Table 6 Safety measures
Outcome domain | Measure | Scale |
|---|---|---|
Adverse event profile | Assess the incidence of SAEs and AEs by severity, recording in app and on site | Tabulations of AEs by severity and SAE listings from baseline to 1 month post-intervention. |
Modification of objective safety measures | Laboratory tests | Complete blood count, liver function, renal function, thyroid function), 12-lead ECG, and vital signs will be measured at baseline and at the 8-week time point and after completion of the extension period. Echocardiogram will be measured at baseline and after the last dose is taken. |
Serotonin syndrome | Complete serotonin syndrome checks at each dosing visit | Clonus, diaphoresis, shiver/tremor, and agitation body temperature. |