{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","spread":"3.4","value":"4"},{"groupId":"OG001","spread":"5.4","value":"5"},{"groupId":"OG002","spread":"4.4","value":"5"},{"groupId":"OG003","spread":"0.0","value":"6"},{"groupId":"OG004","spread":"5.0","value":"7"},{"groupId":"OG005","spread":"1.7","value":"4"},{"groupId":"OG006","spread":"2.9","value":"6"},{"groupId":"OG007","spread":"3.4","value":"4"},{"groupId":"OG008","spread":"2.2","value":"4"}]}],"title":"Number of cycles completed"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"1.2","value":"1"},{"groupId":"OG001","spread":"2.5","value":"2"},{"groupId":"OG002","spread":"1.4","value":"1"},{"groupId":"OG003","spread":"1.4","value":"3"},{"groupId":"OG004","spread":"1.2","value":"1"},{"groupId":"OG005","spread":"0.5","value":"1"},{"groupId":"OG006","spread":"0.8","value":"1"},{"groupId":"OG007","spread":"0.5","value":"0"},{"groupId":"OG008","spread":"1.0","value":"1"}]}],"title":"Number of cycles delayed"}],"denoms":[{"counts":[{"groupId":"OG000","value":"28"},{"groupId":"OG001","value":"30"},{"groupId":"OG002","value":"32"},{"groupId":"OG003","value":"2"},{"groupId":"OG004","value":"3"},{"groupId":"OG005","value":"4"},{"groupId":"OG006","value":"8"},{"groupId":"OG007","value":"7"},{"groupId":"OG008","value":"8"}],"units":"Participants"}],"description":"Average exposure and cycle modifications in chemotherapy (topotecan)","dispersionType":"Standard Deviation","groups":[{"description":"Patients in Parts 2a and 2b were randomized 1:2 to placebo. Patients received placebo administered IV once daily on Days 1 to 5 of each 21-day topotecan chemotherapy cycle.\n\nFollowing administration of placebo on Days 1 to 5, patients received IV topotecan (1.5 mg/m²).\n\nPlacebos\n\nTopotecan","id":"OG000","title":"Placebo + Topotecan 1.5 mg/m² - Parts 2a and 2b"},{"description":"Patients in Part 2a were randomized 2:1 to trilaciclib. Patients received trilaciclib (240 mg/m²) administered 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 mg/m²).\n\nTrilaciclib\n\nTopotecan","id":"OG001","title":"Trilaciclib (G1T28) 240 mg/m² + Topotecan 0.75 mg/m² - Part 2a"},{"description":"Patients in Part 2b were randomized 2:1 to trilaciclib. Patients received trilaciclib (240 mg/m²) administered 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 (1.5 mg/m²).\n\nTrilaciclib\n\nTopotecan","id":"OG002","title":"Trilaciclib (G1T28) 240 mg/m² + Topotecan 1.5 mg/m² - Part 2b"},{"description":"Patients received trilaciclib (200 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 (1.50 mg/m²).","id":"OG003","title":"Trilaciclib (G1T28) 200 mg/m² + Topotecan 1.5 mg/m² - Cohort 1- Part 1"},{"description":"Patients received trilaciclib (200 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 (1.25 mg/m²).","id":"OG004","title":"Trilaciclib (G1T28) 200 mg/m² + Topotecan 1.25 mg/m² - Cohort 2- Part 1"},{"description":"Patients received trilaciclib (200 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 mg/m²).","id":"OG005","title":"Trilaciclib (G1T28) 200 mg/m² + Topotecan 0.75 mg/m² - Cohort 3- Part 1"},{"description":"Patients received trilaciclib (240 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 mg/m²).","id":"OG006","title":"Trilaciclib (G1T28) 240 mg/m² + Topotecan 0.75 mg/m² - Cohorts 4 and 6- Part 1"},{"description":"Patients received trilaciclib (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 mg/m²).","id":"OG007","title":"Trilaciclib (G1T28) 280 mg/m² + Topotecan 0.75 mg/m² - Cohort 5- Part 1"},{"description":"Patients received trilaciclib (240 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 (1.0 mg/m²).","id":"OG008","title":"Trilaciclib (G1T28) 240 mg/m² + Topotecan 1.0 mg/m² - Cohort 7- Part 1"}],"paramType":"MEAN","populationDescription":"Safety analysis set: All enrolled patients who received at least 1 dose of study drug.","reportingStatus":"POSTED","timeFrame":"During the treatment period. From date of first dose, 21 day treatment cycles continue until disease progression, unacceptable toxicity, or discontinuation by the patient or investigator (assessed up to a maximum of 1335 days).","title":"Chemotherapy Cycles and Modifications Overall","type":"SECONDARY","unitOfMeasure":"cycles"}