Dose Escalation Analysis Set Clause Samples

Dose Escalation Analysis Set. The analysis of dose limiting toxicity (DLT) will be conducted on the Phase 1b dose escalation analysis set defined as all DLT evaluable participants. A participant is classified as DLT-evaluable if they have had the opportunity to complete the DLT interval (Days 1 to 14) and received 1 dose of planned OPT-302 or experienced a DLT at any time during the first 14 days on study.