Table 2. Adverse Events.
| Adverse Eventa | No. (%) of Participantsb | |||
|---|---|---|---|---|
| Open-Label Varenicline Phase | Maintenance Treatment Phase | |||
| Before Quite Date, wk 1-4 (n = 188) |
After Quit Date, wk 5-12 (n = 158) |
Placebo n = 47) |
Varenicline (n = 40) |
|
| Nausea | 84 (45) | 40 (25) | 10 (22) | 15 (38) |
| Anxiety | 55 (29) | 47 (30) | 12 (26) | 11 (28) |
| Irritability | 54 (29) | 43 (27) | 13 (28) | 7 (18) |
| Headache | 49 (26) | 48 (30) | 11 (24) | 17 (44)c |
| Agitation | 49 (26) | 51 (32) | 17 (37) | 5 (13)c |
| Excitement | 45 (24) | 45 (28) | 17 (37) | 7 (18)c |
| Insomnia | 45 (24) | 43 (27) | 11 (24) | 11 (28) |
| Vomiting | 40 (21) | 36 (23) | 6 (13) | 10 (26) |
| Tachycardia | 21 (11) | 22 (13) | 12 (26) | 7 (18) |
| Abnormal dreams | 21 (11) | 3 (2) | 2 (4) | 1 (3) |
| Suicidal ideationd | 1 (<1) | 5 (4) | 2 (5) | 2 (6) |
a
Adverse events that occurred in 10% of more of the participants at any time point, with additional inclusion of suicidal ideation.
b
Numbers are presented as the total number of participants providing data in at least 1 study visit in that period.
c
P < .05 Fisher exact test.
d
A rating of 2 or higher in item 8 of the Calgary Depression Scale for Schizophrenia suicide rating indicates active suicidal ideation (there were no ratings higher than 2 and no suicide attempts).