Study: NCT03959241

Adverse event: Acute myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 208 at risk

Adverse event: Fall
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 208 at risk

Adverse event: Intervertebral disc protrusion
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 208 at risk

Adverse event: Embolic stroke
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 208 at risk

Adverse event: Haemorrhage intracranial
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 208 at risk

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 208 at risk

Adverse event: Homicide
Serious: yes
Organ System: Social circumstances
Frequency: 1 affected / 208 at risk

Adverse event: Deep vein thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 208 at risk

Adverse event: Grades 3-5 General Disorders
Serious: no
Organ System: General disorders
Frequency: 51 affected / 208 at risk

Adverse event: Grades 3-5 Immune System Disorders
Serious: no
Organ System: Immune system disorders
Frequency: 5 affected / 208 at risk

Adverse event: Grades 3-5 GI Disorders
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 57 affected / 208 at risk

Adverse event: Grades 3-5 Renal Disorders
Serious: no
Organ System: Renal and urinary disorders
Frequency: 33 affected / 208 at risk

Adverse event: Grades 3-5 Hemorrhagic Disorders
Serious: no
Organ System: Vascular disorders
Frequency: 12 affected / 208 at risk

Adverse event: Grades 3-5 Cardiac Disorders
Serious: no
Organ System: Cardiac disorders
Frequency: 71 affected / 208 at risk

Adverse event: Grades 3-5 Nervous System Disorders
Serious: no
Organ System: Nervous system disorders
Frequency: 12 affected / 208 at risk

Adverse event: Grades 3-5 Blood and Lymphatic Disorders
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 208 at risk

Adverse event: Grades 3-5 Vascular Disorders
Serious: no
Organ System: Vascular disorders
Frequency: 6 affected / 208 at risk

Adverse event: Grades 3-5 Musculoskeletal and Connective Tissue Disorders
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 17 affected / 208 at risk

Adverse event: Grades 3-5 Respiratory, Thoracic and Mediastinal Disorders
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 41 affected / 208 at risk

Adverse event: Grades 3-5 Metabolism and Nutrition Disorders
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 24 affected / 208 at risk

Adverse event: Grades 3-5 Hepatic Disorders
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 24 affected / 208 at risk

Adverse event: Received Dialysis
Serious: no
Organ System: Renal and urinary disorders
Frequency: 11 affected / 208 at risk

Adverse event: Hepatitis
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 6 affected / 208 at risk

Adverse event: Hepatic failure
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 2 affected / 208 at risk

Adverse event: Abnormal liver function
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 14 affected / 208 at risk

Adverse event: Haemolysis
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 212 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 212 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 212 at risk

Adverse event: Ascites
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 212 at risk

Adverse event: Diverticulum
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 212 at risk

Adverse event: Melaena
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 212 at risk

Adverse event: Chest discomfort
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 212 at risk

Adverse event: Mucosal inflammation
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 212 at risk

Adverse event: Hypersensitivity
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 212 at risk

Adverse event: Sialoadenitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 212 at risk

Adverse event: Fall
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 212 at risk

Adverse event: Neck pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 212 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 212 at risk

Adverse event: Embolism venous
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 212 at risk

Adverse event: Grades 3-5 General Disorders
Serious: no
Organ System: General disorders
Frequency: 48 affected / 212 at risk

Adverse event: Grades 3-5 Immune System Disorders
Serious: no
Organ System: Immune system disorders
Frequency: 6 affected / 212 at risk

Adverse event: Grades 3-5 GI Disorders
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 77 affected / 212 at risk

Adverse event: Grades 3-5 Renal Disorders
Serious: no
Organ System: Renal and urinary disorders
Frequency: 30 affected / 212 at risk

Adverse event: Grades 3-5 Hemorrhagic Disorders
Serious: no
Organ System: Vascular disorders
Frequency: 11 affected / 212 at risk

Adverse event: Grades 3-5 Cardiac Disorders
Serious: no
Organ System: Cardiac disorders
Frequency: 72 affected / 212 at risk

Adverse event: Grades 3-5 Nervous System Disorders
Serious: no
Organ System: Nervous system disorders
Frequency: 20 affected / 212 at risk

Adverse event: Grades 3-5 Blood and Lymphatic Disorders
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 212 at risk

Adverse event: Grades 3-5 Vascular Disorders
Serious: no
Organ System: Vascular disorders
Frequency: 12 affected / 212 at risk

Adverse event: Grades 3-5 Musculoskeletal and Connective Tissue Disorders
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 12 affected / 212 at risk

Adverse event: Grades 3-5 Respiratory, Thoracic and Mediastinal Disorders
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 42 affected / 212 at risk

Adverse event: Grades 3-5 Metabolism and Nutrition Disorders
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 33 affected / 212 at risk

Adverse event: Grades 3-5 Hepatic Disorders
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 44 affected / 212 at risk

Adverse event: Received Dialysis
Serious: no
Organ System: Renal and urinary disorders
Frequency: 8 affected / 212 at risk

Adverse event: Hepatitis
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 4 affected / 212 at risk

Adverse event: Hepatic failure
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 4 affected / 212 at risk

Adverse event: Abnormal liver function
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 15 affected / 212 at risk