{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"3.5","upperLimit":"11.3","value":"6.5"},{"groupId":"OG001","lowerLimit":"4.1","upperLimit":"8.1","value":"5.8"},{"groupId":"OG002","lowerLimit":"4.0","upperLimit":"9.9","value":"6.2"},{"comment":"Due to zero events, the median and its confidence limits could not be estimated.","groupId":"OG003","lowerLimit":"NA","upperLimit":"NA","value":"NA"},{"groupId":"OG004","lowerLimit":"8.3","upperLimit":"25.3","value":"10.6"},{"groupId":"OG005","lowerLimit":"4.5","upperLimit":"11.8","value":"8.3"},{"groupId":"OG006","lowerLimit":"1.1","upperLimit":"12.5","value":"9.4"},{"groupId":"OG007","lowerLimit":"2.1","upperLimit":"10.0","value":"4.4"},{"comment":"The upper confidence limit for the median was not estimable, as the upper confidence limits for the survivor function lies above 0.5.","groupId":"OG008","lowerLimit":"2.1","upperLimit":"NA","value":"10.0"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"29"},{"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":"Median time (months) and 95% CI from date of first dose date of study drug/randomization until date of death. Patients who do not die during the study will be censored at the date last known to be alive.","dispersionType":"95% Confidence Interval","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":"MEDIAN","populationDescription":"The intent-to-treat (ITT) analysis set: All enrolled patients who received at least one dose of study drugs in Part 1 and all randomized patients in Part 2 on the basis of the assigned treatment.","reportingStatus":"POSTED","timeFrame":"From date of first dose of study drug (Part 1)/randomization (Part 2) until the date of death due to any cause (evaluated up to a maximum of 2220 days).","title":"Overall Survival (OS)","type":"SECONDARY","unitOfMeasure":"months"}