Safety
blurred vision, Study-drug-related TEAEs, paronychia
RHEGMATOGENOUS RETINAL DETACHMENT, FOLLICULITIS, DRUG WITHDRAWAL, EVENT, PARONYCHIA
Study-drug-related TEAEs were observed in all patients (Nine (47.4%) patients reported grade 3 drug-related TEAEs, including four patients experiencing paronychia and five experiencing folliculitis, which were the main cause of dose reduction (42.1%) and drug interruption (21.2%). Only one grade 3 drug-related TEAE was observed in patients receiving doses below the MTD (paronychia; 6 mg dose). One patient experienced an SAE during treatment that led to drug withdrawal. The SAE, rhegmatogenous retinal detachment, which was present at baseline, worsened (blurred vision developed) during the study and required elective surgical treatment, but the retinal condition did not get worse after FCN-159 administration; the event was subsequently considered unrelated to the study drug. No patients died during the study.