{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"12"},{"groupId":"OG001","value":"8"}]}],"title":"Any TEAE"},{"categories":[{"measurements":[{"groupId":"OG000","value":"4"},{"groupId":"OG001","value":"1"}]}],"title":"Any SAE"},{"categories":[{"measurements":[{"groupId":"OG000","value":"10"},{"groupId":"OG001","value":"8"}]}],"title":"TEAE related to any study drug"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"}]}],"title":"SAE related to any study drug"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"}]}],"title":"TEAE leading to discontinuation of any study drug"}],"denoms":[{"counts":[{"groupId":"OG000","value":"12"},{"groupId":"OG001","value":"8"}],"units":"Participants"}],"description":"An AE was defined as any untoward medical occurrence in a participant administered a medicinal product that did not necessarily have a causal relationship with this treatment. TEAEs were defined as any AE that started on or after the first dose of study drug and up to the last dose +30 days. SAEs were defined as any untoward medical occurrence that at any dose resulted in death, was life threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity or was a congenital anomaly/birth defect. Relatedness to study drug was assessed by the investigator. Related refers to those events that were Possibly, Probably, or Definitely Related. AEs with an unknown/not reported onset date were also included.","groups":[{"description":"Participants received trilaciclib 200 mg/m\\^2 administered intravenously (IV) once daily on Days 1 to 3 of each 21-day E/P chemotherapy cycle.","id":"OG000","title":"Part 1: Cohort 1 Trilaciclib 200 mg/m^2"},{"description":"Participants received trilaciclib 240 mg/m\\^2 administered IV once daily on Days 1 to 3 of each 21-day E/P chemotherapy cycle.","id":"OG001","title":"Part 1: Cohort 2 Trilaciclib 240mg/m^2"}],"paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"Safety analysis set - included all enrolled participants (i.e., signed informed consent) who received at least 1 dose of study drug (etoposide, carboplatin, or trilaciclib).\n\nPart 1: Cohort 1 Trilaciclib 200 mg/m\\^2 included 1 participant from Part 2 and 1 participant from Part 1 240 mg/m\\^2 who received 200 mg/m\\^2.","reportingStatus":"POSTED","timeFrame":"TEAEs were any AE that started on or after the first dose of study drug and up to the last dose +30 days (a minimum of 51 days up to a maximum of 374 days)","title":"Incidence of Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), Related AEs, Related SAEs, and AEs Leading to Study Drug Discontinuation in Part 1","type":"PRIMARY","unitOfMeasure":"Participants"}