| Placebo | TS-141 30 mg | TS-141 60 mg | TS-141 120 mg | Total | P-value | |||||
---|---|---|---|---|---|---|---|---|---|---|---|
n = 52 | n = 54 | n = 52 | n = 53 | n = 211 | |||||||
Gender, n (%) | |||||||||||
 Male | 44 | (84.6) | 47 | (87.0) | 46 | (88.5) | 42 | (79.2) | 179 | (84.8) | p(a) = 0.567 |
 Female | 8 | (15.4) | 7 | (13.0) | 6 | (11.5) | 11 | (20.8) | 32 | (15.2) | |
Age, years | |||||||||||
 Mean ± SD | 9.6 ± 2.1 | 9.8 ± 2.3 | 9.2 ± 2.2 | 9.7 ± 2.5 | 9.5 ± 2.3 | p(b) = 0.493 | |||||
 Median | 9.0 | 10.0 | 9.0 | 10.0 | 9.0 |  | |||||
 Min - Max | 6–14 | 6–16 | 6–16 | 6–16 | 6–16 |  | |||||
Intelligence Quotient | |||||||||||
 Mean ± SD | 96.5 ± 14.5 | 96.6 ± 15.0 | 93.7 ± 12.6 | 94.4 ± 11.7 | 95.3 ± 13.5 | p(b) = 0.662 | |||||
 Median | 95.5 | 94.0 | 92.0 | 93.0 | 93.0 |  | |||||
 Min - Max | 71–142 | 72–145 | 73–137 | 76–126 | 71–145 |  | |||||
ADHD Subtype, n (%) | |||||||||||
 Combined | 31 | (59.6) | 28 | (51.9) | 34 | (65.4) | 30 | (56.6) | 123 | (58.3) | p(a) = 0.538 |
 Inattentive | 21 | (40.4) | 26 | (48.1) | 18 | (34.6) | 22 | (41.5) | 87 | (41.2) | |
 Hyperactive-impulsive |  |  |  |  |  |  | 1 | (1.9) | 1 | (0.5) | |
Complication: ASD, n (%) | |||||||||||
 Absence | 40 | (76.9) | 45 | (83.3) | 37 | (71.2) | 41 | (77.4) | 163 | (77.3) | p(a) = 0.524 |
 Presence | 12 | (23.1) | 9 | (16.7) | 15 | (28.8) | 12 | (22.6) | 48 | (22.7) | |
Prior medication, n (%) | |||||||||||
 Absence | 20 | (38.5) | 27 | (50.0) | 27 | (51.9) | 31 | (58.5) | 105 | (49.8) | p(a) = 0.224 |
 Presence | 32 | (61.5) | 27 | (50.0) | 25 | (48.1) | 22 | (41.5) | 106 | (50.2) | |
ADHD RS-IV-J: investigator | |||||||||||
 Mean ± SD | 34.7 ± 6.4 | 33.4 ± 7.4 | 34.9 ± 7.1 | 32.3 ± 5.8 | 33.8 ± 6.8 | p(c) = 0.176 | |||||
 Median | 34.0 | 32.0 | 35.0 | 32.0 | 33.0 |  | |||||
CYP2D6 Phenotype, n (%) | |||||||||||
 PM |  |  | 1 | (1.9) |  |  |  |  | 1 | (0.5) | – |
 IM | 9 | (17.3) | 9 | (16.7) | 10 | (19.2) | 11 | (20.8) | 39 | (18.5) | |
 EM | 43 | (82.7) | 44 | (81.5) | 39 | (75.0) | 40 | (75.5) | 166 | (78.7) | |
 UM |  |  |  |  | 1 | (1.9) | 2 | (3.8) | 3 | (1.4) | |
 Unknown type/Unable to be determined |  |  |  |  | 2 | (3.8) |  |  | 2 | (0.9) |