{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"56.0","upperLimit":"1021.0","value":"125.50"},{"groupId":"OG001","lowerLimit":"56.0","upperLimit":"565.0","value":"118.00"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"22"},{"groupId":"OG001","value":"21"}],"units":"Participants"}],"description":"Time to worsening in EORTC-QLQ-C30 (physical function scale) is defined as time between randomization and first documentation of a worsening in EORTC-QLQ-C-30. Worsening in the EORTC-QLQ-C30 is defined as 10 points decrease from baseline. It comprises module with 30 items. Questionnaire includes 9 multi-item scales: 5 functional scales (physical, role, cognitive, emotional, and social), 3 symptom scales (fatigue, pain, nausea/vomiting), a global health and quality of life scale, and a number of single items assessing symptoms (dyspnea, loss of appetite, insomnia, constipation, diarrhoea). Instrument contains 28 items using a Likert scale with 4 response options: \"Not at All,\" \"A Little,\" \"Quite a Bit,\" \"Very Much\" (scored 1-4). Two additional items use response options (1-7): 1=Very Poor, to 7=Excellent. All scale and item scores were linearly transformed to be in range from 0-100. A higher score represents a higher (better) level of functioning, or a higher (worse) level of symptoms.","dispersionType":"Full Range","groups":[{"description":"Participants received 15 milligram per kilogram (mg/kg) of siltuximab as a 1-hour intravenous (IV) infusion every 4 weeks until disease progression, unacceptable toxicity, withdrawal of consent, or the end of the study (up to 4 years after randomization of the last participant).","id":"OG000","title":"Siltuximab"},{"description":"Participants received placebo as a 1-hour IV infusion every 4 weeks until disease progression, unacceptable toxicity, withdrawal of consent, or the end of the study (up to 4 years after randomization of the last participant).","id":"OG001","title":"Placebo"}],"paramType":"MEDIAN","populationDescription":"ITT population included participants who were randomly assigned to siltuximab or placebo treatment group based on an IVRS who had 10 points decrease from baseline in the physical function scale.","reportingStatus":"POSTED","timeFrame":"Up to 4.7 Years","title":"Time to Worsening in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire-Core 30 (EORTC-QLQ-C30) Scale Score","type":"SECONDARY","unitOfMeasure":"Days"}