Data on all individuals who underwent randomization were analyzed based on the intention-to-treat basic principle. Analyses were performed with the use of SAS software, version 9.4 . Results Individual and Tumor Characteristics Of the 4004 individuals who underwent randomization, 32 had been clinically ineligible, due to the fact of concurrent disease or a tumor stage that did not meet the eligibility requirements. Another 106 patients weren’t treated based on the protocol . The features of the patients were similar in both study groups .Treatment continued before occurrence of RECIST-described disease progression or scientific deterioration, unacceptable toxic effects, withdrawal from the scholarly study, or death. In patients with RECIST-defined progression, the analysis treatment could be continuing at the investigator’s discretion and with approval from the sponsor. Study Assessments Individuals underwent baseline tumor imaging, with computed tomography or magnetic resonance imaging of the upper body, abdomen, and pelvis. Brain and bone scans were obtained at baseline if disease at these sites was suspected. Tumor assessments were performed by the investigators every 8 weeks until RECIST-described disease progression; starting with cycle 15, tumor assessments could be performed 16 weeks every, as determined by the investigator.
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