Skip to main content

Table 1 Subject Demographics (Safety Population) and Disposition

From: A 13-hour laboratory school study of lisdexamfetamine dimesylate in school-aged children with attention-deficit/hyperactivity disorder

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Consent withdrawn   3 (5.2) 1 (2.0) 1 (4.8) 5 (3.9)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
  1. LDX: lisdexamfetamine dimesylate; ADHD-RS-IV: Attention-Deficit/Hyperactivity Disorder Rating Scale IV
  2. *Includes all subjects who discontinued during dose-optimization and crossover periods based on optimized dose.
  3. 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.