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No clinically notable changes in mean laboratory, vital sign, or electrocardiographic values were observed.
Clinically notable changes in weight were recorded in 29 (9.9 %) patients in the AEP.
There were no reports of clinically notable changes in systolic blood pressure.
A single patient reported clinically notable low systolic blood pressure, and five patients (1.7 %) reported clinically notable changes in diastolic blood pressure (four patients with high, one patient with low).
No patient had a clinically notable low potassium value (i.e. <3.0 mmol/L), while clinically notable hyperglycaemia (>9.99 mmol/L) occurred in fewer patients in the indacaterol group than in the placebo group.
No patient had a clinically notable low potassium value (i.e., <3.0 mmol/L), while the proportion of patients with clinically notable hyperglycaemia (>9.99 mmol/L) was lower in the indacaterol group than in the placebo group (3.3% vs. 6.3%).
Similar(38)
Safety variables were analyzed descriptively, with clinically relevant or notable changes assessed.
Data from multiple randomized adjuvant trials and observational studies suggest that the rate of discontinuation of trastuzumab treatment ranges between 6 and 31%, mainly due to cardiotoxicity [2 10]; and in patients aged ≥65 years old, this figure increases to a notable and clinically relevant rate of 41%[11]].
Therefore, the statistically significant improvements demonstrated by the PETiT assessment after only six weeks of lurasidone therapy are notable and clinically important for patients switching from other antipsychotics.
There were no observable dose-related trends, clinically relevant changes or notable differences in treatment groups in any vital signs parameters, ECG safety parameters or laboratory safety parameters.
Predominance of peroneal neuropathy is notable amongst all nerves clinically and in animal electro-physiologic research [12].
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CEO of Professional Science Editing for Scientists @ prosciediting.com