Table 5.
Summary of AEs from the clinical trials
| AE | Phase 2 trial | Phase 3 trial | ||
|---|---|---|---|---|
| Dextromethorphan-bupropion (n = 48) |
Bupropion (n = 48) |
Dextromethorphan-bupropion (n = 162) | Placebo (n = 164) | |
| Any AE | 35 (72.9) | 31 (64.6) | 100 (61.7) | 74 (45.1) |
| Serious AEa | 0 | 0 | 1 (0.6) | 0 |
| Severe AEb | 3 (6.3) | 1 (2.1) | 1 (0.6) | 2 (1.2) |
| AE leading to discontinuation | 6 (12.5) | 6 (12.5) | 10 (6.2) | 1 (0.6) |
| Dizziness | 10 (20.8) | 2 (4.2) | 26 (16.0) | 10 (6.1) |
| Nausea | 8 (16.7) | 6 (12.5) | 21 (13.0) | 14 (8.5) |
| Headache | NR | NR | 13 (8.0) | 6 (3.7) |
| Diarrhea | NR | NR | 11 (6.8) | 5 (3.0) |
| Somnolence | 1 (2.1) | NR | 11 (6.8) | 5 (3.0) |
| Dry mouth | 5 (10.4) | 4 (8.3) | 9 (5.6) | 4 (2.4) |
| Anxiety | 5 (10.4) | 1 (2.1) | 7 (4.3) | 2 (1.2) |
| Decreased appetite | 5 (10.4) | 4 (8.3) | 6 (3.7) | 1 (0.6) |
| Change in body weight at week 6 (kg) | −0.6 ± 2.4 | 0.1 ± 2.1 | −0.2 ± 7.8 | 0.4 ± 2.3 |
Values are presented as number (%) or mean ± standard deviation.
AE, adverse event; NR, not reported.
aAny AE that results in death, was life threatening, led to hospitalization or prolongation of hospitalization, or caused significant disability or incapacity. bA severe AE that interrupted usual daily activities, significantly affected clinical status, or requires intensive therapeutic intervention.