{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"4"},{"groupId":"OG002","value":"3"},{"groupId":"OG003","value":"6"}],"units":"Participants"}],"description":"Dose-limiting toxicity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0. Pre-specified DLT criteria included the following adverse events (AE), judged to be at least possibly related to study therapy: grade 3 or greater non-hematologic toxicity, grade 3 thrombocytopenia with bleeding, any grade 4 thrombocytopenia, grade 4 febrile neutropenia lasting \\> 7 day, any grade febrile neutropenia, any grade 5 toxicity. Treatment delay of cycle 2 by more than 2 weeks and inability to administer 3 of the 4 doses due to toxicity in the first treatment course were also considered DLTs. Controllable nausea, vomiting and diarrhea, electrolyte toxicities correctable (to baseline or grade 1) with repletion and grade 3 creatinine elevation correctable (to grade 1 or less) with IV hydration were not considered DLT's.","groups":[{"description":"TRC102 50 mg/day PO days 1-4; Pemetrex 500 mg/m\\^2 IV over 10 min day1; Cisplatin 60 mg/m\\^2 IV over 30-60 min day1","id":"OG000","title":"Arm A, Dose Level 1 - 50mg TRC102, 60mg/m^2 Cisplatin (Phase I)"},{"description":"TRC102 75 mg/day PO days 1-4; Pemetrex 500 mg/m\\^2 IV over 10 min day1; Cisplatin 60 mg/m\\^2 IV over 30-60 min day1","id":"OG001","title":"Arm A, Dose Level 2 - 75mg TRC102, 60mg/m^2 Cisplatin (Phase I)"},{"description":"TRC102 100/day mg PO days 1-4; Pemetrex 500 mg/m\\^2 IV over 10 min day1; Cisplatin 60 mg/m\\^2 IV over 30-60 min day1","id":"OG002","title":"Arm A, Dose Level 3 - 100mg TRC102, 60mg/m^2 Cisplatin (Phase I)"},{"description":"TRC102 100/day mg PO days 1-4; Pemetrex 500 mg/m\\^2 IV over 10 min day1; Cisplatin 75 mg/m\\^2 IV over 30-60 min day1","id":"OG003","title":"Arm A, Dose Level 4 - 100mg TRC102, 75mg/m^2 Cisplatin (Phase I)"}],"paramType":"COUNT_OF_PARTICIPANTS","reportingStatus":"POSTED","timeFrame":"During the first cycle of treatment, up to 21 days","title":"Number of Participants With at Least One Dose Limiting Toxicity (DLT) - Phase I","type":"PRIMARY","unitOfMeasure":"Participants"}