Safety assessments
toxicities
ADVERSE EVENTS
All patients were evaluated for new or worsening adverse events by investigator or qualified designee. The assessments were conducted weekly during the first cycle (28 days), and then monthly from cycle 2 onwards. Evaluation could be conducted at higher frequency if required by the patient’s clinical condition. The assessment included a complete physical examination, eastern cooperative oncology group (ECOG) assessment, and the recording of vital signs. All toxicities were carefully evaluated in terms of grading, seriousness, action taken regarding trial agents and causality to each study agent.