Dose Limiting Toxicities Sample Clauses

Dose Limiting Toxicities. (DLT)‌ A DLT is defined as any IP-related adverse event, occurring during Cycle 1 (Week 1–3), which meets the following criteria: • Any ≥ grade 4 hematologic toxicity • Any ≥ grade 3 non-hematologic toxicity (including injection-site reaction), with the exception of: — Grade 3 dermatologic toxicities — Grade 3 hypersensitivity reaction • Diarrhea, nausea, or vomiting will only be considered a DLT when ≥ grade 3 toxicity occurs despite adequate anti-emetics or anti-diarrhea medications • Treatment delay due to toxicity lasting greater than 21 days • Death “IP related” refers to events that are possibly or probably related to the administration of IP or the combined treatment regimen of IP, platinum, 5-FU, and cetuximab, and not clearly attributed to platinum, 5-FU, cetuximab alone, or other causes. DLTs will be assessed for all subjects until at least six subjects randomized to receive VTX-2337 have received one cycle of treatment and the DSMB has completed the assessment of the starting dose. (§9.2.2) Individual subjects who experience DLTs may nevertheless receive additional doses of IP, following careful medical evaluation and appropriate treatment and/or a dose delay of 1 week, at the discretion of the investigator, with input from the medical monitor and study sponsor.
Sample 1
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Dose Limiting Toxicities. ‌ As described in §9.2.2, DLTs will be assessed for all subjects until the DSMB has completed the assessment of the starting dose. Once the investigator has determined a DLT has occurred, the DLT should be reported within 48 hours. This is necessary to allow the DSMB to review DLTs in a timely manner.
Sample 1
Dose Limiting Toxicities. A listing and summary of the subject incidence of DLTs will be provided should they occur.
Sample 1

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