Table 3 Common TEAEs with frequency ≥5% in the LDX (all doses) group and greater than placebo
Preferred terminology (MedDRA 9.1) | Participants, n (%) | |||
|---|---|---|---|---|
Prior AMPH subgroup | Overall safety population | |||
Placebo n = 2 | LDX (All Doses) | Placebo n = 62 | LDX (All Doses) | |
n = 39 | n = 358 | |||
All TEAEs | 2 (100) | 22 (56.4) | 36 (58.1) | 282 (78.8) |
Anorexia | 0 | 0 | 0 | 18 (5.0) |
Anxiety | 0 | 1 (2.6) | 0 | 21 (5.9) |
Decreased appetite | 0 | 2 (5.1) | 1 (1.6) | 95 (26.5) |
Diarrhea | 0 | 0 | 0 | 24 (6.7) |
Dry mouth | 0 | 5 (12.8) | 2 (3.2) | 92 (25.7) |
Fatigue | 0 | 3 (7.7) | 3 (4.8) | 17 (4.7) |
Headache | 0 | 5 (12.8) | 8 (12.9) | 74 (20.7) |
Initial insomnia | 0 | 1 (2.6) | 2 (3.2) | 18 (5.0) |
Insomnia | 0 | 3 (7.7) | 3 (4.8) | 69 (19.3) |
Irritability | 0 | 1 (2.6) | 4 (6.5) | 22 (6.1) |
Nausea | 0 | 2 (5.1) | 0 | 25 (7.0) |
Upper respiratory tract infection | 0 | 1 (2.6) | 3 (4.8) | 20 (5.6) |