{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"169"},{"groupId":"OG001","value":"174"}]}],"title":"Any TEAE"},{"categories":[{"measurements":[{"groupId":"OG000","value":"86"},{"groupId":"OG001","value":"90"}]}],"title":"Severe TEAE"},{"categories":[{"measurements":[{"groupId":"OG000","value":"41"},{"groupId":"OG001","value":"43"}]}],"title":"Serious TEAE"},{"categories":[{"measurements":[{"groupId":"OG000","value":"10"},{"groupId":"OG001","value":"14"}]}],"title":"TEAE leading to death"},{"categories":[{"measurements":[{"groupId":"OG000","value":"16"},{"groupId":"OG001","value":"20"}]}],"title":"TEAE leading to discontinuation from the study"}],"denoms":[{"counts":[{"groupId":"OG000","value":"203"},{"groupId":"OG001","value":"201"}],"units":"Participants"}],"description":"This is a safety study where Adverse Events is the primary outcome (defined by the current ICH Guideline for Good Clinical Practice). Patients are randomized according to a 1:1 ratio (IV NEPA FDC : oral NEPA FDC). No formal comparison is planned, the presence of a control in the same patient population helps interpret any unexpected safety finding in the experimental arm. It is expected that the number of patients randomized to the test group, i.e., 200, will allow approximately 100 patients to be treated with the test drug for 4 cycles. Based on 100 patients treated at Cycle 4 with the IV NEPA FDC , if a given Adverse Event (AE) is not observed, an AE incidence of 3% or greater can be excluded with 95% confidence.","groups":[{"description":"Intravenous Pro-netupitant/Palonosetron (260 mg/0.25 mg) powder for solution for infusion (on Day 1) with oral dexamethasone prior to each scheduled chemotherapy cycle\n\nPro-netupitant/Palonosetron\n\nDexamethasone","id":"OG000","title":"Pro-netupitant/Palonosetron Plus Dexamethasone"},{"description":"Oral netupitant/palonosetron (300 mg/0.50 mg) hard capsule (on Day 1) with oral dexamethasone prior to each scheduled chemotherapy cycle\n\nNetupitant/Palonosetron\n\nDexamethasone","id":"OG001","title":"Netupitant/Palonosetron Plus Dexamethasone"}],"paramType":"COUNT_OF_PARTICIPANTS","reportingStatus":"POSTED","timeFrame":"Participants will be followed for the duration of the chemotherapy, an expected average duration of up to 14 weeks assuming a maximum of 4 chemotherapy cycles given every 3 weeks.","title":"Percentage of Patients With Adverse Events","type":"PRIMARY","unitOfMeasure":"Participants"}