Table 2.
Summary of Safety and Tolerability End Points, Safety Set
| Placebo |
SHP465 MAS |
|
|---|---|---|
| (n = 43) | (n = 45) | |
| Any TEAE, n (%) | 7 (16.3) | 11 (24.4) |
| Serious TEAE | 0 | 0 |
| TEAEs leading to dose discontinuation | 0 | 0 |
| Severe TEAEs | 0 | 0 |
| Serious TEAEs leading to death | 0 | 0 |
| Any TEAEs reported by ≥2 participants, n (%) | ||
| Headache | 3 (7.0) | 2 (4.4) |
| Decreased appetite | 2 (4.7) | 1 (2.2) |
| Diarrhea | 1 (2.3) | 1 (2.2) |
| Medication error | 1 (2.3) | 1 (2.2) |
| Vital signs, mean ± SD change from baseline at FoTA | ||
| SBP, mmHg | −0.8 ± 6.23 | 1.8 ± 6.52 |
| DBP, mmHg | 0.3 ± 6.61 | 3.1 ± 7.24 |
| Pulse, bpm | −1.8 ± 10.02 | −0.5 ± 9.87 |
| Vital sign outliers, n (%) | ||
| SBP >120 mmHg and increase >10 mmHg from baseline on ≥2 consecutive visits over entire study | 0 | 0 |
| SBP >120 mmHg and increase >10 mmHg from baseline at FoTA | 0 | 1 (2.2) |
| DBP >80 mmHg and increase >10 mmHg from baseline on ≥2 consecutive visits over entire study | 0 | 0 |
| DBP >80 mmHg and increase >10 mmHg from baseline at FoTA | 0 | 2 (4.4) |
| Pulse ≥100 bpm and increase >15 bpm from baseline on ≥2 consecutive visits over entire study | 0 | 0 |
| Pulse ≥100 bpm and increase >15 bpm from baseline at FoTA | 1 (2.3) | 0 |
| Weight at FoTA | ||
| Mean ± SD change at FoTA, kg | 0.5 ± 0.77 | 0.1 ± 0.90 |
| Mean ± SD z score | 0.38 ± 1.251 | 0.70 ± 1.420 |
| Median z score | −0.04 | 0.55 |
| Weight decrease ≥7% from baseline, n (%) | 0 | 0 |
| BMI at FoTA | ||
| Mean ± SD change at FoTA, kg/m2 | 0.12 ± 0.428 | −0.09 ± 0.561 |
| Mean ± SD z score | 0.52 ± 1.274 | 0.85 ± 1.080 |
| Median z score | 0.31 | 0.76 |
BMI, body mass index; bpm, beats per minute; DBP, diastolic blood pressure; FoTA, final on-treatment assessment; MAS, mixed amphetamine salts; SBP, systolic blood pressure; SD, standard deviation; TEAE, treatment-emergent adverse event.