Table S4.
CGI-S normal/borderline ill (CGI-S score of 1 or 2) and mildly ill or greater (CGI-S score of ≥3) at baseline and end point by treatment for prior MPH or stimulant-naïve subgroups (LOCF; full-analysis set)
| CGI-S | RCT |
RWS |
||||||
|---|---|---|---|---|---|---|---|---|
| Placebo (n=111) | GXR (n=114) | ATX (n=112) | GXR (n=503) | |||||
|
| ||||||||
| Prior MPH | Stimulant-naïve | Prior MPH | Stimulant-naïve | Prior MPH | Stimulant-naïve | Prior MPH | Stimulant-naïve | |
| Baseline | ||||||||
| Number of participants | 48 | 55 | 46 | 61 | 48 | 58 | 224 | 207 |
| Normal/borderline, n (%) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Mildly ill or greater, n (%) | 48 (100) | 55 (100) | 46 (100) | 61 (100) | 48 (100) | 58 (100) | 224 (100) | 207 (100) |
| End point | ||||||||
| Number of participants | 48 | 55 | 45 | 60 | 48 | 58 | 222 | 206 |
| Normal/borderline, n (%) | 9 (18.8) | 15 (27.3) | 16 (35.6) | 24 (40.0) | 7 (14.6) | 20 (34.5) | 152 (68.5) | 146 (70.9) |
| Mildly ill or greater, n (%) | 39 (81.3) | 40 (72.7) | 29 (64.4) | 36 (60.0) | 41 (85.4) | 38 (65.5) | 70 (31.5) | 60 (29.1) |
| Difference in % normal/borderline from placebo (95% CI; P-value) | 16.8 (−1.0 to 34.6; P=0.070) | 12.7 (−4.4 to 29.8; P=0.073) | −4.2 (−19.1 to 10.7; P=0.516) | 7.2 (−9.8 to 24.2; P=0.242) | ||||
Note: P-values based on Cochran–Mantel–Haenszel statistic comparing the treatment groups, with country and age-group included as stratification factors.
Abbreviations: ATX, atomoxetine; CGI-S, Clinical Global Impression – Severity scale; CI, confidence interval; GXR, guanfacine extended release; LOCF, last observation carried forward; MPH, methylphenidate; RCT, randomized controlled trial; RWS, randomized-withdrawal study.