Fever with Neutropenia Sample Clauses

Fever with Neutropenia. Grade 1 or 2 transient pyrexia is a common side effect of VTX-2337, with typical onset 3–6 hours after dosing with the investigational product and lasting approximately 24 hours. Fever may or may not be accompanied by flu-like symptoms such as shaking, chills, and myalgia. In a Phase 3 study of cetuximab plus platinum-5-FU, more than 25% of subjects experienced grade 3 or 4 neutropenia and 6% of subjects experienced febrile neutropenia.(12) The nadir typically occurs 18–23 days after administration of platinum. It is therefore anticipated that grade 3 or 4 neutropenia will sometimes be present during the 24-hour window in which fever induced by VTX-2337 is anticipated. The following algorithm will be used to carefully evaluate subjects to help determine if the fever reflects the expected pharmacology of VTX-2337 or an infection related to chemotherapy-induced neutropenia. For subjects who experience onset of fever within 8 hours of dosing with IP but are without symptoms or signs of infection, a complete blood count may be drawn. • A: If the ANC is > 500 cells/µL, follow for resolution of fever (expected ≤ 36 hours) — A1: If fever persists > 36 hours and the subject is still asymptomatic, draw blood cultures and repeat CBC. If ANC declined to <500 cells/µL, switch to algorithm B1 below — A2: If fever persists > 36 hours and the subject develops additional symptoms and/or signs of infection, draw blood cultures and repeat CBC. Treat as appropriate, either as an outpatient with oral antibiotics or as inpatient with parenteral antibiotics • B: If the ANC is < 500 cells/µL, draw blood cultures the same day — B1: If fever persists > 36 hours and the subject is asymptomatic, start oral antibiotics — B2: If fever persists > 36 hours and the subject has symptoms of infection, admit the subject to the hospital for parenteral antibiotics