Table 3.
Summary of Changes in Vital Signs, Body Weight, and Body Mass Index, Safety Analysis Set
| Change from baselinea at week 52/ET, mean ± SD | Optimized LDX dose |
Total (N = 113) | ||||
|---|---|---|---|---|---|---|
| 5 mg (n = 1) | 10 mg (n = 12) | 15 mg (n = 21) | 20 mg (n = 26) | 30 mg (n = 53) | ||
| Pulse,b bpm | −11.97 (—) | 6.52 ± 12.271 | 0.43 ± 12.274 | 5.33 ± 10.840 | 5.87 ± 10.033 | 4.67 ± 11.000 |
| SBP,b mmHg | 9.63 (—) | 0.99 ± 7.381 | 3.47 ± 10.692 | 3.62 ± 5.950 | 0.58 ± 7.206 | 1.92 ± 7.729 |
| DBP,b mmHg | 7.70 (—) | 5.03 ± 7.161 | 4.25 ± 8.239 | 4.13 ± 6.021 | 1.64 ± 8.082 | 3.10 ± 7.581 |
| Weight,b kg | 1.90 (—) | 1.47 ± 1.535 | 0.75 ± 1.169 | 0.47 ± 1.017 | 0.30 ± 1.507 | 0.56 ± 1.383 |
| BMI percentileb,c | −9.92 (—) | −13.88 ± 12.594 | −16.41 ± 17.249 | −20.98 ± 19.104 | −19.64 ± 23.250 | −18.65 ± 20.166 |
Baseline is defined as the baseline value from the antecedent study (phase 2 study [NCT02402166]; phase 3 study [NCT03260205]) for antecedent participants or the last observation before the first dose of investigational product for directly enrolled participants.
n = 11 (10 mg), n = 18 (15 mg), n = 23 (20 mg), n = 48 (30 mg), n = 101 (total).
Percentiles were derived using the Centers for Disease Control and Prevention growth charts for children and adolescents.
BMI, body mass index; DBP, diastolic blood pressure; LDX, lisdexamfetamine dimesylate; SBP, systolic blood pressure; SD, standard deviation; week 52/ET, data from protocol-defined last treatment study visit or early termination visit.