{"denoms":[{"counts":[{"groupId":"BG000","value":"19"},{"groupId":"BG001","value":"77"},{"groupId":"BG002","value":"96"}],"units":"Participants"}],"groups":[{"description":"The 1st cohort in Part 1 received trilaciclib 200 mg/m\\^2, IV once daily on Days 1 to 3 of each 21-day E/P cycle. The 2nd cohort in the Phase 1b dose-finding portion of Part 1 \\& the Phase 2a expansion cohort in Part 1 received trilaciclib 240 mg/m\\^2, IV once daily on Days 1 to 3 of each 21-day E/P cycle. Participants received standard E/P chemotherapy in 21-day cycles. Carboplatin dose was calculated using the Calvert formula with a target AUC = 5 (maximum 750 mg) IV on Day 1. Etoposide 100 mg/m\\^2 was given IV daily on Days 1, 2, \\& 3 of each 21-day cycle. Trilaciclib was only given with E/P therapy. If E/P therapy was discontinued, trilaciclib was also to be discontinued. The interval between doses of trilaciclib on successive days was not greater than 28 hours \\& between the dose of trilaciclib \\& the first dose of chemotherapy on a given day (etoposide or carboplatin) not greater than 4 hours.","id":"BG000","title":"Part 1: Dose Finding/Expansion"},{"description":"Eligible participants were randomized (1:1) to trilaciclib or placebo administered IV once daily on Days 1 to 3 of E/P therapy. Randomization was stratified by ECOG performance status (0 to 1 versus 2). Participants received trilaciclib 240 mg/m\\^2 (recommended dose from Part 1) or placebo IV once daily on Days 1 to 3 of each 21-day E/P chemotherapy cycle. Participants received standard E/P chemotherapy in 21-day cycles. The carboplatin dose was calculated using the Calvert formula with a target AUC = 5 (maximum 750 mg) IV on Day 1, and 100 mg/m\\^2 etoposide was administered IV daily on Days 1, 2, and 3 of each 21-day cycle. The interval between doses of trilaciclib/placebo on successive days was not greater than 28 hours and between the dose of trilaciclib/placebo and the first dose of chemotherapy on a given day (etoposide or carboplatin) was not greater than 4 hours.","id":"BG001","title":"Part 2: Trilaciclib/Placebo IV With E/P"},{"description":"Total of all reporting groups","id":"BG002","title":"Total"}],"measures":[{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}],"title":"<=18 years"},{"measurements":[{"groupId":"BG000","value":"7"},{"groupId":"BG001","value":"37"},{"groupId":"BG002","value":"44"}],"title":"Between 18 and 65 years"},{"measurements":[{"groupId":"BG000","value":"12"},{"groupId":"BG001","value":"40"},{"groupId":"BG002","value":"52"}],"title":">=65 years"}],"denoms":[{"counts":[{"groupId":"BG000","value":"19"},{"groupId":"BG001","value":"77"},{"groupId":"BG002","value":"96"}],"units":"Participants"}]}],"paramType":"COUNT_OF_PARTICIPANTS","title":"Age, Categorical","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"8"},{"groupId":"BG001","value":"23"},{"groupId":"BG002","value":"31"}],"title":"Female"},{"measurements":[{"groupId":"BG000","value":"11"},{"groupId":"BG001","value":"54"},{"groupId":"BG002","value":"65"}],"title":"Male"}],"denoms":[{"counts":[{"groupId":"BG000","value":"19"},{"groupId":"BG001","value":"77"},{"groupId":"BG002","value":"96"}],"units":"Participants"}]}],"paramType":"COUNT_OF_PARTICIPANTS","title":"Sex: Female, Male","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"1"},{"groupId":"BG001","value":"2"},{"groupId":"BG002","value":"3"}],"title":"Hispanic or Latino"},{"measurements":[{"groupId":"BG000","value":"18"},{"groupId":"BG001","value":"75"},{"groupId":"BG002","value":"93"}],"title":"Not Hispanic or Latino"},{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}],"title":"Unknown or Not Reported"}],"denoms":[{"counts":[{"groupId":"BG000","value":"19"},{"groupId":"BG001","value":"77"},{"groupId":"BG002","value":"96"}],"units":"Participants"}]}],"paramType":"COUNT_OF_PARTICIPANTS","title":"Ethnicity (NIH/OMB)","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"1"}],"title":"American Indian or Alaska Native"},{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"1"}],"title":"Asian"},{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}],"title":"Native Hawaiian or Other Pacific Islander"},{"measurements":[{"groupId":"BG000","value":"3"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"4"}],"title":"Black or African American"},{"measurements":[{"groupId":"BG000","value":"16"},{"groupId":"BG001","value":"73"},{"groupId":"BG002","value":"89"}],"title":"White"},{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}],"title":"More than one race"},{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"1"}],"title":"Unknown or Not Reported"}],"denoms":[{"counts":[{"groupId":"BG000","value":"19"},{"groupId":"BG001","value":"77"},{"groupId":"BG002","value":"96"}],"units":"Participants"}]}],"paramType":"COUNT_OF_PARTICIPANTS","title":"Race (NIH/OMB)","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"19"},{"groupId":"BG001","value":"39"},{"groupId":"BG002","value":"58"}],"title":"United States"},{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"38"},{"groupId":"BG002","value":"38"}],"title":"Non-United States"}],"denoms":[{"counts":[{"groupId":"BG000","value":"19"},{"groupId":"BG001","value":"77"},{"groupId":"BG002","value":"96"}],"units":"Participants"}]}],"paramType":"COUNT_OF_PARTICIPANTS","title":"Country","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","spread":"0.263","value":"1.90"},{"groupId":"BG001","spread":"0.216","value":"1.90"},{"comment":"Mean body surface area was not calculated for all participants overall.","groupId":"BG002","spread":"NA","value":"NA"}]}],"denoms":[{"counts":[{"groupId":"BG000","value":"19"},{"groupId":"BG001","value":"75"},{"groupId":"BG002","value":"94"}],"units":"Participants"}]}],"dispersionType":"STANDARD_DEVIATION","paramType":"MEAN","populationDescription":"BSA was only available for 75 of the 77 participants in Part 2.","title":"Body Surface Area","unitOfMeasure":"m^2"}],"populationDescription":"All participants randomized"}