Table 3.
Summary of Treatment-Emergent Adverse Events Reported by at Least 5% of Subjects in Either Age Group
| 6- and 7-Year Olds | 8- to 12-Year Olds | ||||||
| ATX | PBO | ATX | PBO | ||||
| N = 183 | N = 95 | N = 542 | N = 316 | ||||
| Event | n (%) | (n) % | p Valuea | (n) % | (n) % | p Valuea | p Valueb |
| Abdominal pain upper | 34 (18.6) | 6 (6.3) | .006 | 83 (15.3) | 40 (12.7) | .313 | .044 |
| Decreased appetite | 30 (16.4) | 3 (3.2) | < .001 | 82 (15.1) | 17 (5.4) | < .001 | .331 |
| Headache | 25 (13.7) | 8 (8.4) | .243 | 90 (16.6) | 54 (17.1) | .850 | .214 |
| Vomiting | 25 (13.7) | 2 (2.1) | .001 | 51 (9.4) | 18 (5.7) | .068 | .053 |
| Cough | 18 (9.8) | 6 (6.3) | .375 | 18 (3.3) | 28 (8.9) | < .001 | .007 |
| Nausea | 13 (7.1) | 2 (2.1) | .097 | 42 (7.7) | 20 (6.3) | .496 | .186 |
| Fatigue | 12 (6.6) | 2 (2.1) | .150 | 39 (7.2) | 8 (2.5) | .003 | .918 |
| Somnolence | 12 (6.6) | 1 (1.1) | .040 | 50 (9.2) | 14 (4.4) | .010 | .294 |
| Irritability | 9 (4.9) | 2 (2.1) | .342 | 33 (6.1) | 9 (2.8) | .034 | .924 |
| Pyrexia | 9 (4.9) | 2 (2.1) | .342 | 15 (2.8) | 17 (5.4) | .062 | .058 |
| Nasopharyngitis | 8 (4.4) | 4 (4.2) | 1.00 | 26 (4.8) | 24 (7.6) | .098 | .442 |
| Upper respiratory tract infection | 8 (4.4) | 3 (3.2) | .754 | 16 (3.0) | 17 (5.4) | .096 | .206 |
| Pharyngolaryngeal pain | 2 (1.1) | 3 (3.2) | .342 | 26 (4.8) | 29 (9.2) | .014 | .687 |
Abbreviations: ATX = atomoxetine; N, n = number; PBO = placebo.
aP values comparing ATX and PBO within each subgroup are based on Fisher's exact test.
bP values comparing odds ratios between children and adolescent