{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"8"},{"groupId":"OG001","value":"7"},{"groupId":"OG002","value":"4"},{"groupId":"OG003","value":"11"},{"groupId":"OG004","value":"7"},{"groupId":"OG005","value":"7"}]}],"title":"Any TEAE"},{"categories":[{"measurements":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"3"},{"groupId":"OG002","value":"2"},{"groupId":"OG003","value":"9"},{"groupId":"OG004","value":"6"},{"groupId":"OG005","value":"4"}]}],"title":"Any TESAE"}],"denoms":[{"counts":[{"groupId":"OG000","value":"10"},{"groupId":"OG001","value":"7"},{"groupId":"OG002","value":"4"},{"groupId":"OG003","value":"11"},{"groupId":"OG004","value":"7"},{"groupId":"OG005","value":"7"}],"units":"Participants"}],"description":"An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE is defined as an AE that meets one of the following criteria: fatal or life-threatening; results in persistent or significant disability/incapacity; constitutes a congenital anomaly/birth defect; medically significant (an event that jeopardizes the participant or may require medical or surgical intervention to prevent one of the outcomes listed above \\[medical and scientific judgment must be exercised in deciding whether an AE is 'medically important'\\]); required inpatient hospitalization or prolongation of existing hospitalization. A TEAE is defined as an AE occurring or worsening during the treatment period including the safety follow-up period.","groups":[{"description":"Participants received 0.1 mg/kg of GEN1029 every 2 weeks (Q2W) until the end of treatment.","id":"OG000","title":"Biweekly Regimen (GEN1029 0.1 mg/kg)"},{"description":"Participants received 0.2 mg/kg of GEN1029 Q2W until the end of treatment.","id":"OG001","title":"Biweekly Regimen (GEN1029 0.2 mg/kg)"},{"description":"Participants received 0.3 mg/kg of GEN1029 Q2W until the end of treatment.","id":"OG002","title":"Biweekly Regimen (GEN1029 0.3 mg/kg)"},{"description":"Participants received 1.0 mg/kg of GEN1029 Q2W until the end of treatment.","id":"OG003","title":"Biweekly Regimen (GEN1029 1.0 mg/kg)"},{"description":"Participants received 2.0 mg/kg of GEN1029 Q2W until the end of treatment.","id":"OG004","title":"Biweekly Regimen (GEN1029 2.0 mg/kg)"},{"description":"Participants received 3.0 mg/kg of GEN1029 Q2W until the end of treatment.","id":"OG005","title":"Biweekly Regimen (GEN1029 3.0 mg/kg)"}],"paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"The Safety Set consists of all participants who received at least one dose of GEN1029 and analyzed according to the actual trial treatment received.","reportingStatus":"POSTED","timeFrame":"Day 1 through Day 565 (corresponding to maximum observed duration)","title":"Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)","type":"PRIMARY","unitOfMeasure":"Participants"}