Table 4 Pre-specified adverse events

Cardiac and Pericardial

• Acute coronary syndrome

• Aortic valve disease

• Atrial fibrillation

• Atrial flutter

• Atrioventricular block

• Conduction disorder

• Constrictive pericarditis

• Heart failure

• Left ventricular systolic dysfunction

• Myocarditis

• Pericardial effusion

• Pericardial tamponade

• Pericarditis

• Cardiomyopathy

• Cardiac disorders-others

Gastrointestinal

• Dyspepsia

• Dysphagia

• Esophageal fistula

• Esophageal hemorrhage

• Esophageal necrosis

• Esophageal obstruction

• Esophageal stenosis

• Esophageal perforation

• Esophagitis

Pulmonary/mediastinal

• Atelectasis

• Bronchial fistula

• Bronchial obstruction

• Bronchopleural fistula

• Bronchopulmonary hemorrhage

• Dyspnea

• ILD or IPF exacerbation

• Pneumonitis

• Tracheal/Pulmonary fistula

• Tracheal stenosis

• Mediastinal hemorrhage

• Pulmonary disorders-others