Safety analysis
dizziness, anorexia, anxiety, myoclonic
ADVERSE EVENTS, ADVERSE EVENT, ANOREXIA
Of the 24 randomized participants who received the study drug, two receiving SXB withdrew due to adverse events (AEs). Average final dose was 6.55 (2.18) g for SXB and 7.81 g (2.20) g for placebo. Two participants, both in the SXB group opted to receive single dose. All-cause treatment-emergent AEs occurred in 11 participants (45.8%): 9 of 12 (75%) in the SXB group, and 2 of the 12 (16.7%) in the placebo group (Safety Analysis. Number of Participants With an Adverse Event (Percentage Within Study Population) and Total Number of Adverse Events (Percentage of All Adverse Events in the Respective Category)No, number.
Serious AEs occurred in 5 of the 12 patients (41.7%) with SXB and none with placebo. In the SXB group, other than anxiety and dizziness, which led two participants to withdraw from the study, serious AEs were: myoclonic episodes after first dose only, sleep terror, and suicidal ideation, both of which resolved after dose adjustment. Most common AEs associated with SXB were anorexia, anxiety, increased sweating, and brain fog (