Table 1.
Baseline demographics and disease characteristics [18]
| Characteristic | Safety analysis population (N = 314) |
|---|---|
| Age, year, n (%) | 11.4 ± 2.88 (6–19)a |
| 6–12 | 202 (64.3) |
| 13–17a | 112 (35.7) |
| Sex, male, n (%) | 250 (79.6) |
| Weight, kg | 46.13 ± 16.434 (23.0–99.5) |
| Height, cm | 152.29 ± 16.633 (113.5–189.4) |
| BMIb, kg/m2 | 19.22 ± 3.389 (13.0–29.8) |
| BMI categoriesb,c, n (%) | |
| Underweight (< 5th percentile) | 6 (1.9) |
| Normal (≥ 5th to < 85th percentile) | 208 (66.2) |
| Overweight (≥ 85th to < 95th percentile) | 83 (26.4) |
| Obese (≥ 95th percentile) | 17 (5.4) |
| ADHD-RS-IV total score | 41.1 ± 7.03 (17–54)d |
| Any prior ADHD medication, n (%) | 271 (86.3) |
Values are mean ± standard deviation (range) unless otherwise stated
ADHD attention-deficit hyperactivity disorder, ADHD-RS-IV Attention-Deficit/Hyperactivity Disorder Rating Scale IV, BMI body mass index
aFour participants were aged > 17 years at baseline and were included in the 13–17 years age category. These participants were enrolled because, for study eligibility purposes only, age was based on the age at the time of consent for this study, or for the previous lisdexamfetamine dimesylate study if applicable
bCalculated at baseline
cCenters for Disease Control BMI categories for children and adolescents
dOne participant had a score of 17, which was lower than the protocol-specified value of ≥ 28; this was recorded as a protocol deviation/violation