Table A10.
Pulmonary related adverse events in Study 2.
| Adverse Event | Placebo (n = 48) |
OnabotA 240 U (n = 53) |
OnabotA 360 U (n = 54) |
|---|---|---|---|
| Overall | 9 (18.8%) | 14 (26.4%) | 15 (27.8%) |
| Upper respiratory tract infection | 3 (6.3%) | 4 (7.5%) | 6 (11.1%) |
| Nasal congestion | 0 (0.0%) | 2 (3.8%) | 2 (3.7%) |
| Nasopharyngitis | 1 (2.1%) | 1 (1.9%) | 2 (3.7%) |
| Cough | 2 (4.2%) | 3 (5.7%) | 0 (0.0%) |
| COPD | 1 (2.1%) | 1 (1.9%) | 1 (1.9%) |
| Rhinitis | 0 (0.0%) | 2 (3.8%) | 0 (0.0%) |
| Bronchitis | 1 (2.1%) | 0 (0.0%) | 1 (1.9%) |
| Vital capacity decreased | 1 (2.1%) | 0 (0.0%) | 1 (1.9%) |
| Rhinorrhea | 1 (2.1%) | 1 (1.9%) | 0 (0.0%) |
| Forced expiratory volume decreased | 2 (4.2%) | 0 (0.0%) | 0 (0.0%) |
| Chest pain | 0 (0.0%) | 0 (0.0%) | 1 (1.9%) |
| Dyspnea | 0 (0.0%) | 0 (0.0%) | 1 (1.9%) |
| Asthma | 0 (0.0%) | 1 (1.9%) | 0 (0.0%) |
| Oropharyngeal pain | 0 (0.0%) | 1 (1.9%) | 0 (0.0%) |
| Pneumonia | 0 (0.0%) | 1 (1.9%) | 0 (0.0%) |
| Productive cough | 0 (0.0%) | 1 (1.9%) | 0 (0.0%) |
| Sinus congestion | 0 (0.0%) | 1 (1.9%) | 0 (0.0%) |
| Epistaxis | 1 (2.1%) | 0 (0.0%) | 0 (0.0%) |
| Sleep apnea syndrome | 1 (2.1%) | 0 (0.0%) | 0 (0.0%) |
COPD = chronic obstructive pulmonary disease.