Efficacy assessments
death, Tumor
DISEASE PROGRESSION, TUMOR
Tumor assessments were performed on Day 29 and every 8 weeks thereafter for the initial 12 cycles, regardless of any dose interruptions or dose delays, and then performed per local standard practice after completion of Cycle 12. Tumor assessments were repeated at the end of study visit if more than 6 weeks had passed since the last evaluation. Unconfirmed objective response by investigator assessment was defined as a complete (disappearance of all target lesions) or partial (at least 30% decrease in the sum of diameters of target lesions) response recorded from Cycle 1 Day 1 until disease progression, start of subsequent anticancer therapy, or death due to any cause. Given the exploratory nature of the efficacy endpoint, confirmation of response was not required. Duration of response, calculated as the time from first documentation of complete response or partial response to date of first documentation of objective progression or death, was only calculated for the subgroup of patients with an unconfirmed objective response.