Table 4.

Primary and Secondary Efficacy Outcomes.

Primary Objective: To Evaluate the Efficacy of a Multidose Regimen of Oral Varespladib-Methyl with SoC in Subjects after Venomous Snakebites
Change in the composite outcome of pulmonary, cardiovascular, hematologic symptoms, renal, and nervous system sections of the modified SSS from baseline to the average of the score from 6 and 9 h after first dose
Secondary Objectives: To evaluate efficacy of varespladib-methyl as treatment for sPLA2-induced venom toxicities
AUC of the pulmonary, cardiovascular, hematologic symptoms, renal, and nervous system sections of the modified SSS from baseline through day 7
Complete SSS from baseline through day 7
SSS neurologic system subscore from baseline through day 3
Coagulation abnormalities from baseline through day 3
Hemolysis markers from baseline through day 3
Levels of the myonecrosis marker, creatine kinase from baseline through day 3
Numeric Pain Rating score in patients able to respond from baseline through day 28
Kidney function markers from baseline through day 28
Total differential antivenom requirement from baseline through day 28
Head-lift duration from baseline through day 7
Total duration of ventilatory support from baseline through day 28
Total duration of Intensive Care Unit stay from baseline through day 28
Total duration of hospitalization from baseline through day 28
All-cause mortality from baseline through day 28
Clinical Global Impression-Improvement from baseline through day 7
Patient Global Impression of Change from baseline through day 7
Patient-specific Functional Scale total score from baseline through day 28