Study: NCT02905266

Adverse event: Angina pectoris
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 53 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 53 at risk

Adverse event: Adrenal insufficiency
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 53 at risk

Adverse event: Hypophysitis
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 53 at risk

Adverse event: Thyroiditis
Serious: yes
Organ System: Endocrine disorders
Frequency: 2 affected / 53 at risk

Adverse event: Iridocyclitis
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 53 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 53 at risk

Adverse event: Abdominal pain upper
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 53 at risk

Adverse event: Autoimmune colitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 53 at risk

Adverse event: Colitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 53 at risk

Adverse event: Cyclic vomiting syndrome
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 53 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 53 at risk

Adverse event: Erosive duodenitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 53 at risk

Adverse event: Immune-mediated enterocolitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 53 at risk

Adverse event: Pancreatitis acute
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 53 at risk

Adverse event: Rectal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 53 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 53 at risk

Adverse event: Adverse drug reaction
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 53 at risk

Adverse event: Chest pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 53 at risk

Adverse event: General physical health deterioration
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 53 at risk

Adverse event: Oedema peripheral
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 53 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 8 affected / 53 at risk

Adverse event: Acute hepatic failure
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 53 at risk

Adverse event: Autoimmune hepatitis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 2 affected / 53 at risk

Adverse event: Cholangitis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 53 at risk

Adverse event: Hepatitis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 2 affected / 53 at risk

Adverse event: Hepatocellular injury
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 6 affected / 53 at risk

Adverse event: Hypertransaminasaemia
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 2 affected / 53 at risk

Adverse event: Drug hypersensitivity
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 53 at risk

Adverse event: Anal abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 53 at risk

Adverse event: Bacterial infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 53 at risk

Adverse event: Lower respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 53 at risk

Adverse event: Parotitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 53 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 53 at risk

Adverse event: Respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 53 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 53 at risk

Adverse event: Alanine aminotransferase increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 53 at risk

Adverse event: Liver function test abnormal
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 53 at risk

Adverse event: Pancreatic enzymes increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 53 at risk

Adverse event: Arthralgia
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 53 at risk

Adverse event: Haematoma muscle
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 53 at risk

Adverse event: Basal cell carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 53 at risk

Adverse event: Lymphoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 53 at risk

Adverse event: Malignant neoplasm progression
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 53 at risk

Adverse event: Squamous cell carcinoma of skin
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 53 at risk

Adverse event: Guillain-Barre syndrome
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 53 at risk

Adverse event: Headache
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 53 at risk

Adverse event: Meningorrhagia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 53 at risk

Adverse event: Motor neurone disease
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 53 at risk

Adverse event: Spinal cord compression
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 53 at risk

Adverse event: Hydronephrosis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 53 at risk

Adverse event: Tubulointerstitial nephritis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 53 at risk

Adverse event: Urinary tract obstruction
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 53 at risk

Adverse event: Cough
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 53 at risk

Adverse event: Interstitial lung disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 53 at risk

Adverse event: Pneumonitis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 53 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 53 at risk

Adverse event: Dermatitis bullous
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 53 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 53 at risk

Adverse event: Hyperthyroidism
Serious: no
Organ System: Endocrine disorders
Frequency: 8 affected / 53 at risk

Adverse event: Hypophysitis
Serious: no
Organ System: Endocrine disorders
Frequency: 2 affected / 53 at risk

Adverse event: Hypothyroidism
Serious: no
Organ System: Endocrine disorders
Frequency: 11 affected / 53 at risk

Adverse event: Thyroiditis
Serious: no
Organ System: Endocrine disorders
Frequency: 2 affected / 53 at risk

Adverse event: Abdominal distension
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 53 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 53 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 53 at risk

Adverse event: Colitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 53 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 53 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 16 affected / 53 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 53 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 53 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 53 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 53 at risk

Adverse event: Asthenia
Serious: no
Organ System: General disorders
Frequency: 17 affected / 53 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 4 affected / 53 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 10 affected / 53 at risk

Adverse event: Influenza like illness
Serious: no
Organ System: General disorders
Frequency: 3 affected / 53 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Frequency: 5 affected / 53 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 14 affected / 53 at risk

Adverse event: Hepatitis
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 4 affected / 53 at risk

Adverse event: Hepatocellular injury
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 7 affected / 53 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 53 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 53 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 53 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 53 at risk

Adverse event: Infusion related reaction
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 4 affected / 53 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 8 affected / 53 at risk

Adverse event: Amylase increased
Serious: no
Organ System: Investigations
Frequency: 5 affected / 53 at risk

Adverse event: Aspartate aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 6 affected / 53 at risk

Adverse event: Blood lactate dehydrogenase increased
Serious: no
Organ System: Investigations
Frequency: 5 affected / 53 at risk

Adverse event: Gamma-glutamyltransferase increased
Serious: no
Organ System: Investigations
Frequency: 3 affected / 53 at risk

Adverse event: Lipase increased
Serious: no
Organ System: Investigations
Frequency: 8 affected / 53 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 10 affected / 53 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 53 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 10 affected / 53 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 8 affected / 53 at risk

Adverse event: Musculoskeletal pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 53 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 7 affected / 53 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 53 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 8 affected / 53 at risk

Adverse event: Paraesthesia
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 53 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 4 affected / 53 at risk

Adverse event: Sleep disorder
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 53 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 13 affected / 53 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 53 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 53 at risk

Adverse event: Pulmonary embolism
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 53 at risk

Adverse event: Erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 53 at risk

Adverse event: Hyperhidrosis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 53 at risk

Adverse event: Lichenoid keratosis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 53 at risk

Adverse event: Night sweats
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 53 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 9 affected / 53 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 15 affected / 53 at risk

Adverse event: Rash pruritic
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 9 affected / 53 at risk

Adverse event: Vitiligo
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 9 affected / 53 at risk

Adverse event: Deep vein thrombosis
Serious: no
Organ System: Vascular disorders
Frequency: 3 affected / 53 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 53 at risk

Adverse event: Hypophysitis
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 53 at risk

Adverse event: Thyroiditis
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 53 at risk

Adverse event: Abdominal pain upper
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 53 at risk

Adverse event: Ascites
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 53 at risk

Adverse event: Autoimmune colitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 53 at risk

Adverse event: Colitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 53 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 53 at risk

Adverse event: Duodenitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 53 at risk

Adverse event: Enteritis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 53 at risk

Adverse event: Gastritis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 53 at risk

Adverse event: Immune-mediated enterocolitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 53 at risk

Adverse event: Intestinal perforation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 53 at risk

Adverse event: Melaena
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 53 at risk

Adverse event: Small intestinal obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 53 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 53 at risk

Adverse event: Hepatic function abnormal
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 53 at risk

Adverse event: Hepatitis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 53 at risk

Adverse event: Hepatocellular injury
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 3 affected / 53 at risk

Adverse event: Autoimmune disorder
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 53 at risk

Adverse event: Erysipelas
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 53 at risk

Adverse event: Gastroenteritis viral
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 53 at risk

Adverse event: Meningitis aseptic
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 53 at risk

Adverse event: Respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 53 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 53 at risk

Adverse event: Urosepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 53 at risk

Adverse event: Infusion related reaction
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 53 at risk

Adverse event: Alanine aminotransferase increased
Serious: yes
Organ System: Investigations
Frequency: 2 affected / 53 at risk

Adverse event: Aspartate aminotransferase increased
Serious: yes
Organ System: Investigations
Frequency: 2 affected / 53 at risk

Adverse event: Pneumocystis test positive
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 53 at risk

Adverse event: Transaminases increased
Serious: yes
Organ System: Investigations
Frequency: 2 affected / 53 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 53 at risk

Adverse event: Arthralgia
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 53 at risk

Adverse event: Basal cell carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 53 at risk

Adverse event: Bowen's disease
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 53 at risk

Adverse event: Lip squamous cell carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 53 at risk

Adverse event: Malignant neoplasm progression
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 7 affected / 53 at risk

Adverse event: Facial paralysis
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 53 at risk

Adverse event: Dysuria
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 53 at risk

Adverse event: Glomerulonephritis rapidly progressive
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 53 at risk

Adverse event: Ovarian cyst
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 53 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 53 at risk

Adverse event: Pneumonitis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 53 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 53 at risk

Adverse event: Thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 53 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 6 affected / 53 at risk

Adverse event: Hyperthyroidism
Serious: no
Organ System: Endocrine disorders
Frequency: 6 affected / 53 at risk

Adverse event: Hypophysitis
Serious: no
Organ System: Endocrine disorders
Frequency: 4 affected / 53 at risk

Adverse event: Hypothyroidism
Serious: no
Organ System: Endocrine disorders
Frequency: 8 affected / 53 at risk

Adverse event: Thyroiditis
Serious: no
Organ System: Endocrine disorders
Frequency: 3 affected / 53 at risk

Adverse event: Abdominal distension
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 53 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 53 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 53 at risk

Adverse event: Colitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 53 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 53 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 25 affected / 53 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 53 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 53 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 12 affected / 53 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 12 affected / 53 at risk

Adverse event: Asthenia
Serious: no
Organ System: General disorders
Frequency: 20 affected / 53 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 4 affected / 53 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 9 affected / 53 at risk

Adverse event: Influenza like illness
Serious: no
Organ System: General disorders
Frequency: 8 affected / 53 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Frequency: 5 affected / 53 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 18 affected / 53 at risk

Adverse event: Hepatitis
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 2 affected / 53 at risk

Adverse event: Hepatocellular injury
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 3 affected / 53 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 53 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 53 at risk

Adverse event: Oral herpes
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 53 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 53 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 53 at risk

Adverse event: Infusion related reaction
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 4 affected / 53 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 7 affected / 53 at risk

Adverse event: Amylase increased
Serious: no
Organ System: Investigations
Frequency: 3 affected / 53 at risk

Adverse event: Aspartate aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 5 affected / 53 at risk

Adverse event: Blood lactate dehydrogenase increased
Serious: no
Organ System: Investigations
Frequency: 4 affected / 53 at risk

Adverse event: Gamma-glutamyltransferase increased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 53 at risk

Adverse event: Lipase increased
Serious: no
Organ System: Investigations
Frequency: 5 affected / 53 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 7 affected / 53 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 53 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 10 affected / 53 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 6 affected / 53 at risk

Adverse event: Musculoskeletal pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 53 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 8 affected / 53 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 53 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 15 affected / 53 at risk

Adverse event: Paraesthesia
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 53 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 5 affected / 53 at risk

Adverse event: Sleep disorder
Serious: no
Organ System: Psychiatric disorders
Frequency: 3 affected / 53 at risk

Adverse event: Dysuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 3 affected / 53 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 7 affected / 53 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 53 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 53 at risk

Adverse event: Pulmonary embolism
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 53 at risk

Adverse event: Erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 53 at risk

Adverse event: Hyperhidrosis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 53 at risk

Adverse event: Lichenoid keratosis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 53 at risk

Adverse event: Night sweats
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 53 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 17 affected / 53 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 12 affected / 53 at risk

Adverse event: Rash pruritic
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 7 affected / 53 at risk

Adverse event: Vitiligo
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 53 at risk