DEFINITION OF DOSE-LIMITING TOXICITY Sample Clauses

DEFINITION OF DOSE-LIMITING TOXICITY. (DLT)‌ Dose-limiting toxicity will be defined as any of the following events that are at least possibly, probably or definitely attributable to the Chemoplaque. The observation period for the purposes of dose- escalation will be 63 days (i.e. 21 days following Chemoplaque removal on day 42). Systemic DLT: any Grade 3 or greater toxicity that is that are at least possibly, probably or definitely attributable to the Chemoplaque Ocular DLT: any of the following that are that are at least possibly, probably or definitely attributable to the Chemoplaque • Grade 2 or greater scleral necrosis (may be detected after Chemoplaque removal) • Grade 2 or greater eye pain • Grade 3 ocular toxicities with the specific exception of Grade 3 conjunctival response in the quadrant containing the Chemoplaque and localized Grade 3 retinal detachment (specifically serous retinal detachment which is not given in CTCAE), which are expected and not considered an ocular DLT
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