Study: NCT02789345

Adverse event: Diverticulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3 at risk

Adverse event: Trichiasis
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 3 at risk

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

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3 at risk

Adverse event: Asthenia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 3 at risk

Adverse event: Chest pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 3 at risk

Adverse event: Gait disturbance
Serious: no
Organ System: General disorders
Frequency: 1 affected / 3 at risk

Adverse event: Non-cardiac chest pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 3 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 2 affected / 3 at risk

Adverse event: Folliculitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 3 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 3 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 3 at risk

Adverse event: Tooth infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 3 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 3 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 3 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 3 at risk

Adverse event: Cerebral haemorrhage
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 3 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 3 at risk

Adverse event: Proteinuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 3 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 3 at risk

Adverse event: Dyspnoea exertional
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 3 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 3 at risk

Adverse event: Productive cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 3 at risk

Adverse event: Sputum discoloured
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 3 at risk

Adverse event: Dermatitis acneiform
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 3 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 3 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 3 at risk

Adverse event: Skin irritation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 3 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 3 at risk

Adverse event: Abdominal pain upper
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 4 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 4 at risk

Adverse event: Trichomegaly
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 4 at risk

Adverse event: Cheilitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 4 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 4 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 4 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 4 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 4 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 4 at risk

Adverse event: Asthenia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 4 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 3 affected / 4 at risk

Adverse event: Mucosal inflammation
Serious: no
Organ System: General disorders
Frequency: 1 affected / 4 at risk

Adverse event: Non-cardiac chest pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 4 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 4 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 4 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 4 at risk

Adverse event: Viral infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 4 at risk

Adverse event: Foot fracture
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 4 at risk

Adverse event: Infusion related reaction
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 4 at risk

Adverse event: Lipase increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 4 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 4 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 4 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 4 at risk

Adverse event: Hypomagnesaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 4 at risk

Adverse event: Hyponatraemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 4 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 4 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 4 at risk

Adverse event: Muscular weakness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 4 at risk

Adverse event: Musculoskeletal chest pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 4 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 4 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 4 at risk

Adverse event: Neuropathy peripheral
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 4 at risk

Adverse event: Presyncope
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 4 at risk

Adverse event: Tremor
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 4 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 4 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 4 at risk

Adverse event: Renal impairment
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 4 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 4 at risk

Adverse event: Dermatitis acneiform
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 4 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 4 at risk

Adverse event: Hirsutism
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 3 at risk

Adverse event: Onycholysis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 4 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 4 at risk

Adverse event: Skin fissures
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 4 at risk

Adverse event: Thrombocytopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 22 at risk

Adverse event: Atrioventricular block second degree
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 22 at risk

Adverse event: Cardiac failure congestive
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 22 at risk

Adverse event: Intestinal obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 22 at risk

Adverse event: Pancreatitis acute
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 22 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 22 at risk

Adverse event: Cystitis klebsiella
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 22 at risk

Adverse event: Device related infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 22 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 22 at risk

Adverse event: Subdural haemorrhage
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 22 at risk

Adverse event: Osteoarthritis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 22 at risk

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 22 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 22 at risk

Adverse event: Pneumothorax
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 22 at risk

Adverse event: Pulmonary oedema
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 22 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 22 at risk

Adverse event: Neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 22 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 22 at risk

Adverse event: Angina pectoris
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 22 at risk

Adverse event: Cardiac failure congestive
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 22 at risk

Adverse event: Palpitations
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 22 at risk

Adverse event: Sinus bradycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 22 at risk

Adverse event: Tinnitus
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 22 at risk

Adverse event: Vertigo
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 22 at risk

Adverse event: Cushingoid
Serious: no
Organ System: Endocrine disorders
Frequency: 1 affected / 22 at risk

Adverse event: Blepharospasm
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 22 at risk

Adverse event: Cataract
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 22 at risk

Adverse event: Diplopia
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 22 at risk

Adverse event: Eye disorder
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 22 at risk

Adverse event: Eyelid oedema
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 22 at risk

Adverse event: Glaucoma
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 22 at risk

Adverse event: Ocular hyperaemia
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 22 at risk

Adverse event: Visual impairment
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 22 at risk

Adverse event: Abdominal distension
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 22 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 22 at risk

Adverse event: Anal fissure
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 22 at risk

Adverse event: Anal haemorrhage
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 22 at risk

Adverse event: Ascites
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 22 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 22 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 14 affected / 22 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 22 at risk

Adverse event: Dysphagia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 22 at risk

Adverse event: Flatulence
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 22 at risk

Adverse event: Gingival bleeding
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 22 at risk

Adverse event: Haemorrhoids
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 22 at risk

Adverse event: Impaired gastric emptying
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 22 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 22 at risk

Adverse event: Odynophagia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 22 at risk

Adverse event: Oesophagitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 22 at risk

Adverse event: Oral pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 22 at risk

Adverse event: Pancreatitis acute
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 22 at risk

Adverse event: Paraesthesia oral
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 22 at risk

Adverse event: Periodontal disease
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 22 at risk

Adverse event: Stomatitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 22 at risk

Adverse event: Transient lingual papillitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 22 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 22 at risk

Adverse event: Asthenia
Serious: no
Organ System: General disorders
Frequency: 2 affected / 22 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 1 affected / 22 at risk

Adverse event: Face oedema
Serious: no
Organ System: General disorders
Frequency: 2 affected / 22 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 3 affected / 22 at risk

Adverse event: Influenza like illness
Serious: no
Organ System: General disorders
Frequency: 1 affected / 22 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Frequency: 1 affected / 22 at risk

Adverse event: Mucosal dryness
Serious: no
Organ System: General disorders
Frequency: 1 affected / 22 at risk

Adverse event: Mucosal inflammation
Serious: no
Organ System: General disorders
Frequency: 3 affected / 22 at risk

Adverse event: Non-cardiac chest pain
Serious: no
Organ System: General disorders
Frequency: 3 affected / 22 at risk

Adverse event: Oedema
Serious: no
Organ System: General disorders
Frequency: 3 affected / 22 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Frequency: 5 affected / 22 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 4 affected / 22 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 3 affected / 22 at risk

Adverse event: Xerosis
Serious: no
Organ System: General disorders
Frequency: 1 affected / 22 at risk

Adverse event: Hypersensitivity
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 22 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 22 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 22 at risk

Adverse event: Gastrointestinal viral infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 22 at risk

Adverse event: Infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 22 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 22 at risk

Adverse event: Nail infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 22 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 22 at risk

Adverse event: Paronychia
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 22 at risk

Adverse event: Periodontitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 22 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 22 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 22 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 22 at risk

Adverse event: Skin infection
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 22 at risk

Adverse event: Tonsillitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 22 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 22 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 22 at risk

Adverse event: Fall
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 22 at risk

Adverse event: Humerus fracture
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 22 at risk

Adverse event: Infusion related reaction
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 22 at risk

Adverse event: Skin laceration
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 22 at risk

Adverse event: Transfusion reaction
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 22 at risk

Adverse event: Wound complication
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 22 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 22 at risk

Adverse event: Amylase increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 22 at risk

Adverse event: Aspartate aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 22 at risk

Adverse event: Blood bilirubin increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 22 at risk

Adverse event: Blood cholesterol increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 22 at risk

Adverse event: Blood creatine phosphokinase increased
Serious: no
Organ System: Investigations
Frequency: 4 affected / 22 at risk

Adverse event: Blood creatinine increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 22 at risk

Adverse event: Gamma-glutamyltransferase increased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 22 at risk

Adverse event: Lipase increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 22 at risk

Adverse event: Neutrophil count decreased
Serious: no
Organ System: Investigations
Frequency: 3 affected / 22 at risk

Adverse event: Platelet count decreased
Serious: no
Organ System: Investigations
Frequency: 6 affected / 22 at risk

Adverse event: Prothrombin time prolonged
Serious: no
Organ System: Investigations
Frequency: 1 affected / 22 at risk

Adverse event: Transaminases increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 22 at risk

Adverse event: Urine output decreased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 22 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Investigations
Frequency: 3 affected / 22 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 9 affected / 22 at risk

Adverse event: Hyperkalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 22 at risk

Adverse event: Hypoalbuminaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 22 at risk

Adverse event: Hyponatraemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 22 at risk

Adverse event: Hypophosphataemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 22 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 22 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 5 affected / 22 at risk

Adverse event: Muscle spasms
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 22 at risk

Adverse event: Musculoskeletal chest pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 22 at risk

Adverse event: Musculoskeletal pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 22 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 22 at risk

Adverse event: Osteoarthritis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 22 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 22 at risk

Adverse event: Spinal osteoarthritis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 22 at risk

Adverse event: Haemangioma
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 22 at risk

Adverse event: Pyogenic granuloma
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 22 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 22 at risk

Adverse event: Dysarthria
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 22 at risk

Adverse event: Facial paralysis
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 22 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 9 affected / 22 at risk

Adverse event: Memory impairment
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 22 at risk

Adverse event: Neurological decompensation
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 22 at risk

Adverse event: Paraesthesia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 22 at risk

Adverse event: Peripheral sensory neuropathy
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 22 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 22 at risk

Adverse event: Confusional state
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 22 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 22 at risk

Adverse event: Mental status changes
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 22 at risk

Adverse event: Cystitis noninfective
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 22 at risk

Adverse event: Dysuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 22 at risk

Adverse event: Haematuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 22 at risk

Adverse event: Micturition disorder
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 22 at risk

Adverse event: Nocturia
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 22 at risk

Adverse event: Pollakiuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 22 at risk

Adverse event: Proteinuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 4 affected / 22 at risk

Adverse event: Pruritus genital
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 22 at risk

Adverse event: Vulvovaginal dryness
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 17 at risk

Adverse event: Asthma
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 22 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 22 at risk

Adverse event: Dry throat
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 22 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 22 at risk

Adverse event: Dyspnoea exertional
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 22 at risk

Adverse event: Epistaxis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 22 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 22 at risk

Adverse event: Nasal dryness
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 22 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 22 at risk

Adverse event: Pleural effusion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 22 at risk

Adverse event: Pleuritic pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 22 at risk

Adverse event: Pneumothorax
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 22 at risk

Adverse event: Productive cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 22 at risk

Adverse event: Pulmonary haemorrhage
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 22 at risk

Adverse event: Rhinitis allergic
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 22 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 22 at risk

Adverse event: Upper-airway cough syndrome
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 22 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 22 at risk

Adverse event: Cold sweat
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 22 at risk

Adverse event: Dermal cyst
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 22 at risk

Adverse event: Dermatitis allergic
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 22 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 22 at risk

Adverse event: Nail dystrophy
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 22 at risk

Adverse event: Onychoclasis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 22 at risk

Adverse event: Onycholysis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 22 at risk

Adverse event: Onychomadesis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 22 at risk

Adverse event: Petechiae
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 22 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 22 at risk

Adverse event: Purpura
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 22 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 22 at risk

Adverse event: Rash maculo-papular
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 22 at risk

Adverse event: Skin exfoliation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 22 at risk

Adverse event: Skin fissures
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 22 at risk

Adverse event: Skin lesion
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 22 at risk

Adverse event: Deep vein thrombosis
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 22 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 14 affected / 22 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 22 at risk