{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"},{"groupId":"OG004","value":"0"},{"groupId":"OG005","value":"1"},{"groupId":"OG006","value":"3"},{"groupId":"OG007","value":"0"},{"groupId":"OG008","value":"0"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"3"},{"groupId":"OG002","value":"3"},{"groupId":"OG003","value":"3"},{"groupId":"OG004","value":"3"},{"groupId":"OG005","value":"6"},{"groupId":"OG006","value":"4"},{"groupId":"OG007","value":"8"},{"groupId":"OG008","value":"1"}],"units":"Participants"}],"description":"Adverse events, including DLTs, were graded using the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. A DLT was considered as any of the below, if judged by the investigator to be possibly related to AMG 224:\n\nHematological:\n\n* Grade 4 neutropenia lasting \\> 7 days\n* Grade 3 or 4 neutropenia with fever \\> 38.5°C\n* Grade 3 thrombocytopenia with ≥ Grade 2 hemorrhage\n* Grade 4 thrombocytopenia lasting \\> 7 days\n* Grade 3 anemia with symptoms or required intervention\n* Grade 4 anemia\n* Lymphopenia is not considered a DLT\n\nNon-hematological:\n\n* ≥ Grade 3 nausea, vomiting or diarrhea persisting \\> 3 days despite optimal medical support\n* Grade 3 fatigue persisting \\> 7 days\n* ≥ Grade 3 acute kidney injury lasting \\> 3 days\n* Elevation of aspartate aminotransferase or alanine aminotransferase \\>3x to \\>8x upper limit of normal (ULT) dependent on criteria\n* Total bilirubin \\> 3x ULN\n\nParticipants meeting the criteria for Hy's Law case were considered to have a DLT.","groups":[{"description":"Participants were administered AMG 224 Dose A as an intravenous (IV) infusion once every 3 weeks (Q3W) on Day 1 of each cycle, where each cycle is 3 weeks.","id":"OG000","title":"Dose Exploration: AMG 224 Dose A"},{"description":"Participants were administered AMG 224 Dose B as an IV infusion Q3W on Day 1 of each cycle, where each cycle is 3 weeks.","id":"OG001","title":"Dose Exploration: AMG 224 Dose B"},{"description":"Participants were administered AMG 224 Dose C as an IV infusion Q3W on Day 1 of each cycle, where each cycle is 3 weeks.","id":"OG002","title":"Dose Exploration: AMG 224 Dose C"},{"description":"Participants were administered AMG 224 Dose D as an IV infusion Q3W on Day 1 of each cycle, where each cycle is 3 weeks.","id":"OG003","title":"Dose Exploration: AMG 224 Dose D"},{"description":"Participants were administered AMG 224 Dose E as an IV infusion Q3W on Day 1 of each cycle, where each cycle is 3 weeks.","id":"OG004","title":"Dose Exploration: AMG 224 Dose E"},{"description":"Participants were administered AMG 224 Dose F as an IV infusion Q3W on Day 1 of each cycle, where each cycle is 3 weeks.","id":"OG005","title":"Dose Exploration: AMG 224 Dose F"},{"description":"Participants were administered AMG 224 Dose G as an IV infusion Q3W on Day 1 of each cycle, where each cycle is 3 weeks.","id":"OG006","title":"Dose Exploration: AMG 224 Dose G"},{"description":"Participants who had prior treatment with CD38-targeting antibody were administered AMG 224 Dose H (the maximum tolerated dose \\[MTD\\] identified based on the dose exploration phase) as an IV infusion Q3W on Day 1 of each cycle, where each cycle is 3 weeks.","id":"OG007","title":"Dose Expansion: AMG 224 Dose H + Prior CD38 Targeting Antibody Treatment"},{"description":"Participants who had no prior treatment with CD38-targeting antibody were administered AMG 224 Dose H (the MTD identified based on the dose exploration phase) as an IV infusion Q3W on Day 1 of each cycle, where each cycle is 3 weeks.","id":"OG008","title":"Dose Expansion: AMG 224 Dose H + no Prior CD38 Targeting Antibody Treatment"}],"paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"DLT analysis set: all participants who are DLT evaluable. A participant was not DLT-evaluable if the participant discontinued treatment for any reason other than a DLT prior to completing the first 28 days of AMG 224 treatment or did not receive 2 doses of AMG 224 during the 28-day DLT window.","reportingStatus":"POSTED","timeFrame":"Day 1 to Day 28","title":"Number of Participants Who Experienced a Dose-Limiting Toxicity (DLT)","type":"PRIMARY","unitOfMeasure":"Participants"}