Study: NCT03152552

Adverse event: Cardiac failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 15 at risk

Adverse event: Diarrhoea infectious
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 15 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 15 at risk

Adverse event: Enteritis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 15 at risk

Adverse event: Flatulence
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 15 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 15 at risk

Adverse event: Limb injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 15 at risk

Adverse event: Heart rate irregular
Serious: no
Organ System: Investigations
Frequency: 1 affected / 15 at risk

Adverse event: Liver function test increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 15 at risk

Adverse event: Diabetes mellitus inadequate control
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 15 at risk

Adverse event: Hypoglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 15 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 15 at risk

Adverse event: Dysaesthesia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 15 at risk

Adverse event: Proteinuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 15 at risk

Adverse event: Gynaecomastia
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 15 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 15 at risk

Adverse event: Epistaxis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 15 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 15 at risk

Adverse event: Coronary artery disease
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 16 at risk

Adverse event: Cardiac death
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 16 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 16 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 16 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Frequency: 1 affected / 16 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 16 at risk

Adverse event: Thirst
Serious: no
Organ System: General disorders
Frequency: 1 affected / 16 at risk

Adverse event: Breast abscess
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 16 at risk

Adverse event: Genital infection fungal
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 16 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 16 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 16 at risk

Adverse event: Fluid retention
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 16 at risk

Adverse event: Hypoglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 16 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 16 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 16 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 16 at risk

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

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

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

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

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

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

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

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

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

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 30 at risk

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

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

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

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

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

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

Adverse event: Benign prostatic hyperplasia
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 30 at risk

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 33 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 33 at risk

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

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

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

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

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

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