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.