Impact on Safety Lab Monitoring and Study Drug Regimen
gastrointestinal AEs, thyrotoxicosis
THYROTOXICOSIS
Serum thyroid function tests did change over time but did not result in clinical thyrotoxicosis. Four out of the initial 7 study participants had to reduce T3 dose over the course of the study because the initial study protocol mandated that this would be needed in the context of an evolving bio-chemical thyrotoxicosis (asymptomatic low TSH [< 0.5 mU/L]). In response to this common occurrence, the DSMB recommended changing the dose escalation schedule (see dosing schedule chart, Fig. Participants 8 through 20 did not require a dose reduction after the revised dose escalation schedule was implemented. Moreover, fewer systemic side effects were observed with the new dose escalation regimen. Specifically, the gastrointestinal AEs decreased to 33% from 70% and HAs decreased to 8% compared to 86%.