TABLE 3.
Crossover Study AEs
| Placebo, N = 34, n | Varenicline, N = 34, n | |
|---|---|---|
| Serious AEs | 1 | 1 |
| Participants with ≥1 serious AE | 1 | 1 |
| Nonserious AEsa | 18 | 35 |
| Participants with ≥1 nonserious AE | 8 | 17 |
| Nonserious AE severity | ||
| Mild | 15 | 29 |
| Moderate | 3 | 6 |
| Nonserious AE relatedness | ||
| Related | 4 | 16 |
| Unrelated | 14 | 19 |
a
Eight nonserious AEs occurred during washout, 6 in the placebo then varenicline arm and 2 in the varenicline then placebo arm; AEs during washout are categorized to the treatment in period 1 in this table; 1 subject randomized to varenicline then placebo had an unknown date of onset and thus is not included in this table (but their nonserious AE is included in summaries in the text).
AE = adverse event.