{"analyses":[{"ciNumSides":"ONE_SIDED","ciPctValue":"95","groupDescription":"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 brain metastases (Yes versus No), and treatment as a fixed effect.","groupIds":["OG000","OG001"],"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 (for 2 primary and 3 key secondary endpoints) in a strong sense at a 1-sided 0.025 level.","statisticalComment":"Hochberg-based gatekeeping procedure","statisticalMethod":"non-parametric ANCOVA"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","spread":"1.0","value":"0"},{"groupId":"OG001","spread":"4.7","value":"4"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"54"},{"groupId":"OG001","value":"53"}],"units":"Participants"}],"description":"Duration of severe neutropenia (DSN; days) was defined as the number of days from the date of the first absolute neutrophil count (ANC) value of \\<0.5 × 10⁹/L observed between start of cycle and end of cycle to the date of the first ANC value ≥0.5 × 10⁹/L that met the following criteria: (1) occurred after the ANC value of \\<0.5 × 10⁹/L and (2) no other ANC values \\<0.5 × 10⁹/L occurred between this day and end of cycle. DSN was set to 0 for patients who did not experience severe neutropenia in a cycle, including those that were randomized and not treated. Data from unscheduled visits and the actual assessment date (rather than visit date) were included in the derivation.","dispersionType":"Standard Deviation","groups":[{"description":"Induction: Patients received trilaciclib 240 mg/m² administered IV once daily prior to E/P/A on Days 1, 2 and 3 of each 21-day E/P/A therapy cycle (up to 4 cycles in total). Etoposide 100 mg/m² was administered IV daily on Days 1, 2, and 3 of each 21-day cycle. Carboplatin was administered on Day 1 of each 21-day cycle using the Calvert formula with a target AUC = 5 mg/mL/min to calculate the dose. Atezolizumab 1200 mg was administered as an IV infusion on Day 1 of each 21-day cycle.\n\nMaintenance: Following the induction phase, patients received maintenance atezolizumab at a dose of 1200 mg on Day 1 of every 21-day cycle until disease progression, unacceptable toxicity, or discontinuation by the patient or investigator.","id":"OG000","title":"Trilaciclib+Etoposide/Carboplatin/Atezolizumab"},{"description":"Induction: Patients received placebo administered IV once daily prior to E/P/A on Days 1, 2 and 3 of each 21-day E/P/A therapy cycle (up to 4 cycles in total). Etoposide 100 mg/m² was administered IV daily on Days 1, 2, and 3 of each 21-day cycle. Carboplatin was administered on Day 1 of each 21-day cycle using the Calvert formula with a target AUC = 5 mg/mL/min to calculate the dose. Atezolizumab 1200 mg was administered as an IV infusion on Day 1 of each 21-day cycle.\n\nMaintenance: Following the induction phase, patients received maintenance atezolizumab at a dose of 1200 mg on Day 1 of every 21-day cycle until disease progression, unacceptable toxicity, or discontinuation by the patient or investigator.","id":"OG001","title":"Placebo+Etoposide/Carboplatin/Atezolizumab"}],"paramType":"MEAN","populationDescription":"Intent-to-treat (ITT) analysis set included all randomized patients. Analysis using the ITT analysis set were conducted on the basis of the randomly assigned treatment.","reportingStatus":"POSTED","timeFrame":"Evaluated for Cycle 1 of the Induction Period (i.e., from randomization to the end of Cycle 1, each cycle = 21 days).","title":"Duration of Severe (Grade 4) Neutropenia in Cycle 1","type":"PRIMARY","unitOfMeasure":"days"}