Study: NCT02636725

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 33 at risk

Adverse event: Alanine aminotransferase increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 33 at risk

Adverse event: Decreased appetite
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 33 at risk

Adverse event: Aspartate aminotransferase increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 33 at risk

Adverse event: Back pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 33 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 33 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 33 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 33 at risk

Adverse event: Gastrointestinal disorders - Other
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Nausea and Vomiting
Frequency: 1 affected / 33 at risk

Adverse event: Hypertriglyceridaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 33 at risk

Adverse event: Investigations - Other
Serious: yes
Organ System: Investigations
Notes: Transaminitis
Frequency: 1 affected / 33 at risk

Adverse event: Rash pustular
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 33 at risk

Adverse event: Pericardial effusion
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 33 at risk

Adverse event: Pneumothorax
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 33 at risk

Adverse event: Radiculopathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 33 at risk

Adverse event: Renal and urinary disorders - Other
Serious: yes
Organ System: Renal and urinary disorders
Notes: Acute renal failure
Frequency: 1 affected / 33 at risk

Adverse event: Renal and urinary disorders - Other
Serious: yes
Organ System: Renal and urinary disorders
Notes: Uremia
Frequency: 1 affected / 33 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 33 at risk

Adverse event: Syncope
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 33 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 33 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 12 affected / 33 at risk

Adverse event: Acidosis
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 33 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 14 affected / 33 at risk

Adverse event: Blood alkaline phosphatase increased
Serious: no
Organ System: Investigations
Frequency: 10 affected / 33 at risk

Adverse event: Rhinitis allergic
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 33 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 33 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 6 affected / 33 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 12 affected / 33 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 33 at risk

Adverse event: Aspartate aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 13 affected / 33 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 6 affected / 33 at risk

Adverse event: Abdominal distension
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 33 at risk

Adverse event: Blood bilirubin increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 33 at risk

Adverse event: Breast pain
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 33 at risk

Adverse event: Contusion
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 33 at risk

Adverse event: Angina pectoris
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 33 at risk

Adverse event: Musculoskeletal chest pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 33 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 1 affected / 33 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 33 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 14 affected / 33 at risk

Adverse event: Blood creatinine increased
Serious: no
Organ System: Investigations
Frequency: 7 affected / 33 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 26 affected / 33 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 33 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 33 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 33 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 33 at risk

Adverse event: Ear and labyrinth disorders - Other
Serious: no
Organ System: Ear and labyrinth disorders
Notes: Ear congestion
Frequency: 4 affected / 33 at risk

Adverse event: Ear pain
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 2 affected / 33 at risk

Adverse event: Face oedema
Serious: no
Organ System: General disorders
Frequency: 1 affected / 33 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Frequency: 2 affected / 33 at risk

Adverse event: Ejection fraction decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 33 at risk

Adverse event: Epistaxis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 33 at risk

Adverse event: Erythema multiforme
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 33 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 26 affected / 33 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 33 at risk

Adverse event: Gastrointestinal disorders - Other
Serious: no
Organ System: Gastrointestinal disorders
Notes: Acid reflux
Frequency: 1 affected / 33 at risk

Adverse event: Gastrointestinal disorders - Other
Serious: no
Organ System: Gastrointestinal disorders
Notes: Mouth sensitivity
Frequency: 3 affected / 33 at risk

Adverse event: Gastrointestinal disorders - Other
Serious: no
Organ System: Gastrointestinal disorders
Notes: Mouth soreness
Frequency: 1 affected / 33 at risk

Adverse event: Gastrointestinal disorders - Other
Serious: no
Organ System: Gastrointestinal disorders
Notes: Rectal irritation
Frequency: 1 affected / 33 at risk

Adverse event: Gastrointestinal disorders - Other
Serious: no
Organ System: Gastrointestinal disorders
Notes: Stomatitis
Frequency: 1 affected / 33 at risk

Adverse event: General disorders and administration site conditions - Other
Serious: no
Organ System: General disorders
Notes: Decreased appetite
Frequency: 1 affected / 33 at risk

Adverse event: General disorders and administration site conditions - Other
Serious: no
Organ System: General disorders
Notes: Headaches (morning)
Frequency: 1 affected / 33 at risk

Adverse event: General disorders and administration site conditions - Other
Serious: no
Organ System: General disorders
Notes: Itching skin
Frequency: 1 affected / 33 at risk

Adverse event: General disorders and administration site conditions - Other
Serious: no
Organ System: General disorders
Notes: Weakness
Frequency: 1 affected / 33 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 33 at risk

Adverse event: Haematuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 33 at risk

Adverse event: Haemoglobin increased
Serious: no
Organ System: Investigations
Frequency: 5 affected / 33 at risk

Adverse event: Haemorrhoids
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 33 at risk

Adverse event: Dysphonia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 33 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 33 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 14 affected / 33 at risk

Adverse event: Hyperthyroidism
Serious: no
Organ System: Endocrine disorders
Frequency: 2 affected / 33 at risk

Adverse event: Hypertriglyceridaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 33 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 33 at risk

Adverse event: Hypothyroidism
Serious: no
Organ System: Endocrine disorders
Frequency: 18 affected / 33 at risk

Adverse event: Immune system disorders - Other
Serious: no
Organ System: Immune system disorders
Notes: Disseminated Herpes Zoster
Frequency: 1 affected / 33 at risk

Adverse event: Infections and infestations - Other
Serious: no
Organ System: Infections and infestations
Notes: Herpes simplex - Eye lesion
Frequency: 1 affected / 33 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 5 affected / 33 at risk

Adverse event: Investigations - Other
Serious: no
Organ System: Investigations
Notes: Elevated triglycerides
Frequency: 1 affected / 33 at risk

Adverse event: Investigations - Other
Serious: no
Organ System: Investigations
Notes: Elevated thyroid stimulating hormone (TSH)
Frequency: 3 affected / 33 at risk

Adverse event: Investigations - Other
Serious: no
Organ System: Investigations
Notes: Eosinophilia
Frequency: 1 affected / 33 at risk

Adverse event: Investigations - Other
Serious: no
Organ System: Investigations
Notes: Hand sensitivity
Frequency: 2 affected / 33 at risk

Adverse event: Investigations - Other
Serious: no
Organ System: Investigations
Notes: Hyperlipidemia
Frequency: 1 affected / 33 at risk

Adverse event: Investigations - Other
Serious: no
Organ System: Investigations
Notes: Increased blood urea nitrogen (BUN)
Frequency: 1 affected / 33 at risk

Adverse event: Investigations - Other
Serious: no
Organ System: Investigations
Notes: Lung discomfort
Frequency: 1 affected / 33 at risk

Adverse event: Investigations - Other
Serious: no
Organ System: Investigations
Notes: Mouth sensitivity
Frequency: 1 affected / 33 at risk

Adverse event: Investigations - Other
Serious: no
Organ System: Investigations
Notes: Mouth sensitivity - spicy foods
Frequency: 1 affected / 33 at risk

Adverse event: Investigations - Other
Serious: no
Organ System: Investigations
Notes: Mouth sores
Frequency: 1 affected / 33 at risk

Adverse event: Investigations - Other
Serious: no
Organ System: Investigations
Notes: Muscle aches
Frequency: 1 affected / 33 at risk

Adverse event: Investigations - Other
Serious: no
Organ System: Investigations
Notes: Sputum production
Frequency: 1 affected / 33 at risk

Adverse event: Joint effusion
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 33 at risk

Adverse event: Stomatitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 14 affected / 33 at risk

Adverse event: Musculoskeletal and connective tissue disorder - Other
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Foot sensitivity
Frequency: 1 affected / 33 at risk

Adverse event: Musculoskeletal and connective tissue disorder - Other
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Hand sensitivity
Frequency: 2 affected / 33 at risk

Adverse event: Musculoskeletal and connective tissue disorder - Other
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Intermittent hand sensitivity
Frequency: 1 affected / 33 at risk

Adverse event: Musculoskeletal and connective tissue disorder - Other
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Oligoarthritis
Frequency: 1 affected / 33 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 7 affected / 33 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 19 affected / 33 at risk

Adverse event: Nervous system disorders - Other
Serious: no
Organ System: Nervous system disorders
Notes: Hand sensitivity
Frequency: 1 affected / 33 at risk

Adverse event: Nervous system disorders - Other
Serious: no
Organ System: Nervous system disorders
Notes: Right-sided sciatica
Frequency: 1 affected / 33 at risk

Adverse event: Non-cardiac chest pain
Serious: no
Organ System: General disorders
Frequency: 5 affected / 33 at risk

Adverse event: Oral dysaesthesia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 33 at risk

Adverse event: Mouth haemorrhage
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 33 at risk

Adverse event: Oral pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 33 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 17 affected / 33 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 6 affected / 33 at risk

Adverse event: Palmar-plantar erythrodysaesthesia syndrome
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 8 affected / 33 at risk

Adverse event: Rash pustular
Serious: no
Organ System: Infections and infestations
Frequency: 8 affected / 33 at risk

Adverse event: Paraesthesia
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 33 at risk

Adverse event: Platelet count decreased
Serious: no
Organ System: Investigations
Frequency: 3 affected / 33 at risk

Adverse event: Upper-airway cough syndrome
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 33 at risk

Adverse event: Proteinuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 33 at risk

Adverse event: Dermatitis acneiform
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 33 at risk

Adverse event: Rash maculo-papular
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 33 at risk

Adverse event: Rash pustular
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 33 at risk

Adverse event: Renal and urinary disorders - Other
Serious: no
Organ System: Renal and urinary disorders
Notes: Urinary urgency
Frequency: 1 affected / 33 at risk

Adverse event: Renal and urinary disorders - Other
Serious: no
Organ System: Renal and urinary disorders
Notes: Glycosuria
Frequency: 1 affected / 33 at risk

Adverse event: Reproductive system and breast disorders - Other
Serious: no
Organ System: Reproductive system and breast disorders
Notes: Vaginal irritation
Frequency: 2 affected / 33 at risk

Adverse event: Respiratory, thoracic and mediastinal disorders - Other
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Hemoptysis
Frequency: 1 affected / 33 at risk

Adverse event: Respiratory, thoracic and mediastinal disorders - Other
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Rhinorrhea
Frequency: 1 affected / 33 at risk

Adverse event: Respiratory, thoracic and mediastinal disorders - Other
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Shortness of breath with exertion
Frequency: 1 affected / 33 at risk

Adverse event: Skin and subcutaneous tissue disorders - Other
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Acne
Frequency: 1 affected / 33 at risk

Adverse event: Skin and subcutaneous tissue disorders - Other
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Eczema exacerbation
Frequency: 1 affected / 33 at risk

Adverse event: Skin and subcutaneous tissue disorders - Other
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Fingertip sensitivity
Frequency: 1 affected / 33 at risk

Adverse event: Skin and subcutaneous tissue disorders - Other
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Foot rash
Frequency: 1 affected / 33 at risk

Adverse event: Skin and subcutaneous tissue disorders - Other
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Foot sensitivity
Frequency: 2 affected / 33 at risk

Adverse event: Skin and subcutaneous tissue disorders - Other
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Hand and foot sensitivity
Frequency: 1 affected / 33 at risk

Adverse event: Skin and subcutaneous tissue disorders - Other
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Lip skin thickening
Frequency: 1 affected / 33 at risk

Adverse event: Skin and subcutaneous tissue disorders - Other
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Skin irritation
Frequency: 1 affected / 33 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 33 at risk

Adverse event: Telangiectasia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 33 at risk

Adverse event: Embolism
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 33 at risk

Adverse event: Toothache
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 33 at risk

Adverse event: Tumour pain
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 7 affected / 33 at risk

Adverse event: Vertigo
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 33 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 14 affected / 33 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Investigations
Frequency: 4 affected / 33 at risk

Adverse event: Wheezing
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 33 at risk

Adverse event: White blood cell count decreased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 33 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 33 at risk

Adverse event: Tooth infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 33 at risk

Adverse event: Thrombotic thrombocytopenic purpura
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 33 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 33 at risk

Adverse event: Skin and subcutaneous tissue disorders - Other
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Skin lesions
Frequency: 1 affected / 33 at risk

Adverse event: Skin and subcutaneous tissue disorders - Other
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Hand nodules
Frequency: 1 affected / 33 at risk

Adverse event: Skin and subcutaneous tissue disorders - Other
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Left scalp lesion
Frequency: 1 affected / 33 at risk

Adverse event: Sinus tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 33 at risk

Adverse event: Respiratory, thoracic and mediastinal disorders - Other
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Pneumonia
Frequency: 1 affected / 33 at risk

Adverse event: Respiratory, thoracic and mediastinal disorders - Other
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Nose dryness
Frequency: 1 affected / 33 at risk

Adverse event: Respiratory, thoracic and mediastinal disorders - Other
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Post-viral bronchitis
Frequency: 1 affected / 33 at risk

Adverse event: Reproductive system and breast disorders - Other
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Herpes simplex virus (HSV) Flare
Frequency: 1 affected / 33 at risk

Adverse event: Renal and urinary disorders - Other
Serious: no
Organ System: Renal and urinary disorders
Notes: Acute renal insufficiency
Frequency: 1 affected / 33 at risk

Adverse event: Psychiatric disorders - Other
Serious: no
Organ System: Psychiatric disorders
Notes: Mood changes
Frequency: 1 affected / 33 at risk

Adverse event: Presyncope
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 33 at risk

Adverse event: Pleural effusion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 33 at risk

Adverse event: Neuralgia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 33 at risk

Adverse event: Nervous system disorders - Other
Serious: no
Organ System: Nervous system disorders
Notes: Right leg neuropathy
Frequency: 1 affected / 33 at risk

Adverse event: Nervous system disorders - Other
Serious: no
Organ System: Nervous system disorders
Notes: Right arm neuropathy
Frequency: 1 affected / 33 at risk

Adverse event: Nervous system disorders - Other
Serious: no
Organ System: Nervous system disorders
Notes: Altered mental status
Frequency: 1 affected / 33 at risk

Adverse event: Neck pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 33 at risk

Adverse event: Musculoskeletal and connective tissue disorder - Other
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Right neck pulsation
Frequency: 1 affected / 33 at risk

Adverse event: Musculoskeletal and connective tissue disorder - Other
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Shoulder dislocation
Frequency: 1 affected / 33 at risk

Adverse event: Musculoskeletal and connective tissue disorder - Other
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Right ankle sprain
Frequency: 1 affected / 33 at risk

Adverse event: Musculoskeletal and connective tissue disorder - Other
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Intermittent muscle spasms
Frequency: 1 affected / 33 at risk

Adverse event: Muscular weakness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 33 at risk

Adverse event: Metabolism and nutrition disorders - Other
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Hyponatremia
Frequency: 1 affected / 33 at risk

Adverse event: Investigations - Other
Serious: no
Organ System: Investigations
Notes: Left Chest pressure/sharpness with inspiration
Frequency: 1 affected / 33 at risk

Adverse event: Investigations - Other
Serious: no
Organ System: Investigations
Notes: Lower respiratory infection
Frequency: 1 affected / 33 at risk

Adverse event: Investigations - Other
Serious: no
Organ System: Investigations
Notes: Soreness and bruising at biopsy site
Frequency: 1 affected / 33 at risk

Adverse event: Investigations - Other
Serious: no
Organ System: Investigations
Notes: Tooth Abcess
Frequency: 1 affected / 33 at risk

Adverse event: Investigations - Other
Serious: no
Organ System: Investigations
Notes: Tooth pain
Frequency: 1 affected / 33 at risk

Adverse event: Investigations - Other
Serious: no
Organ System: Investigations
Notes: Cold like symptoms
Frequency: 1 affected / 33 at risk

Adverse event: Infections and infestations - Other
Serious: no
Organ System: Infections and infestations
Notes: Not otherwise specified (NOS)
Frequency: 1 affected / 33 at risk

Adverse event: Infections and infestations - Other
Serious: no
Organ System: Infections and infestations
Notes: Fungal groin infection
Frequency: 1 affected / 33 at risk

Adverse event: Infections and infestations - Other
Serious: no
Organ System: Infections and infestations
Notes: Upper respiratory infection with low grade fever
Frequency: 1 affected / 33 at risk

Adverse event: Hypoxia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 33 at risk

Adverse event: Hyponatraemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 33 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 33 at risk

Adverse event: Hypercalcaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 33 at risk

Adverse event: Hot flush
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 33 at risk

Adverse event: Muscular weakness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 33 at risk

Adverse event: General disorders and administration site conditions - Other
Serious: no
Organ System: General disorders
Notes: Cold
Frequency: 1 affected / 33 at risk

Adverse event: General disorders and administration site conditions - Other
Serious: no
Organ System: General disorders
Notes: Diaphragm cramping intermittent
Frequency: 1 affected / 33 at risk

Adverse event: General disorders and administration site conditions - Other
Serious: no
Organ System: General disorders
Notes: Diffuse body aches
Frequency: 1 affected / 33 at risk

Adverse event: General disorders and administration site conditions - Other
Serious: no
Organ System: General disorders
Notes: Dysuria
Frequency: 1 affected / 33 at risk

Adverse event: General disorders and administration site conditions - Other
Serious: no
Organ System: General disorders
Notes: Fainting
Frequency: 1 affected / 33 at risk

Adverse event: General disorders and administration site conditions - Other
Serious: no
Organ System: General disorders
Notes: Neck pain
Frequency: 1 affected / 33 at risk

Adverse event: General disorders and administration site conditions - Other
Serious: no
Organ System: General disorders
Notes: Night sweats
Frequency: 1 affected / 33 at risk

Adverse event: General disorders and administration site conditions - Other
Serious: no
Organ System: General disorders
Notes: Right Inner Thigh Muscular Pain with Noticeable Tumor Inflammation
Frequency: 1 affected / 33 at risk

Adverse event: General disorders and administration site conditions - Other
Serious: no
Organ System: General disorders
Notes: Runny nose
Frequency: 1 affected / 33 at risk

Adverse event: Gastrointestinal disorders - Other
Serious: no
Organ System: Gastrointestinal disorders
Notes: Tongue sensitity
Frequency: 1 affected / 33 at risk

Adverse event: Gastrointestinal disorders - Other
Serious: no
Organ System: Gastrointestinal disorders
Notes: Thrush
Frequency: 2 affected / 33 at risk

Adverse event: Fracture
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 33 at risk

Adverse event: Influenza like illness
Serious: no
Organ System: General disorders
Frequency: 2 affected / 33 at risk

Adverse event: Flank pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 33 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 3 affected / 33 at risk

Adverse event: Fall
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 33 at risk

Adverse event: Eye pain
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 33 at risk

Adverse event: Dysphagia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 33 at risk

Adverse event: Dysmenorrhoea
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 33 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 33 at risk

Adverse event: Dehydration
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 33 at risk

Adverse event: Cholecystitis
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 33 at risk

Adverse event: Blood and lymphatic system disorders - Other
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Thrombocytopenia
Frequency: 1 affected / 33 at risk

Adverse event: Atrial fibrillation
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 33 at risk

Adverse event: Hypersensitivity
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 33 at risk