Study: NCT00013611

Adverse event: Aneamias nonhaemolytic and marrow depression
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 849 at risk

Adverse event: Haemolyses and related conditions
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 849 at risk

Adverse event: Platelet disorders
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 849 at risk

Adverse event: Spleen, lymphatic and reticuloendothelial system disorders
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 849 at risk

Adverse event: Cardiac arrythmias
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 849 at risk

Adverse event: Cornoary artery disorders
Serious: yes
Organ System: Cardiac disorders
Frequency: 20 affected / 849 at risk

Adverse event: Heart failures
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 849 at risk

Adverse event: Myocardial disorders
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 849 at risk

Adverse event: Pericardial disorders
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 849 at risk

Adverse event: Cardiac valve disorders
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 849 at risk

Adverse event: Renal and urinary tract disoerders congenital
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 849 at risk

Adverse event: Abdominal hernias and other adominal wall conditions
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 849 at risk

Adverse event: Diverticular disorders
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 849 at risk

Adverse event: Exocrine pancreas conditions
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 849 at risk

Adverse event: Gastrointestinal condictions NEC
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 849 at risk

Adverse event: Gastrointestinal haemorrhages NEC
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 13 affected / 849 at risk

Adverse event: Gastrointestinal inflammatory conditions
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 849 at risk

Adverse event: Gastrointestinal motility and defaecation conditions
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 849 at risk

Adverse event: Gastrointestinal stenosis and obstructions
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 849 at risk

Adverse event: Gastrointestinal signs and symptoms
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 849 at risk

Adverse event: Gastrointestinal ulceration and perforation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 849 at risk

Adverse event: Gastrointestinal vascular conditions
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 849 at risk

Adverse event: Peritoneal and retrooperationael conditions
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 849 at risk

Adverse event: Body temperature conditions
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 849 at risk

Adverse event: General system disorders NEC
Serious: yes
Organ System: General disorders
Frequency: 6 affected / 849 at risk

Adverse event: Fatal outcomes
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 849 at risk

Adverse event: Therapeutic and nontherapeutic effects (excl toxicity)
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 849 at risk

Adverse event: Gallbladder disorders
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 4 affected / 849 at risk

Adverse event: Hepatic and hepatobiliary disorders
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 20 affected / 849 at risk

Adverse event: Allergic conditions
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 849 at risk

Adverse event: Bacterial infectious disorders
Serious: yes
Organ System: Infections and infestations
Frequency: 14 affected / 849 at risk

Adverse event: Fungal infectious disorders
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 849 at risk

Adverse event: Infections - pathogen unspecified
Serious: yes
Organ System: Infections and infestations
Frequency: 28 affected / 849 at risk

Adverse event: Mycobacterial infectious disorders
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 849 at risk

Adverse event: Viral infectious disorders
Serious: yes
Organ System: Infections and infestations
Frequency: 11 affected / 849 at risk

Adverse event: Bone and joint injuries
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 6 affected / 849 at risk

Adverse event: Injuries NEC
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 849 at risk

Adverse event: Procedural and device related injuries and complications NEC
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 849 at risk

Adverse event: Medications errors
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 849 at risk

Adverse event: Chemical injury and poisoning
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 849 at risk

Adverse event: Gastrointestinal investigations
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 849 at risk

Adverse event: Electrolyte and fluid balance conditions
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 849 at risk

Adverse event: Glucose metabolism disorders (incl diabetes mellitus)
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 849 at risk

Adverse event: Purine and pyrimidine metabolism disorders
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 849 at risk

Adverse event: Bone disorders (excl congenital and fractuers)
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 6 affected / 849 at risk

Adverse event: Joint disorders
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 849 at risk

Adverse event: Musculoskeletal and connective tissue disorders NEC
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 849 at risk

Adverse event: Endocrine neoplasms malignant and unspecified
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 849 at risk

Adverse event: Gastrointestinal neoplasms malignant and unspecified
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 7 affected / 849 at risk

Adverse event: Hepatic and biliary neoplasms benign
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 849 at risk

Adverse event: Hepatobiliary neoplasms malignant and unspecified
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 849 at risk

Adverse event: Leukaemias
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 849 at risk

Adverse event: Miscellaneuous and site unspecified neoplasms malignant and unspecified
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 5 affected / 849 at risk

Adverse event: Nervous system neoplasms malignant and unspecified NEC
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 849 at risk

Adverse event: Renal and urinary tract neoplasms malignant and unspecified
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 3 affected / 849 at risk

Adverse event: Reproductive neoplasms female malignant and unspecified
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 849 at risk

Adverse event: Reproductive neoplasms male malignant and unspecified
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 5 affected / 849 at risk

Adverse event: Respiratory and mediastinal neoplams malignant and unspecified
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 12 affected / 849 at risk

Adverse event: Skin neoplasms malignant and unspecified
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 7 affected / 849 at risk

Adverse event: Oncologic complications and emergencies
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 849 at risk

Adverse event: Central nervous system vascular disorders
Serious: yes
Organ System: Nervous system disorders
Frequency: 9 affected / 849 at risk

Adverse event: Cranial nerve disorders (excl neoplasms)
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 849 at risk

Adverse event: Encephalopathies
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 849 at risk

Adverse event: Headaches
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 849 at risk

Adverse event: Movement disorders (incl parkinsonism)
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 849 at risk

Adverse event: Neuromuscular disorders
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 849 at risk

Adverse event: Seizures (incl subtypes)
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 849 at risk

Adverse event: Spinal cord and nreve root disorders
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 849 at risk

Adverse event: Structural brain disorders
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 849 at risk

Adverse event: Anxiety disorders and symptoms
Serious: yes
Organ System: Psychiatric disorders
Frequency: 3 affected / 849 at risk

Adverse event: Cognitive and attention disorders and distrubances
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 849 at risk

Adverse event: Deliria (incl confusion)
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 849 at risk

Adverse event: Depressed mood disorders and disturbances
Serious: yes
Organ System: Psychiatric disorders
Frequency: 7 affected / 849 at risk

Adverse event: Manic and bipolar mood disorders and disturbances
Serious: yes
Organ System: Psychiatric disorders
Frequency: 2 affected / 849 at risk

Adverse event: Psychiatric disorders NEC
Serious: yes
Organ System: Psychiatric disorders
Frequency: 4 affected / 849 at risk

Adverse event: Schizophrenia and other psychotic disorders
Serious: yes
Organ System: Psychiatric disorders
Frequency: 2 affected / 849 at risk

Adverse event: Suicidal and self-injurious behaviours NEC
Serious: yes
Organ System: Psychiatric disorders
Frequency: 10 affected / 849 at risk

Adverse event: Nephropathies
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 849 at risk

Adverse event: Renal disorders (excl nephropathies)
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 5 affected / 849 at risk

Adverse event: Urinary tract signs and symptoms
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 849 at risk

Adverse event: Urolithiases
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 4 affected / 849 at risk

Adverse event: Male reproductive tract infections and inflammations
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 849 at risk

Adverse event: Bronchial disorders (excl neoplasms)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 849 at risk

Adverse event: Thoracic disorders (excl lung and pleura)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 849 at risk

Adverse event: Lower respiratory tract disorders (excl obstruction and infection)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 849 at risk

Adverse event: Pleural disorders
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 849 at risk

Adverse event: Pulmonary vascular disorders
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 849 at risk

Adverse event: Respiratory disorders NEC
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 849 at risk

Adverse event: Epidermal and dermal conditions
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 849 at risk

Adverse event: Vascular therapeutic procedures
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 849 at risk

Adverse event: Nervous system, skull and spine therapeutic procedures
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 849 at risk

Adverse event: Hepatobiliary therapeutic procedures
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 849 at risk

Adverse event: Aneurysms and artery dissections
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 849 at risk

Adverse event: Arteriosclerosis, stenosis, vascular insufficiency and necrosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 849 at risk

Adverse event: Decreased and nonspecific blood pressure disorders and shock
Serious: yes
Organ System: Vascular disorders
Frequency: 3 affected / 849 at risk

Adverse event: Embolism and thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 4 affected / 849 at risk

Adverse event: Vascular disorders NEC
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 849 at risk

Adverse event: Vascular haemorrhagic disorders
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 849 at risk

Adverse event: Aneamias nonhaemolytic and marrow depression
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 6 affected / 846 at risk

Adverse event: White blood cell disorders
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 846 at risk

Adverse event: Cardiac arrythmias
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 846 at risk

Adverse event: Cardiac disorder signs and symptoms
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 846 at risk

Adverse event: Cornoary artery disorders
Serious: yes
Organ System: Cardiac disorders
Frequency: 20 affected / 846 at risk

Adverse event: Heart failures
Serious: yes
Organ System: Cardiac disorders
Frequency: 6 affected / 846 at risk

Adverse event: Myocardial disorders
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 846 at risk

Adverse event: Pericardial disorders
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 846 at risk

Adverse event: Cardiac valve disorders
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 846 at risk

Adverse event: Endocrine disorders of gonadal function
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 846 at risk

Adverse event: Thyroid gland disorders
Serious: yes
Organ System: Endocrine disorders
Frequency: 2 affected / 846 at risk

Adverse event: Ocular neuromuscular disorders
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 846 at risk

Adverse event: Diverticular disorders
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 846 at risk

Adverse event: Exocrine pancreas conditions
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 846 at risk

Adverse event: Gastrointestinal condictions NEC
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 846 at risk

Adverse event: Gastrointestinal haemorrhages NEC
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 846 at risk

Adverse event: Gastrointestinal inflammatory conditions
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 846 at risk

Adverse event: Gastrointestinal motility and defaecation conditions
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 846 at risk

Adverse event: Gastrointestinal stenosis and obstructions
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 846 at risk

Adverse event: Gastrointestinal signs and symptoms
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 846 at risk

Adverse event: Gastrointestinal ulceration and perforation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 846 at risk

Adverse event: Gastrointestinal vascular conditions
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 846 at risk

Adverse event: Peritoneal and retrooperationael conditions
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 846 at risk

Adverse event: Body temperature conditions
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 846 at risk

Adverse event: General system disorders NEC
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 846 at risk

Adverse event: Bile duct disorders
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 2 affected / 846 at risk

Adverse event: Gallbladder disorders
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 7 affected / 846 at risk

Adverse event: Hepatic and hepatobiliary disorders
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 10 affected / 846 at risk

Adverse event: Allergic conditions
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 846 at risk

Adverse event: Immune disorders NEC
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 846 at risk

Adverse event: Bacterial infectious disorders
Serious: yes
Organ System: Infections and infestations
Frequency: 18 affected / 846 at risk

Adverse event: Infections - pathogen unspecified
Serious: yes
Organ System: Infections and infestations
Frequency: 27 affected / 846 at risk

Adverse event: Viral infectious disorders
Serious: yes
Organ System: Infections and infestations
Frequency: 11 affected / 846 at risk

Adverse event: Bone and joint injuries
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 846 at risk

Adverse event: Injuries NEC
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 5 affected / 846 at risk

Adverse event: Procedural and device related injuries and complications NEC
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 5 affected / 846 at risk

Adverse event: Medications errors
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 846 at risk

Adverse event: Chemical injury and poisoning
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 846 at risk

Adverse event: Hepatobiliary investigations
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 846 at risk

Adverse event: Lipid analyses
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 846 at risk

Adverse event: Metabolic, nutritional and blood gas investigations
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 846 at risk

Adverse event: Acid-base disorders
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 846 at risk

Adverse event: Appetite and general nutritional disorders
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 846 at risk

Adverse event: Electrolyte and fluid balance conditions
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 846 at risk

Adverse event: Glucose metabolism disorders (incl diabetes mellitus)
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 846 at risk

Adverse event: Purine and pyrimidine metabolism disorders
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 846 at risk

Adverse event: Bone disorders (excl congenital and fractuers)
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 846 at risk

Adverse event: Joint disorders
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 6 affected / 846 at risk

Adverse event: Musculoskeletal and connective tissue deformities (incl intervertebral disc disorders)
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 846 at risk

Adverse event: Musculoskeletal and connective tissue disorders NEC
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 846 at risk

Adverse event: Endocrine neoplasms malignant and unspecified
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 846 at risk

Adverse event: Gastrointestinal neoplasms malignant and unspecified
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 10 affected / 846 at risk

Adverse event: Hepatobiliary neoplasms malignant and unspecified
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 846 at risk

Adverse event: Leukaemias
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 846 at risk

Adverse event: Mesotheliomas
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 846 at risk

Adverse event: Metastases
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 846 at risk

Adverse event: Miscellaneuous and site unspecified neoplasms malignant and unspecified
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 3 affected / 846 at risk

Adverse event: Miscellaneous and site unspecified neoplasms benign
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 846 at risk

Adverse event: Renal and urinary tract neoplasms malignant and unspecified
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 846 at risk

Adverse event: Reproductive neoplasms female malignant and unspecified
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 846 at risk

Adverse event: Reproductive neoplasms male malignant and unspecified
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 3 affected / 846 at risk

Adverse event: Respiratory and mediastinal neoplams malignant and unspecified
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 11 affected / 846 at risk

Adverse event: Skin neoplasms malignant and unspecified
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 4 affected / 846 at risk

Adverse event: Central nervous system vascular disorders
Serious: yes
Organ System: Nervous system disorders
Frequency: 8 affected / 846 at risk

Adverse event: Cranial nerve disorders (excl neoplasms)
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 846 at risk

Adverse event: Encephalopathies
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 846 at risk

Adverse event: Neurological disorders NEC
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 846 at risk

Adverse event: Seizures (incl subtypes)
Serious: yes
Organ System: Nervous system disorders
Frequency: 4 affected / 846 at risk

Adverse event: Spinal cord and nreve root disorders
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 846 at risk

Adverse event: Deliria (incl confusion)
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 846 at risk

Adverse event: Depressed mood disorders and disturbances
Serious: yes
Organ System: Psychiatric disorders
Frequency: 4 affected / 846 at risk

Adverse event: Personality disorders and disturbances in behaviour
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 846 at risk

Adverse event: Suicidal and self-injurious behaviours NEC
Serious: yes
Organ System: Psychiatric disorders
Frequency: 4 affected / 846 at risk

Adverse event: Nephropathies
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 4 affected / 846 at risk

Adverse event: Renal disorders (excl nephropathies)
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 12 affected / 846 at risk

Adverse event: Urinary tract signs and symptoms
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 846 at risk

Adverse event: Urolithiases
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 3 affected / 846 at risk

Adverse event: Breast disorders
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 846 at risk

Adverse event: Cervix disorders (excl infections and inflammations)
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 2 affected / 846 at risk

Adverse event: Prostatic disorders (excl infections and inflammations)
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 846 at risk

Adverse event: Uterine, pelvic and broad ligament disorders
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 3 affected / 846 at risk

Adverse event: Vulvovaginal disorders (excl infections and inflammations)
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 846 at risk

Adverse event: Bronchial disorders (excl neoplasms)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 846 at risk

Adverse event: Lower respiratory tract disorders (excl obstruction and infection)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 846 at risk

Adverse event: Pleural disorders
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 846 at risk

Adverse event: Pulmonary vascular disorders
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 846 at risk

Adverse event: Respiratory disorders NEC
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 11 affected / 846 at risk

Adverse event: Upper respiratory tract disorders (excl infections)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 846 at risk

Adverse event: Skin and subcutaenous tissue disorders NEC
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 846 at risk

Adverse event: Hepatobiliary therapeutic procedures
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 846 at risk

Adverse event: Arteriosclerosis, stenosis, vascular insufficiency and necrosis
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 846 at risk

Adverse event: Decreased and nonspecific blood pressure disorders and shock
Serious: yes
Organ System: Vascular disorders
Frequency: 3 affected / 846 at risk

Adverse event: Vascular hypertensive disorders
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 846 at risk