{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"4"},{"groupId":"OG001","value":"5"},{"groupId":"OG002","value":"3"},{"groupId":"OG003","value":"3"},{"groupId":"OG004","value":"3"},{"groupId":"OG005","value":"6"},{"groupId":"OG006","value":"1"},{"groupId":"OG007","value":"25"}]}],"title":"At Least 1 TEAE"},{"categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"2"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"1"},{"groupId":"OG004","value":"1"},{"groupId":"OG005","value":"1"},{"groupId":"OG006","value":"0"},{"groupId":"OG007","value":"6"}]}],"title":"Treatment-emergent Serious Adverse Event"},{"categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"1"},{"groupId":"OG003","value":"2"},{"groupId":"OG004","value":"1"},{"groupId":"OG005","value":"0"},{"groupId":"OG006","value":"0"},{"groupId":"OG007","value":"5"}]}],"title":"Discontinued due to Adverse Events"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"1"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"},{"groupId":"OG004","value":"0"},{"groupId":"OG005","value":"0"},{"groupId":"OG006","value":"0"},{"groupId":"OG007","value":"1"}]}],"title":"Adverse Events Leading to Death"}],"denoms":[{"counts":[{"groupId":"OG000","value":"4"},{"groupId":"OG001","value":"5"},{"groupId":"OG002","value":"3"},{"groupId":"OG003","value":"3"},{"groupId":"OG004","value":"3"},{"groupId":"OG005","value":"7"},{"groupId":"OG006","value":"1"},{"groupId":"OG007","value":"26"}],"units":"Participants"}],"description":"A TEAE was defined as any event not present prior to exposure to samalizumab or any event already present that worsened in either intensity or frequency following exposure to samalizumab. A treatment-emergent serious adverse event was defined as any event that resulted in death, was immediately life threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, or was a congenital anomaly/birth defect. A summary of serious and all other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.","groups":[{"description":"Participants assigned to this dose cohort received a single IV dose of samalizumab 50 mg/m\\^2. Participants who tolerated the drug and demonstrated at least stable disease received up to 3 additional cycles of samalizumab at the same dose originally received at a minimum of 28-day intervals and beginning no sooner than 6 weeks after the initial dose.","id":"OG000","title":"Samalizumab 50 mg/m^2"},{"description":"Participants assigned to this dose cohort received a single IV dose of samalizumab 100 mg/m\\^2. Participants who tolerated the drug and demonstrated at least stable disease received up to 3 additional cycles of samalizumab at the same dose originally received at a minimum of 28-day intervals and beginning no sooner than 6 weeks after the initial dose.","id":"OG001","title":"Samalizumab 100 mg/m^2"},{"description":"Participants assigned to this dose cohort received a single IV dose of samalizumab 200 mg/m\\^2. Participants who tolerated the drug and demonstrated at least stable disease received up to 3 additional cycles of samalizumab at the same dose originally received at a minimum of 28-day intervals and beginning no sooner than 6 weeks after the initial dose.","id":"OG002","title":"Samalizumab 200 mg/m^2"},{"description":"Participants assigned to this dose cohort received a single IV dose of samalizumab 300 mg/m\\^2. Participants who tolerated the drug and demonstrated at least stable disease received up to 3 additional cycles of samalizumab at the same dose originally received at a minimum of 28-day intervals and beginning no sooner than 6 weeks after the initial dose.","id":"OG003","title":"Samalizumab 300 mg/m^2"},{"description":"Participants assigned to this dose cohort received a single IV dose of samalizumab 400 mg/m\\^2. Participants who tolerated the drug and demonstrated at least stable disease received up to 3 additional cycles of samalizumab at the same dose originally received at a minimum of 28-day intervals and beginning no sooner than 6 weeks after the initial dose.","id":"OG004","title":"Samalizumab 400 mg/m^2"},{"description":"Participants assigned to this dose cohort received a single IV dose of samalizumab 500 mg/m\\^2. Participants who tolerated the drug and demonstrated at least stable disease received up to 3 additional cycles of samalizumab at the same dose originally received at a minimum of 28-day intervals and beginning no sooner than 6 weeks after the initial dose.","id":"OG005","title":"Samalizumab 500 mg/m^2"},{"description":"Participants assigned to this dose cohort received a single IV dose of samalizumab 600 mg/m\\^2. Participants who tolerated the drug and demonstrated at least stable disease received up to 3 additional cycles of samalizumab at the same dose originally received at a minimum of 28-day intervals and beginning no sooner than 6 weeks after the initial dose.","id":"OG006","title":"Samalizumab 600 mg/m^2"},{"description":"All doses of samalizumab were individualized based on the participant's body surface area in mg/m\\^2 based on screening height and weight. Participants were assigned to a dose cohort, ranging from 50 to 600 mg/m\\^2, and received a single IV dose of samalizumab. Participants who tolerated the drug and demonstrated at least stable disease received up to 3 additional cycles of samalizumab at the same dose originally received at a minimum of 28-day intervals and beginning no sooner than 6 weeks after the initial dose.","id":"OG007","title":"Overall"}],"paramType":"NUMBER","populationDescription":"All participants who received at least 1 dose of samalizumab.","reportingStatus":"POSTED","timeFrame":"From first dose through 10 weeks after the last dose","title":"Number Of Participants With Treatment-Emergent Adverse Events (TEAEs)","type":"PRIMARY","unitOfMeasure":"participants"}