Study: NCT03848182

Adverse event: Gallbladder rupture
Serious: yes
Organ System: Hepatobiliary disorders
Notes: Verbatim Term: Perforated Gall Bladder
Frequency: 1 affected / 10 at risk

Adverse event: Small intestinal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 10 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 5 affected / 10 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 10 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 10 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 10 at risk

Adverse event: Rash maculo-papular
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 10 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Notes: Verbatim Terms: Abdominal Pain, Intermittent Abdominal Pain, Abdominal Discomfort
Frequency: 8 affected / 10 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Verbatim Terms: Dyspnea, Shortness of Breath
Frequency: 3 affected / 10 at risk

Adverse event: Chest pain
Serious: no
Organ System: Cardiac disorders
Notes: Verbatim Terms: Chest Pain, Occasional Chest Pain
Frequency: 2 affected / 10 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 10 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Notes: Verbatim Term: Bilateral Lower Extremity Edema
Frequency: 1 affected / 10 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 10 at risk

Adverse event: Muscular weakness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Verbatim Term: Weakness
Frequency: 5 affected / 10 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Verbatim Terms: Intermittent Cough, Blood-tinged Cough
Frequency: 2 affected / 10 at risk

Adverse event: Poor Appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Verbatim Terms: Poor Appetite, Poor PO Intake, Appetite Change
Frequency: 5 affected / 10 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Investigations
Notes: Verbatim Terms: Weight Loss, Weight Loss (\>40lbs in one month)
Frequency: 4 affected / 10 at risk

Adverse event: Gait disturbance
Serious: no
Organ System: General disorders
Notes: Verbatim Term: Gait Problem
Frequency: 3 affected / 10 at risk

Adverse event: Febrile neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Verbatim Term: Neutropenic
Frequency: 1 affected / 10 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: Verbatim Term: Emesis
Frequency: 2 affected / 10 at risk

Adverse event: Spleen disorder
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Verbatim Term: Thrombocytopenia
Frequency: 1 affected / 10 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 10 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Verbatim Term: Glucose, uncontrolled
Frequency: 1 affected / 10 at risk

Adverse event: Paraesthesia
Serious: no
Organ System: Nervous system disorders
Notes: Verbatim Terms: Numbness of Hands, Numbness in Extremities
Frequency: 2 affected / 10 at risk

Adverse event: Dysuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 10 at risk

Adverse event: Sleep disorder
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 10 at risk

Adverse event: Hypoacusis
Serious: no
Organ System: Ear and labyrinth disorders
Notes: Verbatim Term: Hearing Loss
Frequency: 1 affected / 10 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 10 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 10 at risk

Adverse event: Abdominal distension
Serious: no
Organ System: Gastrointestinal disorders
Notes: Verbatim Term: Burping
Frequency: 1 affected / 10 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Verbatim Terms: Left Upper Extremity (LUE) Pain; Left Lateral Thigh Pain
Frequency: 2 affected / 10 at risk

Adverse event: Pain (general)
Serious: no
Organ System: General disorders
Notes: Verbatim Terms: Left Upper Quadrant (LUQ) Pain; Right Upper Quadrant (RUQ) Pain
Frequency: 2 affected / 10 at risk

Adverse event: Haematochezia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 10 at risk

Adverse event: Embolism
Serious: no
Organ System: Vascular disorders
Notes: Verbatim Terms: Deep Vein Thrombosis (DVT) in Right Lower Extremity; Superficial Vein Thrombosis
Frequency: 1 affected / 10 at risk