Adverse Events Reported in the Phase-I Study.
pulmonary embolus
ADVERSE EVENT, PULMONARY EMBOLUS
AE: adverse event* Relatedness of AEs to flubentylosin as determined by study investigator† Two subjects with AE of elevated serum liver enzymes†† Unconfirmed pulmonary embolus 8 days after administration of study drug, deemed not related to study drug.Lastly, there did not appear to be a relationship between flubentylosin concentrations and changes in QTcF from baseline. The upper bounds of the 90% confidence intervals of ΔΔQTcF ranged from 2.45 to 5.01 msec, well below the 10-msec threshold, for all dose levels tested, suggesting that flubentylosin had no clinically relevant effects on QTc prolongation.