{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"},{"groupId":"OG004","value":"0"},{"groupId":"OG005","value":"0"},{"groupId":"OG006","value":"0"},{"groupId":"OG007","value":"0"},{"groupId":"OG008","value":"0"}]}],"title":"Complete Response (CR)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"5"},{"groupId":"OG001","value":"3"},{"groupId":"OG002","value":"5"},{"groupId":"OG003","value":"1"},{"groupId":"OG004","value":"2"},{"groupId":"OG005","value":"0"},{"groupId":"OG006","value":"1"},{"groupId":"OG007","value":"0"},{"groupId":"OG008","value":"1"}]}],"title":"Partial Response (PR)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"10"},{"groupId":"OG001","value":"15"},{"groupId":"OG002","value":"13"},{"groupId":"OG003","value":"1"},{"groupId":"OG004","value":"0"},{"groupId":"OG005","value":"3"},{"groupId":"OG006","value":"6"},{"groupId":"OG007","value":"3"},{"groupId":"OG008","value":"3"}]}],"title":"Stable Disease (SD)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"6"},{"groupId":"OG001","value":"9"},{"groupId":"OG002","value":"6"},{"groupId":"OG003","value":"0"},{"groupId":"OG004","value":"1"},{"groupId":"OG005","value":"1"},{"groupId":"OG006","value":"1"},{"groupId":"OG007","value":"2"},{"groupId":"OG008","value":"2"}]}],"title":"Progressive Disease (PD)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"2"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"},{"groupId":"OG004","value":"0"},{"groupId":"OG005","value":"0"},{"groupId":"OG006","value":"0"},{"groupId":"OG007","value":"0"},{"groupId":"OG008","value":"0"}]}],"title":"Not Evaluable (NE)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"2"},{"groupId":"OG001","value":"2"},{"groupId":"OG002","value":"6"},{"groupId":"OG003","value":"0"},{"groupId":"OG004","value":"0"},{"groupId":"OG005","value":"0"},{"groupId":"OG006","value":"0"},{"groupId":"OG007","value":"1"},{"groupId":"OG008","value":"1"}]}],"title":"No post-baseline tumor assessment (Missing)"}],"denoms":[{"counts":[{"groupId":"OG000","value":"26"},{"groupId":"OG001","value":"29"},{"groupId":"OG002","value":"30"},{"groupId":"OG003","value":"2"},{"groupId":"OG004","value":"3"},{"groupId":"OG005","value":"4"},{"groupId":"OG006","value":"8"},{"groupId":"OG007","value":"6"},{"groupId":"OG008","value":"7"}],"units":"Participants"}],"description":"The percentage of patients who fall into each category of Best overall response (BOR) as defined by RECIST, Version 1.1.\n\nComplete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions.\n\nProgressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions.\n\nStable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.\n\nWhen no imaging/measurement is done, the patient is not evaluable (NE); and if only a subset of lesion measurements are made, usually the case is also considered NE.","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":"COUNT_OF_PARTICIPANTS","populationDescription":"Response-Evaluable analysis set: All patients who are in the mITT, have measurable disease (target lesions) at the baseline tumor assessment, and either (i) have at least 1 post-baseline tumor assessment, (ii) have clinical progression as noted by the investigator before their first post-baseline tumor scan, or (iii) have died due to disease progression before their first post-baseline tumor scan.","reportingStatus":"POSTED","timeFrame":"From date of first dose of study drug (Part 1)/randomization (Part 2) until the occurrence of progressive disease, withdrawal of consent, or initiation of subsequent anti-cancer therapy, (assessed up to a maximum of 1335 days).","title":"Tumor Response Based on RECIST, Version 1.1","type":"SECONDARY","unitOfMeasure":"Participants"}