{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.132"},{"groupId":"OG001","value":"0.058"}]}],"title":"Major adverse hematologic events (MAHE)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0.032"},{"groupId":"OG001","value":"0.030"}]}],"title":"All-cause hospitalizations"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0.021"},{"groupId":"OG001","value":"0.085"}]}],"title":"All-cause dose reductions"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0.002"},{"groupId":"OG001","value":"0.004"}]}],"title":"Febrile neutropenia TEAEs"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0.017"},{"groupId":"OG001","value":"0.026"}]}],"title":"RBC transfusions on/after Week 5"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0.005"},{"groupId":"OG001","value":"0.170"}]}],"title":"Prolonged SN (>5 days)"}],"denoms":[{"counts":[{"groupId":"OG000","value":"54"},{"groupId":"OG001","value":"53"}],"units":"Participants"}],"description":"The composite endpoint \"major adverse hematologic events\" (MAHE) included the following aspects of myelosuppression:\n\nAll-cause hospitalizations - Each recorded preferred term (PT) with a unique start date was counted as an event.\n\nAll-cause dose reductions - Dose reductions were permitted for E/P but not for trilaciclib or atezolizumab. No more than 2 dose reductions were allowed. Each dose reduction was counted as a separate event.\n\nFebrile neutropenia-Each febrile neutropenia event with a unique start date during the Induction Period was defined as a separate event.\n\nProlonged severe neutropenia (SN)-Each cycle with a severe neutropenia duration greater than 5 days was counted as an event, with the date of the first Grade 4 laboratory value defined as the start date for the time-to-first event analysis.\n\nRed blood cell (RBC) transfusion on/after Week 5-Each RBC transfusion with a unique start date on/after Week 5 on study during the Induction Period was defined as a separate event.","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":"NUMBER","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":"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":"Major Adverse Hematologic Events (MAHE) (Composite Endpoint)","type":"SECONDARY","unitOfMeasure":"event rate per week"}