{"calculatePct":false,"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"2"},{"groupId":"OG001","value":"1"}]}],"title":"Number of participants meeting ≥1 DLT criteria"},{"categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"0"}]}],"title":"Grade 4 TCP or ≥Grade 3 TCP with bleeding"},{"categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"1"}]}],"title":"Unable to start next cycle of chemotherapy"}],"denoms":[{"counts":[{"groupId":"OG000","value":"12"},{"groupId":"OG001","value":"8"}],"units":"Participants"}],"description":"Dose-limiting toxicities (DLTs) were drug-related toxicities defined as follows:\n\n1. Absolute neutrophil count (ANC) \\< 0.5 × 10\\^9/L lasting for ≥ 7 days\n2. ≥ Grade 3 neutropenic infection/febrile neutropenia\n3. Grade 4 thrombocytopenia (TCP) or ≥ Grade 3 TCP with bleeding\n4. Unable to start next cycle of chemotherapy due to lack of recovery to an ANC ≥ 1.5 × 10\\^9/L and platelet count ≥ 100 × 10\\^9/L\n5. ≥ Grade 3 nonhematologic toxicity (nausea, vomiting, and diarrhea failing maximal medical management; fatigue lasting for \\> 72 hours)\n\nToxicities not clearly related to etoposide/carboplatin therapy were also considered for the purposes of determining DLTs.","groups":[{"description":"Participants received trilaciclib 200 mg/m\\^2 administered intravenously (IV) once daily on Days 1 to 3 of each 21-day E/P chemotherapy cycle.","id":"OG000","title":"Part 1: Cohort 1 Trilaciclib 200 mg/m^2"},{"description":"Participants received trilaciclib 240 mg/m\\^2 administered IV once daily on Days 1 to 3 of each 21-day E/P chemotherapy cycle.","id":"OG001","title":"Part 1: Cohort 2 Trilaciclib 240mg/m^2"}],"paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"Safety analysis set - included all enrolled participants (i.e., signed informed consent) who received at least 1 dose of study drug (etoposide, carboplatin, or trilaciclib).\n\nPart 1: Cohort 1 Trilaciclib 200 mg/m\\^2 included 1 participant from Part 2 and 1 participant from Part 1 240 mg/m\\^2 who received 200 mg/m\\^2.","reportingStatus":"POSTED","timeFrame":"Days 1-21 of Cycle 1","title":"Number of Participants With Dose Limiting Toxicities by Cohort in Cycle 1, Part 1","type":"PRIMARY","unitOfMeasure":"Participants"}