Study: NCT03229538

Adverse event: Cardiac dysfunction
Serious: yes
Organ System: Cardiac disorders
Notes: Study drug-related.
Frequency: 1 affected / 599 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Vascular disorders
Notes: Study drug-related.
Frequency: 1 affected / 599 at risk

Adverse event: Enterovirus infection
Serious: yes
Organ System: Infections and infestations
Notes: Study drug-related.
Frequency: 1 affected / 599 at risk

Adverse event: Rhinovirus infection
Serious: yes
Organ System: Infections and infestations
Notes: Study drug-related.
Frequency: 1 affected / 599 at risk

Adverse event: Arrhythmia
Serious: no
Organ System: Cardiac disorders
Frequency: 155 affected / 599 at risk

Adverse event: Cardiac dysfunction
Serious: no
Organ System: Cardiac disorders
Frequency: 133 affected / 599 at risk

Adverse event: Cardiac arrest
Serious: no
Organ System: Cardiac disorders
Frequency: 31 affected / 599 at risk

Adverse event: Pericardial effusion
Serious: no
Organ System: Cardiac disorders
Frequency: 14 affected / 599 at risk

Adverse event: Cardiac ventricular thrombosis
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 599 at risk

Adverse event: Postoperative thoracic procedure complication
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 125 affected / 599 at risk

Adverse event: Procedural complication
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 41 affected / 599 at risk

Adverse event: Wound dehiscence
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 11 affected / 599 at risk

Adverse event: Subdural haemorrhage
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 4 affected / 599 at risk

Adverse event: Anaesthetic complication
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 599 at risk

Adverse event: Respiratory failure
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 74 affected / 599 at risk

Adverse event: Chylothorax
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 36 affected / 599 at risk

Adverse event: Laryngeal dyskinesia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 27 affected / 599 at risk

Adverse event: Pleural effusion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 14 affected / 599 at risk

Adverse event: Pulmonary hypertension
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 15 affected / 599 at risk

Adverse event: Diaphragmatic paralysis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 10 affected / 599 at risk

Adverse event: Pneumothorax
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 7 affected / 599 at risk

Adverse event: Pulmonary hypertensive crisis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 599 at risk

Adverse event: Cardiac operation
Serious: no
Organ System: Surgical and medical procedures
Frequency: 30 affected / 599 at risk

Adverse event: Ventricular assist device insertion
Serious: no
Organ System: Surgical and medical procedures
Frequency: 31 affected / 599 at risk

Adverse event: Hospitalisation
Serious: no
Organ System: Surgical and medical procedures
Frequency: 19 affected / 599 at risk

Adverse event: Cardiac pacemaker insertion
Serious: no
Organ System: Surgical and medical procedures
Frequency: 7 affected / 599 at risk

Adverse event: Wound infection
Serious: no
Organ System: Infections and infestations
Frequency: 14 affected / 599 at risk

Adverse event: Sepsis
Serious: no
Organ System: Infections and infestations
Frequency: 22 affected / 599 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 599 at risk

Adverse event: Mediastinitis
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 599 at risk

Adverse event: Venous occlusion
Serious: no
Organ System: Vascular disorders
Frequency: 12 affected / 599 at risk

Adverse event: Haemorrhage
Serious: no
Organ System: Vascular disorders
Frequency: 7 affected / 599 at risk

Adverse event: Deep vein thrombsis
Serious: no
Organ System: Vascular disorders
Frequency: 7 affected / 599 at risk

Adverse event: Catheterisation cardiac
Serious: no
Organ System: Investigations
Frequency: 22 affected / 599 at risk

Adverse event: Seizure
Serious: no
Organ System: Nervous system disorders
Frequency: 11 affected / 599 at risk

Adverse event: Cerebrovascular accident
Serious: no
Organ System: Nervous system disorders
Frequency: 10 affected / 599 at risk

Adverse event: Nervous system disorder
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 599 at risk

Adverse event: Intraventricular haemorrhage
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 599 at risk

Adverse event: Multiple organ dysfunction syndrome
Serious: no
Organ System: General disorders
Frequency: 3 affected / 599 at risk

Adverse event: Acute kidney injury
Serious: no
Organ System: Renal and urinary disorders
Frequency: 4 affected / 599 at risk

Adverse event: Arrhythmia
Serious: no
Organ System: Cardiac disorders
Frequency: 176 affected / 601 at risk

Adverse event: Cardiac dysfunction
Serious: no
Organ System: Cardiac disorders
Frequency: 135 affected / 601 at risk

Adverse event: Cardiac arrest
Serious: no
Organ System: Cardiac disorders
Frequency: 37 affected / 601 at risk

Adverse event: Pericardial effusion
Serious: no
Organ System: Cardiac disorders
Frequency: 21 affected / 601 at risk

Adverse event: Cardiac ventricular thrombosis
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 601 at risk

Adverse event: Postoperative thoracic procedure complication
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 135 affected / 601 at risk

Adverse event: Procedural complication
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 42 affected / 601 at risk

Adverse event: Wound dehiscence
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 9 affected / 601 at risk

Adverse event: Subdural haemorrhage
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 601 at risk

Adverse event: Anaesthetic complication
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 601 at risk

Adverse event: Respiratory failure
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 83 affected / 601 at risk

Adverse event: Chylothorax
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 37 affected / 601 at risk

Adverse event: Laryngeal dyskinesia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 35 affected / 601 at risk

Adverse event: Pleural effusion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 27 affected / 601 at risk

Adverse event: Pulmonary hypertension
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 19 affected / 601 at risk

Adverse event: Diaphragmatic paralysis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 9 affected / 601 at risk

Adverse event: Pneumothorax
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 7 affected / 601 at risk

Adverse event: Pulmonary hypertensive crisis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 601 at risk

Adverse event: Pulmonary thrombosis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 601 at risk

Adverse event: Cardiac operation
Serious: no
Organ System: Surgical and medical procedures
Frequency: 35 affected / 601 at risk

Adverse event: Ventricular assist device insertion
Serious: no
Organ System: Surgical and medical procedures
Frequency: 25 affected / 601 at risk

Adverse event: Hospitalisation
Serious: no
Organ System: Surgical and medical procedures
Frequency: 27 affected / 601 at risk

Adverse event: Cardiac pacemaker insertion
Serious: no
Organ System: Surgical and medical procedures
Frequency: 8 affected / 601 at risk

Adverse event: Wound infection
Serious: no
Organ System: Infections and infestations
Frequency: 21 affected / 601 at risk

Adverse event: Sepsis
Serious: no
Organ System: Infections and infestations
Frequency: 11 affected / 601 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Infections and infestations
Frequency: 11 affected / 601 at risk

Adverse event: Mediastinitis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 601 at risk

Adverse event: Venous occlusion
Serious: no
Organ System: Vascular disorders
Frequency: 19 affected / 601 at risk

Adverse event: Haemorrhage
Serious: no
Organ System: Vascular disorders
Frequency: 21 affected / 601 at risk

Adverse event: Deep vein thrombsis
Serious: no
Organ System: Vascular disorders
Frequency: 14 affected / 601 at risk

Adverse event: Catheterisation cardiac
Serious: no
Organ System: Investigations
Frequency: 33 affected / 601 at risk

Adverse event: Seizure
Serious: no
Organ System: Nervous system disorders
Frequency: 13 affected / 601 at risk

Adverse event: Cerebrovascular accident
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 601 at risk

Adverse event: Nervous system disorder
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 601 at risk

Adverse event: Intraventricular haemorrhage
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 601 at risk

Adverse event: Multiple organ dysfunction syndrome
Serious: no
Organ System: General disorders
Frequency: 6 affected / 601 at risk

Adverse event: Acute kidney injury
Serious: no
Organ System: Renal and urinary disorders
Frequency: 4 affected / 601 at risk