|
AE
Preferred Term, % (n)
|
Crossover Phase
(Randomized Population)
|
|---|
| |
LDX-All Doses
(n = 115)
a
|
Placebo
(n = 117)
a
|
|
Any TEAE
|
27.8 (32)
|
35.9 (42)
|
|
Anxiety
|
1.7 (2)
|
0
|
|
Decreased appetite
|
3.5 (4)
|
1.7 (2)
|
|
Dry mouth
|
3.5 (4)
|
0.9 (1)
|
|
Fatigue
|
0.9 (1)
|
12.0 (14)
|
|
Feeling jittery
|
0
|
0
|
|
Headache
|
1.7 (2)
|
2.6 (3)
|
|
Insomnia
|
2.6 (3)
|
1.7 (2)
|
|
Irritability
|
0
|
0.9 (1)
|
|
Nausea
|
1.7 (2)
|
0
|
|
Upper respiratory tract infection
|
1.7 (2)
|
7.7 (9)
|
- TEAEs were assigned to either the open-label dose-optimization phase or the double-blind crossover phase of the study and were summarized separately. TEAEs that continued uninterrupted from the dose-optimization to the crossover phase without a change in severity were counted only in the dose-optimization phase category. TEAEs with a change in severity across phases or that resolved and then restarted in the crossover phase were counted both in the dose-optimization and crossover arms. TEAEs for which a missing or incomplete start date made it impossible to determine in which phase of the study they started were counted as starting in the dose-optimization phase.
- aPercentages are based on the number of subjects who received each dose at any point during the crossover phase.
- AE = adverse event; LDX = lisdexamfetamine dimesylate, TEAE = treatment-emergent adverse event.
