Table 2.
Treatment-Emergent Adverse Events Reported by ≥5% of Participants in Any Group and Vital Sign Changes from Baseline, Enrolled and Randomized Safety Populations
| |
Open-label phase |
Double-blind phase |
|
|---|---|---|---|
| n (%) | DR/ER-MPH N = 125 | DR/ER-MPH n = 65 | Placebo n = 54 |
| Participants with at least one TEAEa | 111 (88.8) | 24 (36.9) | 22 (40.7) |
| Any insomniab | 51 (40.8) | 5 (7.7) | 5 (9.3) |
| Decreased appetite | 34 (27.2) | 0 | 0 |
| Affect lability | 27 (21.6) | 0 | 0 |
| Headache | 22 (17.6) | 1 (1.5) | 1 (1.9) |
| Upper respiratory tract infection | 20 (16.0) | 3 (4.6) | 2 (3.7) |
| Nausea or vomiting | 11 (8.8) | 0 | 2 (3.7) |
| Upper abdominal pain | 11 (8.8) | 0 | 0 |
| Increased diastolic blood pressure | 10 (8.0) | 9 (13.8) | 7 (13.0) |
| Tachycardia | 9 (7.2) | 0 | 1 (1.9) |
| Irritability | 8 (6.4) | 0 | 0 |
| Vital sign, mean (SD) | Change from baseline to the end of the open-label phase | Change from baseline to the end of the double-blind phase | |
|---|---|---|---|
| Systolic blood pressure, mmHg |
6.2 (10.37) |
6.3 (9.32) |
3.6 (10.64) |
| Diastolic blood pressure, mmHg |
6.5 (8.50) |
5.1 (8.10) |
5.9 (8.27) |
| Pulse, bpm | 2.4 (13.55) | 1.7 (11.12) | −0.2 (14.08) |
a
Preferred terms are based on the Medical Dictionary for Regulatory Activities, Version 18.0 coding dictionary.
b
Includes the preferred terms insomnia (not specified), initial insomnia, middle insomnia, and terminal insomnia.
bpm, beats per minute; DR/ER-MPH, delayed-release and extended-release methylphenidate; SD, standard deviation; TEAE, treatment-emergent adverse event.