Safety
nausea, diarrhea, abdominal pain, diabetes mellitus, vomiting, dizziness, bacterial vaginosis, deaths, treatment-related TEAEs
ADVERSE EVENTS, DIABETES MELLITUS, ADVERSE EVENT, BACTERIAL VAGINOSIS, COMPLICATIONS
In the pooled analysis, ibrexafungerp remained well tolerated with 26.1% (142 of 545 patients) treatment-related treatment-emergent adverse events (TEAEs) compared with 9.8% (27 of 275 patients) in the placebo group. The majority of adverse events reported were gastrointestinal related and mild-to-moderate in severity. The most commonly reported treatment-related TEAEs with ibrexafungerp (occurring in >2% of patients) compared with placebo included diarrhea (13.8% [75 of 545 patients] vs. 2.2% [6 of 275 patients]); nausea (8.4% [46 of 545 patients] vs. 2.5% [7 of 275 patients]); abdominal pain (3.1% [17 of 545 patients] vs. 0% [0 of 275 patients]); abdominal discomfort (2.6% [14 of 545 patients] vs. 0.7% [2 of 275 patients]); and dizziness (2.4% [13 of 545 patients] vs. 0.7% [2 of 275 patients]).Seven of 545 women receiving ibrexafungerp discontinued the study or treatment due to an adverse event—vomiting (1), dizziness (1), bacterial vaginosis (4), and newly diagnosed diabetes mellitus (1). Two of these discontinuations were due to treatment-related TEAEs: vomiting of mild severity and dizziness of moderate severity. No patients in the placebo group discontinued due to a TEAE. No treatment-related serious adverse events or deaths were reported nor did any laboratory evaluations reveal any trends potentially associated with ibrexafungerp administration. Although patients of reproductive potential agreed to use an effective contraceptive method or remain abstinent through ≥10 days after completion of study therapy, three pregnancies were reported in the ibrexafungerp group; one pregnancy was electively terminated and two resulted in live births with no maternal or neonatal complications.