{"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityType":"OTHER","pValue":"= 0.0097","pValueComment":"The p-value was calculated using the stratified log-rank test to account for the baseline ECOG status (0-1 vs 2) as the stratification factor. Significance level was set as two-sided 0.2.","statisticalComment":"p-value calculated using stratified log-rank test with baseline ECOG status (0-1 vs 2) as stratification factor. Significance level was two-sided 0.2.","statisticalMethod":"Stratified log-rank test"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"7","upperLimit":"8","value":"8"},{"groupId":"OG001","lowerLimit":"2","upperLimit":"3","value":"3"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"16"},{"groupId":"OG001","value":"2"}],"units":"Participants"}],"description":"Severe (Grade 4) neutropenia was defined as at least 1 ANC value \\<0.5 × 10\\^9/L during the treatment period. Within each cycle, the duration (days) of severe neutropenia 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. The duration of severe neutropenia only included participants who had at least 1 severe neutropenia event in the cycle, and censoring rules were applied for unresolved severe neutropenia in a cycle. For the treatment period, the overall duration of severe neutropenia was the median value among the durations from all cycles.","dispersionType":"Inter-Quartile Range","groups":[{"description":"Participants received placebo IV once daily on Days 1 to 3 of each 21-day E/P chemotherapy cycle.","id":"OG000","title":"Part 2: Placebo"},{"description":"Participants received trilaciclib 240 mg/m\\^2 IV once daily on Days 1 to 3 of each 21-day E/P chemotherapy cycle.","id":"OG001","title":"Part 2: Trilaciclib 240 mg/m^2"}],"paramType":"MEDIAN","populationDescription":"Full analysis set (FAS) - included all randomized participants who received at least 1 dose of study drug (etoposide, carboplatin, or trilaciclib). Analyses using the FAS were conducted on the basis of the assigned treatment.","reportingStatus":"POSTED","timeFrame":"From randomization to the end of the treatment period (a minimum of 51 days up to a maximum of 379 days)","title":"Duration of Severe (Grade 4) Neutropenia in Part 2","type":"PRIMARY","unitOfMeasure":"Days"}