Table 1.
Baseline demographics and disease characteristics (safety population)
| Characteristic | Safety population (N = 314) |
|---|---|
| Demographics | |
| Age, years | 11.4 ± 2.88 (6–19)a |
| 6–12 | 202 (64.3) |
| 13–17a | 112 (35.7) |
| Sex, male | 250 (79.6) |
| Race, White | 310 (98.7) |
| Body mass index, kg/m2b | 19.22 ± 3.389 (13.0–29.8) |
| Participants who received at least one previous ADHD medication | 271 (86.3) |
| Disease characteristics | |
| ADHD subtype | |
| Combined | 251 (79.9) |
| Predominantly inattentive | 56 (17.8) |
| Predominantly hyperactive-impulsive | 7 (2.2) |
| ADHD-RS-IV total score | 41.1 ± 7.03 (17–54)c |
| Inattention subscale score | 22.1 ± 3.52 (11–27) |
| Hyperactivity/impulsivity subscale score | 19.0 ± 5.86 (2–27) |
Data are presented as n (%) or mean ± SD (range)
ADHD attention-deficit/hyperactivity disorder, ADHD-RS-IV ADHD Rating Scale IV, LDX lisdexamfetamine dimesylate, SD standard deviation
aFour participants were aged >17 years at baseline and were included in the age category 13–17 years. These participants were enrolled because, for study eligibility purposes only, age was based on age at the time of consent for this study or for the previous LDX study if applicable
bCalculated at screening
cOne participant had a score of 17, which was lower than the protocol-specified value of ≥ 28; this was recorded as a protocol deviation/violation