Study: NCT02749903

Adverse event: Cardiac failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 46 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 46 at risk

Adverse event: Dysphagia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 46 at risk

Adverse event: Small intestinal obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 46 at risk

Adverse event: Osteomyelitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 46 at risk

Adverse event: Infections and infestations - Oth spec
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 46 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 46 at risk

Adverse event: Spinal fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 46 at risk

Adverse event: Blood alkaline phosphatase increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 46 at risk

Adverse event: Hypoalbuminaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 46 at risk

Adverse event: Back pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 46 at risk

Adverse event: Musculoskeletal, conn tissue - Oth spec
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 46 at risk

Adverse event: Tumour pain
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 46 at risk

Adverse event: Dizziness
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 46 at risk

Adverse event: Brain oedema
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 46 at risk

Adverse event: Headache
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 46 at risk

Adverse event: Nervous system disorders - Oth spec
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 46 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 46 at risk

Adverse event: Insomnia
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 46 at risk

Adverse event: Pleural effusion
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 46 at risk

Adverse event: Resp, thoracic, mediastinal - Oth spec
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 46 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 46 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 11 affected / 46 at risk

Adverse event: Atrial fibrillation
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 46 at risk

Adverse event: Cardiac disorders - Other, specify
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 46 at risk

Adverse event: Cardiac failure
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 46 at risk

Adverse event: Ear pain
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 2 affected / 46 at risk

Adverse event: Hypoacusis
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 46 at risk

Adverse event: Tinnitus
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 46 at risk

Adverse event: Vision blurred
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 46 at risk

Adverse event: Dry eye
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 46 at risk

Adverse event: Eye disorders - Other, specify
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 46 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 46 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 46 at risk

Adverse event: Dental caries
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 46 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 13 affected / 46 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 46 at risk

Adverse event: Dysphagia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 46 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 46 at risk

Adverse event: Gastrointestinal disorders - Oth spec
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 46 at risk

Adverse event: Stomatitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 46 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 46 at risk

Adverse event: Oral pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 46 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 46 at risk

Adverse event: Toothache
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 46 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 46 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Frequency: 2 affected / 46 at risk

Adverse event: Facial pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 46 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 40 affected / 46 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 46 at risk

Adverse event: Gen disord and admin site conds-Oth spec
Serious: no
Organ System: General disorders
Frequency: 3 affected / 46 at risk

Adverse event: Localised oedema
Serious: no
Organ System: General disorders
Frequency: 9 affected / 46 at risk

Adverse event: Localised oedema
Serious: no
Organ System: General disorders
Frequency: 1 affected / 46 at risk

Adverse event: Non-cardiac chest pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 46 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 6 affected / 46 at risk

Adverse event: Gingivitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 46 at risk

Adverse event: Fall
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 46 at risk

Adverse event: Fracture
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 46 at risk

Adverse event: Inj, pois and proced complic - Oth spec
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 46 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 3 affected / 46 at risk

Adverse event: Blood alkaline phosphatase increased
Serious: no
Organ System: Investigations
Frequency: 5 affected / 46 at risk

Adverse event: Aspartate aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 6 affected / 46 at risk

Adverse event: Blood bilirubin increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 46 at risk

Adverse event: Blood creatinine increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 46 at risk

Adverse event: Investigations - Other, specify
Serious: no
Organ System: Investigations
Frequency: 1 affected / 46 at risk

Adverse event: Lymphocyte count decreased
Serious: no
Organ System: Investigations
Frequency: 8 affected / 46 at risk

Adverse event: Neutrophil count decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 46 at risk

Adverse event: Platelet count decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 46 at risk

Adverse event: Weight increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 46 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Investigations
Frequency: 21 affected / 46 at risk

Adverse event: White blood cell count decreased
Serious: no
Organ System: Investigations
Frequency: 5 affected / 46 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 10 affected / 46 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 7 affected / 46 at risk

Adverse event: Hypoalbuminaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 46 at risk

Adverse event: Hypocalcaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 46 at risk

Adverse event: Hypoglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 46 at risk

Adverse event: Hyponatraemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 46 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 46 at risk

Adverse event: Arthritis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 46 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 5 affected / 46 at risk

Adverse event: Flank pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 46 at risk

Adverse event: Muscular weakness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 46 at risk

Adverse event: Joint effusion
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 46 at risk

Adverse event: Muscular weakness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 46 at risk

Adverse event: Musculoskeletal, conn tissue - Oth spec
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 46 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 46 at risk

Adverse event: Neck pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 46 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 6 affected / 46 at risk

Adverse event: Tumour pain
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 46 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 13 affected / 46 at risk

Adverse event: Dysgeusia
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 46 at risk

Adverse event: Aphasia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 46 at risk

Adverse event: Facial nerve disorder
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 46 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 46 at risk

Adverse event: Paraesthesia
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 46 at risk

Adverse event: Peripheral sensory neuropathy
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 46 at risk

Adverse event: Seizure
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 46 at risk

Adverse event: Syncope
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 46 at risk

Adverse event: Tremor
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 46 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 46 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 46 at risk

Adverse event: Hallucination
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 46 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 8 affected / 46 at risk

Adverse event: Libido decreased
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 46 at risk

Adverse event: Psychiatric disorders - Other, specify
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 46 at risk

Adverse event: Renal and urinary disorders - Oth spec
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 46 at risk

Adverse event: Urinary tract pain
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 46 at risk

Adverse event: Breast pain
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 10 affected / 46 at risk

Adverse event: Gynaecomastia
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 8 affected / 46 at risk

Adverse event: Pelvic pain
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 2 affected / 46 at risk

Adverse event: Reproductive system and breast -Oth spec
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 46 at risk

Adverse event: Rhinitis allergic
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 46 at risk

Adverse event: Aspiration
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 46 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 46 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 46 at risk

Adverse event: Dysphonia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 46 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 46 at risk

Adverse event: Pleural effusion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 46 at risk

Adverse event: Productive cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 46 at risk

Adverse event: Wheezing
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 46 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 46 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 46 at risk

Adverse event: Hyperhidrosis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 46 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 46 at risk

Adverse event: Rash maculo-papular
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 46 at risk

Adverse event: Skin and subcut tissue disord - Oth spec
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 46 at risk

Adverse event: Skin induration
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 46 at risk

Adverse event: Hot flush
Serious: no
Organ System: Vascular disorders
Frequency: 22 affected / 46 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 34 affected / 46 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 46 at risk