Study: NCT02979353

Adverse event: Cardiac failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 6 affected / 186 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 8 affected / 186 at risk

Adverse event: Cardiac Arrhythmias
Serious: yes
Organ System: Cardiac disorders
Frequency: 8 affected / 186 at risk

Adverse event: Fall
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 8 affected / 186 at risk

Adverse event: Respiratory Disorders
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 186 at risk

Adverse event: Urinary Tract Infections
Serious: yes
Organ System: Infections and infestations
Frequency: 5 affected / 186 at risk

Adverse event: Infections - Pathogen Unspecified
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 186 at risk

Adverse event: Bacterial Infections Disorders
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 186 at risk

Adverse event: Renal Disorders
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 3 affected / 186 at risk

Adverse event: Vascular Hypotensive Disorders
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 186 at risk

Adverse event: Encephalopathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 186 at risk

Adverse event: Sepsis - Pathogen unspecified
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 186 at risk

Adverse event: Bone & Joint Fractures
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 4 affected / 186 at risk

Adverse event: Central Nervous System Vascular Disorders
Serious: yes
Organ System: Nervous system disorders
Frequency: 4 affected / 186 at risk

Adverse event: General System Disorders (NEC)
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 186 at risk

Adverse event: Coronary artery disease
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 186 at risk

Adverse event: Gastrointestinal Motility and Defecation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 186 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 186 at risk

Adverse event: Bronchial Disorders (excludes neoplasms)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 186 at risk

Adverse event: Electrolyte and Fluid Balance Conditions
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 186 at risk

Adverse event: Mental Disorders
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 186 at risk

Adverse event: Cerebral Injuries
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 186 at risk

Adverse event: Exocrine Pancreas Conditions
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 186 at risk

Adverse event: Gastrointestinal Signs & Symptoms
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 186 at risk

Adverse event: Gastrointestinal Stenosis & Obstructions
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 186 at risk

Adverse event: Glucose Metabolism Disorder
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 186 at risk

Adverse event: Anaemias (NEC)
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 186 at risk

Adverse event: Calcium Metabolic Disorders
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 186 at risk

Adverse event: Delusion Symptoms
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 186 at risk

Adverse event: Device Issues
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 186 at risk

Adverse event: Embolism & Thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 186 at risk

Adverse event: Gallbladder Disorders
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 186 at risk

Adverse event: Phosphorous Metabolism Disorders
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 186 at risk

Adverse event: Spleen Disorders
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 186 at risk

Adverse event: White Blood Cell Disorders
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 186 at risk

Adverse event: Fall
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 8 affected / 186 at risk

Adverse event: Mental status changes
Serious: no
Organ System: Psychiatric disorders
Frequency: 4 affected / 186 at risk

Adverse event: Cardiac failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 11 affected / 186 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 6 affected / 186 at risk

Adverse event: Cardiac Arrhythmias
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 186 at risk

Adverse event: Fall
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 186 at risk

Adverse event: Respiratory Disorders
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 8 affected / 186 at risk

Adverse event: Urinary Tract Infections
Serious: yes
Organ System: Infections and infestations
Frequency: 6 affected / 186 at risk

Adverse event: Infections - Pathogen Unspecified
Serious: yes
Organ System: Infections and infestations
Frequency: 6 affected / 186 at risk

Adverse event: Bacterial Infections Disorders
Serious: yes
Organ System: Infections and infestations
Frequency: 6 affected / 186 at risk

Adverse event: Renal Disorders
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 4 affected / 186 at risk

Adverse event: Vascular Hypotensive Disorders
Serious: yes
Organ System: Vascular disorders
Frequency: 5 affected / 186 at risk

Adverse event: Encephalopathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 5 affected / 186 at risk

Adverse event: Sepsis - Pathogen unspecified
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 186 at risk

Adverse event: Bone & Joint Fractures
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 186 at risk

Adverse event: Central Nervous System Vascular Disorders
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 186 at risk

Adverse event: General System Disorders (NEC)
Serious: yes
Organ System: General disorders
Frequency: 4 affected / 186 at risk

Adverse event: Coronary artery disease
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 186 at risk

Adverse event: Gastrointestinal Motility and Defecation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 186 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 186 at risk

Adverse event: Bronchial Disorders (excludes neoplasms)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 186 at risk

Adverse event: Electrolyte and Fluid Balance Conditions
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 186 at risk

Adverse event: Gastrointestinal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 186 at risk

Adverse event: Mental Disorders
Serious: yes
Organ System: Psychiatric disorders
Frequency: 2 affected / 186 at risk

Adverse event: Cerebral Injuries
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 186 at risk

Adverse event: Depressive Disorders
Serious: yes
Organ System: Psychiatric disorders
Frequency: 2 affected / 186 at risk

Adverse event: Gastrointestinal Signs & Symptoms
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 186 at risk

Adverse event: Glucose Metabolism Disorder
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 186 at risk

Adverse event: Vascular Hypertensive Disorders
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 186 at risk

Adverse event: Anxiety Disorders & Symptoms
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 186 at risk

Adverse event: Fungal Infection Disorders
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 186 at risk

Adverse event: Haematology Investigations
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 186 at risk

Adverse event: Joint Disorders
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 186 at risk

Adverse event: Respiratory disorder
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 186 at risk

Adverse event: Male Reproductive Tract Infections & Inflammations
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 186 at risk

Adverse event: Peripheral Neuropathies
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 186 at risk

Adverse event: Plasma Cell Neoplasms
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 186 at risk

Adverse event: Pleural Disorders
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 186 at risk

Adverse event: Poisoning & Toxicity
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 186 at risk

Adverse event: Procedural Related Injuries & Complications
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 186 at risk

Adverse event: Pulmonary Hypertensions
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 186 at risk

Adverse event: Urinary Tract Signs & Symptoms
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 186 at risk

Adverse event: Vascular Haemorrhagic Disorders
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 186 at risk

Adverse event: Viral Infectious Disorders
Serious: yes
Organ System: Infections and infestations
Notes: COVID-19
Frequency: 1 affected / 186 at risk

Adverse event: Fall
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 4 affected / 186 at risk

Adverse event: Mental status changes
Serious: no
Organ System: Psychiatric disorders
Frequency: 4 affected / 186 at risk