Safety results
nausea, tachycardia, psychotic disorder, leukopenia, palpitations, sinus tachycardia, aggression, asthma, irritability, increased blood potassium
ADVERSE EVENT, LEUKOPENIA, SINGLE SEIZURE, SINUS TACHYCARDIA, STEROID-INDUCED DIABETES, HYPERGLYCEMIA, ADVERSE EVENT, ASTHMA
In the DO phase (safety population, Treatment-Emergent Adverse Events During the Dose Optimization and Open-Label Treatment for Up to 12 Months (Safety Population)Values shown are DO, dose optimization; TEAE, treatment-emergent adverse event.All AEs leading to discontinuation of study drug during the DO phase and treatment phase were classified as TEAEs. During the DO phase, four subjects (1.9%) with at least one TEAE discontinued treatment because of an AE. TEAEs leading to treatment discontinuation in the DO phase were aggression, irritability, psychotic disorder, and nausea (each Two subjects experienced a total of eight SAEs during the treatment phase. One subject had seven SAEs because of preexisting conditions of asthma and steroid-induced diabetes mellitus, and another subject experienced a single seizure that was unrelated to treatment with SDX/d-MPH.TEAEs related to vital sign assessments in the DO phase were increased blood pressure (two subjects [1.0%]), increased heart rate (one subject [0.5%]), and tachycardia (four subjects [1.9%]); and in the treatment phase, vital sign-related TEAEs were increased blood pressure (two subjects [0.8%]), increased diastolic blood pressure (one subject [0.4%]), tachycardia (two subjects [0.8%]), and sinus tachycardia (one subject [0.4%]). A total of four subjects experienced seven laboratory-related TEAEs during the study in the treatment phase related to severe hyperglycemia, mild increased alkaline phosphatase, mild increased blood potassium, moderate decreased neutrophil and white blood cell counts, leukopenia, and high glucose level.Overall, there were no clinically meaningful trends in ECG parameters over time, and no clinically significant ECG abnormalities were reported. One subject had a dose reduction implemented because of palpitations.The mean body weight (SD) at baseline was 38.6 kg (13.9 kg), and after ∼12 months of treatment, the mean body weight was 41.1 kg (14.6 kg); a mean change from baseline weight of +3.4 kg (4.3 kg). Body weight decreased in 18 subjects (7.6%) and increased in 12 subjects (5.0%) during the treatment phase. The mean weight 