Table 6.
Emergent adverse events by study and for the merged safety population
| CONFIDENCE II (N = 1332) |
PROTECT I (N = 1069) |
STH I (N = 709) |
STH II (N = 431) |
Merged safety (N = 3541) |
|
|---|---|---|---|---|---|
| Total number of EAEs reported | 147 | 106 | 73 | 62 | 388 |
| No. of patients reporting at least one EAE, n (%) | 99 (7.4) | 83 (7.8) | 58 (8.2) | 42 (9.7) | 282 (8.0) |
| No. of patients reporting most common EAE (PT), n (%) | |||||
| Cough | 65 (4.9) | 46 (4.3) | 35 (4.9) | 12 (2.8) | 158 (4.5) |
| Dizziness | 6 (0.5) | 10 (0.9) | 3 (0.4) | 10 (2.3) | 29 (0.8) |
| Fatigue | 7 (0.5) | 3 (0.3) | 3 (0.4) | 1 (0.2) | 14 (0.4) |
| Headache | 8 (0.6) | 14 (1.3) | 7 (1.0) | 2 (0.5) | 31 (0.9) |
| Nausea | 4 (0.3) | 2 (0.2) | 1 (0.1) | 4 (0.9) | 11 (0.3) |
EAE emergent adverse event PT Preferred term, STH Shake the Habit