Adverse events
lethargy, skin rash, toxic epidermal necrolysis, Tau
ADVERSE EVENTS, TOXIC EPIDERMAL NECROLYSIS, ADVERSE EVENT
Both adverse events (AEs) and serious adverse events (SAEs) were monitored by the study team and SAEs reported in writing to Sigma Tau as well as to University of Makerere’s internal review board (IRB) and the study’s project advisory committee (PAC), a subset of whose members functioned as a data safety and monitoring board (DSMB). Three SAE’s were reported in the MDA arm. The only one with a high likelihood of being related to the study medication was a case of toxic epidermal necrolysis in a two year old girl who fully recovered. One study-related adverse event of skin rash from prolonged sleeping contact with a newly sprayed wall was reported in the IRS only arm. The leading AEs after MDA were lethargy and stomach upset.