Table 2.

List of MedDRA preferred terms (other than bronchospasm and bronchospasm paradoxical) that could possibly indicate ARB

○ Asthma ○ Bronchial hyperactivity ○ Bronchial obstruction ○ Bronchial edema ○ Chest discomfort ○ Chest pain ○ Cough ○ COPD ○ COPD exacerbated ○ Dyspnea ○ Dyspnea at rest ○ Dyspnea exacerbated ○ Dyspnea exertional ○ Hyperventilation ○ Increased bronchial secretion ○ Increased viscosity of bronchial secretion ○ Intercostal retraction ○ Obstructive airways disorder ○ Obstructive chronic bronchitis with acute exacerbation ○ Productive cough ○ Pulmonary congestion ○ Respiration abnormal ○ Respiratory tract congestion ○ Reversible airways obstruction ○ Status asthmaticus ○ Suffocation feeling ○ Tachypnea ○ Wheezing

Abbreviations: ARB, administration-related bronchoconstriction; COPD, chronic obstructive pulmonary disease; MedDRA, Medical Dictionary for Regulatory Activities.