{"anticipatedPostingDate":"2029-05","denomUnitsSelected":"Participants","description":"Adverse event (AE): any untoward medical occurrence in clinical study participant, temporally associated with use of study treatment, whether or not considered related to study treatment. AEs included both SAEs and all other (non-SAEs) AEs. SAE: any untoward medical occurrence, at any dose met one or more of following criteria: death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect or other important medical events. TEAEs: AEs that occur on or after first dose of study treatment up to 28 days after last dose of study treatment. Relatedness to study drug were judged by investigator. As per National Cancer Institute Common Terminology Criteria for AE (NCI CTCAE) severity of AEs were graded as following, Grade 1: mild, Grade 2: moderate, Grade 3: severe, Grade 4: life-threatening; urgent treatment indicated, Grade 5: death related to AE.","reportingStatus":"NOT_POSTED","timeFrame":"From the first dose of study treatment up to 28 days after last dose of study treatment","title":"Number of Participants With Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), Treatment Related TEAEs, Grade 3 or 4 and Grade 5 TEAEs as Assessed by NCI CTCAE v5.0","type":"SECONDARY"}