Study: NCT02030834

Adverse event: Febrile neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 50 at risk

Adverse event: Sinus tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 50 at risk

Adverse event: Eye disorders - Other, specify
Serious: yes
Organ System: Eye disorders
Notes: Scotoma left eye
Frequency: 1 affected / 50 at risk

Adverse event: Gastrointestinal disorders - Other, specify
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Incarcerated umbilical hernia
Frequency: 1 affected / 50 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 6 affected / 50 at risk

Adverse event: Pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 50 at risk

Adverse event: Hypersensitivity
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 50 at risk

Adverse event: Cytokine release syndrome
Serious: yes
Organ System: Immune system disorders
Frequency: 20 affected / 50 at risk

Adverse event: Enterocolitis infectious
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 50 at risk

Adverse event: Infections and infestations - Other, specify
Serious: yes
Organ System: Infections and infestations
Notes: Influenza A
Frequency: 1 affected / 50 at risk

Adverse event: Infections and infestations - Other, specify
Serious: yes
Organ System: Infections and infestations
Notes: Streptococcal Bacteremia
Frequency: 1 affected / 50 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 50 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 50 at risk

Adverse event: Sinusitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 50 at risk

Adverse event: Upper respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 50 at risk

Adverse event: Back pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 50 at risk

Adverse event: Myelodysplastic syndrome
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 50 at risk

Adverse event: Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: Second primary cancer
Frequency: 1 affected / 50 at risk

Adverse event: Encephalopathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 50 at risk

Adverse event: Syncope
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 50 at risk

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 50 at risk

Adverse event: Haematuria
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 50 at risk

Adverse event: Aspiration
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 50 at risk

Adverse event: Hypoxia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 50 at risk

Adverse event: Pleural effusion
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 50 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 50 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 14 affected / 50 at risk

Adverse event: Blood and lymphatic system disorders - Other, specify
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Splenomegaly
Frequency: 1 affected / 50 at risk

Adverse event: Febrile neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 50 at risk

Adverse event: Thrombotic thrombocytopenic purpura
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 50 at risk

Adverse event: Atrial fibrillation
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 50 at risk

Adverse event: Cardiac arrest
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 50 at risk

Adverse event: Angina pectoris
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 50 at risk

Adverse event: Restrictive cardiomyopathy
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 50 at risk

Adverse event: Sinus tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 8 affected / 50 at risk

Adverse event: Hypoacusis
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 50 at risk

Adverse event: Vertigo
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 2 affected / 50 at risk

Adverse event: Hypothyroidism
Serious: no
Organ System: Endocrine disorders
Frequency: 1 affected / 50 at risk

Adverse event: Vision blurred
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 50 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 50 at risk

Adverse event: Eye disorders - Other, specify
Serious: no
Organ System: Eye disorders
Notes: Fogginess
Frequency: 1 affected / 50 at risk

Adverse event: Vitreous floaters
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 50 at risk

Adverse event: Optic nerve disorder
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 50 at risk

Adverse event: Abdominal distension
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 50 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 50 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 50 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 8 affected / 50 at risk

Adverse event: Dysphagia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 50 at risk

Adverse event: Enterocolitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 50 at risk

Adverse event: Flatulence
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 50 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 50 at risk

Adverse event: Gastrointestinal disorders - Other, specify
Serious: no
Organ System: Gastrointestinal disorders
Notes: Barrett's Esophagus
Frequency: 1 affected / 50 at risk

Adverse event: Intra-abdominal haemorrhage
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 50 at risk

Adverse event: Stomatitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 50 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 50 at risk

Adverse event: Small intestinal obstruction
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 50 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 50 at risk

Adverse event: Gastrointestinal disorders - Other, specify
Serious: no
Organ System: Gastrointestinal disorders
Notes: White on tongue
Frequency: 1 affected / 50 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 50 at risk

Adverse event: Localised oedema
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 50 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 23 affected / 50 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 5 affected / 50 at risk

Adverse event: General disorders and administration site conditions - Other, specify
Serious: no
Organ System: General disorders
Notes: Rigors
Frequency: 1 affected / 50 at risk

Adverse event: Localised oedema
Serious: no
Organ System: General disorders
Frequency: 1 affected / 50 at risk

Adverse event: Non-cardiac chest pain
Serious: no
Organ System: General disorders
Frequency: 3 affected / 50 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 7 affected / 50 at risk

Adverse event: Hypersensitivity
Serious: no
Organ System: Immune system disorders
Frequency: 2 affected / 50 at risk

Adverse event: Abdominal infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 50 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 50 at risk

Adverse event: Gingivitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 50 at risk

Adverse event: Infections and infestations - Other, specify
Serious: no
Organ System: Infections and infestations
Notes: Bronchiolitis
Frequency: 1 affected / 50 at risk

Adverse event: Infections and infestations - Other, specify
Serious: no
Organ System: Infections and infestations
Notes: Clostridium difficile
Frequency: 1 affected / 50 at risk

Adverse event: Infections and infestations - Other, specify
Serious: no
Organ System: Infections and infestations
Notes: flu
Frequency: 1 affected / 50 at risk

Adverse event: Infections and infestations - Other, specify
Serious: no
Organ System: Infections and infestations
Notes: Lymphadenitis: inguinal
Frequency: 1 affected / 50 at risk

Adverse event: Infections and infestations - Other, specify
Serious: no
Organ System: Infections and infestations
Notes: Upper Respiratory Infection
Frequency: 1 affected / 50 at risk

Adverse event: Infections and infestations - Other, specify
Serious: no
Organ System: Infections and infestations
Notes: UTI
Frequency: 1 affected / 50 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 50 at risk

Adverse event: Mucosal infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 50 at risk

Adverse event: Otitis media
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 50 at risk

Adverse event: Rash pustular
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 50 at risk

Adverse event: Rash pustular
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 50 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 50 at risk

Adverse event: Skin infection
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 50 at risk

Adverse event: Enteritis infectious
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 50 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 10 affected / 50 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 50 at risk

Adverse event: Vaginal infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 50 at risk

Adverse event: Injury, poisoning and procedural complications - Other, specify
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Head Laceration
Frequency: 1 affected / 50 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 11 affected / 50 at risk

Adverse event: Blood alkaline phosphatase increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 50 at risk

Adverse event: Aspartate aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 10 affected / 50 at risk

Adverse event: Blood bilirubin increased
Serious: no
Organ System: Investigations
Frequency: 6 affected / 50 at risk

Adverse event: CD4 lymphocytes decreased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 50 at risk

Adverse event: Blood cholesterol increased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 50 at risk

Adverse event: Blood creatinine increased
Serious: no
Organ System: Investigations
Frequency: 6 affected / 50 at risk

Adverse event: Lymphocyte count decreased
Serious: no
Organ System: Investigations
Frequency: 7 affected / 50 at risk

Adverse event: Lymphocyte count increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 50 at risk

Adverse event: Neutrophil count decreased
Serious: no
Organ System: Investigations
Frequency: 19 affected / 50 at risk

Adverse event: Platelet count decreased
Serious: no
Organ System: Investigations
Frequency: 10 affected / 50 at risk

Adverse event: Weight increased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 50 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Investigations
Frequency: 4 affected / 50 at risk

Adverse event: White blood cell count decreased
Serious: no
Organ System: Investigations
Frequency: 13 affected / 50 at risk

Adverse event: Acidosis
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 50 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 50 at risk

Adverse event: Dehydration
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 50 at risk

Adverse event: Hypercalcaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 50 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 11 affected / 50 at risk

Adverse event: Hypermagnesaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 50 at risk

Adverse event: Hypoalbuminaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 12 affected / 50 at risk

Adverse event: Hypocalcaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 16 affected / 50 at risk

Adverse event: Hypoglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 50 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 13 affected / 50 at risk

Adverse event: Hypomagnesaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 10 affected / 50 at risk

Adverse event: Hyponatraemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 18 affected / 50 at risk

Adverse event: Hypophosphataemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 12 affected / 50 at risk

Adverse event: Iron overload
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 50 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 6 affected / 50 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 8 affected / 50 at risk

Adverse event: Flank pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 50 at risk

Adverse event: Joint range of motion decreased
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 50 at risk

Adverse event: Muscular weakness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 50 at risk

Adverse event: Musculoskeletal and connective tissue disorder - Other, specify
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Body aches in joints and muscles
Frequency: 1 affected / 50 at risk

Adverse event: Musculoskeletal and connective tissue disorder - Other, specify
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Calcium Pyrophosphate Deposition Disease
Frequency: 1 affected / 50 at risk

Adverse event: Musculoskeletal and connective tissue disorder - Other, specify
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Cramps
Frequency: 1 affected / 50 at risk

Adverse event: Musculoskeletal and connective tissue disorder - Other, specify
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Lateral epicondylitis
Frequency: 1 affected / 50 at risk

Adverse event: Musculoskeletal and connective tissue disorder - Other, specify
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Muscular atrophy
Frequency: 1 affected / 50 at risk

Adverse event: Musculoskeletal and connective tissue disorder - Other, specify
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Twitching: finger
Frequency: 1 affected / 50 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 50 at risk

Adverse event: Neck pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 50 at risk

Adverse event: Osteoporosis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 50 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 50 at risk

Adverse event: Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: Basal cell carcinoma
Frequency: 1 affected / 50 at risk

Adverse event: Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: Melanoma (T1A)
Frequency: 1 affected / 50 at risk

Adverse event: Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: Squamous cell carcinoma
Frequency: 1 affected / 50 at risk

Adverse event: Cognitive disorder
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 50 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 50 at risk

Adverse event: Dysgeusia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 50 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 11 affected / 50 at risk

Adverse event: Hydrocephalus
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 50 at risk

Adverse event: Memory impairment
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 50 at risk

Adverse event: Dyskinesia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 50 at risk

Adverse event: Nervous system disorders - Other, specify
Serious: no
Organ System: Nervous system disorders
Notes: Tingling
Frequency: 1 affected / 50 at risk

Adverse event: Paraesthesia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 50 at risk

Adverse event: Peripheral motor neuropathy
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 50 at risk

Adverse event: Muscle spasticity
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 50 at risk

Adverse event: Tremor
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 50 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 3 affected / 50 at risk

Adverse event: Confusional state
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 50 at risk

Adverse event: Delirium
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 50 at risk

Adverse event: Hallucination
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 50 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 50 at risk

Adverse event: Acute kidney injury
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 50 at risk

Adverse event: Renal and urinary disorders - Other, specify
Serious: no
Organ System: Renal and urinary disorders
Notes: Hydroureteronephrosis
Frequency: 1 affected / 50 at risk

Adverse event: Renal and urinary disorders - Other, specify
Serious: no
Organ System: Renal and urinary disorders
Notes: Urinary hesitancy
Frequency: 1 affected / 50 at risk

Adverse event: Renal and urinary disorders - Other, specify
Serious: no
Organ System: Renal and urinary disorders
Notes: Urine: foamy
Frequency: 1 affected / 50 at risk

Adverse event: Pollakiuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 50 at risk

Adverse event: Micturition urgency
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 50 at risk

Adverse event: Oedema genital
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 50 at risk

Adverse event: Perineal pain
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 50 at risk

Adverse event: Rhinitis allergic
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 50 at risk

Adverse event: Aspiration
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 50 at risk

Adverse event: Bronchostenosis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 50 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 7 affected / 50 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 50 at risk

Adverse event: Dysphonia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 50 at risk

Adverse event: Hypoxia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 50 at risk

Adverse event: Laryngeal oedema
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 50 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 50 at risk

Adverse event: Pleural effusion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 50 at risk

Adverse event: Pneumonitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 50 at risk

Adverse event: Upper-airway cough syndrome
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 50 at risk

Adverse event: Pulmonary oedema
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 50 at risk

Adverse event: Respiratory, thoracic and mediastinal disorders - Other, specify
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Lungs: decreased breath sounds
Frequency: 1 affected / 50 at risk

Adverse event: Respiratory, thoracic and mediastinal disorders - Other, specify
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Lungs: crackles
Frequency: 1 affected / 50 at risk

Adverse event: Respiratory, thoracic and mediastinal disorders - Other, specify
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Morning cough and sputum production
Frequency: 1 affected / 50 at risk

Adverse event: Differentiation syndrome
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 50 at risk

Adverse event: Sleep apnoea syndrome
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 50 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 50 at risk

Adverse event: Erythema multiforme
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 50 at risk

Adverse event: Dermatitis exfoliative generalised
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 50 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 50 at risk

Adverse event: Purpura
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 50 at risk

Adverse event: Rash maculo-papular
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 50 at risk

Adverse event: Skin and subcutaneous tissue disorders - Other, specify
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Actinic keratosis
Frequency: 1 affected / 50 at risk

Adverse event: Skin and subcutaneous tissue disorders - Other, specify
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Bloody lips
Frequency: 1 affected / 50 at risk

Adverse event: Skin and subcutaneous tissue disorders - Other, specify
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Contact dermatitis
Frequency: 1 affected / 50 at risk

Adverse event: Skin and subcutaneous tissue disorders - Other, specify
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Erythematous rash
Frequency: 1 affected / 50 at risk

Adverse event: Skin and subcutaneous tissue disorders - Other, specify
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Night sweats
Frequency: 1 affected / 50 at risk

Adverse event: Skin and subcutaneous tissue disorders - Other, specify
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Rash
Frequency: 2 affected / 50 at risk

Adverse event: Skin and subcutaneous tissue disorders - Other, specify
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Skin excoriation
Frequency: 1 affected / 50 at risk

Adverse event: Skin and subcutaneous tissue disorders - Other, specify
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Verruca vulgaris
Frequency: 1 affected / 50 at risk

Adverse event: Skin and subcutaneous tissue disorders - Other, specify
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Warts
Frequency: 3 affected / 50 at risk

Adverse event: Skin ulcer
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 50 at risk

Adverse event: Hot flush
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 50 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 4 affected / 50 at risk

Adverse event: Hypotension
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 6 affected / 50 at risk

Adverse event: Lymphoedema
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 50 at risk

Adverse event: Embolism
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 50 at risk

Adverse event: Vascular disorders - Other, specify
Serious: no
Organ System: Vascular disorders
Notes: Fluid overload
Frequency: 1 affected / 50 at risk

Adverse event: Vascular disorders - Other, specify
Serious: no
Organ System: Vascular disorders
Notes: Night sweats
Frequency: 1 affected / 50 at risk

Adverse event: Sinus tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 3 at risk

Adverse event: Supraventricular tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 3 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 3 at risk

Adverse event: Cytokine release syndrome
Serious: yes
Organ System: Immune system disorders
Frequency: 2 affected / 3 at risk

Adverse event: Haematoma
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 3 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 3 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 3 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 3 at risk

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

Adverse event: Diarrhoea
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 3 at risk

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

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 3 at risk

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

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

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

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

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

Adverse event: Infections and infestations - Other, specify
Serious: no
Organ System: Infections and infestations
Notes: Giardia in stool
Frequency: 1 affected / 3 at risk

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

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 3 at risk

Adverse event: Blood alkaline phosphatase increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 3 at risk

Adverse event: Aspartate aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 3 affected / 3 at risk

Adverse event: Blood creatinine increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 3 at risk

Adverse event: Blood fibrinogen decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 3 at risk

Adverse event: Neutrophil count decreased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 3 at risk

Adverse event: Platelet count decreased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 3 at risk

Adverse event: White blood cell count decreased
Serious: no
Organ System: Investigations
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: Hyperkalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 3 at risk

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

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

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

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

Adverse event: Hyponatraemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 3 at risk

Adverse event: Hypophosphataemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 3 at risk

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

Adverse event: Musculoskeletal and connective tissue disorder - Other, specify
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Cramps
Frequency: 1 affected / 3 at risk

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

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

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 3 at risk

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

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

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

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

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

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

Adverse event: Skin and subcutaneous tissue disorders - Other, specify
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Erythematous rash
Frequency: 1 affected / 3 at risk

Adverse event: Skin and subcutaneous tissue disorders - Other, specify
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Vescular rash
Frequency: 1 affected / 3 at risk

Adverse event: Skin and subcutaneous tissue disorders - Other, specify
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Folliculitis
Frequency: 1 affected / 3 at risk

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

Adverse event: Vascular disorders - Other, specify
Serious: no
Organ System: Vascular disorders
Notes: Night sweats
Frequency: 1 affected / 3 at risk

Adverse event: Vascular disorders - Other, specify
Serious: no
Organ System: Vascular disorders
Notes: Livedo reticularis
Frequency: 1 affected / 3 at risk

Adverse event: Febrile neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 10 at risk

Adverse event: Cytokine release syndrome
Serious: yes
Organ System: Immune system disorders
Frequency: 4 affected / 10 at risk

Adverse event: Hypercalcaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 10 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 10 at risk

Adverse event: Sinus node dysfunction
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 10 at risk

Adverse event: Photopsia
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 10 at risk

Adverse event: Photophobia
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 10 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 10 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 10 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 10 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 10 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 10 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 1 affected / 10 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 10 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 3 affected / 10 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 2 affected / 10 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 2 affected / 10 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 10 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 10 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 10 at risk

Adverse event: Aspartate aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 3 affected / 10 at risk

Adverse event: Blood creatinine increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 10 at risk

Adverse event: Investigations - Other, specify
Serious: no
Organ System: Investigations
Notes: Headache
Frequency: 1 affected / 10 at risk

Adverse event: Lymphocyte count decreased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 10 at risk

Adverse event: Neutrophil count decreased
Serious: no
Organ System: Investigations
Frequency: 5 affected / 10 at risk

Adverse event: Platelet count decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 10 at risk

Adverse event: White blood cell count decreased
Serious: no
Organ System: Investigations
Frequency: 3 affected / 10 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 10 at risk

Adverse event: Hypercalcaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 10 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 10 at risk

Adverse event: Hyperkalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 10 at risk

Adverse event: Hypoalbuminaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 10 at risk

Adverse event: Hypocalcaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 10 at risk

Adverse event: Hypomagnesaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 10 at risk

Adverse event: Hyponatraemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 10 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 10 at risk

Adverse event: Musculoskeletal and connective tissue disorder - Other, specify
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Labral tear
Frequency: 1 affected / 10 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 10 at risk

Adverse event: Neck pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 10 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 10 at risk

Adverse event: Dysgeusia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 10 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 10 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 10 at risk

Adverse event: Dermatitis acneiform
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 10 at risk

Adverse event: Vascular disorders - Other, specify
Serious: no
Organ System: Vascular disorders
Notes: Night sweats
Frequency: 1 affected / 10 at risk