{"analyses":[{"groupDescription":"Analysis was for Part 2 data: Treatment difference was evaluated using a nonparametric analysis of covariance (ANCOVA). The nonparametric ANCOVA included study baseline ANC value as covariate, stratification factors of ECOG performance status (0 to 1 versus 2) and sensitivity to first line treatment (sensitive or resistant) and treatment as fixed effects.","groupIds":["OG000","OG002"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.0001","pValueComment":"A Hochberg-based gatekeeping procedure was used to control the global familywise error rate across the multiple null hypotheses (primary and key secondary myelosuppression efficacy endpoints) in a strong sense at a 1-sided 0.10 level.","statisticalComment":"Hochberg-based gatekeeping procedure","statisticalMethod":"non-parametric ANCOVA"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","spread":"6.0","value":"8"},{"groupId":"OG001","spread":"3.1","value":"1"},{"groupId":"OG002","spread":"3.9","value":"2"},{"groupId":"OG003","spread":"1.4","value":"14"},{"groupId":"OG004","spread":"6.8","value":"8"},{"groupId":"OG005","spread":"0","value":"0"},{"groupId":"OG006","spread":"0","value":"0"},{"groupId":"OG007","spread":"3.6","value":"2"},{"groupId":"OG008","spread":"5.5","value":"3"}]}]}],"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":"Duration of severe neutropenia (DSN; days) was defined as the number of days from the date of the first ANC value of \\<0.5 × 10\\^9/L observed between start of cycle and end of cycle to the date of the first ANC value ≥0.5 × 10\\^9/L that met the following criteria: (1) occurred after the ANC value of \\<0.5 × 10\\^9/L and (2) no other ANC values \\<0.5 × 10\\^9/L occurred between this day and end of cycle. DSN is set to 0 for patients who did not experience SN in a cycle, including those who were randomized but never treated. Data from unscheduled visits and the actual assessment date (rather than visit date) were included in the derivation.","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\nPlacebo\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":"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":"Evaluated for Cycle 1 (i.e., from date of first dose of study drug (Part 1)/randomization (Part 2) to the end of Cycle 1, each cycle = 21 days)","title":"Duration of Severe (Grade 4) Neutropenia in Cycle 1","type":"PRIMARY","unitOfMeasure":"days"}