{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"1"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"8"},{"groupId":"OG001","value":"15"}],"units":"Participants"}],"description":"A DLT is defined as an Adverse Event (AE) that is likely related to the study medication or combination, and fulfills any one of the following criteria, graded according to the National Cancer Institute's (NCI) Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5.0:\n\n1\\. Any death not clearly due to the underlying disease or extraneous causes 2. Neutropenic fever 2. Any Grade ≥3 non-hematologic toxicity 3. Grade ≥4 neutropenia or thrombocytopenia \\>7 days 4. Grade ≥3 thrombocytopenia with bleeding 5. Grade ≥3 nausea/vomiting or diarrhea\\>72 hours with adequate antiemetic and other supportive care 6. Grade ≥3 fatigue ≥1 week 7. Grade ≥3 electrolyte abnormality that lasts\\>72 hours, unless the Participant has clinical symptoms, in which case all Grade 3+electrolyte abnormality regardless of duration should count as a DLT.\n\n8\\. Grade ≥3 prolongation of QT interval corrected using the Fridericia formula on 2 separate electrocardiogram readings approximately 5 min apart.","groups":[{"description":"Participants received 8 mg/kg Ramucirumab administered as an intravenous infusion Q2W with 3 doses per 42 day cycle.","id":"OG000","title":"8 mg/kg Ramucirumab (Part A)"},{"description":"Participants received 12 mg/kg Ramucirumab as an intravenous injection Q2W with 3 doses per cycle.","id":"OG001","title":"12 mg/kg Ramucirumab (Part A)"}],"paramType":"NUMBER","populationDescription":"All randomized participants from Part A, who received at least one dose of study drug.","reportingStatus":"POSTED","timeFrame":"Baseline to Study Completion (Up to 42 Months)","title":"Part A: Number of Participants With Dose Limiting Toxicities (DLTs): Maximum Tolerated Dose of Ramucirumab","type":"PRIMARY","unitOfMeasure":"Participants"}