Table 2.
Participant baseline characteristics and demographic data from the RCT (safety population/full-analysis set) and the RWS (safety population), according to prior stimulant-medication status
| Characteristic | RCT |
RWS |
||||||
|---|---|---|---|---|---|---|---|---|
| Placebo (n=111) |
GXR (n=114) |
ATX (n=112) |
n=526a
|
|||||
| Prior MPH | Stimulant-naïve | Prior MPH | Stimulant-naïve | Prior MPH | Stimulant-naïve | Prior MPH | Stimulant-naïve | |
|
| ||||||||
| n=48 | n=55 | n=46 | n=61 | n=48 | n=58 | n=227 | n=227 | |
| Age (years), mean (SD) | 11.0 (2.32) | 10.7 (3.04) | 11.5 (2.52) | 10.4 (2.97) | 10.8 (2.79) | 10.3 (2.86) | 10.9 (2.52) | 10.1 (2.76) |
| Male, n (%) | 41 (85.4) | 42 (76.4) | 33 (71.7) | 39 (63.9) | 42 (87.5) | 41 (70.7) | 173 (76.2) | 163 (71.8) |
| BMI (kg/m2), mean (SD) | 18.29 (2.48) | 19.08 (2.85) | 18.52 (3.11) | 18.81 (2.93) | 18.71 (3.12) | 18.77 (2.86) | 18.38 (2.84) | 18.98 (2.85) |
| ADHD subtype, n (%) | ||||||||
| Predominantly inattentive | 3 (6.3) | 7 (12.7) | 10 (21.7) | 3 (4.9) | 4 (8.3) | 6 (10.3) | 28 (12.3) | 31 (13.7) |
| Predominantly hyperactive–impulsive | 1 (2.1) | 4 (7.3) | 1 (2.2) | 5 (8.2) | 0 | 3 (5.2) | 11 (4.8) | 7 (3.1) |
| Combined | 44 (91.7) | 44 (80.0) | 35 (76.1) | 53 (86.9) | 44 (91.7) | 49 (84.5) | 188 (82.8) | 189 (83.3) |
| Baseline ADHD-RS-IV score, mean (SD) | 43.7 (5.34) | 42.7 (5.71) | 43.5 (5.44) | 42.7 (5.57) | 44.7 (5.55) | 42.7 (5.98) | 45.1 (6.02) | 42.7 (6.39) |
| Baseline CGI-S, n (%) | ||||||||
| Moderately ill | 11 (22.9) | 18 (32.7) | 3 (6.5) | 17 (27.9) | 3 (6.3) | 17 (29.3) | 35 (15.4) | 60 (26.4) |
| Markedly ill | 18 (37.5) | 28 (50.9) | 21 (45.7) | 34 (55.7) | 25 (52.1) | 28 (48.3) | 103 (45.4) | 123 (54.2) |
| Severely ill | 18 (37.5) | 8 (14.5) | 19 (41.3) | 10 (16.4) | 18 (37.5) | 13 (22.4) | 66 (29.1) | 41 (18.1) |
| Among the most extremely ill | 1 (2.1) | 1 (1.8) | 3 (6.5) | 0 | 2 (4.2) | 0 | 23 (10.1) | 3 (1.3) |
| Baseline CPRS-R:L oppositional subscale score, mean (SD) | 15.0 (7.22) | 13.3 (6.85) | 14.8 (7.92) | 13.0 (6.47) | 16.3 (7.00) | 14.4 (7.20) | 16.5 (7.96) | 15.5 (7.42) |
Notes:
The safety population for the RWS comprised 526 participants, of whom 503 were included in the full-analysis set. Percentages based on the number of participants in each subgroup for each treatment. Participants who received prior non-MPH treatment not included in this table.
Abbreviations: ADHD, attention-deficit/hyperactivity disorder; ADHD-RS-IV, ADHD Rating Scale version IV; ATX, atomoxetine; BMI, body mass index; CGI-S, Clinical Global Impression – Severity scale; CPRS-R:L, Conners Parent Rating Scales – revised: long; GXR, guanfacine extended release; MPH, methylphenidate; RCT, randomized controlled trial; RWS, randomized-withdrawal study; SD, standard deviation.