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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Consent withdrawn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.