cardiogenic shock
Serious: yes
Organ System: Cardiac disorders
Frequency: 8 affected / 3494 at risk

Adverse event: Atrioventricular block complete
Serious: yes
Organ System: Cardiac disorders
Frequency: 9 affected / 3494 at risk

Adverse event: Cardiac failure acute
Serious: yes
Organ System: Cardiac disorders
Frequency: 10 affected / 3494 at risk

Adverse event: Cardio-respiratory arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 8 affected / 3494 at risk

Adverse event: Coronary artery stenosis
Serious: yes
Organ System: Cardiac disorders
Frequency: 5 affected / 3494 at risk

Adverse event: Bradycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 5 affected / 3494 at risk

Adverse event: Sinus node dysfunction
Serious: yes
Organ System: Cardiac disorders
Frequency: 7 affected / 3494 at risk

Adverse event: Acute left ventricular failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Atrioventricular block second degree
Serious: yes
Organ System: Cardiac disorders
Frequency: 5 affected / 3494 at risk

Adverse event: Coronary artery occlusion
Serious: yes
Organ System: Cardiac disorders
Frequency: 6 affected / 3494 at risk

Adverse event: Arteriosclerosis coronary artery
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 3494 at risk

Adverse event: Atrioventricular block
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 3494 at risk

Adverse event: Ischaemic cardiomyopathy
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 3494 at risk

Adverse event: Ventricular tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 3494 at risk

Adverse event: Cardiomyopathy
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 3494 at risk

Adverse event: Cardiopulmonary failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 3494 at risk

Adverse event: Ventricular fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Arrhythmia
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 3494 at risk

Adverse event: Cardiovascular insufficiency
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 3494 at risk

Adverse event: Sinus bradycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 3494 at risk

Adverse event: Supraventricular tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Aortic valve incompetence
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Bundle branch block left
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Cardiac disorder
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 3494 at risk

Adverse event: Diastolic dysfunction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Mitral valve incompetence
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 3494 at risk

Adverse event: Myocardial fibrosis
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Pericardial effusion
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 3494 at risk

Adverse event: Silent myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Sinus tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Systolic dysfunction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Aortic valve disease
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Cardiac tamponade
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Conduction disorder
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Cyanosis
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Degenerative mitral valve disease
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Mitral valve stenosis
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Pericarditis constrictive
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Pulseless electrical activity
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Tachyarrhythmia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Tricuspid valve incompetence
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Trifascicular block
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Vascular disorders
Frequency: 32 affected / 3494 at risk

Adverse event: Hypertensive crisis
Serious: yes
Organ System: Vascular disorders
Frequency: 16 affected / 3494 at risk

Adverse event: Peripheral arterial occlusive disease
Serious: yes
Organ System: Vascular disorders
Frequency: 18 affected / 3494 at risk

Adverse event: Deep vein thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 12 affected / 3494 at risk

Adverse event: Peripheral artery occlusion
Serious: yes
Organ System: Vascular disorders
Frequency: 5 affected / 3494 at risk

Adverse event: Peripheral ischaemia
Serious: yes
Organ System: Vascular disorders
Frequency: 5 affected / 3494 at risk

Adverse event: Aortic stenosis
Serious: yes
Organ System: Vascular disorders
Frequency: 8 affected / 3494 at risk

Adverse event: Peripheral vascular disorder
Serious: yes
Organ System: Vascular disorders
Frequency: 6 affected / 3494 at risk

Adverse event: Extremity necrosis
Serious: yes
Organ System: Vascular disorders
Frequency: 3 affected / 3494 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Vascular disorders
Frequency: 5 affected / 3494 at risk

Adverse event: Peripheral artery stenosis
Serious: yes
Organ System: Vascular disorders
Frequency: 3 affected / 3494 at risk

Adverse event: Orthostatic hypotension
Serious: yes
Organ System: Vascular disorders
Frequency: 6 affected / 3494 at risk

Adverse event: Aortic aneurysm
Serious: yes
Organ System: Vascular disorders
Frequency: 4 affected / 3494 at risk

Adverse event: Hypovolaemic shock
Serious: yes
Organ System: Vascular disorders
Frequency: 4 affected / 3494 at risk

Adverse event: Peripheral vein thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 3 affected / 3494 at risk

Adverse event: Arteriosclerosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Hypertensive emergency
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 3494 at risk

Adverse event: Circulatory collapse
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 3494 at risk

Adverse event: Accelerated hypertension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Angiopathy
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Dry gangrene
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Intermittent claudication
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 3494 at risk

Adverse event: Thrombophlebitis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Superficial vein thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 3494 at risk

Adverse event: Varicose ulceration
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 3494 at risk

Adverse event: Arterial insufficiency
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Arterial rupture
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Blood pressure inadequately controlled
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Diabetic vascular disorder
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Embolism arterial
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Embolism venous
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Femoral artery aneurysm
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Iliac artery occlusion
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Peripheral artery thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Peripheral venous disease
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Subclavian artery stenosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 21 affected / 3494 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 16 affected / 3494 at risk

Adverse event: Pulmonary oedema
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 16 affected / 3494 at risk

Adverse event: Acute pulmonary oedema
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 13 affected / 3494 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 13 affected / 3494 at risk

Adverse event: Pulmonary hypertension
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 12 affected / 3494 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 9 affected / 3494 at risk

Adverse event: Acute respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 9 affected / 3494 at risk

Adverse event: Pleural effusion
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 3494 at risk

Adverse event: Asthma
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 3494 at risk

Adverse event: Dyspnoea exertional
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Pulmonary fibrosis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Hypoxia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 3494 at risk

Adverse event: Epistaxis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 3494 at risk

Adverse event: Pulmonary mass
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 3494 at risk

Adverse event: Respiratory arrest
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 3494 at risk

Adverse event: Haemoptysis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 3494 at risk

Adverse event: Pneumonia aspiration
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 3494 at risk

Adverse event: Respiratory distress
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 3494 at risk

Adverse event: Sleep apnoea syndrome
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Asphyxia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 3494 at risk

Adverse event: Chronic respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Cough
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Emphysema
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 3494 at risk

Adverse event: Pulmonary congestion
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Wheezing
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 3494 at risk

Adverse event: Acute respiratory distress syndrome
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Aspiration
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Atelectasis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Eosinophilic pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Haemothorax
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Interstitial lung disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Laryngeal oedema
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Mediastinal mass
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Pneumonitis aspiration
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Pneumonitis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Portopulmonary hypertension
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Vocal cord polyp
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Gastrointestinal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 3494 at risk

Adverse event: Gastritis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 3494 at risk

Adverse event: Upper gastrointestinal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 3494 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 3494 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 3494 at risk

Adverse event: Pancreatitis acute
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 3494 at risk

Adverse event: Inguinal hernia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 3494 at risk

Adverse event: Pancreatitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 3494 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 3494 at risk

Adverse event: Constipation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 3494 at risk

Adverse event: Pancreatitis chronic
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 3494 at risk

Adverse event: Abdominal hernia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 3494 at risk

Adverse event: Large intestine polyp
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 3494 at risk

Adverse event: Lower gastrointestinal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 3494 at risk

Adverse event: Intestinal obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 3494 at risk

Adverse event: Colitis ischaemic
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 3494 at risk

Adverse event: Gastric ulcer
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 3494 at risk

Adverse event: Chronic gastritis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 3494 at risk

Adverse event: Haematochezia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 3494 at risk

Adverse event: Rectal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 3494 at risk

Adverse event: Small intestinal obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 3494 at risk

Adverse event: Haemorrhoids
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 3494 at risk

Adverse event: Hiatus hernia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Melaena
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 3494 at risk

Adverse event: Abdominal adhesions
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 3494 at risk

Adverse event: Abdominal wall haematoma
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Ascites
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Colitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 3494 at risk

Adverse event: Diverticulum intestinal
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Diverticulum intestinal haemorrhagic
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 3494 at risk

Adverse event: Enterocolitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Gastric haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Gastric polyps
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Gastrointestinal necrosis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Ileus
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Incarcerated inguinal hernia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Intestinal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Irritable bowel syndrome
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Mesenteric artery thrombosis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Obstructive pancreatitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Abdominal hernia obstructive
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Abdominal tenderness
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Anal fissure
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Barrett's oesophagus
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Duodenal perforation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Duodenal vascular ectasia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Duodenitis haemorrhagic
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Enteritis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Enterocolitis haemorrhagic
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Enterovesical fistula
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Faecaloma
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Gastric antral vascular ectasia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Gastritis erosive
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Gastritis haemorrhagic
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Haematemesis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Large intestinal obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Mechanical ileus
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Oedema mouth
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Pancreatic failure
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Retroperitoneal fibrosis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Tongue oedema
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Cholelithiasis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 10 affected / 3494 at risk

Adverse event: Cholecystitis acute
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 10 affected / 3494 at risk

Adverse event: Cholecystitis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 7 affected / 3494 at risk

Adverse event: Hepatic cirrhosis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 5 affected / 3494 at risk

Adverse event: Hepatic failure
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 3 affected / 3494 at risk

Adverse event: Bile duct stone
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 2 affected / 3494 at risk

Adverse event: Biliary colic
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 2 affected / 3494 at risk

Adverse event: Cholecystitis chronic
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Hepatic steatosis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 2 affected / 3494 at risk

Adverse event: Autoimmune hepatitis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Biliary obstruction
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Biliary dyspepsia
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Jaundice
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Portal hypertension
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Portal vein thrombosis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Diabetic foot
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 21 affected / 3494 at risk

Adverse event: Skin ulcer
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 7 affected / 3494 at risk

Adverse event: Angioedema
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 3494 at risk

Adverse event: Ischaemic skin ulcer
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Pemphigoid
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 3494 at risk

Adverse event: Pruritus
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 3494 at risk

Adverse event: Decubitus ulcer
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Dermal cyst
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Dermatitis bullous
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Dermatitis exfoliative generalised
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Ichthyosis acquired
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Lentigo
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Rash
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Skin necrosis
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Skin ulcer haemorrhage
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Swelling face
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Toxic epidermal necrolysis
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Osteoarthritis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 15 affected / 3494 at risk

Adverse event: Musculoskeletal chest pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 3494 at risk

Adverse event: Intervertebral disc protrusion
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 3494 at risk

Adverse event: Lumbar spinal stenosis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Rhabdomyolysis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 3494 at risk

Adverse event: Spinal osteoarthritis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 3494 at risk

Adverse event: Arthritis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 3494 at risk

Adverse event: Back pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 3494 at risk

Adverse event: Spinal stenosis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 3494 at risk

Adverse event: Intervertebral disc disorder
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 3494 at risk

Adverse event: Musculoskeletal pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 3494 at risk

Adverse event: Pain in extremity
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Polymyalgia rheumatica
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 3494 at risk

Adverse event: Spinal pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 3494 at risk

Adverse event: Spondylolisthesis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 3494 at risk

Adverse event: Arthralgia
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Plantar fasciitis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Rotator cuff syndrome
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 3494 at risk

Adverse event: Bursitis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Fibromyalgia
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Gouty arthritis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Joint range of motion decreased
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Limb discomfort
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Myopathy
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Neuropathic arthropathy
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Osteonecrosis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Pathological fracture
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Periostitis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Rheumatoid arthritis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Vertebral osteophyte
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 96 affected / 3494 at risk

Adverse event: End stage renal disease
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 38 affected / 3494 at risk

Adverse event: Chronic kidney disease
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 49 affected / 3494 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 32 affected / 3494 at risk

Adverse event: Renal impairment
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 24 affected / 3494 at risk

Adverse event: Diabetic nephropathy
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 9 affected / 3494 at risk

Adverse event: Nephrolithiasis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 5 affected / 3494 at risk

Adverse event: Urinary retention
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 5 affected / 3494 at risk

Adverse event: Haematuria
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 5 affected / 3494 at risk

Adverse event: Nephrotic syndrome
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 7 affected / 3494 at risk

Adverse event: Azotaemia
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Nephropathy
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 3 affected / 3494 at risk

Adverse event: Hydronephrosis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 4 affected / 3494 at risk

Adverse event: Ureterolithiasis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 4 affected / 3494 at risk

Adverse event: Urinary tract obstruction
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 3494 at risk

Adverse event: Calculus bladder
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 3494 at risk

Adverse event: Nephropathy toxic
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Renal artery stenosis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Renal colic
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Renal mass
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Glomerulonephritis membranous
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Renal pain
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Urethral haemorrhage
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Benign prostatic hyperplasia
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 4 affected / 3494 at risk

Adverse event: Acquired hydrocele
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 2 affected / 3494 at risk

Adverse event: Acquired phimosis
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Haemorrhagic ovarian cyst
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Accessory spleen
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Atrial septal defect
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Myocardial bridging
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 16 affected / 3494 at risk

Adverse event: Non-cardiac chest pain
Serious: yes
Organ System: General disorders
Frequency: 15 affected / 3494 at risk

Adverse event: Sudden death
Serious: yes
Organ System: General disorders
Frequency: 10 affected / 3494 at risk

Adverse event: Cardiac death
Serious: yes
Organ System: General disorders
Frequency: 7 affected / 3494 at risk

Adverse event: Asthenia
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 3494 at risk

Adverse event: Chest pain
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 3494 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 5 affected / 3494 at risk

Adverse event: Multiple organ dysfunction syndrome
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 3494 at risk

Adverse event: Generalised oedema
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 3494 at risk

Adverse event: Oedema peripheral
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Sudden cardiac death
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Chest discomfort
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 3494 at risk

Adverse event: Vascular stent stenosis
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 3494 at risk

Adverse event: Catheter site haemorrhage
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 3494 at risk

Adverse event: Chills
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 3494 at risk

Adverse event: Complication associated with device
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 3494 at risk

Adverse event: General physical health deterioration
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 3494 at risk

Adverse event: Necrobiosis
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 3494 at risk

Adverse event: Application site haemorrhage
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Feeling abnormal
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Medical device site joint inflammation
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Systemic inflammatory response syndrome
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Ulcer haemorrhage
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Vascular stent occlusion
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 3494 at risk

Adverse event: Glomerular filtration rate decreased
Serious: yes
Organ System: Investigations
Frequency: 36 affected / 3494 at risk

Adverse event: Lipase increased
Serious: yes
Organ System: Investigations
Frequency: 4 affected / 3494 at risk

Adverse event: Blood creatinine increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 3494 at risk

Adverse event: Blood pressure increased
Serious: yes
Organ System: Investigations
Frequency: 2 affected / 3494 at risk

Adverse event: Angiocardiogram
Serious: yes
Organ System: Investigations
Frequency: 2 affected / 3494 at risk

Adverse event: Blood glucose increased
Serious: yes
Organ System: Investigations
Frequency: 2 affected / 3494 at risk

Adverse event: Troponin increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 3494 at risk

Adverse event: Catheterisation cardiac
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 3494 at risk

Adverse event: Echocardiogram
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 3494 at risk

Adverse event: Ejection fraction decreased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 3494 at risk

Adverse event: Electrocardiogram T wave inversion
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 3494 at risk

Adverse event: Influenza A virus test positive
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 3494 at risk

Adverse event: Intracardiac pressure increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 3494 at risk

Adverse event: Liver function test increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 3494 at risk

Adverse event: Fall
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 19 affected / 3494 at risk

Adverse event: Femur fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 10 affected / 3494 at risk

Adverse event: Hip fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 3494 at risk

Adverse event: Limb injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 5 affected / 3494 at risk

Adverse event: Road traffic accident
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 3494 at risk

Adverse event: Contusion
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 5 affected / 3494 at risk

Adverse event: Tibia fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 4 affected / 3494 at risk

Adverse event: Humerus fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 3494 at risk

Adverse event: Rib fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 5 affected / 3494 at risk

Adverse event: Subdural haematoma
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 5 affected / 3494 at risk

Adverse event: Ankle fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 5 affected / 3494 at risk

Adverse event: Femoral neck fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 3494 at risk

Adverse event: Head injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 3494 at risk

Adverse event: Craniofacial fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 3494 at risk

Adverse event: Foot fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 3494 at risk

Adverse event: Lower limb fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 3494 at risk

Adverse event: Patella fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 3494 at risk

Adverse event: Pelvic fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 3494 at risk

Adverse event: Tendon rupture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 3494 at risk

Adverse event: Wound dehiscence
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 3494 at risk

Adverse event: Craniocerebral injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 3494 at risk

Adverse event: Overdose
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 3494 at risk

Adverse event: Arteriovenous fistula site complication
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 3494 at risk

Adverse event: Back injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 3494 at risk

Adverse event: Fibula fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 3494 at risk

Adverse event: Hyphaema
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 3494 at risk

Adverse event: Incisional hernia
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 3494 at risk

Adverse event: Joint dislocation
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 3494 at risk

Adverse event: Post procedural haemorrhage
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 3494 at risk

Adverse event: Subarachnoid haemorrhage
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 3494 at risk

Adverse event: Anastomotic complication
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 3494 at risk

Adverse event: Animal bite
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 3494 at risk

Adverse event: Vascular graft occlusion
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 3494 at risk

Adverse event: Arteriovenous fistula thrombosis
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 3494 at risk

Adverse event: Colon injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 3494 at risk

Adverse event: Coronary artery restenosis
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 3494 at risk

Adverse event: Endotracheal intubation complication
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 3494 at risk

Adverse event: Fracture displacement
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 3494 at risk

Adverse event: Joint injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 3494 at risk

Adverse event: Limb crushing injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 3494 at risk

Adverse event: Peritoneal dialysis complication
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 3494 at risk

Adverse event: Pneumothorax traumatic
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 3494 at risk

Adverse event: Postoperative delirium
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 3494 at risk

Adverse event: Postoperative respiratory distress
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 3494 at risk

Adverse event: Radius fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 3494 at risk

Adverse event: Skull fractured base
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 3494 at risk

Adverse event: Compression fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 3494 at risk

Adverse event: Sternal fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 3494 at risk

Adverse event: Stomal hernia
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 3494 at risk

Adverse event: Thoracic vertebral fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 3494 at risk

Adverse event: Traumatic intracranial haemorrhage
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 3494 at risk

Adverse event: Vascular pseudoaneurysm
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 3494 at risk

Adverse event: Wrist fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 3494 at risk

Adverse event: Coronary revascularisation
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 2 affected / 3494 at risk

Adverse event: Hospitalisation
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 3494 at risk

Adverse event: Homicide
Serious: yes
Organ System: Social circumstances
Frequency: 1 affected / 3494 at risk

Adverse event: Limb prosthesis user
Serious: yes
Organ System: Social circumstances
Frequency: 1 affected / 3494 at risk

Adverse event: Device malfunction
Serious: yes
Organ System: Product Issues
Frequency: 2 affected / 3494 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 196 affected / 3494 at risk

Adverse event: Hypoglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1022 affected / 3494 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 208 affected / 3494 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 216 affected / 3494 at risk

Adverse event: Glomerular filtration rate decreased
Serious: no
Organ System: Investigations
Frequency: 202 affected / 3494 at risk