Table 3.
Treatment emergent adverse effects reported by ≥5 % of patients in any treatment group (safety population)a
| TEAE, preferred term, n (%) | LDX (n = 111) | Placebo (n = 110) | OROS-MPH (n = 111) |
|---|---|---|---|
| Any TEAE | 80 (72.1) | 63 (57.3) | 72 (64.9) |
| TEAEs (≥5 % of patients in any treatment group) b | |||
| Decreased appetite | 28 (25.2) | 3 (2.7) | 17 (15.3) |
| Headache | 16 (14.4) | 22 (20.0) | 22 (19.8) |
| Insomnia | 16 (14.4) | 0 | 9 (8.1) |
| Decreased weight | 15 (13.5) | 0 | 5 (4.5) |
| Nausea | 12 (10.8) | 3 (2.7) | 8 (7.2) |
| Anorexia | 12 (10.8) | 2 (1.8) | 6 (5.4) |
| Nasopharyngitis | 8 (7.2) | 8 (7.3) | 14 (12.6) |
| Upper abdominal pain | 8 (7.2) | 6 (5.5) | 9 (8.1) |
| Abdominal pain | 6 (5.4) | 6 (5.5) | 4 (3.6) |
| Sleep disorder | 6 (5.4) | 1 (0.9) | 2 (1.8) |
| Cough | 3 (2.7) | 0 | 8 (7.2) |
| Initial insomnia | 3 (2.7) | 1 (0.9) | 7 (6.3) |
aSafety outcomes have previously been reported in detail [13]
bTEAEs are presented in order of decreasing frequency in the LDX treatment group
LDX lisdexamfetamine dimesylate, OROS-MPH osmotic-release oral system methylphenidate, TEAE treatment-emergent adverse event