Primary and secondary endpoints
Cancer
ADVERSE EVENTS, ADVERSE EVENT, CANCER
To assess safety as a primary outcome, patients were evaluated for presence of and changes in adverse events during each visit and were asked to report symptoms if those had occurred between visits. Adverse events (AEs) and serious adverse events (SAE) were registered and graded in accordance with the National Cancer Institute Common Terminology Criteria for AEs (CTCAE Version 4.03). On pre-defined time points around each dosing, safety laboratory assessments were done (blood chemistry, urine analysis, and hematology). The full schedule of assessments can be found in Supplementary Table 