Polyvalent Antivenom (Premium-PANAF) for Snakebite Envenoming in Ethiopia

Proportion of patients with severe allergic reactions within 6 hours of antivenom administration according to the Brown grading system

Correction of coagulopathy as measured by the 20-minute whole blood clotting test at 6 hours after antivenom administration

Number of doses (vials) needed to reverse the envenomation syndrome

Proportion of patients who require rescue treatment with EchiTab-Plus or SAIMR due to lack of responsiveness to Premium-PANAF

Death from any cause within 42 days of treatment with antivenom

Patient-specific Function Scale (PSFS) score

Proportion of patients with in-hospital major bleeding (defined according to the International Society on Thrombosis and Haemostasis criteria)

Proportion of patients with cessation of bleeding

Proportion of patients with reversal of correction of coagulopathy as measured by serial 20min WBCT

Proportion of patients who require blood transfusion during hospitalization

Proportion of patients who require surgical intervention

Mean and median total surface area of full thickness skin necrosis in cm2

Reduction of swelling extension

Proportion of participants referred for renal replacement therapy

Peak serum creatine kinase in U/L

Proportion of participants needing mechanical or manual ventilation

Proportion of patients with shock (shock defined as systolic blood pressure <90mmHg in adults, or age adjusted blood pressure in children)

Proportion of patients requiring adrenaline

Proportion of patients experiencing anaphylaxis after antivenom administration

Proportion of patients requiring IV fluids following an allergic reaction

Proportion of patients with confirmed or probable serum sickness

Any other (serious) adverse events after enrolment in the study among participants with at least one dose of antivenom delivered