Study: NCT01626495

Adverse event: Febrile neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 46 affected / 73 at risk

Adverse event: Disseminated intravascular coagulation
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 6 affected / 73 at risk

Adverse event: Coagulopathy
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 73 at risk

Adverse event: Hypofibrinogenaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 73 at risk

Adverse event: Left ventricular dysfunction
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 73 at risk

Adverse event: Bradycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 73 at risk

Adverse event: Cardio-respiratory arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 73 at risk

Adverse event: Visual impairment
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 73 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 73 at risk

Adverse event: Haematochezia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 73 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 15 affected / 73 at risk

Adverse event: Vascular stent thrombosis
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 73 at risk

Adverse event: Cytokine release syndrome
Serious: yes
Organ System: Immune system disorders
Frequency: 52 affected / 73 at risk

Adverse event: Anaphylactic reaction
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 73 at risk

Adverse event: Device related infection
Serious: yes
Organ System: Infections and infestations
Frequency: 5 affected / 73 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 73 at risk

Adverse event: Staphylococcal infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 73 at risk

Adverse event: Streptococcal infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 73 at risk

Adverse event: Varicella zoster virus infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 73 at risk

Adverse event: Thermal burn
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 73 at risk

Adverse event: Transfusion reaction
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 73 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 73 at risk

Adverse event: Decreased appetite
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 73 at risk

Adverse event: Hyperkalaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 73 at risk

Adverse event: Hypokalaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 73 at risk

Adverse event: Pain in extremity
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 73 at risk

Adverse event: Encephalopathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 17 affected / 73 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 4 affected / 73 at risk

Adverse event: Generalised tonic-clonic seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 73 at risk

Adverse event: Headache
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 73 at risk

Adverse event: Speech disorder
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 73 at risk

Adverse event: Mental status changes
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 73 at risk

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 5 affected / 73 at risk

Adverse event: Hypoxia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 10 affected / 73 at risk

Adverse event: Acute respiratory distress syndrome
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 73 at risk

Adverse event: Apnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 73 at risk

Adverse event: Epistaxis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 73 at risk

Adverse event: Pleural effusion
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 73 at risk

Adverse event: Respiratory alkalosis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 73 at risk

Adverse event: Respiratory distress
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 73 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 73 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Vascular disorders
Frequency: 24 affected / 73 at risk

Adverse event: Capillary leak syndrome
Serious: yes
Organ System: Vascular disorders
Frequency: 10 affected / 73 at risk

Adverse event: Haemolysis
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 73 at risk

Adverse event: Atrial thrombosis
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 73 at risk

Adverse event: Adrenal insufficiency
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 73 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 73 at risk

Adverse event: Facial pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 73 at risk

Adverse event: Pain
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 73 at risk

Adverse event: BK virus infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 73 at risk

Adverse event: Enterococcal bacteraemia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 73 at risk

Adverse event: Gastroenteritis salmonella
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 73 at risk

Adverse event: Klebsiella infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 73 at risk

Adverse event: Stomatococcal infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 73 at risk

Adverse event: Lower limb fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 73 at risk

Adverse event: Weight decreased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 73 at risk

Adverse event: Tumour lysis syndrome
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 73 at risk

Adverse event: Bone pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 73 at risk

Adverse event: Unresponsive to stimuli
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 73 at risk

Adverse event: Acute respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 73 at risk

Adverse event: Asthma
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 73 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 73 at risk

Adverse event: Pyomyositis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 73 at risk

Adverse event: Staphylococcal skin infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 73 at risk

Adverse event: Arthralgia
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 73 at risk

Adverse event: Aspiration
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 73 at risk

Adverse event: Staphylococcal bacteraemia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 73 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 73 at risk

Adverse event: Complication associated with device
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 73 at risk

Adverse event: Clostridium difficile colitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 73 at risk

Adverse event: Acidosis
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 73 at risk

Adverse event: Central nervous system haemorrhage
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 73 at risk

Adverse event: Facial paresis
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 73 at risk

Adverse event: Confusional state
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 73 at risk

Adverse event: Febrile neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 10 affected / 73 at risk

Adverse event: Lymphopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 50 affected / 73 at risk

Adverse event: Splenomegaly
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 5 affected / 73 at risk

Adverse event: Sinus tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 12 affected / 73 at risk

Adverse event: Tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 30 affected / 73 at risk

Adverse event: Conjunctival haemorrhage
Serious: no
Organ System: Eye disorders
Frequency: 4 affected / 73 at risk

Adverse event: Diplopia
Serious: no
Organ System: Eye disorders
Frequency: 4 affected / 73 at risk

Adverse event: Photophobia
Serious: no
Organ System: Eye disorders
Frequency: 4 affected / 73 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 21 affected / 73 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 73 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 35 affected / 73 at risk

Adverse event: Haematochezia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 73 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 45 affected / 73 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 48 affected / 73 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 27 affected / 73 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 29 affected / 73 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 28 affected / 73 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 15 affected / 73 at risk

Adverse event: Hepatomegaly
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 5 affected / 73 at risk

Adverse event: Hyperbilirubinaemia
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 13 affected / 73 at risk

Adverse event: Cytokine release syndrome
Serious: no
Organ System: Immune system disorders
Frequency: 5 affected / 73 at risk

Adverse event: Hypogammaglobulinaemia
Serious: no
Organ System: Immune system disorders
Frequency: 42 affected / 73 at risk

Adverse event: Otitis media
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 73 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 73 at risk

Adverse event: Respiratory syncytial virus infection
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 73 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 10 affected / 73 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 11 affected / 73 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 73 at risk

Adverse event: Contusion
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 7 affected / 73 at risk

Adverse event: Fall
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 4 affected / 73 at risk

Adverse event: Infusion related reaction
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 4 affected / 73 at risk

Adverse event: Procedural pain
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 11 affected / 73 at risk

Adverse event: Activated partial thromboplastin time prolonged
Serious: no
Organ System: Investigations
Frequency: 22 affected / 73 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 45 affected / 73 at risk

Adverse event: Aspartate aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 46 affected / 73 at risk

Adverse event: Blood bilirubin increased
Serious: no
Organ System: Investigations
Frequency: 15 affected / 73 at risk

Adverse event: Blood creatinine increased
Serious: no
Organ System: Investigations
Frequency: 23 affected / 73 at risk

Adverse event: Blood fibrinogen decreased
Serious: no
Organ System: Investigations
Frequency: 11 affected / 73 at risk

Adverse event: Blood immunoglobulin A decreased
Serious: no
Organ System: Investigations
Frequency: 5 affected / 73 at risk

Adverse event: Blood immunoglobulin M decreased
Serious: no
Organ System: Investigations
Frequency: 5 affected / 73 at risk

Adverse event: Blood uric acid increased
Serious: no
Organ System: Investigations
Frequency: 11 affected / 73 at risk

Adverse event: Haemoglobin decreased
Serious: no
Organ System: Investigations
Frequency: 57 affected / 73 at risk

Adverse event: International normalised ratio increased
Serious: no
Organ System: Investigations
Frequency: 16 affected / 73 at risk

Adverse event: Lipase increased
Serious: no
Organ System: Investigations
Frequency: 4 affected / 73 at risk

Adverse event: Lymphocyte count decreased
Serious: no
Organ System: Investigations
Frequency: 6 affected / 73 at risk

Adverse event: Neutrophil count decreased
Serious: no
Organ System: Investigations
Frequency: 56 affected / 73 at risk

Adverse event: Platelet count decreased
Serious: no
Organ System: Investigations
Frequency: 54 affected / 73 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Investigations
Frequency: 5 affected / 73 at risk

Adverse event: White blood cell count decreased
Serious: no
Organ System: Investigations
Frequency: 58 affected / 73 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 43 affected / 73 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 7 affected / 73 at risk

Adverse event: Hyperphosphataemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 22 affected / 73 at risk

Adverse event: Hyperuricaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 8 affected / 73 at risk

Adverse event: Hypocalcaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 10 affected / 73 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 11 affected / 73 at risk

Adverse event: Hyponatraemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 6 affected / 73 at risk

Adverse event: Hypophosphataemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 15 affected / 73 at risk

Adverse event: Metabolic acidosis
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 8 affected / 73 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 9 affected / 73 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 5 affected / 73 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 14 affected / 73 at risk

Adverse event: Neck pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 73 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 14 affected / 73 at risk

Adverse event: Pain in jaw
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 73 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 12 affected / 73 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 46 affected / 73 at risk

Adverse event: Tremor
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 73 at risk

Adverse event: Device occlusion
Serious: no
Organ System: Product Issues
Frequency: 4 affected / 73 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 5 affected / 73 at risk

Adverse event: Confusional state
Serious: no
Organ System: Psychiatric disorders
Frequency: 15 affected / 73 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 8 affected / 73 at risk

Adverse event: Haematuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 4 affected / 73 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 35 affected / 73 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 73 at risk

Adverse event: Epistaxis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 15 affected / 73 at risk

Adverse event: Hypoxia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 9 affected / 73 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 13 affected / 73 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 73 at risk

Adverse event: Pleural effusion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 73 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 16 affected / 73 at risk

Adverse event: Tachypnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 10 affected / 73 at risk

Adverse event: Dermatitis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 73 at risk

Adverse event: Petechiae
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 9 affected / 73 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 6 affected / 73 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 8 affected / 73 at risk

Adverse event: Rash erythematous
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 6 affected / 73 at risk

Adverse event: Rash papular
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 8 affected / 73 at risk

Adverse event: Skin lesion
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 6 affected / 73 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 13 affected / 73 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 13 affected / 73 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 73 at risk

Adverse event: Vision blurred
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 73 at risk

Adverse event: Gingival bleeding
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 73 at risk

Adverse event: Mouth haemorrhage
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 73 at risk

Adverse event: Catheter site haemorrhage
Serious: no
Organ System: General disorders
Frequency: 3 affected / 73 at risk

Adverse event: Catheter site pain
Serious: no
Organ System: General disorders
Frequency: 3 affected / 73 at risk

Adverse event: Complication associated with device
Serious: no
Organ System: General disorders
Frequency: 3 affected / 73 at risk

Adverse event: Face oedema
Serious: no
Organ System: General disorders
Frequency: 3 affected / 73 at risk

Adverse event: Generalised oedema
Serious: no
Organ System: General disorders
Frequency: 3 affected / 73 at risk

Adverse event: Withdrawal syndrome
Serious: no
Organ System: General disorders
Frequency: 3 affected / 73 at risk

Adverse event: Seasonal allergy
Serious: no
Organ System: Immune system disorders
Frequency: 3 affected / 73 at risk

Adverse event: Clostridium difficile colitis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 73 at risk

Adverse event: Escherichia urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 73 at risk

Adverse event: Oral candidiasis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 73 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 73 at risk

Adverse event: Transfusion reaction
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 73 at risk

Adverse event: Amylase increased
Serious: no
Organ System: Investigations
Frequency: 3 affected / 73 at risk

Adverse event: Prothrombin time prolonged
Serious: no
Organ System: Investigations
Frequency: 3 affected / 73 at risk

Adverse event: Dehydration
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 73 at risk

Adverse event: Hypernatraemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 73 at risk

Adverse event: Hypoglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 73 at risk

Adverse event: Joint range of motion decreased
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 73 at risk

Adverse event: Skin papilloma
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 3 affected / 73 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 3 affected / 73 at risk

Adverse event: Irritability
Serious: no
Organ System: Psychiatric disorders
Frequency: 3 affected / 73 at risk

Adverse event: Acute kidney injury
Serious: no
Organ System: Renal and urinary disorders
Frequency: 3 affected / 73 at risk

Adverse event: Dysuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 3 affected / 73 at risk

Adverse event: Pulmonary oedema
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 73 at risk

Adverse event: Rhinitis allergic
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 73 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 73 at risk

Adverse event: Eczema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 73 at risk