2.7 Statistical Analyses
The safety and response evaluable populations were composed of all patients who received at least 1 dose of any of the three study agents. The dose-determining analysis population consisted of all patients from the safety population who either met the minimum exposure criterion and completed the cycle 1 DLT evaluation period without experiencing a DLT or received at least 1 dose of any of the three study agents and experienced a first-cycle DLT. The minimum exposure criterion was defined as receiving at least 80% of the planned doses of each of the three study agents (cabozantinib, topotecan and cyclophosphamide) in the first cycle. A 95% exact two-sided confidence interval was placed on the proportion of responders. Analyses were performed using R version 4.0.2.