Table 2.
Summary of Safety and Tolerability Endpoints, Safety Analysis Set
| Placebo (n = 131) | SHP465 MAS (n = 132) | |
|---|---|---|
| Any TEAE, n (%) | 61 (46.6) | 89 (67.4) |
| TEAEs related to the study drug | 34 (26.0) | 70 (53.0) |
| Severe TEAEs* | 1 (0.8) | 4 (3.0) |
| TEAEs leading to discontinuation† | 3 (2.3) | 11 (8.3) |
| Serious TEAEs | 0 | 0 |
| TEAEs in ≥2% of participants in either treatment group, n (%) | ||
| Decreased appetite | 9 (6.9) | 40 (30.3) |
| Insomnia‡ | 3 (2.3) | 22 (16.7) |
| Headache | 14 (10.7) | 16 (12.1) |
| Irritability | 2 (1.5) | 9 (6.8) |
| Nausea | 4 (3.1) | 9 (6.8) |
| Weight decreased | 1 (0.8) | 7 (5.3) |
| Dizziness | 0 | 6 (4.5) |
| Heart rate increased | 1 (0.8) | 5 (3.8) |
| Abdominal pain upper | 2 (1.5) | 4 (3.0) |
| Upper respiratory tract infection | 2 (1.5) | 3 (2.3) |
| Fatigue | 4 (3.1) | 2 (1.5) |
| Nasopharyngitis | 4 (3.1) | 0 |
| Oropharyngeal pain | 3 (2.3) | 0 |
| Weight increased | 3 (2.3) | 0 |
| Vital signs, mean ± SD change at final on-treatment assessment¶ | ||
| SBP, mmHg | 2.1 ± 8.72 | 3.8 ± 9.15 |
| DBP, mmHg | 0.5 ± 7.45 | 4.0 ± 8.23 |
| Pulse, bpm | 0.7 ± 10.79 | 5.7 ± 11.78 |
| Vital sign outliers at any time during treatment,§n (%) | ||
| SBP >120 mmHg and increase of >10 mmHg from baseline in children | 3 (6.0) | 4 (7.8) |
| SBP >140 mmHg and increase of >10 mmHg from baseline in adolescents | 0 | 1 (1.3) |
| DBP >80 mmHg and increase of >10 mmHg from baseline in children | 3 (6.0) | 3 (5.9) |
| DBP >90 mmHg and increase of >10 mmHg from baseline in adolescents | 0 | 1 (1.3) |
| Pulse rate ≥100 bpm and increase >15 bpm from baseline in children | 1 (2.0) | 9 (17.6) |
| Pulse rate ≥100 bpm and increase >15 bpm from baseline in adolescents | 2 (2.5) | 5 (6.5) |
| Weight at final on-treatment assessment¶ | ||
| Mean ± SD change at final on-treatment assessment, kg | 0.70 ± 1.256 | −0.92 ± 1.480 |
| Mean ± SD z-score | 0.04 ± 0.138 | −0.12 ± 0.164 |
| Median z-score | 0.04 | −0.11 |
| Weight decrease ≥7% from baseline, n (%) | 2 (1.6) | 7 (5.5) |
| BMI at final on-treatment assessment¶ | ||
| Mean ± SD change at final on-treatment assessment, kg/m2 | 0.30 ± 0.541 | −0.37 ± 0.576 |
| Mean ± SD z-score | 0.08 ± 0.185 | −0.14 ± 0.251 |
| Median z-score | 0.06 | −0.10 |
Severe TEAEs: placebo (muscle strain [n = 1]); SHP465 MAS (nausea [n = 1]; back pain [n = 1]; neck pain [n = 1]; dizziness [n = 1]; and lethargy [n = 1]; insomnia [n = 1]).
TEAEs leading to discontinuation: placebo (bundle branch block right [n = 1]; acute psychosis [n = 1]; and suicidal ideation [n = 1]); SHP465 MAS (abdominal pain upper [n = 1]; viral infection [n = 1]; heart rate increased [n = 1]; decreased appetite [n = 1]; dizziness [n = 2]; seizure [n = 1]; depressed mood [n = 1]; insomnia [n = 1]; irritability [n = 1]; and hemoptysis [n = 1]).
Includes preferred terms of insomnia, initial insomnia, and middle insomnia.
Based on n = 129 for placebo and n = 128 for SHP465 MAS.
Based on n = 50 children and n = 79 adolescents for placebo, and n = 51 children and n = 77 adolescents for SHP465 MAS.
BMI, body mass index; DBP, diastolic blood pressure; MAS, mixed amphetamine salts; SBP, systolic blood pressure; SD, standard deviation; TEAE, treatment-emergent adverse event.