Study: NCT01996332

Adverse event: Hemoglobbin
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 1805 at risk

Adverse event: Neutrophil count
Serious: yes
Organ System: Investigations
Frequency: 2 affected / 1805 at risk

Adverse event: Platelets
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 1805 at risk

Adverse event: Arrhythmia
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 1805 at risk

Adverse event: Myocardial ischaemia
Serious: yes
Organ System: Cardiac disorders
Frequency: 6 affected / 1805 at risk

Adverse event: Cardio-respiratory arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 6 affected / 1805 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 1805 at risk

Adverse event: Left ventricular dysfunction
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 1805 at risk

Adverse event: Pericardial effusion
Serious: yes
Organ System: Cardiac disorders
Frequency: 7 affected / 1805 at risk

Adverse event: Pericarditis
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1805 at risk

Adverse event: Right ventricular dysfunction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1805 at risk

Adverse event: Alcohol poisoning
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1805 at risk

Adverse event: Asthenia
Serious: yes
Organ System: General disorders
Frequency: 17 affected / 1805 at risk

Adverse event: Constitutional symptoms/other
Serious: yes
Organ System: General disorders
Frequency: 14 affected / 1805 at risk

Adverse event: Drug abuser
Serious: yes
Organ System: Social circumstances
Frequency: 1 affected / 1805 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 17 affected / 1805 at risk

Adverse event: Drug abuse
Serious: yes
Organ System: Social circumstances
Frequency: 2 affected / 1805 at risk

Adverse event: Hyperhidrosis
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 1805 at risk

Adverse event: Weight decreased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 1805 at risk

Adverse event: Dermatology/skin - other
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 1805 at risk

Adverse event: Rash
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 1805 at risk

Adverse event: Decreased appetite
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 6 affected / 1805 at risk

Adverse event: Constipation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1805 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 28 affected / 1805 at risk

Adverse event: Dyspepsia/heartburn
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1805 at risk

Adverse event: Dysphagia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 1805 at risk

Adverse event: Oesophagitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1805 at risk

Adverse event: Gastrointestinal/other
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1805 at risk

Adverse event: Ileus GI
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 1805 at risk

Adverse event: Intestinal perforation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 1805 at risk

Adverse event: Mucosal inflammation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 1805 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 1805 at risk

Adverse event: Obstruction/GU
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1805 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 1805 at risk

Adverse event: Pulmonary haemorrhage
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 21 affected / 1805 at risk

Adverse event: Haemorrhage
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 17 affected / 1805 at risk

Adverse event: Hepatic cyst
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 1805 at risk

Adverse event: Liver dysfunction
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 4 affected / 1805 at risk

Adverse event: Febrile neutropenia
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 1805 at risk

Adverse event: Cholecystitis infective
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1805 at risk

Adverse event: Infection
Serious: yes
Organ System: Infections and infestations
Frequency: 67 affected / 1805 at risk

Adverse event: Infection - anal/perianal
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1805 at risk

Adverse event: Infection - appendix
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1805 at risk

Adverse event: Infection - blood
Serious: yes
Organ System: Infections and infestations
Frequency: 6 affected / 1805 at risk

Adverse event: Infection - brain (encephalitis, infectious)
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1805 at risk

Adverse event: Infection - bronchus
Serious: yes
Organ System: Infections and infestations
Frequency: 5 affected / 1805 at risk

Adverse event: Infection - catheter - related
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1805 at risk

Adverse event: Infection - kidney
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1805 at risk

Adverse event: Infection - liver
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1805 at risk

Adverse event: Infection - lung (pneumonia)
Serious: yes
Organ System: Infections and infestations
Frequency: 44 affected / 1805 at risk

Adverse event: Infection - skin (cellulitis)
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 1805 at risk

Adverse event: Infection - soft tissue NOS
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 1805 at risk

Adverse event: Infection - upper aerodigestive NOS
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1805 at risk

Adverse event: Infection - urinary tract NOS
Serious: yes
Organ System: Infections and infestations
Frequency: 6 affected / 1805 at risk

Adverse event: Infection - wound
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1805 at risk

Adverse event: Edema Limb
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 1805 at risk

Adverse event: Acidosis
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 1805 at risk

Adverse event: Blood bilirubin
Serious: yes
Organ System: Investigations
Frequency: 2 affected / 1805 at risk

Adverse event: Hypercalcaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 1805 at risk

Adverse event: Hyperglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 1805 at risk

Adverse event: Hyponatraemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 1805 at risk

Adverse event: Ascites
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 1805 at risk

Adverse event: Fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 4 affected / 1805 at risk

Adverse event: Muscular weakness
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 1805 at risk

Adverse event: Musculoskeletal/other
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 1805 at risk

Adverse event: Trismus
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 1805 at risk

Adverse event: Ataxia
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 1805 at risk

Adverse event: CNS ischemia
Serious: yes
Organ System: Nervous system disorders
Frequency: 14 affected / 1805 at risk

Adverse event: Cognitive disorder
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 1805 at risk

Adverse event: Confusional state
Serious: yes
Organ System: Psychiatric disorders
Frequency: 11 affected / 1805 at risk

Adverse event: Dizziness
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 1805 at risk

Adverse event: Encephalopathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1805 at risk

Adverse event: Involuntary movement
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1805 at risk

Adverse event: Mood alteration - agitation
Serious: yes
Organ System: Psychiatric disorders
Frequency: 2 affected / 1805 at risk

Adverse event: Mood alteration - anxiety
Serious: yes
Organ System: Psychiatric disorders
Frequency: 2 affected / 1805 at risk

Adverse event: Neurology/other
Serious: yes
Organ System: Psychiatric disorders
Frequency: 15 affected / 1805 at risk

Adverse event: Neuropathy/motor
Serious: yes
Organ System: Nervous system disorders
Frequency: 7 affected / 1805 at risk

Adverse event: Neuropathy/sensory
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 1805 at risk

Adverse event: Psychotic disorder
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 1805 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 1805 at risk

Adverse event: Somnolence
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 1805 at risk

Adverse event: Speech impairment
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 1805 at risk

Adverse event: Syncope
Serious: yes
Organ System: Nervous system disorders
Frequency: 4 affected / 1805 at risk

Adverse event: Diplopia
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 1805 at risk

Adverse event: Keratitis
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 1805 at risk

Adverse event: Pain
Serious: yes
Organ System: General disorders
Frequency: 22 affected / 1805 at risk

Adverse event: Pain - abdominal NOS
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 1805 at risk

Adverse event: Pain - bone
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 1805 at risk

Adverse event: Pain - chest wall
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 7 affected / 1805 at risk

Adverse event: Pain - headache
Serious: yes
Organ System: Nervous system disorders
Frequency: 5 affected / 1805 at risk

Adverse event: Pain - joint
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 1805 at risk

Adverse event: Pain - limb
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 1805 at risk

Adverse event: Pain - liver
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1805 at risk

Adverse event: Pain - muscle
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 15 affected / 1805 at risk

Adverse event: Pain - neuralgia/peripheral nerve
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1805 at risk

Adverse event: Pain - pleura
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1805 at risk

Adverse event: Acute respiratory distress syndrome
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 1805 at risk

Adverse event: Airway obstruction/upper respiratory
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1805 at risk

Adverse event: Bronchospasm
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 1805 at risk

Adverse event: Cough
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 1805 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 188 affected / 1805 at risk

Adverse event: Hypoxia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 1805 at risk

Adverse event: Pleural effusion
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 9 affected / 1805 at risk

Adverse event: Pneumonitis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 1805 at risk

Adverse event: Pneumothorax
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 1805 at risk

Adverse event: Pulmonary/obstruction/stenosis of airway (bronchus)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1805 at risk

Adverse event: Pulmonary/others
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 1805 at risk

Adverse event: Tracheal fistula
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1805 at risk

Adverse event: Obstruction/GI
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 1805 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 10 affected / 1805 at risk

Adverse event: Secondary Malignancy
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 1805 at risk

Adverse event: Procedural complication
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 1805 at risk

Adverse event: Antiphospholipid syndrome
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 1805 at risk

Adverse event: Flu-like syndrome
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 1805 at risk

Adverse event: Ill-defined disorder
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 1805 at risk

Adverse event: Syndromes/other-superior cava vein
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 9 affected / 1805 at risk

Adverse event: Uncoded
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 1805 at risk

Adverse event: Phlebitis
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 1805 at risk

Adverse event: Thrombosis/embolism
Serious: yes
Organ System: Vascular disorders
Frequency: 25 affected / 1805 at risk

Adverse event: Vascular/other
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 1805 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Infections and infestations
Frequency: 14 affected / 1797 at risk

Adverse event: Hypersensitivity
Serious: no
Organ System: Immune system disorders
Frequency: 3 affected / 1797 at risk

Adverse event: Vasculitis
Serious: no
Organ System: Vascular disorders
Frequency: 3 affected / 1797 at risk

Adverse event: Hearing
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 5 affected / 1797 at risk

Adverse event: Tinnitus
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 3 affected / 1797 at risk

Adverse event: Haemoglobin
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 89 affected / 1797 at risk

Adverse event: Platelets
Serious: no
Organ System: Investigations
Frequency: 8 affected / 1797 at risk

Adverse event: Neutrophil count
Serious: no
Organ System: Investigations
Frequency: 7 affected / 1797 at risk

Adverse event: Leucocytes
Serious: no
Organ System: Investigations
Frequency: 4 affected / 1797 at risk

Adverse event: Lymphopenia
Serious: no
Organ System: Investigations
Frequency: 1 affected / 1797 at risk

Adverse event: Band neutrophil percentage increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 1797 at risk

Adverse event: Arrhythmia
Serious: no
Organ System: Cardiac disorders
Frequency: 27 affected / 1797 at risk

Adverse event: Vasovagal episodes
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 1797 at risk

Adverse event: Palpitations
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 1797 at risk

Adverse event: Pericardial effusion
Serious: no
Organ System: Cardiac disorders
Frequency: 8 affected / 1797 at risk

Adverse event: Myocardial ischaemia
Serious: no
Organ System: Cardiac disorders
Frequency: 7 affected / 1797 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 7 affected / 1797 at risk

Adverse event: Cardio-respiratory arrest
Serious: no
Organ System: Cardiac disorders
Frequency: 6 affected / 1797 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 5 affected / 1797 at risk

Adverse event: Left ventricular dysfunction
Serious: no
Organ System: Cardiac disorders
Frequency: 5 affected / 1797 at risk

Adverse event: Right ventricular dysfunction
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 1797 at risk

Adverse event: Valvular heart disease
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 1797 at risk

Adverse event: Pulmonary hypertension
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1797 at risk

Adverse event: Pericarditis
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 1797 at risk

Adverse event: Asthenia
Serious: no
Organ System: General disorders
Frequency: 650 affected / 1797 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 210 affected / 1797 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Investigations
Frequency: 91 affected / 1797 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 67 affected / 1797 at risk

Adverse event: Constitutional symptoms/other
Serious: no
Organ System: General disorders
Frequency: 42 affected / 1797 at risk

Adverse event: Hyperhidrosis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 10 affected / 1797 at risk

Adverse event: Mucosal dryness
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 1797 at risk

Adverse event: Pallor
Serious: no
Organ System: Vascular disorders
Frequency: 6 affected / 1797 at risk

Adverse event: Inflammation
Serious: no
Organ System: General disorders
Frequency: 5 affected / 1797 at risk

Adverse event: Drug abuse
Serious: no
Organ System: Social circumstances
Frequency: 3 affected / 1797 at risk

Adverse event: Rigors/chills
Serious: no
Organ System: General disorders
Frequency: 3 affected / 1797 at risk

Adverse event: Drug abuser
Serious: no
Organ System: Social circumstances
Frequency: 1 affected / 1797 at risk

Adverse event: Hypothermia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 1797 at risk

Adverse event: Weight increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 1797 at risk

Adverse event: Alcohol poisoning
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1797 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 897 affected / 1797 at risk

Adverse event: Dermatology/skin-other
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 307 affected / 1797 at risk

Adverse event: Acne
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 152 affected / 1797 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 137 affected / 1797 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 95 affected / 1797 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 92 affected / 1797 at risk

Adverse event: Nail disorder
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 71 affected / 1797 at risk

Adverse event: Ulcer
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 15 affected / 1797 at risk

Adverse event: Hand foot skin reaction
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 9 affected / 1797 at risk

Adverse event: Decubitus ulcer
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 6 affected / 1797 at risk

Adverse event: Hyperpigmentation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 1797 at risk

Adverse event: Flushing
Serious: no
Organ System: Vascular disorders
Frequency: 3 affected / 1797 at risk

Adverse event: Thermal burn
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1797 at risk

Adverse event: Telangiectasia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 1797 at risk

Adverse event: Cushingoid
Serious: no
Organ System: Endocrine disorders
Frequency: 6 affected / 1797 at risk

Adverse event: Blood antidiuretic hormone
Serious: no
Organ System: Investigations
Frequency: 1 affected / 1797 at risk

Adverse event: Glucose tolerance impaired
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 1797 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 631 affected / 1797 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 462 affected / 1797 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 204 affected / 1797 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 196 affected / 1797 at risk

Adverse event: Mucosal inflammation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 167 affected / 1797 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 110 affected / 1797 at risk

Adverse event: Dysphagia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 49 affected / 1797 at risk

Adverse event: Dyspepsia/heartburn
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 40 affected / 1797 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 36 affected / 1797 at risk

Adverse event: Gastrointestinal/other
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 35 affected / 1797 at risk

Adverse event: Dysgeusia
Serious: no
Organ System: Nervous system disorders
Frequency: 17 affected / 1797 at risk

Adverse event: Haemorrhoids
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 1797 at risk

Adverse event: Incontinence, anal
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 1797 at risk

Adverse event: Distension
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 1797 at risk

Adverse event: Flatulence
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 1797 at risk

Adverse event: Ileus GI
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 1797 at risk

Adverse event: Dehydration
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 1797 at risk

Adverse event: Oesophagitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 1797 at risk

Adverse event: Enteritis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 1797 at risk

Adverse event: Intestinal perforation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 1797 at risk

Adverse event: Taste Alteration (dysgeusia)
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 1797 at risk

Adverse event: Anal fistula
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1797 at risk

Adverse event: Obstruction/GU
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1797 at risk

Adverse event: Tooth disorder
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1797 at risk

Adverse event: Pulmonary haemorrhage
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 167 affected / 1797 at risk

Adverse event: Hemorrhage/GI
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 43 affected / 1797 at risk

Adverse event: Hemorrhage/GU
Serious: no
Organ System: Renal and urinary disorders
Frequency: 14 affected / 1797 at risk

Adverse event: Petechiae
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 6 affected / 1797 at risk

Adverse event: Hemorrhage/other
Serious: no
Organ System: General disorders
Frequency: 3 affected / 1797 at risk

Adverse event: Liver dysfunction
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 10 affected / 1797 at risk

Adverse event: Hepatobiliary/other
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 6 affected / 1797 at risk

Adverse event: Cholecystitis
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 1797 at risk

Adverse event: Hepatic cysts
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 1797 at risk

Adverse event: Infection
Serious: no
Organ System: Infections and infestations
Frequency: 148 affected / 1797 at risk

Adverse event: Infection - conjunctiva
Serious: no
Organ System: Infections and infestations
Frequency: 108 affected / 1797 at risk

Adverse event: Infection - lung (pneumonia)
Serious: no
Organ System: Infections and infestations
Frequency: 51 affected / 1797 at risk

Adverse event: Infection - ungual (nail)
Serious: no
Organ System: Infections and infestations
Frequency: 51 affected / 1797 at risk

Adverse event: Infection - urinary tract nos
Serious: no
Organ System: Infections and infestations
Frequency: 31 affected / 1797 at risk

Adverse event: Infection - skin (cellulitis)
Serious: no
Organ System: Infections and infestations
Frequency: 29 affected / 1797 at risk

Adverse event: Infection - bronchus
Serious: no
Organ System: Infections and infestations
Frequency: 18 affected / 1797 at risk

Adverse event: Infection - eye nos
Serious: no
Organ System: Infections and infestations
Frequency: 17 affected / 1797 at risk

Adverse event: Infection - soft tissue nos
Serious: no
Organ System: Infections and infestations
Frequency: 13 affected / 1797 at risk

Adverse event: Infection - upper aerodigestive nos
Serious: no
Organ System: Infections and infestations
Frequency: 13 affected / 1797 at risk

Adverse event: Infection - pharynx
Serious: no
Organ System: Infections and infestations
Frequency: 9 affected / 1797 at risk

Adverse event: Infection - blood
Serious: no
Organ System: Infections and infestations
Frequency: 8 affected / 1797 at risk

Adverse event: Infection - lip/perioral
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 1797 at risk

Adverse event: Infection - anal/perianal
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 1797 at risk

Adverse event: Infection - upper airway nos
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 1797 at risk

Adverse event: Tooth infection
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 1797 at risk

Adverse event: Infection - vagina
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 1797 at risk

Adverse event: Infection - auditory ear
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 1797 at risk

Adverse event: Febrile neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 1797 at risk

Adverse event: Cholecystitis infective
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 1797 at risk

Adverse event: Infection - brain (encephalitis, infectious)
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 1797 at risk

Adverse event: Infection - sinus
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 1797 at risk

Adverse event: Infection - bone (osteomyelitis)
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 1797 at risk

Adverse event: Infection - kidney
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 1797 at risk

Adverse event: Infection - liver
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 1797 at risk

Adverse event: Infection - salivary gland
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 1797 at risk

Adverse event: Infection - dental-tooth
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 1797 at risk

Adverse event: Infection - peritoneal cavity
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 1797 at risk

Adverse event: Infection - wound
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 1797 at risk

Adverse event: Infection - appendix
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 1797 at risk

Adverse event: Infection - catheter-related
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 1797 at risk

Adverse event: Infection - colon
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 1797 at risk

Adverse event: Infection - vulva
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 1797 at risk

Adverse event: Edema limb
Serious: no
Organ System: General disorders
Frequency: 80 affected / 1797 at risk

Adverse event: Oedema
Serious: no
Organ System: General disorders
Frequency: 33 affected / 1797 at risk

Adverse event: Edema head and neck
Serious: no
Organ System: General disorders
Frequency: 12 affected / 1797 at risk

Adverse event: Lymphatic/other
Serious: no
Organ System: General disorders
Frequency: 2 affected / 1797 at risk

Adverse event: Blood bilirubin
Serious: no
Organ System: Investigations
Frequency: 23 affected / 1797 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 17 affected / 1797 at risk

Adverse event: Alanine aminotransferase
Serious: no
Organ System: Investigations
Frequency: 14 affected / 1797 at risk

Adverse event: Aspartate aminotransferase
Serious: no
Organ System: Investigations
Frequency: 14 affected / 1797 at risk

Adverse event: Blood alkaline phosphatase
Serious: no
Organ System: Investigations
Frequency: 11 affected / 1797 at risk

Adverse event: Hypercalcaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 11 affected / 1797 at risk

Adverse event: Gamma-glutamyltransferase
Serious: no
Organ System: Investigations
Frequency: 10 affected / 1797 at risk

Adverse event: Hyperkalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 9 affected / 1797 at risk

Adverse event: Hypocalcaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 8 affected / 1797 at risk

Adverse event: Hyponatraemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 7 affected / 1797 at risk

Adverse event: Metabolic lab/other
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 6 affected / 1797 at risk

Adverse event: Hyperuricaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 1797 at risk

Adverse event: Hypercholesterolaemia
Serious: no
Organ System: Investigations
Frequency: 4 affected / 1797 at risk

Adverse event: Hypoalbuminaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 1797 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 1797 at risk

Adverse event: Hypoglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 1797 at risk

Adverse event: Acidosis
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 1797 at risk

Adverse event: Amylase
Serious: no
Organ System: Investigations
Frequency: 1 affected / 1797 at risk

Adverse event: Hypernatraemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 1797 at risk

Adverse event: Blood creatine phosphokinase
Serious: no
Organ System: Investigations
Frequency: 1 affected / 1797 at risk

Adverse event: Hypomagnesaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 1797 at risk

Adverse event: Hypophosphataemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 1797 at risk

Adverse event: Alkalosis
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 1797 at risk

Adverse event: Hypertriglyceridaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 1797 at risk

Adverse event: Musculoskeletal/other
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 77 affected / 1797 at risk

Adverse event: Muscular weakness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 24 affected / 1797 at risk

Adverse event: Fracture
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 12 affected / 1797 at risk

Adverse event: Ascites
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 1797 at risk

Adverse event: Gait
Serious: no
Organ System: General disorders
Frequency: 8 affected / 1797 at risk

Adverse event: Arthritis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 6 affected / 1797 at risk

Adverse event: Osteonecrosis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 1797 at risk

Adverse event: Myositis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 1797 at risk

Adverse event: Trismus
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 1797 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 94 affected / 1797 at risk

Adverse event: Neuropathy/sensory
Serious: no
Organ System: Nervous system disorders
Frequency: 74 affected / 1797 at risk

Adverse event: Ataxia
Serious: no
Organ System: Nervous system disorders
Frequency: 57 affected / 1797 at risk

Adverse event: Confusional state
Serious: no
Organ System: Psychiatric disorders
Frequency: 55 affected / 1797 at risk

Adverse event: Neurology/other
Serious: no
Organ System: Nervous system disorders
Frequency: 53 affected / 1797 at risk

Adverse event: Mood alteration-anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 51 affected / 1797 at risk

Adverse event: Mood alteration-depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 45 affected / 1797 at risk

Adverse event: Neuropathy/motor
Serious: no
Organ System: Nervous system disorders
Frequency: 38 affected / 1797 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 38 affected / 1797 at risk

Adverse event: Cognitive disorder
Serious: no
Organ System: Nervous system disorders
Frequency: 28 affected / 1797 at risk

Adverse event: Speech impairment
Serious: no
Organ System: Nervous system disorders
Frequency: 27 affected / 1797 at risk

Adverse event: Mood alteration-agitation
Serious: no
Organ System: Psychiatric disorders
Frequency: 23 affected / 1797 at risk

Adverse event: CNS ischemia
Serious: no
Organ System: Nervous system disorders
Frequency: 16 affected / 1797 at risk

Adverse event: Tremor
Serious: no
Organ System: Nervous system disorders
Frequency: 16 affected / 1797 at risk

Adverse event: Syncope
Serious: no
Organ System: Nervous system disorders
Frequency: 15 affected / 1797 at risk

Adverse event: Seizure
Serious: no
Organ System: Nervous system disorders
Frequency: 15 affected / 1797 at risk

Adverse event: Mood alteration
Serious: no
Organ System: Psychiatric disorders
Frequency: 14 affected / 1797 at risk

Adverse event: Memory impairment
Serious: no
Organ System: Nervous system disorders
Frequency: 11 affected / 1797 at risk

Adverse event: Psychotic disorder
Serious: no
Organ System: Psychiatric disorders
Frequency: 7 affected / 1797 at risk

Adverse event: Involuntary movement
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 1797 at risk

Adverse event: Encephalopathy
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 1797 at risk

Adverse event: Neuropathy cranial
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 1797 at risk

Adverse event: Mood alteration-depression-anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 4 affected / 1797 at risk

Adverse event: Vision blurred
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 1797 at risk

Adverse event: Extrapyramidal disorder
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 1797 at risk

Adverse event: Seizure
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 1797 at risk

Adverse event: Eye disorder
Serious: no
Organ System: Eye disorders
Frequency: 48 affected / 1797 at risk

Adverse event: Watery eye
Serious: no
Organ System: Eye disorders
Frequency: 7 affected / 1797 at risk

Adverse event: Dry eye
Serious: no
Organ System: Eye disorders
Frequency: 6 affected / 1797 at risk

Adverse event: Diplopia
Serious: no
Organ System: Eye disorders
Frequency: 5 affected / 1797 at risk

Adverse event: Keratitis
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 1797 at risk

Adverse event: Cataract
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 1797 at risk

Adverse event: Vision-flashing lights/floaters
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 1797 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 229 affected / 1797 at risk

Adverse event: Pain - chest wall
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 211 affected / 1797 at risk

Adverse event: Pain - muscle
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 139 affected / 1797 at risk

Adverse event: Pain - abdomen nos
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 108 affected / 1797 at risk

Adverse event: Pain - headache
Serious: no
Organ System: Nervous system disorders
Frequency: 97 affected / 1797 at risk

Adverse event: Pain - joint
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 95 affected / 1797 at risk

Adverse event: Pain - bone
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 78 affected / 1797 at risk

Adverse event: Pain - limb
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 51 affected / 1797 at risk

Adverse event: Pain - pleura
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 25 affected / 1797 at risk

Adverse event: Pain - neck
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 21 affected / 1797 at risk

Adverse event: Pain - neuralgia/peripheral nerve
Serious: no
Organ System: Nervous system disorders
Frequency: 18 affected / 1797 at risk

Adverse event: Pain - liver
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 8 affected / 1797 at risk

Adverse event: Pain - eye
Serious: no
Organ System: Eye disorders
Frequency: 5 affected / 1797 at risk

Adverse event: Pain - throat/pharynx/larynx
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 1797 at risk

Adverse event: Pain - tumor
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 3 affected / 1797 at risk

Adverse event: Pain - face
Serious: no
Organ System: General disorders
Frequency: 2 affected / 1797 at risk

Adverse event: Pain - Kidney
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 1797 at risk

Adverse event: Pain - foot
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 1797 at risk

Adverse event: Pain - dental/teeth/peridontal
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1797 at risk

Adverse event: Pain - ear
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 1797 at risk

Adverse event: Pain - rectum
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1797 at risk

Adverse event: Pain - scalp
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 1797 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 691 affected / 1797 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 436 affected / 1797 at risk

Adverse event: Pulmonary/other
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 138 affected / 1797 at risk

Adverse event: Voice changes
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 87 affected / 1797 at risk

Adverse event: Bronchospasm
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 18 affected / 1797 at risk

Adverse event: Pleural effusion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 12 affected / 1797 at risk

Adverse event: Hypoxia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 8 affected / 1797 at risk

Adverse event: Hiccoughs
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 7 affected / 1797 at risk

Adverse event: Pulmonary/obstruction/stenosis of airway (bronchus)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 1797 at risk

Adverse event: Pneumonitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 1797 at risk

Adverse event: Pneumothorax
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 1797 at risk

Adverse event: Atelectasis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 1797 at risk

Adverse event: Acute respiratory distress syndrome
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 1797 at risk

Adverse event: Chest tube drainage or leak
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1797 at risk

Adverse event: Trachael fistula
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1797 at risk

Adverse event: Airway obstruction/upper respiratory
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1797 at risk

Adverse event: Renal failure
Serious: no
Organ System: Renal and urinary disorders
Frequency: 39 affected / 1797 at risk

Adverse event: Cystitis
Serious: no
Organ System: Renal and urinary disorders
Frequency: 12 affected / 1797 at risk

Adverse event: Pollakiuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 11 affected / 1797 at risk

Adverse event: Renal/other
Serious: no
Organ System: Renal and urinary disorders
Frequency: 8 affected / 1797 at risk

Adverse event: Obstruction/GI
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 1797 at risk

Adverse event: Incontinence, urinary
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 1797 at risk

Adverse event: Urine colour change
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 1797 at risk

Adverse event: Urinary retention
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 1797 at risk

Adverse event: Urogenital disorder
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 1797 at risk

Adverse event: Secondary malignancy
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 1797 at risk

Adverse event: Sexual/reproductive function
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 3 affected / 1797 at risk

Adverse event: Menstruation irregular
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 2 affected / 1797 at risk

Adverse event: Vulvovaginal dryness
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 1797 at risk

Adverse event: Erectile dysfunction
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 1797 at risk

Adverse event: Procedural complication
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 1797 at risk

Adverse event: Flu-like syndrome
Serious: no
Organ System: General disorders
Frequency: 102 affected / 1797 at risk

Adverse event: Syndromes/other-superior cava vein
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 15 affected / 1797 at risk

Adverse event: Syndromes/other
Serious: no
Organ System: General disorders
Frequency: 3 affected / 1797 at risk

Adverse event: Antiphospholipid syndrome
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 1797 at risk

Adverse event: Ill-defined disorder
Serious: no
Organ System: General disorders
Frequency: 1 affected / 1797 at risk

Adverse event: Uncoded
Serious: no
Organ System: General disorders
Frequency: 11 affected / 1797 at risk

Adverse event: Thrombosis/embolism
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 42 affected / 1797 at risk

Adverse event: Vascular/other
Serious: no
Organ System: Vascular disorders
Frequency: 10 affected / 1797 at risk

Adverse event: Phlebitis
Serious: no
Organ System: Vascular disorders
Frequency: 7 affected / 1797 at risk