{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"86.0"},{"groupId":"OG001","value":"91.3"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"308"},{"groupId":"OG001","value":"104"}],"units":"Participants"}],"description":"This was a safety study where Adverse Events is the primary outcome (defined by the current ICH Guideline for Good Clinical Practice). Patients were randomized according to a 3:1 ratio (netupitant/palonosetron:aprepitant/palonosetron). No formal comparison was planned, the presence of a control in the same patient population helped interpret any unexpected safety finding in the experimental arm.The number of patients was estimated in order to have more than 100 patients treated with the netupitant/palonosetron comination for up to at least six cycles. Based on 100 patients, if a given AE is not observed, an AE incidence of 3% or greater can be excluded with 95% confidence.","groups":[{"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 and Palonosetron\n\nDexamethasone","id":"OG000","title":"Netupitant and Palonosetron Plus Dexamethasone"},{"description":"Oral aprepitant hard capsule 125 mg (on Day 1) + 80 mg daily (for the following two days) and oral palonosetron soft capsule 0.50 mg (on Day 1) given with oral dexamethasone at each scheduled chemotherapy cycle.\n\nAprepitant\n\nPalonosetron\n\nDexamethasone","id":"OG001","title":"Aprepitant and Palonosetron Plus Dexamethasone"}],"paramType":"NUMBER","populationDescription":"Safety Population","reportingStatus":"POSTED","timeFrame":"Participants will be followed for the duration of the chemotherapy, an expected average duration of up to 24 weeks assuming 6 chemotherapy cycles given every 4 weeks","title":"Percentage of Patients With Adverse Events","type":"PRIMARY","unitOfMeasure":"percentage of patients with TEAE"}