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) |