Safety and tolerability
taste disorder, Taste-related adverse, hypogeusia, taste disorders, ageusia, dysgeusia
TASTE DISORDER, ADVERSE EVENTS, ADVERSE EVENT, EVENT, TASTE DISORDERS
Treatment-emergent AEs were reported for 22 of the 23 study participants (details in Additional file Taste-related AEs were reported mainly but not exclusively during treatment with filapixant (13 patients on filapixant; 3 patients on placebo). Qualitative changes in taste perception In addition to the standard AE analysis with frequency counts based on the AE’s onset date only (Table Taste-related adverse events (conventional analysis)Percentages refer to the total number of patients (N = 23)This table shows data only for the dose level at which the event first occurred, regardless of whether the event continued or recurred at subsequent dose levels. Adverse events were coded using MedDRA v22.0Taste-related adverse events (additional “cumulative” analysis)The table provides the number of patients reporting taste-related adverse events for each dose step where such an event was present, irrespective of the time of its onset. The number of patients reporting taste-related AEs might decrease from one dose step to the next when taste disorders disappear in a patient. Taste-related adverse events were ageusia, dysgeusia, hypogeusia, and taste disorder without further specification (MedDRA v22.0 preferred terms)No clinically relevant changes were noted in the safety laboratory parameters, vital signs (heart rate, blood pressure, and body temperature), and electrocardiogram assessments after treatment with filapixant.