{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"10"},{"groupId":"OG001","value":"12"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"54"},{"groupId":"OG001","value":"53"}],"units":"Participants"}],"description":"Occurrence of an IV antibiotics administration during the induction treatment period is defined as a binary variable (Yes or No); Yes if total number of IV antibiotics administration ≥ 1 is observed, No for other scenarios. Each IV antibiotic with a unique start date during the induction treatment period will be defined as a separate event. The criteria for identifying an IV antibiotic administration event was (1) if the therapeutic subgroup from WHO-DD Version September 2017 (ie, TEXT2 for CODE2) takes the value \"ANTIBACTERIALS FOR SYSTEMIC USE,\" and (2) the route of medication was \"intravenous\" or the route was \"other\" with the detailed specification as \"IVPB.\"","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":"COUNT_OF_PARTICIPANTS","populationDescription":"Intent-to-treat","reportingStatus":"POSTED","timeFrame":"Induction Period. From date of randomization, 21 day treatment cycles to a maximum of 4 cycles or until (if earlier) disease progression, unacceptable toxicity, or discontinuation by the patient or investigator, assessed up to a maximum of 409 days.","title":"Number of Participants With at Least 1 Occurrence of IV Antibiotic Uses","type":"SECONDARY","unitOfMeasure":"Participants"}