Progression-free survival was defined as the time from enrollment in the study to the first documented disease progression using Response Evaluation Criteria In Solid Tumors (RECIST) or death from any cause, whichever occurred first.

Intent-to-treat population: All participants who were enrolled in the study.

An objective response was defined as a complete or partial response determined on 2 consecutive occasions ≥ 4 weeks apart using Response Evaluation Criteria in Solid Tumors (RECIST). Complete response was defined as the disappearance of all target and non-target lesions. Any pathological lymph nodes (whether target or non-target) must be < 10 mm on the short axis. Partial response was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum.

Intent-to-treat population: All participants who were enrolled in the study. Only participants who had a response evaluation were included in the analysis.

Duration of the objective response is defined as the time from a complete or partial response to disease progression or death due to disease.

Intent-to-treat population: All participants who were enrolled in the study. Only participants who had a response were included in the analysis.

Overall survival is defined as the time from the first dose of study medication until death.

Intent-to-treat population: All participants who were enrolled in the study.