Study: NCT03713944

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 30 at risk

Adverse event: Back pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 30 at risk

Adverse event: Large intestine perforation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 30 at risk

Adverse event: Confusional state
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 30 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 30 at risk

Adverse event: Oesophageal stenosis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 30 at risk

Adverse event: Fall
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 30 at risk

Adverse event: Febrile neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 30 at risk

Adverse event: GASTROINTESTINAL DISORDERS - OTHER, SPECIFY
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 30 at risk

Adverse event: Cardiac failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 30 at risk

Adverse event: Hypernatraemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 30 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 30 at risk

Adverse event: Hypoxia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 30 at risk

Adverse event: Ileus
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 30 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 30 at risk

Adverse event: Pain in extremity
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 30 at risk

Adverse event: Pleural effusion
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 30 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 30 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 30 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 30 at risk

Adverse event: Skin infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 30 at risk

Adverse event: Embolism
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 30 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 30 at risk

Adverse event: Abdominal infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 30 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 30 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 8 affected / 30 at risk

Adverse event: Blood alkaline phosphatase increased
Serious: no
Organ System: Investigations
Frequency: 3 affected / 30 at risk

Adverse event: Hypersensitivity
Serious: no
Organ System: Immune system disorders
Frequency: 2 affected / 30 at risk

Adverse event: Rhinitis allergic
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 9 affected / 30 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 30 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 18 affected / 30 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 12 affected / 30 at risk

Adverse event: Anosmia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 30 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 5 affected / 30 at risk

Adverse event: Aortic valve disease
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 30 at risk

Adverse event: Embolism arterial
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 30 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 10 affected / 30 at risk

Adverse event: Arthritis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 30 at risk

Adverse event: Aspartate aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 9 affected / 30 at risk

Adverse event: Atrial fibrillation
Serious: no
Organ System: Cardiac disorders
Frequency: 5 affected / 30 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 11 affected / 30 at risk

Adverse event: Eructation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 30 at risk

Adverse event: Abdominal distension
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 30 at risk

Adverse event: BLOOD AND LYMPHATIC SYSTEM DISORDERS
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 30 at risk

Adverse event: Blood lactate dehydrogenase increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 30 at risk

Adverse event: Bone pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 30 at risk

Adverse event: Breast pain
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 30 at risk

Adverse event: CARDIAC DISORDERS
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 30 at risk

Adverse event: Troponin I increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 30 at risk

Adverse event: Cataract
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 30 at risk

Adverse event: Device related infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 30 at risk

Adverse event: Musculoskeletal chest pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 30 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 1 affected / 30 at risk

Adverse event: Blood cholesterol increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 30 at risk

Adverse event: Chronic kidney disease
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 30 at risk

Adverse event: Cognitive disorder
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 30 at risk

Adverse event: Confusional state
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 30 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 30 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 21 affected / 30 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 18 affected / 30 at risk

Adverse event: Blood creatinine increased
Serious: no
Organ System: Investigations
Frequency: 8 affected / 30 at risk

Adverse event: Dehydration
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 7 affected / 30 at risk

Adverse event: Delirium
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 30 at risk

Adverse event: Dental caries
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 30 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 8 affected / 30 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 12 affected / 30 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 30 at risk

Adverse event: Dry eye
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 30 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 30 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 30 at risk

Adverse event: Dysarthria
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 30 at risk

Adverse event: Dysgeusia
Serious: no
Organ System: Nervous system disorders
Frequency: 8 affected / 30 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 30 at risk

Adverse event: Dysphagia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 30 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 17 affected / 30 at risk

Adverse event: Ear pain
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 30 at risk

Adverse event: Face oedema
Serious: no
Organ System: General disorders
Frequency: 3 affected / 30 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Frequency: 11 affected / 30 at risk

Adverse event: Localised oedema
Serious: no
Organ System: General disorders
Frequency: 1 affected / 30 at risk

Adverse event: ENDOCRINE DISORDERS
Serious: no
Organ System: Endocrine disorders
Frequency: 6 affected / 30 at risk

Adverse event: Epistaxis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 7 affected / 30 at risk

Adverse event: Erectile dysfunction
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 2 affected / 30 at risk

Adverse event: Oesophagitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 30 at risk

Adverse event: EYE DISORDERS
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 30 at risk

Adverse event: Eye pain
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 30 at risk

Adverse event: Fall
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 30 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 27 affected / 30 at risk

Adverse event: Febrile neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 30 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 4 affected / 30 at risk

Adverse event: Flank pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 30 at risk

Adverse event: Flatulence
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 30 at risk

Adverse event: Flushing
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 30 at risk

Adverse event: Folliculitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 30 at risk

Adverse event: Gastritis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 30 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 30 at risk

Adverse event: GASTROINTESTINAL DISORDERS
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 30 at risk

Adverse event: GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS
Serious: no
Organ System: General disorders
Frequency: 5 affected / 30 at risk

Adverse event: Generalised oedema
Serious: no
Organ System: General disorders
Frequency: 2 affected / 30 at risk

Adverse event: Muscular weakness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 30 at risk

Adverse event: Gingival pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 30 at risk

Adverse event: Hallucination
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 30 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 10 affected / 30 at risk

Adverse event: Hypoacusis
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 30 at risk

Adverse event: Cardiac failure
Serious: no
Organ System: Cardiac disorders
Frequency: 4 affected / 30 at risk

Adverse event: Haematuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 30 at risk

Adverse event: Haemoglobinuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 30 at risk

Adverse event: Haemorrhoidal haemorrhage
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 30 at risk

Adverse event: Haemorrhoids
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 30 at risk

Adverse event: Herpes simplex reactivation
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 30 at risk

Adverse event: Hiccups
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 30 at risk

Adverse event: Dysphonia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 30 at risk

Adverse event: Hot flush
Serious: no
Organ System: Vascular disorders
Frequency: 3 affected / 30 at risk

Adverse event: Hypercalcaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 30 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 9 affected / 30 at risk

Adverse event: Hyperkalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 30 at risk

Adverse event: Hyperlipidaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 15 affected / 30 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 24 affected / 30 at risk

Adverse event: Hyperthyroidism
Serious: no
Organ System: Endocrine disorders
Frequency: 6 affected / 30 at risk

Adverse event: Hypoalbuminaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 30 at risk

Adverse event: Hypocalcaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 30 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 30 at risk

Adverse event: Hypomagnesaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 30 at risk

Adverse event: Hyponatraemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 7 affected / 30 at risk

Adverse event: Hypophosphataemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 30 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 30 at risk

Adverse event: Hypothyroidism
Serious: no
Organ System: Endocrine disorders
Frequency: 7 affected / 30 at risk

Adverse event: Hypoxia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 30 at risk

Adverse event: IMMUNE SYSTEM DISORDERS
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 30 at risk

Adverse event: INFECTIONS AND INFESTATIONS
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 30 at risk

Adverse event: Infusion related reaction
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 30 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 16 affected / 30 at risk

Adverse event: Cardiac procedure complication
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 30 at risk

Adverse event: INVESTIGATIONS
Serious: no
Organ System: Investigations
Frequency: 1 affected / 30 at risk

Adverse event: Laryngeal haemorrhage
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 30 at risk

Adverse event: Leukocytosis
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 30 at risk

Adverse event: Lipase increased
Serious: no
Organ System: Investigations
Frequency: 3 affected / 30 at risk

Adverse event: Localised oedema
Serious: no
Organ System: General disorders
Frequency: 3 affected / 30 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 30 at risk

Adverse event: Lymphocyte count decreased
Serious: no
Organ System: Investigations
Frequency: 6 affected / 30 at risk

Adverse event: Mania
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 30 at risk

Adverse event: METABOLISM AND NUTRITION DISORDERS
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 30 at risk

Adverse event: Mitral valve disease
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 30 at risk

Adverse event: Dyskinesia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 30 at risk

Adverse event: Stomatitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 30 at risk

Adverse event: Muscle spasms
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 30 at risk

Adverse event: MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDER
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 5 affected / 30 at risk

Adverse event: Nail disorder
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 30 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 30 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 21 affected / 30 at risk

Adverse event: Neck pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 30 at risk

Adverse event: NEOPLASMS BENIGN, MALIGNANT AND UNSPECIFIED (INCL CYSTS AND POLYPS)
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 30 at risk

Adverse event: NERVOUS SYSTEM DISORDERS
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 30 at risk

Adverse event: Neuralgia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 30 at risk

Adverse event: Neutrophil count decreased
Serious: no
Organ System: Investigations
Frequency: 9 affected / 30 at risk

Adverse event: Non-cardiac chest pain
Serious: no
Organ System: General disorders
Frequency: 10 affected / 30 at risk

Adverse event: Optic nerve disorder
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 30 at risk

Adverse event: Mouth haemorrhage
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 30 at risk

Adverse event: Oral pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 30 at risk

Adverse event: Osteoporosis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 30 at risk

Adverse event: Otitis externa
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 30 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 11 affected / 30 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 8 affected / 30 at risk

Adverse event: Pain of skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 30 at risk

Adverse event: Palpitations
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 30 at risk

Adverse event: Pancreatitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 30 at risk

Adverse event: Rash pustular
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 30 at risk

Adverse event: Paraesthesia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 30 at risk

Adverse event: Paronychia
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 30 at risk

Adverse event: Atrial tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 30 at risk

Adverse event: Pericardial effusion
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 30 at risk

Adverse event: Peripheral ischaemia
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 30 at risk

Adverse event: Peripheral motor neuropathy
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 30 at risk

Adverse event: Peripheral sensory neuropathy
Serious: no
Organ System: Nervous system disorders
Frequency: 9 affected / 30 at risk

Adverse event: Phlebitis
Serious: no
Organ System: Vascular disorders
Frequency: 4 affected / 30 at risk

Adverse event: Phlebitis infective
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 30 at risk

Adverse event: Platelet count decreased
Serious: no
Organ System: Investigations
Frequency: 6 affected / 30 at risk

Adverse event: Pleural effusion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 30 at risk

Adverse event: Pneumonitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 30 at risk

Adverse event: Prostatic obstruction
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 30 at risk

Adverse event: Proteinuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 7 affected / 30 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 6 affected / 30 at risk

Adverse event: PSYCHIATRIC DISORDERS
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 30 at risk

Adverse event: Dermatitis acneiform
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 30 at risk

Adverse event: Rash maculo-papular
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 30 at risk

Adverse event: Rectal haemorrhage
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 30 at risk

Adverse event: RENAL AND URINARY DISORDERS
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 30 at risk

Adverse event: REPRODUCTIVE SYSTEM AND BREAST DISORDERS
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 2 affected / 30 at risk

Adverse event: RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 30 at risk

Adverse event: Retinal detachment
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 30 at risk

Adverse event: Retinal tear
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 30 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 30 at risk

Adverse event: Pain of skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 30 at risk

Adverse event: Amylase increased
Serious: no
Organ System: Investigations
Frequency: 6 affected / 30 at risk

Adverse event: Herpes zoster
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 30 at risk

Adverse event: Sinus bradycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 30 at risk

Adverse event: Sinus tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 30 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 30 at risk

Adverse event: SKIN AND SUBCUTANEOUS TISSUE DISORDERS
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 30 at risk

Adverse event: Skin hyperpigmentation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 30 at risk

Adverse event: Skin infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 30 at risk

Adverse event: Skin ulcer
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 30 at risk

Adverse event: Sleep apnoea syndrome
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 30 at risk

Adverse event: Spinal fracture
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 30 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 30 at risk

Adverse event: SURGICAL AND MEDICAL PROCEDURES
Serious: no
Organ System: Surgical and medical procedures
Frequency: 2 affected / 30 at risk

Adverse event: Syncope
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 30 at risk

Adverse event: Embolism
Serious: no
Organ System: Vascular disorders
Frequency: 3 affected / 30 at risk

Adverse event: Candida infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 30 at risk

Adverse event: Blood thyroid stimulating hormone increased
Serious: no
Organ System: Investigations
Frequency: 7 affected / 30 at risk

Adverse event: Tinnitus
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 30 at risk

Adverse event: Toothache
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 30 at risk

Adverse event: Tremor
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 30 at risk

Adverse event: Tricuspid valve disease
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 30 at risk

Adverse event: Tumour pain
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 3 affected / 30 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 30 at risk

Adverse event: Pollakiuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 3 affected / 30 at risk

Adverse event: Urinary retention
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 30 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 30 at risk

Adverse event: Vulvovaginal dryness
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 30 at risk

Adverse event: VASCULAR DISORDERS
Serious: no
Organ System: Vascular disorders
Frequency: 3 affected / 30 at risk

Adverse event: Venous injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 30 at risk

Adverse event: Ventricular fibrillation
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 30 at risk

Adverse event: Ventricular tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 30 at risk

Adverse event: Vertigo
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 2 affected / 30 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 13 affected / 30 at risk

Adverse event: Lacrimation increased
Serious: no
Organ System: Eye disorders
Frequency: 4 affected / 30 at risk

Adverse event: Weight increased
Serious: no
Organ System: Investigations
Frequency: 6 affected / 30 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Investigations
Frequency: 10 affected / 30 at risk

Adverse event: White blood cell count decreased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 30 at risk

Adverse event: Wound dehiscence
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 30 at risk