Table 3.
Demographics and baseline characteristics of patients in the short-term and longer-term studies (integrated analyses).
| Parameter | Short-term studies integrated analysis |
Longer-term studies integrated analysis |
||||
|---|---|---|---|---|---|---|
| Placebo | ATX | p-value | Placebo | ATX | p-value | |
| Age (years), N | 980 | 981 | 624 | 789 | ||
| Mean±SD | 34.2±11.1 | 34.8±11.3 | 0.39 | 38.6±9.0 | 38.7±8.8 | 0.48 |
| Sex, N | 980 | 981 | 624 | 789 | ||
| Male, n (%) | 575 (58.7) | 575 (58.6) | 1.00 | 320 (51.3) | 413 (52.3) | 0.71 |
| Female | 405 (41.3) | 406 (41.4) | 304 (48.7) | 376 (47.7) | ||
| Ethnic origin, N | 980 | 981 | 624 | 789 | ||
| White, n (%) | 632 (64.5) | 646 (65.9) | 0.61 | 531 (85.0) | 671 (85.0) | 0.90 |
| Black | 53 (5.4) | 46 (4.7) | 32 (5.1) | 37 (4.7) | ||
| Asian | 214 (21.8) | 216 (22.0) | 6 (1.0) | 9 (1.1) | ||
| Hispanic | 69 (7.0) | 67 (6.8) | 45 (7.2) | 54 (6.8) | ||
| Other | 12 (1.2) | 6 (0.6) | 10 (1.6) | 18 (2.3) | ||
| ADHD subtype, N | 980 | 979 | 623 | 789 | ||
| Inattentive, n (%) | 331 (33.8) | 325 (33.2) | 0.73 | 177 (28.4) | 239 (30.3) | 0.72 |
| Hyperactive/impulsive | 18 (1.8) | 14 (1.4) | 5 (0.8) | 5 (0.6) | ||
| Combined | 631 (64.4) | 640 (65.4) | 441 (70.8) | 545 (69.1) | ||
| CAARS-Inv: SV scores, N | 905 | 909 | 623 | 786 | ||
| Mean±SD | 35.3±8.1 | 35.1±8.2 | 0.55 | 35.8 ±8.3 | 35.0±8.2 | 0.11 |
| CGI-ADHD-S scores, N | 687 | 685 | 624 | 789 | ||
| Mean±SD | 4.7±0.7 | 4.8±0.7 | 0.30 | 4.6±0.6 | 4.6±0.7 | 0.42 |
| <4, n (%) | 0 (0.0) | 0 (0.0) | 0.18 | 0 (0.0) | 1 (0.1) | 0.26 |
| 4–5 | 591 (86.0) | 571 (83.4) | 579 (92.8) | 717 (90.9) | ||
| >5 | 96 (14.0) | 114 (16.6) | 45 (7.2) | 71 (9.0) | ||
ATX: atomoxetine; CAARS-Inv: SV: Conners’ Adult ADHD Rating Scale–Investigator-Rated; CGI-ADHD-S: Clinical Global Impressions of ADHD-Severity; N: number of randomized patients per parameter; n: number of patients per sub-parameter; SD: standard deviation.
Studies LYBY and LYDQ are excluded from CGI-ADHD-S descriptive statistics because they were conducted in comorbid populations. Similarly, Study LYBY did not collect CAARS-Inv: SV, therefore the numbers of patients included in the analyses are lower than the numbers randomized, p-values for categorical data are from Fisher’s exact test; p-values for ethnicity are from the chi-square test; p-values for continuous data are from the Type III sums of squares analysis of variance (ANOVA) model with terms for treatment and study.