Table V.
Number (%) of patients experiencing ≥1 adverse event (AE), by treatment group.∗
| AE | Phen (n = 188) | Phen-Fen (n = 258) |
|---|---|---|
| CNS | ||
| Insomnia | 18 (9.6) | 52 (20.2)† |
| Depression | 7 (3.7) | 4 (1.6) |
| Anxiety | 6 (3.2) | 12 (4.7) |
| Dizziness | 6 (3.2) | 11 (4.3) |
| Headache | 4 (2.1) | 15 (5.8) |
| Cardiovascular | ||
| Palpitations | 1 (0.5) | 5 (1.9) |
| Tachycardia | 1 (0.5)‡ | 4 (1.6) |
| Other | ||
| Dry mouth | 38 (20.2) | 98 (38.0)§ |
| Constipation | 22 (11.7) | 58 (22.5)‖ |
| Fatigue | 15 (8.0) | 23 (8.9) |
| Urticaria | 3 (1.6) | 2 (0.8) |
| Unpleasant taste | 2 (1.1) | 0 (0.0) |
| Tremor | 2 (1.1) | 5 (1.9) |
| Blurred vision | 0 (0.0) | 1 (0.4) |
| Abdominal pain | 0 (0.0) | 1 (0.4) |
Phen = phentermine; Phen-Fen = phentermine-fenfluramine; CNS = central nervous system.
∗
All AEs were mild or moderate.
†
P=0.002 versus Phen group.
‡
This patient withdrew due to this AE.
§
P<0.001 versus Phen group.
∥
P<0.004 versus Phen group.