Study: NCT00418574

Adverse event: Anaemias NEC
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 592 at risk

Adverse event: Lymphatic system disorders NEC
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 592 at risk

Adverse event: Thrombocytopenias
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 592 at risk

Adverse event: Ischaemic coronary artery disorders
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 592 at risk

Adverse event: Pericardial disorders NEC
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 592 at risk

Adverse event: Supraventricular arrhythmias
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 592 at risk

Adverse event: Tympanic membrane disorders (excl infections)
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 592 at risk

Adverse event: Thyroid disorders NEC
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 592 at risk

Adverse event: Glaucomas (excl congenital)
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 592 at risk

Adverse event: Abdominal hernias, site unspecified
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 592 at risk

Adverse event: Acute and chronic pancreatitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 592 at risk

Adverse event: Diarrhoea (excl infective)
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 592 at risk

Adverse event: Duodenal and small intestinal stenosis and obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 592 at risk

Adverse event: Dyspeptic signs and symptoms
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 592 at risk

Adverse event: Gastritis (excl infective)
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 592 at risk

Adverse event: Gastrointestinal and abdominal pains (excl oral and throat)
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 11 affected / 592 at risk

Adverse event: Gastrointestinal atonic and hypomotility disorders NEC
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 592 at risk

Adverse event: Gastrointestinal inflammatory disorders NEC
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 592 at risk

Adverse event: Gastrointestinal necrosis and gangrene (excl gangrenous hernia)
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 592 at risk

Adverse event: Gastrointestinal stenosis and obstruction NEC
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 14 affected / 592 at risk

Adverse event: Nausea and vomiting symptoms
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 592 at risk

Adverse event: Non-site specific gastrointestinal haemorrhages
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 592 at risk

Adverse event: Peritoneal and retroperitoneal disorders
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 18 affected / 592 at risk

Adverse event: Peritoneal and retroperitoneal fibrosis and adhesions
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 592 at risk

Adverse event: Febrile disorders
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 592 at risk

Adverse event: General signs and symptoms NEC
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 592 at risk

Adverse event: Hernias NEC
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 592 at risk

Adverse event: Oedema NEC
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 592 at risk

Adverse event: Pain and discomfort NEC
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 592 at risk

Adverse event: Therapeutic and nontherapeutic responses
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 592 at risk

Adverse event: Cholecystitis and cholelithiasis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 592 at risk

Adverse event: Cholestasis and jaundice
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 592 at risk

Adverse event: Gallbladder disorders NEC
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 592 at risk

Adverse event: Allergic conditions NEC
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 592 at risk

Adverse event: Abdominal and gastrointestinal infections
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 592 at risk

Adverse event: Aspergillus infections
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 592 at risk

Adverse event: Ear infections
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 592 at risk

Adverse event: Sepsis, bacteraemia, viraemia and fungaemia NEC
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 592 at risk

Adverse event: Streptococcal infections
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 592 at risk

Adverse event: Urinary tract infections
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 592 at risk

Adverse event: Vascular infections
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 592 at risk

Adverse event: Abdominal injuries NEC
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 592 at risk

Adverse event: Lower limb fractures and dislocations
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 592 at risk

Adverse event: Non-site specific injuries NEC
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 592 at risk

Adverse event: Non-site specific procedural complications
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 7 affected / 592 at risk

Adverse event: Upper limb fractures and dislocations
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 592 at risk

Adverse event: Digestive enzymes
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 592 at risk

Adverse event: Liver function analyses
Serious: yes
Organ System: Investigations
Frequency: 3 affected / 592 at risk

Adverse event: Renal function analyses
Serious: yes
Organ System: Investigations
Frequency: 2 affected / 592 at risk

Adverse event: Skeletal and cardiac muscle analyses
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 592 at risk

Adverse event: Tissue enzyme analyses NEC
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 592 at risk

Adverse event: Appetite disorders
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 592 at risk

Adverse event: Bone related signs and symptoms
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 592 at risk

Adverse event: Intervertebral disc disorders NEC
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 592 at risk

Adverse event: Joint related signs and symptoms
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 592 at risk

Adverse event: Metabolic bone disorders
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 592 at risk

Adverse event: Musculoskeletal and connective tissue pain and discomfort
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 592 at risk

Adverse event: Osteoarthropathies
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 592 at risk

Adverse event: Soft tissue disorders NEC
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 592 at risk

Adverse event: Spine and neck deformities
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 592 at risk

Adverse event: Endocrine neoplasms malignant and unspecified NEC
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 592 at risk

Adverse event: Gastrointestinal neoplasms malignant NEC
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 592 at risk

Adverse event: Metastases to specified sites
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 14 affected / 592 at risk

Adverse event: Neoplasms malignant site unspecified NEC
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 592 at risk

Adverse event: Neoplasms unspecified malignancy and site unspecified NEC
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 592 at risk

Adverse event: Nervous system neoplasms unspecified malignancy NEC
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 592 at risk

Adverse event: Non-small cell neoplasms malignant of the respiratory tract cell type specified
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 592 at risk

Adverse event: Oncologic complications and emergencies
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 592 at risk

Adverse event: Ovarian neoplasms malignant (excl germ cell)
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 61 affected / 592 at risk

Adverse event: Rectal neoplasms malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 592 at risk

Adverse event: Vaginal neoplasms malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 592 at risk

Adverse event: Central nervous system haemorrhages and cerebrovascular accidents
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 592 at risk

Adverse event: Neurological signs and symptoms NEC
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 592 at risk

Adverse event: Seizures and seizure disorders NEC
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 592 at risk

Adverse event: Transient cerebrovascular events
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 592 at risk

Adverse event: Anxiety symptoms
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 592 at risk

Adverse event: Renal failure and impairment
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 592 at risk

Adverse event: Renal obstructive disorders
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 592 at risk

Adverse event: Ureteric disorders NEC
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 592 at risk

Adverse event: Breast disorders NEC
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 592 at risk

Adverse event: Uterine disorders NEC
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 592 at risk

Adverse event: Breathing abnormalities
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 592 at risk

Adverse event: Pneumothorax and pleural effusions NEC
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 7 affected / 592 at risk

Adverse event: Pulmonary thrombotic and embolic conditions
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 592 at risk

Adverse event: Dermal and epidermal conditions NEC
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 592 at risk

Adverse event: Accelerated and malignant hypertension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 592 at risk

Adverse event: Aortic embolism and thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 592 at risk

Adverse event: Lymphangiopathies
Serious: yes
Organ System: Vascular disorders
Frequency: 3 affected / 592 at risk

Adverse event: Non-site specific embolism and thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 592 at risk

Adverse event: Diarrhoea (excl infective)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 98 affected / 592 at risk

Adverse event: Flatulence, bloating and distension
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 45 affected / 592 at risk

Adverse event: Gastrointestinal and abdominal pains (excl oral and throat)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 183 affected / 592 at risk

Adverse event: Gastrointestinal atonic and hypomotility disorders NEC
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 82 affected / 592 at risk

Adverse event: Nausea and vomiting symptoms
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 130 affected / 592 at risk

Adverse event: Asthenic conditions
Serious: no
Organ System: General disorders
Frequency: 191 affected / 592 at risk

Adverse event: Febrile disorders
Serious: no
Organ System: General disorders
Frequency: 67 affected / 592 at risk

Adverse event: Feelings and sensations NEC
Serious: no
Organ System: General disorders
Frequency: 34 affected / 592 at risk

Adverse event: General signs and symptoms NEC
Serious: no
Organ System: General disorders
Frequency: 44 affected / 592 at risk

Adverse event: Injection site reactions
Serious: no
Organ System: General disorders
Frequency: 467 affected / 592 at risk

Adverse event: Oedema NEC
Serious: no
Organ System: General disorders
Frequency: 61 affected / 592 at risk

Adverse event: Pain and discomfort NEC
Serious: no
Organ System: General disorders
Frequency: 37 affected / 592 at risk

Adverse event: Lower respiratory tract and lung infections
Serious: no
Organ System: Infections and infestations
Frequency: 43 affected / 592 at risk

Adverse event: Upper respiratory tract infections
Serious: no
Organ System: Infections and infestations
Frequency: 142 affected / 592 at risk

Adverse event: Urinary tract infections
Serious: no
Organ System: Infections and infestations
Frequency: 80 affected / 592 at risk

Adverse event: Physical examination procedures
Serious: no
Organ System: Investigations
Frequency: 33 affected / 592 at risk

Adverse event: Bone related signs and symptoms
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 41 affected / 592 at risk

Adverse event: Joint related signs and symptoms
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 134 affected / 592 at risk

Adverse event: Muscle pains
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 59 affected / 592 at risk

Adverse event: Musculoskeletal and connective tissue pain and discomfort
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 171 affected / 592 at risk

Adverse event: Headaches NEC
Serious: no
Organ System: Nervous system disorders
Frequency: 83 affected / 592 at risk

Adverse event: Neurological signs and symptoms NEC
Serious: no
Organ System: Nervous system disorders
Frequency: 42 affected / 592 at risk

Adverse event: Peripheral neuropathies NEC
Serious: no
Organ System: Nervous system disorders
Frequency: 46 affected / 592 at risk

Adverse event: Disturbances in initiating and maintaining sleep
Serious: no
Organ System: Psychiatric disorders
Frequency: 31 affected / 592 at risk

Adverse event: Bladder and urethral symptoms
Serious: no
Organ System: Renal and urinary disorders
Frequency: 38 affected / 592 at risk

Adverse event: Breathing abnormalities
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 48 affected / 592 at risk

Adverse event: Coughing and associated symptoms
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 43 affected / 592 at risk

Adverse event: Erythemas
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 40 affected / 592 at risk

Adverse event: Pruritus NEC
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 30 affected / 592 at risk

Adverse event: Rashes, eruptions and exanthems NEC
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 33 affected / 592 at risk

Adverse event: Peripheral vascular disorders NEC
Serious: no
Organ System: Vascular disorders
Frequency: 49 affected / 592 at risk

Adverse event: Anaemias NEC
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 294 at risk

Adverse event: Lymphatic system disorders NEC
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 294 at risk

Adverse event: Inner ear signs and symptoms
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 294 at risk

Adverse event: Thyroid hyperfunction disorders
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 294 at risk

Adverse event: Retinal structural change, deposit and degeneration
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 294 at risk

Adverse event: Abdominal findings abnormal
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 294 at risk

Adverse event: Abdominal hernias, site unspecified
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 294 at risk

Adverse event: Gastric and oesophageal haemorrhages
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 294 at risk

Adverse event: Gastrointestinal and abdominal pains (excl oral and throat)
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 294 at risk

Adverse event: Gastrointestinal atonic and hypomotility disorders NEC
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 294 at risk

Adverse event: Gastrointestinal stenosis and obstruction NEC
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 12 affected / 294 at risk

Adverse event: Large intestinal stenosis and obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 294 at risk

Adverse event: Nausea and vomiting symptoms
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 294 at risk

Adverse event: Non-site specific gastrointestinal haemorrhages
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 294 at risk

Adverse event: Peritoneal and retroperitoneal disorders
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 294 at risk

Adverse event: Device issues NEC
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 294 at risk

Adverse event: Febrile disorders
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 294 at risk

Adverse event: Hernias NEC
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 294 at risk

Adverse event: Injection site reactions
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 294 at risk

Adverse event: Pain and discomfort NEC
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 294 at risk

Adverse event: Cholecystitis and cholelithiasis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 294 at risk

Adverse event: Cholestasis and jaundice
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 294 at risk

Adverse event: Abdominal and gastrointestinal infections
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 294 at risk

Adverse event: Bacterial infections NEC
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 294 at risk

Adverse event: Dental and oral soft tissue infections
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 294 at risk

Adverse event: Herpes viral infections
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 294 at risk

Adverse event: Influenza viral infections
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 294 at risk

Adverse event: Lower respiratory tract and lung infections
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 294 at risk

Adverse event: Streptococcal infections
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 294 at risk

Adverse event: Upper respiratory tract infections
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 294 at risk

Adverse event: Lower limb fractures and dislocations
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 294 at risk

Adverse event: Non-site specific injuries NEC
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 294 at risk

Adverse event: Pelvic fractures and dislocations
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 294 at risk

Adverse event: Spinal fractures and dislocations
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 294 at risk

Adverse event: Diabetes mellitus (incl subtypes)
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 294 at risk

Adverse event: Osteoarthropathies
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 294 at risk

Adverse event: Bone neoplasms benign (excl cysts)
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 294 at risk

Adverse event: Metastases to specified sites
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 13 affected / 294 at risk

Adverse event: Neoplasms unspecified malignancy and site unspecified NEC
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 294 at risk

Adverse event: Oncologic complications and emergencies
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 294 at risk

Adverse event: Ovarian neoplasms malignant (excl germ cell)
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 41 affected / 294 at risk

Adverse event: Skin neoplasms malignant and unspecified (excl melanoma)
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 294 at risk

Adverse event: Central nervous system haemorrhages and cerebrovascular accidents
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 294 at risk

Adverse event: Disturbances in consciousness NEC
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 294 at risk

Adverse event: Neurological signs and symptoms NEC
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 294 at risk

Adverse event: Peripheral neuropathies NEC
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 294 at risk

Adverse event: Speech and language abnormalities
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 294 at risk

Adverse event: Depressive disorders
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 294 at risk

Adverse event: Pelvic prolapse conditions
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 294 at risk

Adverse event: Pneumothorax and pleural effusions NEC
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 294 at risk

Adverse event: Connective tissue disorders
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 294 at risk

Adverse event: Dermatitis and eczema
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 294 at risk

Adverse event: Lymphoedemas
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 294 at risk

Adverse event: Peripheral embolism and thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 294 at risk

Adverse event: Diarrhoea (excl infective)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 41 affected / 294 at risk

Adverse event: Flatulence, bloating and distension
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 25 affected / 294 at risk

Adverse event: Gastrointestinal and abdominal pains (excl oral and throat)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 81 affected / 294 at risk

Adverse event: Gastrointestinal atonic and hypomotility disorders NEC
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 38 affected / 294 at risk

Adverse event: Nausea and vomiting symptoms
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 64 affected / 294 at risk

Adverse event: Asthenic conditions
Serious: no
Organ System: General disorders
Frequency: 89 affected / 294 at risk

Adverse event: Febrile disorders
Serious: no
Organ System: General disorders
Frequency: 40 affected / 294 at risk

Adverse event: Feelings and sensations NEC
Serious: no
Organ System: General disorders
Frequency: 14 affected / 294 at risk

Adverse event: General signs and symptoms NEC
Serious: no
Organ System: General disorders
Frequency: 19 affected / 294 at risk

Adverse event: Injection site reactions
Serious: no
Organ System: General disorders
Frequency: 222 affected / 294 at risk

Adverse event: Oedema NEC
Serious: no
Organ System: General disorders
Frequency: 32 affected / 294 at risk

Adverse event: Pain and discomfort NEC
Serious: no
Organ System: General disorders
Frequency: 20 affected / 294 at risk

Adverse event: Lower respiratory tract and lung infections
Serious: no
Organ System: Infections and infestations
Frequency: 8 affected / 294 at risk

Adverse event: Upper respiratory tract infections
Serious: no
Organ System: Infections and infestations
Frequency: 70 affected / 294 at risk

Adverse event: Urinary tract infections
Serious: no
Organ System: Infections and infestations
Frequency: 27 affected / 294 at risk

Adverse event: Physical examination procedures
Serious: no
Organ System: Investigations
Frequency: 20 affected / 294 at risk

Adverse event: Bone related signs and symptoms
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 26 affected / 294 at risk

Adverse event: Joint related signs and symptoms
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 67 affected / 294 at risk

Adverse event: Muscle pains
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 35 affected / 294 at risk

Adverse event: Musculoskeletal and connective tissue pain and discomfort
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 79 affected / 294 at risk

Adverse event: Headaches NEC
Serious: no
Organ System: Nervous system disorders
Frequency: 38 affected / 294 at risk

Adverse event: Neurological signs and symptoms NEC
Serious: no
Organ System: Nervous system disorders
Frequency: 25 affected / 294 at risk

Adverse event: Peripheral neuropathies NEC
Serious: no
Organ System: Nervous system disorders
Frequency: 25 affected / 294 at risk

Adverse event: Disturbances in initiating and maintaining sleep
Serious: no
Organ System: Psychiatric disorders
Frequency: 17 affected / 294 at risk

Adverse event: Bladder and urethral symptoms
Serious: no
Organ System: Renal and urinary disorders
Frequency: 25 affected / 294 at risk

Adverse event: Breathing abnormalities
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 23 affected / 294 at risk

Adverse event: Coughing and associated symptoms
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 25 affected / 294 at risk

Adverse event: Erythemas
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 22 affected / 294 at risk

Adverse event: Pruritus NEC
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 15 affected / 294 at risk

Adverse event: Rashes, eruptions and exanthems NEC
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 19 affected / 294 at risk

Adverse event: Peripheral vascular disorders NEC
Serious: no
Organ System: Vascular disorders
Frequency: 26 affected / 294 at risk