Table 2.
Total reported, n (%) | Severe or intolerable, n (%) | |
---|---|---|
Any AEs | 28 (78) | 12 (33) |
Nausea | 12 (33) | 2 (6) |
Abnormal dreams | 11 (31) | 2 (6) |
Affect labilitya | 7 (19) | 3 (8) |
Insomnia | 7 (19) | 2 (6) |
Headache | 5 (14) | 2 (6) |
Gastroesophageal reflux disease | 4 (11) | 2 (6) |
Abdominal pain | 4 (11) | 1 (3) |
Nightmares | 3 (8) | 2 (6) |
Sleep disorder | 3 (8) | 1 (3) |
Weight gain | 3 (8) | 1 (3) |
Vomiting | 3 (8) | 0 |
Constipation | 3 (8) | 0 |
Taste perversion | 3 (8) | 0 |
Fatigue | 3 (8) | 0 |
Depressed mood | 2 (6) | 1 (3) |
Smell perversion | 2 (6) | 1 (3) |
Gas | 2 (6) | 0 |
Sweat | 2 (6) | 0 |
Increased appetite | 1 (3) | 1 (3) |
Dry mouth | 1 (3) | 0 |
Dizziness | 1 (3) | 0 |
Hot flush | 1 (3) | 0 |
Muscle pain | 1 (3) | 0 |
Affect lability, included irritability, mood swing, agitation, and anger.
AEs, adverse events.