{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"70.81","upperLimit":"98.94","value":"83.98"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"4"}],"units":"Participants"}],"description":"FLIE is a patient-completed quality of life assessment modified from the original Functional Living Index - Cancer questionnaire. FLIE contains two domains: nausea and vomiting with nine items in each domain. The first item asks the patient to rate how much nausea (or vomiting) has occurred over a 5 day period. The remaining eight items ask patients to rate the impact of nausea (or vomiting) on various aspects of a patient's life (for example, ability to enjoy meals/liquids). Each item is answered using a 7 point visual analog scale with 7 being \"none /not at all\" and 1 being \"a great deal\". The two domains are summed for a total score with a possible range of 18-126. Higher scores indicate a more favorable quality of life. A total score of \\>108 defines those patients who had a minimal impact of CINV on quality of life. All particpants discontinued the trial after one cycle of cisplatin.","dispersionType":"Full Range","groups":[{"description":"Patients receive cisplatin IV on day 1. Treatment repeats every 21 days for up to 3 courses. Patients undergo radiotherapy once daily 5 days a week for up to 7 weeks.\n\nPatients receive fosaprepitant dimeglumine IV, palonosetron hydrochloride IV, and dexamethasone IV on day 1.Patients receive oral dexamethasone on days 2-4. Patients with no emesis or need for rescue anti-emetics in the first 120 hours after cisplatin infusion continue to receive the anti-emetic regimen as above with the second and third courses of cisplatin.\n\nPatients complete an emesis diary daily for 5 days after each cisplatin infusion. Patients also complete a Functional Living Index-Emesis Questionnaire on day 8 after each cisplatin infusion.\n\nfosaprepitant dimeglumine: Given IV\n\ncisplatin: Given IV\n\npalonosetron hydrochloride: Given IV\n\ndexamethasone: Given IV and orally\n\nFunctional Living Index-Emesis Questionnaire: Ancillary studies\n\nEmesis Diary: Ancillary studies\n\nRadiotherapy: Undergo r","id":"OG000","title":"Arm I"}],"paramType":"MEAN","populationDescription":"Two patients did not complete the Functional Living Index-Emesis (FLIE) Questionnaire.","reportingStatus":"POSTED","timeFrame":"5 days following cisplatin infusion","title":"Impact of Cisplatin-induced Nausea and Vomiting on Daily Life During the 5 Day Period Following Cisplatin Infusion for Multiple Cycles as Measured by the Functional Living Index-Emesis Questionnaire","type":"SECONDARY","unitOfMeasure":"units on a scale"}