Study: NCT01259856

Adverse event: Bile Duct Disorder
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 82 at risk

Adverse event: Cardiac arrhythmias
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 82 at risk

Adverse event: Cardiac disorder signs and symptoms
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 82 at risk

Adverse event: Electrolyte and fluid balance conditions
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 82 at risk

Adverse event: Exocrine pancreas conditions
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 82 at risk

Adverse event: Gastrointestinal haemorrahges NEC
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 82 at risk

Adverse event: Gastrointestinal signs and symptoms
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 82 at risk

Adverse event: General system disorders NEC
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 82 at risk

Adverse event: Headaches
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 82 at risk

Adverse event: Neoplasms benign, malignant and unspecified - Other
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 82 at risk

Adverse event: Platelet disorders
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 82 at risk

Adverse event: Pregnancy, labour, delivery and postpartum conditions
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 82 at risk

Adverse event: Skin and subcutaneous tissue infections and infestations
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 82 at risk

Adverse event: Gallbladder disorders
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 82 at risk

Adverse event: Administration site reactions
Serious: no
Organ System: General disorders
Frequency: 15 affected / 82 at risk

Adverse event: Administration site reactions
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 82 at risk

Adverse event: Alanine aminotransferace increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 82 at risk

Adverse event: Allergic conditions
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 82 at risk

Adverse event: Anaemias nonhaemolytic and marrow depression
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 10 affected / 82 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 82 at risk

Adverse event: Anxeity disorders and symptoms
Serious: no
Organ System: Psychiatric disorders
Frequency: 4 affected / 82 at risk

Adverse event: Appetite and general nutrition disorders
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 7 affected / 82 at risk

Adverse event: Arteriosclerosis, stenosis, vascular insufficiency and necrosis
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 82 at risk

Adverse event: Aural disorders NEC
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 7 affected / 82 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Back pain due to retroperitoneal fibrosis
Frequency: 1 affected / 82 at risk

Adverse event: Bacterial infectious disorders
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 82 at risk

Adverse event: Body temperature conditions
Serious: no
Organ System: General disorders
Frequency: 4 affected / 82 at risk

Adverse event: Bone and joint injuries
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 6 affected / 82 at risk

Adverse event: Bone disorders (excl congenital and fractures)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 82 at risk

Adverse event: Bone, calcium, magnesium and phosphorus metabolism disorders
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 82 at risk

Adverse event: Cardiac arrhythmias
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 82 at risk

Adverse event: Cardiac disorder signs and symptoms
Serious: no
Organ System: Cardiac disorders
Frequency: 11 affected / 82 at risk

Adverse event: Central nervous system vascular disorders
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 82 at risk

Adverse event: Chest pain
Serious: no
Organ System: Cardiac disorders
Notes: Gastrointestinal nonspecific symptoms and therapeutic procedures (SMQ) Cardiomyopathy
Frequency: 1 affected / 82 at risk

Adverse event: Cognitive and attention disorders and disturbances
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 82 at risk

Adverse event: Cranial nerve disorders (excl neoplasms)
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 82 at risk

Adverse event: Cutaneous neoplasms benign
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 82 at risk

Adverse event: Decreased and nonspecific blood pressure disorders and shock
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 82 at risk

Adverse event: Dental and gingival conditions
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 82 at risk

Adverse event: Depressed mood disorders and disturbances
Serious: no
Organ System: Psychiatric disorders
Frequency: 11 affected / 82 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 82 at risk

Adverse event: Dermatitis and eczema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 82 at risk

Adverse event: Dermatology/skin, other
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 82 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 82 at risk

Adverse event: Diverticular disorders
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 82 at risk

Adverse event: Dysgeusia
Serious: no
Organ System: Nervous system disorders
Notes: Taste and smell disorders
Frequency: 1 affected / 82 at risk

Adverse event: Dysgeusia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 82 at risk

Adverse event: Electrolyte and fluid balance conditions
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 82 at risk

Adverse event: Elevated ALT
Serious: no
Organ System: Investigations
Frequency: 1 affected / 82 at risk

Adverse event: Endocrine disorders of gonadal function
Serious: no
Organ System: Endocrine disorders
Frequency: 1 affected / 82 at risk

Adverse event: Enzyme investigations NEC
Serious: no
Organ System: Investigations
Frequency: 2 affected / 82 at risk

Adverse event: Epidermal and Dermal Conditions
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 24 affected / 82 at risk

Adverse event: Exocrine pancreas conditions
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 82 at risk

Adverse event: Eye disorders NEC
Serious: no
Organ System: Eye disorders
Frequency: 6 affected / 82 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 3 affected / 82 at risk

Adverse event: Fatigue (asthenia, lethargy, malaise)
Serious: no
Organ System: General disorders
Frequency: 1 affected / 82 at risk

Adverse event: Fungal infectious disorders
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 82 at risk

Adverse event: Gallbladder disorders
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 82 at risk

Adverse event: Gastrointestinal conditions NEC
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 82 at risk

Adverse event: Gastrointestinal inflammatory conditions
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 82 at risk

Adverse event: Gastrointestinal motility and defaecation conditions
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 16 affected / 82 at risk

Adverse event: Gastrointestinal signs and symptoms
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 24 affected / 82 at risk

Adverse event: Gastrointestinal stenosis and obstruction
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 82 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Frequency: 1 affected / 82 at risk

Adverse event: General system disorders NEC
Serious: no
Organ System: General disorders
Frequency: 50 affected / 82 at risk

Adverse event: Genitourinary tract disorders NEC
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 82 at risk

Adverse event: Glucose metabolism disorders (incl diabetes mellitus)
Serious: no
Organ System: Endocrine disorders
Frequency: 4 affected / 82 at risk

Adverse event: Glucose metabolism disorders (incl diabetes mellitus)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 82 at risk

Adverse event: Haematology investigations (incl blood groups)
Serious: no
Organ System: Investigations
Frequency: 11 affected / 82 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 16 affected / 82 at risk

Adverse event: Heart failures
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 82 at risk

Adverse event: Hepatic and hepatobiliary disorders
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 82 at risk

Adverse event: Hepatobiliary investigations
Serious: no
Organ System: Investigations
Frequency: 12 affected / 82 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 82 at risk

Adverse event: Hyperuricaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 82 at risk

Adverse event: Infections - pathogen unspecified
Serious: no
Organ System: Infections and infestations
Frequency: 12 affected / 82 at risk

Adverse event: Injection site reaction/extravasation changes
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 82 at risk

Adverse event: Injuries NEC
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 82 at risk

Adverse event: Inner ear and VIIIth cranial nerve disorders
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 5 affected / 82 at risk

Adverse event: Investigations, imaging and histopathology procedures NEC
Serious: no
Organ System: Investigations
Frequency: 1 affected / 82 at risk

Adverse event: Joint Disorders
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 16 affected / 82 at risk

Adverse event: Lipid analyses
Serious: no
Organ System: Investigations
Frequency: 3 affected / 82 at risk

Adverse event: Lipid metabolism disorders
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 82 at risk

Adverse event: Lymphomas non-Hodgkin's T-cell
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 82 at risk

Adverse event: Male reproductive tract infections and inflammations
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 2 affected / 82 at risk

Adverse event: Mental impairment disorders
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 82 at risk

Adverse event: Metabolic, nutritional and blood gas investigations
Serious: no
Organ System: Investigations
Frequency: 2 affected / 82 at risk

Adverse event: Metabolic/laboratory, other
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 82 at risk

Adverse event: Migraine
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 82 at risk

Adverse event: Mood disorders and disturbances NEC
Serious: no
Organ System: Psychiatric disorders
Frequency: 3 affected / 82 at risk

Adverse event: Muscle disorders
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 9 affected / 82 at risk

Adverse event: Musculoskeletal and connective tissue disorders NEC
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 17 affected / 82 at risk

Adverse event: Musculoskeletal and connective tissue neoplasms
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 82 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 82 at risk

Adverse event: Colon cancer
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 82 at risk

Adverse event: Neurological disorders NEC
Serious: no
Organ System: Nervous system disorders
Frequency: 17 affected / 82 at risk

Adverse event: Neurological signs and symptoms NEC
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 82 at risk

Adverse event: Neutrophils/granulocytes (ANC/AGC)
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Blood/bone marrow
Frequency: 1 affected / 82 at risk

Adverse event: Non-cardiac chest pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 82 at risk

Adverse event: Ocular haemorrhages and vascular disorders NEC
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 82 at risk

Adverse event: Ocular infections, irritations and inflammations
Serious: no
Organ System: Eye disorders
Frequency: 9 affected / 82 at risk

Adverse event: Ocular surface disease
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 82 at risk

Adverse event: Oral soft tissue conditions
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 82 at risk

Adverse event: Skin disorders, Other
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 82 at risk

Adverse event: Pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 82 at risk

Adverse event: Peripheral neuropathies
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 82 at risk

Adverse event: Physical examination topics
Serious: no
Organ System: Investigations
Frequency: 1 affected / 82 at risk

Adverse event: Platelet disorders
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 7 affected / 82 at risk

Adverse event: Procedural related injuries and complications NEC
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 82 at risk

Adverse event: Prostatic disorders (excl infections and inflammations)
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 82 at risk

Adverse event: Protein and amino acid metabolism disorders NEC
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 82 at risk

Adverse event: Purine and pyrimidine metabolism disorders
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 82 at risk

Adverse event: Rash maculo-papular
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 82 at risk

Adverse event: Renal and urinary tract investigations and urinalyses
Serious: no
Organ System: Investigations
Frequency: 3 affected / 82 at risk

Adverse event: Respiratory disorders NEC
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 20 affected / 82 at risk

Adverse event: Respiratory tract infections
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 82 at risk

Adverse event: Salivary gland conditions
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 82 at risk

Adverse event: Sensory Abnormalities NEC
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 82 at risk

Adverse event: Sexual dysfunctions, disturbances and gender identity disorders
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 82 at risk

Adverse event: Sexual function and fertility disorders
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 82 at risk

Adverse event: Skin appendage conditions
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 8 affected / 82 at risk

Adverse event: Skin vascular abnormalities
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 82 at risk

Adverse event: Sleep disturbances (incl subtypes)
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 82 at risk

Adverse event: Spleen, lymphatic and reticuloendothelial system disorders
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 82 at risk

Adverse event: Synovial and bursal disorders
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 82 at risk

Adverse event: Tendon, ligament and cartilage disorders
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 82 at risk

Adverse event: Thyroid gland disorders
Serious: no
Organ System: Endocrine disorders
Frequency: 4 affected / 82 at risk

Adverse event: Tongue conditions
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 82 at risk

Adverse event: Upper respiratory tract disorders (excl infections)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 82 at risk

Adverse event: Upper respiratory tract infections - pathogen class unspecified
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 82 at risk

Adverse event: Urinary tract signs and symptoms
Serious: no
Organ System: Renal and urinary disorders
Frequency: 3 affected / 82 at risk

Adverse event: Urolithiases
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 82 at risk

Adverse event: Vascular disorders NEC
Serious: no
Organ System: Vascular disorders
Frequency: 3 affected / 82 at risk

Adverse event: Vascular haemorrhagic disorders
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 82 at risk

Adverse event: Vascular hypertensive disorders
Serious: no
Organ System: Vascular disorders
Frequency: 7 affected / 82 at risk

Adverse event: Viral infectious disorders
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 82 at risk

Adverse event: Vision disorders
Serious: no
Organ System: Eye disorders
Frequency: 8 affected / 82 at risk

Adverse event: Vision disorders
Serious: no
Organ System: Eye disorders
Frequency: 8 affected / 82 at risk

Adverse event: Water, electrolyte and mineral investigations
Serious: no
Organ System: Investigations
Frequency: 2 affected / 82 at risk

Adverse event: White blood cell disorders
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 15 affected / 82 at risk

Adverse event: Vision blurred
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 82 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 1 affected / 82 at risk

Adverse event: Influenza like illness
Serious: no
Organ System: General disorders
Frequency: 1 affected / 82 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 82 at risk

Adverse event: General system disorders NEC
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 86 at risk

Adverse event: Infections - pathogen unspecified
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 86 at risk

Adverse event: Respiratory and mediastinal neoplasms malignant and unspecified
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 86 at risk

Adverse event: Abdominal Distenstion
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 86 at risk

Adverse event: Abdominal hernias and other abdominal wall conditions
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 86 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 86 at risk

Adverse event: Allergic conditions
Serious: no
Organ System: Immune system disorders
Frequency: 2 affected / 86 at risk

Adverse event: Anaemias nonhaemolytic and marrow depression
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 10 affected / 86 at risk

Adverse event: Anxeity disorders and symptoms
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 86 at risk

Adverse event: Appetite and general nutrition disorders
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 86 at risk

Adverse event: Arteriosclerosis, stenosis, vascular insufficiency and necrosis
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 86 at risk

Adverse event: Aural disorders NEC
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 4 affected / 86 at risk

Adverse event: Bacterial infectious disorders
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 86 at risk

Adverse event: Benign neoplasms gastrointestinal
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 86 at risk

Adverse event: Bladder and bladder neck disorders (excl calculi)
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 86 at risk

Adverse event: Blood bilirubin increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 86 at risk

Adverse event: Vision blurred
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 86 at risk

Adverse event: Body temperature conditions
Serious: no
Organ System: General disorders
Frequency: 5 affected / 86 at risk

Adverse event: Bone disorders (excl congenital and fractures)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 86 at risk

Adverse event: Bone pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 86 at risk

Adverse event: Contusion
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 86 at risk

Adverse event: Cardiac Signs and Symptoms NEC
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 86 at risk

Adverse event: Cardiac and vascular investigations (excl enzyme tests)
Serious: no
Organ System: Investigations
Frequency: 3 affected / 86 at risk

Adverse event: Cardiac arrhythmias
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 86 at risk

Adverse event: Cardiac disorder signs and symptoms
Serious: no
Organ System: Cardiac disorders
Frequency: 6 affected / 86 at risk

Adverse event: Coagulopathies and bleeding diatheses (excl thrombocytopenic)
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 86 at risk

Adverse event: Cognitive and attention disorders and disturbances
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 86 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 86 at risk

Adverse event: Coronary artery disorders
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 86 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 86 at risk

Adverse event: Cranial nerve disorders (excl neoplasms)
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 86 at risk

Adverse event: Decreased and nonspecific blood pressure disorders and shock
Serious: no
Organ System: Vascular disorders
Frequency: 3 affected / 86 at risk

Adverse event: Dental and gingival conditions
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 86 at risk

Adverse event: Depressed mood disorders and disturbances
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 86 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 86 at risk

Adverse event: Diarrhoea (excl infective)
Serious: no
Organ System: Gastrointestinal disorders
Notes: Gastrointestinal motility and defaecation conditions
Frequency: 1 affected / 86 at risk

Adverse event: Diverticular disorders
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 86 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 86 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 86 at risk

Adverse event: Dysgeusia
Serious: no
Organ System: Nervous system disorders
Notes: Taste and smell disorders
Frequency: 1 affected / 86 at risk

Adverse event: Dysgeusia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 86 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 86 at risk

Adverse event: Electrolyte and fluid balance conditions
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 86 at risk

Adverse event: Endocrine disorders of gonadal function
Serious: no
Organ System: Endocrine disorders
Frequency: 1 affected / 86 at risk

Adverse event: Epidermal and Dermal Conditions
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 86 at risk

Adverse event: Epidermal and Dermal Conditions
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 19 affected / 86 at risk

Adverse event: Eye disorders NEC
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 86 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 1 affected / 86 at risk

Adverse event: Fatigue or Tiredness
Serious: no
Organ System: General disorders
Frequency: 1 affected / 86 at risk

Adverse event: Fatigue or Tiredness
Serious: no
Organ System: General disorders
Frequency: 2 affected / 86 at risk

Adverse event: Influenza like illness
Serious: no
Organ System: General disorders
Frequency: 1 affected / 86 at risk

Adverse event: Gastrointestinal infections
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 86 at risk

Adverse event: Gastrointestinal inflammatory conditions
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 86 at risk

Adverse event: Gastrointestinal motility and defaecation conditions
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 20 affected / 86 at risk

Adverse event: Gastrointestinal signs and symptoms
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 18 affected / 86 at risk

Adverse event: Gastrointestinal vascular conditions
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 86 at risk

Adverse event: General system disorders NEC
Serious: no
Organ System: General disorders
Frequency: 42 affected / 86 at risk

Adverse event: Genitourinary tract disorders NEC
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 86 at risk

Adverse event: Gingival bleeding
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 86 at risk

Adverse event: Glucose metabolism disorders (incl diabetes mellitus)
Serious: no
Organ System: Endocrine disorders
Frequency: 3 affected / 86 at risk

Adverse event: Glucose metabolism disorders (incl diabetes mellitus)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 86 at risk

Adverse event: Haematology investigations (incl blood groups)
Serious: no
Organ System: Investigations
Frequency: 12 affected / 86 at risk

Adverse event: Haematopoietic neoplasms (excl leukaemias and lymphomas)
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 86 at risk

Adverse event: Hair loss/alopecia (scalp or body)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 86 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 11 affected / 86 at risk

Adverse event: Hearing disorders
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 86 at risk

Adverse event: Heart failures
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 86 at risk

Adverse event: Hepatic and hepatobiliary disorders
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 86 at risk

Adverse event: Hepatobiliary Disorders - Other
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 86 at risk

Adverse event: Hepatobiliary investigations
Serious: no
Organ System: Investigations
Frequency: 5 affected / 86 at risk

Adverse event: Hyperhidrosis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 86 at risk

Adverse event: Infections - Pathogen Unspecified
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 86 at risk

Adverse event: Infections - pathogen class unspecified
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 86 at risk

Adverse event: Infections - pathogen unspecified
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 86 at risk

Adverse event: Injuries NEC
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 4 affected / 86 at risk

Adverse event: Inner ear and VIIIth cranial nerve disorders
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 2 affected / 86 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 86 at risk

Adverse event: Joint Disorders
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 9 affected / 86 at risk

Adverse event: Lipid analyses
Serious: no
Organ System: Investigations
Frequency: 1 affected / 86 at risk

Adverse event: Lipid metabolism disorders
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 86 at risk

Adverse event: Lymphocyte count decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 86 at risk

Adverse event: Menstrual cycle and uterine bleeding disorders
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 86 at risk

Adverse event: Mental impairment disorders
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 86 at risk

Adverse event: Metabolic, nutritional and blood gas investigations
Serious: no
Organ System: Investigations
Frequency: 3 affected / 86 at risk

Adverse event: Middle ear disorders (excl congenital)
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 3 affected / 86 at risk

Adverse event: Movement disorders (incl parkinsonism)
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 86 at risk

Adverse event: Stomatitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 86 at risk

Adverse event: Muscle disorders
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 6 affected / 86 at risk

Adverse event: Muscle spasms
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: dystonia
Frequency: 1 affected / 86 at risk

Adverse event: Musculoskeletal and connective tissue deformities (incl intervertebral disc disorders)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 86 at risk

Adverse event: Musculoskeletal and connective tissue disorders NEC
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 17 affected / 86 at risk

Adverse event: Myocardial disorders
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 86 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 86 at risk

Adverse event: Neck pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: A disorder characterized by marked discomfort sensation in the neck area.
Frequency: 1 affected / 86 at risk

Adverse event: Nervous system disorders, unspecified
Serious: no
Organ System: Nervous system disorders
Notes: A disorder characterized by a sensation of marked discomfort in various parts of the head, not confined to the area of distribution of any nerve.
Frequency: 1 affected / 86 at risk

Adverse event: Neurological disorders NEC
Serious: no
Organ System: Nervous system disorders
Frequency: 15 affected / 86 at risk

Adverse event: Neutrophil count decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 86 at risk

Adverse event: Non-cardiac chest pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 86 at risk

Adverse event: Ocular infections, irritations and inflammations
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 86 at risk

Adverse event: Ocular sensory symptoms NEC
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 86 at risk

Adverse event: Oral soft tissue conditions
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 12 affected / 86 at risk

Adverse event: Pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 86 at risk

Adverse event: Penile and scrotal disorders (excl infections and inflammations)
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 86 at risk

Adverse event: Peripheral neuropathies
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 86 at risk

Adverse event: Physical examination topics
Serious: no
Organ System: Investigations
Frequency: 1 affected / 86 at risk

Adverse event: Pigmentation disorders
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 86 at risk

Adverse event: Platelet disorders
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 8 affected / 86 at risk

Adverse event: Prostatic disorders (excl infections and inflammations)
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 86 at risk

Adverse event: Purine and pyrimidine metabolism disorders
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 86 at risk

Adverse event: Renal and urinary tract investigations and urinalyses
Serious: no
Organ System: Investigations
Frequency: 2 affected / 86 at risk

Adverse event: Renal and urinary tract neoplasms benign
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 86 at risk

Adverse event: Renal disorders (excl nephropathies)
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 86 at risk

Adverse event: Reproductive neoplasms female benign
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 86 at risk

Adverse event: Respiratory disorders NEC
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 12 affected / 86 at risk

Adverse event: Respiratory tract infections
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 10 affected / 86 at risk

Adverse event: Retina, choroid, and vitreous haemorrhages and vascular disorders
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 86 at risk

Adverse event: Salivary gland conditions
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 86 at risk

Adverse event: Sexual dysfunctions, disturbances and gender identity disorders
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 86 at risk

Adverse event: Sexual function and fertility disorders
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 86 at risk

Adverse event: Skin and subcutaneous tissue disorders - Other
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 86 at risk

Adverse event: Skin and subcutaneous tissue disorders NEC
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 86 at risk

Adverse event: Skin and subcutaneous tissue infections and infestations
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 86 at risk

Adverse event: Skin appendage conditions
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 7 affected / 86 at risk

Adverse event: Skin investigations
Serious: no
Organ System: Investigations
Frequency: 1 affected / 86 at risk

Adverse event: Skin neoplasms malignant and unspecified
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 86 at risk

Adverse event: Skin vascular abnormalities
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 86 at risk

Adverse event: Sleep disorders and disturbances
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 86 at risk

Adverse event: Sleep disturbances (incl subtypes)
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 86 at risk

Adverse event: Spinal osteoarthritis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Arthritis
Frequency: 1 affected / 86 at risk

Adverse event: Synovial and bursal disorders
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 86 at risk

Adverse event: Thyroid gland disorders
Serious: no
Organ System: Endocrine disorders
Frequency: 2 affected / 86 at risk

Adverse event: Tongue conditions
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 86 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 86 at risk

Adverse event: Upper respiratory tract disorders (excl infections)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 86 at risk

Adverse event: Urinary incontinence
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 86 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Investigations
Frequency: 1 affected / 86 at risk

Adverse event: Urinary tract signs and symptoms
Serious: no
Organ System: Renal and urinary disorders
Frequency: 3 affected / 86 at risk

Adverse event: Vascular haemorrhagic disorders
Serious: no
Organ System: Vascular disorders
Frequency: 3 affected / 86 at risk

Adverse event: Vascular hypertensive disorders
Serious: no
Organ System: Vascular disorders
Frequency: 3 affected / 86 at risk

Adverse event: Venous varices
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 86 at risk

Adverse event: Viral infectious disorders
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 86 at risk

Adverse event: Vision disorders
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 86 at risk

Adverse event: Vision disorders
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 86 at risk

Adverse event: Vitamin related disorders
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 86 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 86 at risk

Adverse event: White blood cell disorders
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 6 affected / 86 at risk

Adverse event: Nephrolithiasis
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 86 at risk

Adverse event: muscle, tendon, and ligament injuries
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 86 at risk

Adverse event: rashes, eruptions, and exanthems NEC
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 86 at risk

Adverse event: skin and subcutaneous conditions NEC
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 86 at risk

Adverse event: skin appendage conditions
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 86 at risk

Adverse event: skin appendage disorders
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 86 at risk