{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"13"},{"groupId":"OG003","value":"0"},{"groupId":"OG004","value":"0"},{"groupId":"OG005","value":"0"},{"groupId":"OG006","value":"0"},{"groupId":"OG007","value":"0"},{"groupId":"OG008","value":"0"},{"groupId":"OG009","value":"0"},{"groupId":"OG010","value":"0"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"5"},{"groupId":"OG001","value":"3"},{"groupId":"OG002","value":"8"},{"groupId":"OG003","value":"6"},{"groupId":"OG004","value":"6"},{"groupId":"OG005","value":"6"},{"groupId":"OG006","value":"8"},{"groupId":"OG007","value":"7"},{"groupId":"OG008","value":"9"},{"groupId":"OG009","value":"11"},{"groupId":"OG010","value":"11"}],"units":"Participants"}],"description":"Toxicity was graded and recorded according to National Cancer Institute (NCI) Common Toxicity Criteria for Adverse Events version 3.0 (CTCAE 3.0). A DLT was defined as any Grade 3 or 4 toxicity. A Grade 3 toxicity was defined as severe or medically significant but not immediately life-threatening OR hospitalization or prolongation of hospitalization indicated OR disabling OR limiting self care activities of daily living. A Grade 4 toxicity was defined as: life-threatening consequences OR urgent intervention indicated. Participants were monitored for the occurrence of DLTs during the first 3 weeks of dosing with dalotuzumab.","groups":[{"description":"Participants received dalotuzumab 1.25 mg/kg (10 mg/mL) IV infusion Q1W.","id":"OG000","title":"Dalotuzumab 1.25 mg/kg Q1W (10 mg/mL)"},{"description":"Participants received dalotuzumab 2.5 mg/kg (10 mg/mL) IV infusion Q1W.","id":"OG001","title":"Dalotuzumab 2.5 mg/kg Q1W (10 mg/mL)"},{"description":"Participants received dalotuzumab 5 mg/kg (10 mg/mL) IV infusion Q1W.","id":"OG002","title":"Dalotuzumab 5 mg/kg Q1W (10 mg/mL)"},{"description":"Participants received dalotuzumab 10 mg/kg (10 mg/mL) IV infusion Q1W.","id":"OG003","title":"Dalotuzumab 10 mg/kg Q1W (10 mg/mL)"},{"description":"Participants received dalotuzumab 10 mg/kg (20 mg/mL) IV infusion Q1W.","id":"OG004","title":"Dalotuzumab 10 mg/kg Q1W (20 mg/mL)"},{"description":"Participants received dalotuzumab 15 mg/kg (10 mg/mL) IV infusion Q1W.","id":"OG005","title":"Dalotuzumab 15 mg/kg Q1W (10 mg/mL)"},{"description":"Participants received dalotuzumab 15 mg/kg (20 mg/ mL) IV infusion Q1W.","id":"OG006","title":"Dalotuzumab 15 mg/kg Q1W (20 mg/mL)"},{"description":"Participants received dalotuzumab 20 mg/kg (10 mg/mL) IV infusion Q1W.","id":"OG007","title":"Dalotuzumab 20 mg/kg Q1W (10 mg/mL)"},{"description":"Participants received dalotuzumab 20.0 mg/kg (20 mg/mL) IV infusion Q1W.","id":"OG008","title":"Dalotuzumab 20 mg/kg Q1W (20 mg/mL)"},{"description":"Participants received dalotuzumab 20 mg/kg (20 mg/mL) IV infusion Q2W.","id":"OG009","title":"Dalotuzumab 20 mg/kg Q2W (20 mg/mL)"},{"description":"Participants received dalotuzumab 30 mg/kg (20 mg/mL) IV infusion Q3W.","id":"OG010","title":"Dalotuzumab 30 mg/kg Q3W (20 mg/mL)"}],"paramType":"NUMBER","populationDescription":"The population consisted of all participants who received at least one dose of study drug.","reportingStatus":"POSTED","timeFrame":"Up to 3 weeks","title":"Percentage of Participants Who Experienced One or More Dose-limiting Toxicities (DLTs)","type":"PRIMARY","unitOfMeasure":"Percentage of Participants"}