{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"1.6","upperLimit":"6.2","value":"4.2"},{"groupId":"OG001","lowerLimit":"1.7","upperLimit":"3.6","value":"3.0"},{"groupId":"OG002","lowerLimit":"2.1","upperLimit":"5.2","value":"4.2"},{"comment":"Due to only 1 event, the confidence limits for the median could not be estimated.","groupId":"OG003","lowerLimit":"NA","upperLimit":"NA","value":"5.5"},{"groupId":"OG004","lowerLimit":"1.4","upperLimit":"8.9","value":"4.3"},{"groupId":"OG005","lowerLimit":"2.1","upperLimit":"4.2","value":"3.6"},{"groupId":"OG006","lowerLimit":"0.7","upperLimit":"5.9","value":"4.5"},{"groupId":"OG007","lowerLimit":"1.3","upperLimit":"6.9","value":"1.8"},{"groupId":"OG008","lowerLimit":"1.4","upperLimit":"7.5","value":"2.1"}]}]}],"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 of study drug/randomization until date of documented disease progression or death due to any cause.\n\nInvestigators followed the Response Evaluation Criteria in Solid Tumors (RECIST), Version 1.1 guidelines for tumor assessments to determine progression. Progressive Disease (PD) was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression).","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 date of documented disease progression or death due to any cause (evaluated up to a maximum of 1335 days).","title":"Progression Free Survival (PFS)","type":"SECONDARY","unitOfMeasure":"months"}