{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"18"},{"groupId":"OG001","value":"31"}]}],"title":"Number of patients with any cycle delays"},{"categories":[{"measurements":[{"groupId":"OG000","value":"34"},{"groupId":"OG001","value":"22"}]}],"title":"0 cycles"},{"categories":[{"measurements":[{"groupId":"OG000","value":"14"},{"groupId":"OG001","value":"18"}]}],"title":"1 cycle"},{"categories":[{"measurements":[{"groupId":"OG000","value":"2"},{"groupId":"OG001","value":"10"}]}],"title":"2 cycles"},{"categories":[{"measurements":[{"groupId":"OG000","value":"2"},{"groupId":"OG001","value":"3"}]}],"title":"3 or more cycles"}],"denoms":[{"counts":[{"groupId":"OG000","value":"52"},{"groupId":"OG001","value":"53"}],"units":"Participants"}],"description":"After Cycle 1, patients need to meet pre-specified laboratory parameter criteria before initiating Cycle 2 and each subsequent cycle of chemotherapy. A \"Cycle Day Status\" page asks if the cycle was delayed. If the start of the current cycle was delayed (the site answers \"Yes\"), this will be counted as a delay. Cycle delays could occur for management of toxicity (hematologic or non-hematologic) or for administrative/logistic reasons. The reason for each cycle delay was captured in the eCRF if it was related to AEs. Reasons other than AEs were not captured.","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":"Safety analysis","reportingStatus":"POSTED","timeFrame":"Induction Period. From date of first dose, 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 Any Cycle Delays and the Number of Cycles Delayed (Induction Period)","type":"SECONDARY","unitOfMeasure":"Participants"}