TABLE 3.
Adverse Events by Preferred Term
| Low-dependence Stratum (2 mg) | High-dependence Stratum (4 mg) | |||
| AE, n % | Nicotine (n = 241) | 2 mg Placebo (n = 242) | Nicotine (n = 119) | 4 mg Placebo (n = 118) |
| Any AE | 111 (46.1) | 91 (37.6) | 61 (51.3) | 58 (49.2) |
| URTI | 27 (11.2) | 19 (7.9) | 17 (14.3) | 11 (9.3) |
| Nasopharyngitis | 16 (6.6) | 14 (5.8) | 13 (10.9) | 5 (4.2) |
| Nausea | 15 (6.2) | 10 (4.1) | 7 (5.9) | 8 (6.8) |
| Diarrhea | 9 (3.7) | 9 (3.7) | 2 (1.7) | 2 (1.7) |
| Abdominal distension | 6 (2.5) | 2 (0.8) | 1 (0.8) | 3 (2.5) |
| Oropharyngeal discomfort | 7 (2.9) | 0 | 0 | 0 |
| Vomiting | 5 (2.1) | 0 | 0 | 1 (0.9) |
| Dizziness | 10 (4.2) | 0 | 3 (2.5) | 4 (3.4) |
| Palpitations | 5 (2.1) | 1 (0.4) | 3 (2.5) | 2 (1.7) |
| Hypertension | 5 (2.1) | 0 | 0 | 2 (1.7) |
| Somnolence | 0 | 0 | 3 (2.5) | 0 |
| Insomnia | 1 (0.4) | 0 | 3 (2.5) | 2 (1.7) |
| Dyspnea | 1 (0.4) | 2 (0.8) | 6 (5.0) | 2 (1.7) |
AE, adverse event; URTI, upper respiratory tract infection.