Table 1.
Subject Demographics (Safety Population) and Disposition
| Subject Category | LDX Optimal Dose | ||||
| 30 mg/d | 50 mg/d | 70 mg/d | All Doses | ||
| Safety population | 58 (100.0) | 50 (100.0) | 21 (100.0) | 129 (100.0) | |
| Age (years) | Mean (SD) | 9.8 (1.5) | 10.2 (1.3) | 10.4 (1.9) | 10.1 (1.5) |
| Gender | |||||
| Male | n (%) | 44 (75.9) | 37 (74.0) | 17 (81.0) | 98 (76.0) |
| Female | 14 (24.1) | 13 (26.0) | 4 (19.0) | 31 (24.0) | |
| Race | |||||
| Caucasian | 38 (65.5) | 37 (74.0) | 16 (76.2) | 91 (70.5) | |
| Black or African American | 11 (19.0) | 4 (8.0) | 2 (9.5) | 17 (13.2) | |
| Native Hawaiian or Other Pacific Islander | n (%) | 0 | 1 (2.0) | 0 | 1 (0.8) |
| Asian | 0 | 0 | 0 | 0 | |
| American Indian or Alaska Native | 2 (3.4) | 0 | 0 | 2 (1.6) | |
| Other | 7 (12.1) | 8 (16.0) | 3 (14.3) | 18 (14.0) | |
| Ethnicity | |||||
| Hispanic or Latino | n (%) | 9 (15.5) | 11 (22.0) | 6 (28.6) | 26 (20.2) |
| Not Hispanic or Latino | 49 (84.5) | 39 (78.0) | 15 (71.4) | 103 (79.8) | |
| ADHD-RS-IV Total Score at Baseline | Mean (SD) | 40.5 (6.7) | 43.4 (7.5) | 45.7 (5.7) | 42.4 (7.1) |
| Randomized population | 46 (79.3) | 50 (100.0) | 21 (100.0) | 117 (90.7) | |
| Intent-to-treat population | 46 (79.3) | 47 (94.0) | 20 (95.2) | 113 (87.6) | |
| Completed study | 44 (75.9) | 47 (94.0) | 20 (95.2) | 111 (86.0) | |
| Reason for discontinuation* | |||||
| Adverse event† | 8 (13.8) | 1 (2.0) | 0 | 9 (7.0) | |
| Protocol violation | 1 (1.7) | 1 (2.0) | 0 | 2 (1.6) | |
| Consent withdrawn | 3 (5.2) | 1 (2.0) | 1 (4.8) | 5 (3.9) | |
| Lost to follow-up | 2 (3.4) | 0 | 0 | 2 (1.6) | |
| Lack of efficacy | 0 | 0 | 0 | 0 | |
| Other | 0 | 0 | 0 | 0 | |
LDX: lisdexamfetamine dimesylate; ADHD-RS-IV: Attention-Deficit/Hyperactivity Disorder Rating Scale IV
*Includes all subjects who discontinued during dose-optimization and crossover periods based on optimized dose.
†All AEs leading to discontinuation occurred during dose optimization. Eight discontinuations occurred before randomization. These subjects were taking 30 mg/d LDX when the discontinuation-related AE occurred. One discontinuation occurred after randomization. This subject was taking 50 mg/d LDX when he experienced acute gastritis, causing him to miss the visit 4 practice day.