{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"2"},{"groupId":"OG001","value":"2"},{"groupId":"OG002","value":"2"},{"groupId":"OG003","value":"0"},{"groupId":"OG004","value":"2"},{"groupId":"OG005","value":"2"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"2"},{"groupId":"OG001","value":"3"},{"groupId":"OG002","value":"4"},{"groupId":"OG003","value":"8"},{"groupId":"OG004","value":"7"},{"groupId":"OG005","value":"8"}],"units":"Participants"}],"description":"The percentage of patients experiencing DLTs in Part 1 of the study in each cohort, including:\n\n* Absolute neutrophil count (ANC) \\< 0.5 × 10\\^9/L lasting for ≥ 7 days\n* ≥ Grade 3 neutropenic infection/febrile neutropenia\n* Grade 4 thrombocytopenia or ≥ Grade 3 thrombocytopenia with bleeding\n* 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; a delay of up to 1 week from the scheduled start of Cycle 2 is allowed for recovery of ANC and platelet count, and is not considered a DLT\n* ≥ Grade 3 nonhematologic toxicity (nausea, vomiting, and diarrhea failing maximal medical management; fatigue lasting for \\> 72 hours)","groups":[{"description":"Patients received trilaciclib (200, 240, or 280 mg/m²) administered intravenously (IV) once daily on Days 1 to 5 of each 21-day topotecan chemotherapy cycle.\n\nFollowing administration of trilaciclib on Days 1 to 5, patients received IV topotecan (0.75, 1.0, 1.25, or 1.50 mg/m²).\n\nTrilaciclib\n\nTopotecan","id":"OG000","title":"Trilaciclib (G1T28) 200 mg/m² + Topotecan 1.5 mg/m²- Part 1 Cohort 1"},{"description":"Patients received trilaciclib (200, 240, or 280 mg/m²) administered intravenously (IV) once daily on Days 1 to 5 of each 21-day topotecan chemotherapy cycle.\n\nFollowing administration of trilaciclib on Days 1 to 5, patients received IV topotecan (0.75, 1.0, 1.25, or 1.50 mg/m²).\n\nTrilaciclib\n\nTopotecan","id":"OG001","title":"Trilaciclib (G1T28) 200 mg/m² + Topotecan 1.25 mg/m²- Part 1 Cohort 2"},{"description":"Patients received trilaciclib (200, 240, or 280 mg/m²) administered intravenously (IV) once daily on Days 1 to 5 of each 21-day topotecan chemotherapy cycle.\n\nFollowing administration of trilaciclib on Days 1 to 5, patients received IV topotecan (0.75, 1.0, 1.25, or 1.50 mg/m²).\n\nTrilaciclib\n\nTopotecan","id":"OG002","title":"Trilaciclib (G1T28) 200 mg/m² + Topotecan 0.75 mg/m²- Part 1 Cohort 3"},{"description":"Patients received trilaciclib (200, 240, or 280 mg/m²) administered intravenously (IV) once daily on Days 1 to 5 of each 21-day topotecan chemotherapy cycle.\n\nFollowing administration of trilaciclib on Days 1 to 5, patients received IV topotecan (0.75, 1.0, 1.25, or 1.50 mg/m²).\n\nTrilaciclib\n\nTopotecan","id":"OG003","title":"Trilaciclib (G1T28) 240 mg/m² + Topotecan 0.75 mg/m²- Part 1 Cohorts 4 and 6"},{"description":"Patients received trilaciclib (200, 240, or 280 mg/m²) administered intravenously (IV) once daily on Days 1 to 5 of each 21-day topotecan chemotherapy cycle.\n\nFollowing administration of trilaciclib on Days 1 to 5, patients received IV topotecan (0.75, 1.0, 1.25, or 1.50 mg/m²).\n\nTrilaciclib\n\nTopotecan","id":"OG004","title":"Trilaciclib (G1T28) 280 mg/m² + Topotecan 0.75 mg/m²- Part 1 Cohort 5"},{"description":"Patients received trilaciclib (200, 240, or 280 mg/m²) administered intravenously (IV) once daily on Days 1 to 5 of each 21-day topotecan chemotherapy cycle.\n\nFollowing administration of trilaciclib on Days 1 to 5, patients received IV topotecan (0.75, 1.0, 1.25, or 1.50 mg/m²).\n\nTrilaciclib\n\nTopotecan","id":"OG005","title":"Trilaciclib (G1T28) 240 mg/m² + Topotecan 1.0 mg/m²- Part 1 Cohort 7"}],"paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"The safety analysis set: All enrolled patients who received at least 1 dose of study drug.","reportingStatus":"POSTED","timeFrame":"Evaluated for Cycle 1 (i.e., from date of first dose of study drug (Part 1) to the end of Cycle 1, each cycle = 21 days)","title":"Assess the Dose Limiting Toxicities (DLTs) of G1T28/Trilaciclib Administered With Topotecan in Part 1","type":"PRIMARY","unitOfMeasure":"Participants"}