Study: NCT02774291

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: Intermittent, Grades 1-2
Frequency: 2 affected / 3 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Notes: Bilateral legs, right\>left. Grade 2
Frequency: 1 affected / 3 at risk

Adverse event: Weight increased
Serious: no
Organ System: Investigations
Notes: Grade 1
Frequency: 2 affected / 3 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Intermittent, highest severity Grade 2
Frequency: 1 affected / 3 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: Intermittent, Grades 1-2
Frequency: 2 affected / 3 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Intermittent, highest severity Grade 2
Frequency: 1 affected / 3 at risk

Adverse event: Erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Right Lower Extremity, Grade 1
Frequency: 1 affected / 3 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Notes: Grade 1
Frequency: 2 affected / 3 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Notes: Intermittent, highest severity Grade 2
Frequency: 2 affected / 3 at risk

Adverse event: Sinus tachycardia
Serious: no
Organ System: Cardiac disorders
Notes: Intermittent, highest severity Grade 2
Frequency: 1 affected / 3 at risk

Adverse event: Hypomagnesaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Intermittent, highest severity Grade 2
Frequency: 1 affected / 3 at risk

Adverse event: Neutrophil count decreased
Serious: no
Organ System: Investigations
Notes: Intermittent, Grades 2-4
Frequency: 2 affected / 3 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Intermittent,, Grades 1-2
Frequency: 1 affected / 3 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: At rest, Grade 1
Frequency: 1 affected / 3 at risk

Adverse event: Hypoglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Intermittent, highest severity Grade 1
Frequency: 1 affected / 3 at risk

Adverse event: Lethargy
Serious: no
Organ System: Nervous system disorders
Notes: Grade 1
Frequency: 1 affected / 3 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Generalized, abdomen-back. Grade 1
Frequency: 1 affected / 3 at risk

Adverse event: Confusional state
Serious: no
Organ System: Psychiatric disorders
Notes: Grade 1
Frequency: 1 affected / 3 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: 'generalized weakness', Grade 1
Frequency: 1 affected / 3 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: Grade 1
Frequency: 1 affected / 3 at risk

Adverse event: Hypophosphataemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Intermittent, Grades 1-3
Frequency: 1 affected / 3 at risk

Adverse event: Blood creatinine increased
Serious: no
Organ System: Investigations
Notes: Grade 1
Frequency: 1 affected / 3 at risk

Adverse event: Platelet count decreased
Serious: no
Organ System: Investigations
Notes: Grade 4
Frequency: 1 affected / 3 at risk

Adverse event: Chest pain
Serious: no
Organ System: General disorders
Notes: Nonspecific. Grade 2
Frequency: 1 affected / 3 at risk

Adverse event: Flushing
Serious: no
Organ System: Vascular disorders
Notes: Grade 1
Frequency: 1 affected / 3 at risk

Adverse event: Bone pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Jaw, Grade 2
Frequency: 1 affected / 3 at risk

Adverse event: Appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Loss of appetite. Grade 1
Frequency: 1 affected / 3 at risk

Adverse event: Sleep apnoea syndrome
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Intermittent, positional desaturation (lying down). Grade 2
Frequency: 1 affected / 3 at risk

Adverse event: Acidosis
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Grade 2
Frequency: 1 affected / 3 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Grade 4
Frequency: 1 affected / 3 at risk

Adverse event: Blood bilirubin increased
Serious: no
Organ System: Investigations
Notes: Grade 2
Frequency: 1 affected / 3 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Grade 2
Frequency: 1 affected / 3 at risk

Adverse event: Pollakiuria
Serious: no
Organ System: Renal and urinary disorders
Notes: Grade 1
Frequency: 1 affected / 3 at risk

Adverse event: Tachycardia
Serious: no
Organ System: Cardiac disorders
Notes: Nonspecified, Grade 1
Frequency: 1 affected / 3 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Intermittent, Grade 1
Frequency: 1 affected / 3 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: 'hair loss.' Grade 1
Frequency: 1 affected / 3 at risk

Adverse event: Stomatitis
Serious: no
Organ System: Gastrointestinal disorders
Notes: Grade 1
Frequency: 1 affected / 3 at risk