{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","spread":"20.49","value":"-7.97"},{"groupId":"OG001","spread":"21.47","value":"-12.73"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"77"},{"groupId":"OG001","value":"22"}],"units":"Participants"}],"title":"Physical Functioning Follow-Up 1"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"16.05","value":"-3.66"},{"groupId":"OG001","spread":"16.02","value":"-7.14"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"62"},{"groupId":"OG001","value":"28"}],"units":"Participants"}],"title":"Physical Functioning Follow-Up 2"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"31.13","value":"-14.94"},{"groupId":"OG001","spread":"29.76","value":"-15.91"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"77"},{"groupId":"OG001","value":"22"}],"units":"Participants"}],"title":"Role Functioning Follow-Up 1"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"25.56","value":"-7.80"},{"groupId":"OG001","spread":"21.52","value":"-8.33"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"62"},{"groupId":"OG001","value":"28"}],"units":"Participants"}],"title":"Role Functioning Follow-Up 2"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"21.59","value":"-5.09"},{"groupId":"OG001","spread":"24.48","value":"-15.48"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"77"},{"groupId":"OG001","value":"21"}],"units":"Participants"}],"title":"Emotional Functioning Follow-Up 1"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"19.15","value":"-0.94"},{"groupId":"OG001","spread":"25.98","value":"-5.36"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"62"},{"groupId":"OG001","value":"28"}],"units":"Participants"}],"title":"Emotional Functioning Follow-Up 2"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"16.79","value":"-7.58"},{"groupId":"OG001","spread":"17.17","value":"-7.94"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"77"},{"groupId":"OG001","value":"21"}],"units":"Participants"}],"title":"Cognitive Functioning Follow-Up 1"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"15.43","value":"-3.49"},{"groupId":"OG001","spread":"13.55","value":"-1.19"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"62"},{"groupId":"OG001","value":"28"}],"units":"Participants"}],"title":"Cognitive Functioning Follow-Up 2"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"29.45","value":"-8.66"},{"groupId":"OG001","spread":"26.82","value":"-18.25"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"77"},{"groupId":"OG001","value":"21"}],"units":"Participants"}],"title":"Social Functioning Follow-Up 1"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"29.52","value":"-1.61"},{"groupId":"OG001","spread":"24.69","value":"-4.17"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"62"},{"groupId":"OG001","value":"28"}],"units":"Participants"}],"title":"Social Functioning Follow-Up 2"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"22.44","value":"-8.23"},{"groupId":"OG001","spread":"17.71","value":"-10.71"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"77"},{"groupId":"OG001","value":"21"}],"units":"Participants"}],"title":"Global Health Status Follow-Up 1"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"18.53","value":"-1.61"},{"groupId":"OG001","spread":"12.07","value":"-3.27"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"62"},{"groupId":"OG001","value":"28"}],"units":"Participants"}],"title":"Global Health Status Follow-Up 2"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"27.96","value":"6.06"},{"groupId":"OG001","spread":"24.67","value":"16.67"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"77"},{"groupId":"OG001","value":"22"}],"units":"Participants"}],"title":"Dyspnea Follow-Up 1"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"22.20","value":"5.91"},{"groupId":"OG001","spread":"24.61","value":"7.14"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"62"},{"groupId":"OG001","value":"28"}],"units":"Participants"}],"title":"Dyspnea Follow-Up 2"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"32.26","value":"3.46"},{"groupId":"OG001","spread":"30.86","value":"0.00"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"77"},{"groupId":"OG001","value":"22"}],"units":"Participants"}],"title":"Insomnia Follow-Up 1"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"25.50","value":"-4.84"},{"groupId":"OG001","spread":"30.09","value":"0.00"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"62"},{"groupId":"OG001","value":"28"}],"units":"Participants"}],"title":"Insomnia Follow-Up 2"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"28.79","value":"6.93"},{"groupId":"OG001","spread":"24.47","value":"13.64"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"77"},{"groupId":"OG001","value":"22"}],"units":"Participants"}],"title":"Apatite loss Follow-Up 1"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"30.49","value":"5.91"},{"groupId":"OG001","spread":"22.09","value":"2.38"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"62"},{"groupId":"OG001","value":"28"}],"units":"Participants"}],"title":"Apatite loss Follow-Up 2"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"28.93","value":"7.36"},{"groupId":"OG001","spread":"23.57","value":"0.00"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"77"},{"groupId":"OG001","value":"21"}],"units":"Participants"}],"title":"Constipation Follow-Up 1"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"22.48","value":"2.15"},{"groupId":"OG001","spread":"29.99","value":"-2.38"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"62"},{"groupId":"OG001","value":"28"}],"units":"Participants"}],"title":"Constipation Follow-Up 2"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"19.86","value":"-0.43"},{"groupId":"OG001","spread":"22.65","value":"6.35"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"77"},{"groupId":"OG001","value":"21"}],"units":"Participants"}],"title":"Diarrhea Follow-Up 1"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"20.88","value":"1.08"},{"groupId":"OG001","spread":"16.93","value":"1.19"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"62"},{"groupId":"OG001","value":"28"}],"units":"Participants"}],"title":"Diarrhea Follow-Up 2"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"25.87","value":"-1.73"},{"groupId":"OG001","spread":"39.84","value":"4.76"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"77"},{"groupId":"OG001","value":"21"}],"units":"Participants"}],"title":"Financial Difficulties Follow-Up 1"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"22.56","value":"-1.08"},{"groupId":"OG001","spread":"28.59","value":"-2.38"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"62"},{"groupId":"OG001","value":"28"}],"units":"Participants"}],"title":"Financial Difficulties Follow-Up 2"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"23.78","value":"8.95"},{"groupId":"OG001","spread":"28.00","value":"15.66"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"77"},{"groupId":"OG001","value":"22"}],"units":"Participants"}],"title":"Fatigue Follow-Up 1"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"22.55","value":"4.84"},{"groupId":"OG001","spread":"21.85","value":"7.14"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"62"},{"groupId":"OG001","value":"28"}],"units":"Participants"}],"title":"Fatigue Follow-Up 2"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"17.19","value":"2.81"},{"groupId":"OG001","spread":"25.48","value":"10.61"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"77"},{"groupId":"OG001","value":"22"}],"units":"Participants"}],"title":"Nausea and Vomiting Follow-Up 1"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"15.39","value":"0.00"},{"groupId":"OG001","spread":"18.73","value":"2.98"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"272"},{"groupId":"OG001","value":"133"}],"units":"Participants"}],"title":"Nausea and Vomiting Follow-Up 2"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"31.17","value":"6.06"},{"groupId":"OG001","spread":"25.02","value":"6.82"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"77"},{"groupId":"OG001","value":"22"}],"units":"Participants"}],"title":"Pain Follow-Up 1"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"24.84","value":"5.38"},{"groupId":"OG001","spread":"14.59","value":"-1.79"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"272"},{"groupId":"OG001","value":"133"}],"units":"Participants"}],"title":"Pain Follow-Up 2"}],"denoms":[{"counts":[{"groupId":"OG000","value":"272"},{"groupId":"OG001","value":"133"}],"units":"Participants"}],"description":"Health-related Quality of Life (HRQoL) was assessed with the EORTC QLQ-C30 questionnaire, which is the most commonly used quality-of-life instrument in oncology trials. The instrument's 30 items were divided among 5 functional scales (physical, role, cognitive, emotional, and social), 9 symptom scales (fatigue, pain, nausea/vomiting, dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties), and a global health/quality of life scale. Raw scores for the EORTC QLQ-C30 were transformed to a 0-100 metric.\n\nHigher scores for all functional scales and Global Health Status=better HRQoL Increase from baseline indicates improvement in HRQoL. Lower scores for symptom scales=better HRQoL Decline from baseline for symptom scales =improvement in symptoms compared to baseline.\n\nA 10 point difference on a 100 point scale between treatments was considered clinically significant.","dispersionType":"Standard Deviation","groups":[{"description":"Nivolumab 3 mg/kg IV over 60 minutes Q2W","id":"OG000","title":"Nivolumab"},{"description":"Dacarbazine: 1000 mg/m\\^2 IV Q3W Carboplatin: Area under the concentration-time curve (AUC) 6 IV Q3W Paclitaxel: 175 mg/m\\^2 IV Q3W","id":"OG001","title":"Investigator's Choice (Dacarbazine or Carboplatin+Paclitaxel)"}],"paramType":"MEAN","populationDescription":"All randomized participants","reportingStatus":"POSTED","timeFrame":"From Baseline (Day1) to second Follow-Up (Up to 96 months)","title":"Mean Change From Baseline in Health-related Quality of Life (HRQoL)","type":"SECONDARY","unitOfMeasure":"Units on a scale"}