Table 2.
Treatment-Emergent AEs*
| Varenicline (n=353), n (%) |
Placebo (n=350), n (%) |
Difference Between Groups, % |
95% CI for Difference |
|
|---|---|---|---|---|
| Total AEs† | 949 | 656 | ||
| Participants with ≥1 AE | 288 (81.6) | 227 (64.9) | 16.7 | 10.3–23.2 |
| Participants who stopped drug because of AE | 34 (9.6) | 15 (4.3) | 5.3 | 1.6–9.1 |
| Participants with ≥1 serious AE | 23 (6.5) | 21 (6.0) | 0.5 | −3.1–4.1 |
| Deaths (all causes) | 2 (0.6) | 5 (1.4) | −0.8 | −2.3–0.6 |
| Most common AEs‡ | ||||
| Nausea | 104 (29.5) | 30 (8.6) | 20.9 | 15.3–26.5 |
| Headache | 45 (12.7) | 39 (11.1) | 1.6 | −3.2–6.4 |
| Insomnia | 42 (11.9) | 23 (6.6) | 5.3 | 1.1–9.6 |
| Vomiting | 29 (8.2) | 4 (1.1) | 7.1 | 4.0–10.1 |
| Abnormal dreams | 28 (7.9) | 6 (1.7) | 6.2 | 3.1–9.4 |
| Fatigue | 25 (7.1) | 14 (4.0) | 3.1 | −0.3–6.5 |
| Nasopharyngitis | 23 (6.5) | 30 (8.6) | −2.1 | −6.0–1.8 |
| Constipation | 23 (6.5) | 7 (2.0) | 4.5 | 1.6–7.5 |
| Diarrhea | 22 (6.2) | 18 (5.1) | 1.1 | −2.3–4.5 |
| Dizziness | 22 (6.2) | 16 (4.6) | 1.7 | −1.7–5.0 |
| Dyspepsia | 19 (5.4) | 12 (3.4) | 2.0 | −1.1–5.0 |
| Psychiatric AEs§ | ||||
| Sleep disorders or disturbances (abnormal dreams, insomnia, nightmare, sleep disorder) | 78 (22.1) | 34 (9.7) | 12.4 | 7.1–17.7 |
| Anxiety disorders or symptoms (anxiety, generalized anxiety disorder, neurosis, phobia, stress) | 12 (3.4) | 16 (4.6) | −1.2 | −4.1–1.7 |
| Depressed mood disorders or disturbances (depression, depressed mood, depressive symptom, dysthymia) | 11 (3.1) | 8 (2.3) | 0.8 | −1.6–3.2 |
| Bipolar disorder | 1 (0.3) | 0 (0) | 0.3 | −0.4–1.0 |
| Other mood disorders or disturbances (apathy, listlessness, dysphoria, mood alteration, mood swings, emotional disorder) | 9 (2.5) | 3 (0.9) | 1.7 | −0.2–3.6 |
| Suicidal and self-injurious behaviors | 0 (0) | 0 (0) | … | … |
| Change in physical activity (restlessness) | 3 (0.8) | 3 (0.9) | −0.01 | −1.4–1.4 |
| Sexual dysfunction (decreased libido) | 2 (0.6) | 1 (0.3) | 0.3 | −0.7–1.2 |
| Delirium (confusion) | 1 (0.3) | 0 (0) | 0.3 | −0.4–1.0 |
| Disturbances in behavior (aggression) | 0 (0) | 1 (0.3) | −0.3 | −1.0–0.4 |
| Cognitive and attention disorders | 0 | 0 | … | … |
| Dissociative disorders | 0 | 0 | … | … |
| Disturbances in thinking and perception | 0 | 0 | … | … |
*
AEs that began or increased in severity during treatment or up to 30 days after the last administration of the investigational product. SAEs that occurred at any time are reported. Except for the number of AEs, participants are counted only once per treatment in each row.
†
Multiple AEs of the same type in an individual participant were counted only once.
‡
Occurring in ≥5% of participants in either group.
§
Includes all AEs reported in the MedDRA System Organ Class of Psychiatric Disorders. Each row represents a higher-level group term, which is a combination of individual symptom terms. Symptoms actually reported are in parentheses.