{"classes":[{"categories":[{"measurements":[{"comment":"Upper limit of 95% CI was not estimable due to low number of participants with events.","groupId":"OG000","lowerLimit":"20.4","upperLimit":"NA","value":"23.9"},{"groupId":"OG001","lowerLimit":"8.1","upperLimit":"24.0","value":"14.7"},{"comment":"Upper limit of 95% CI was not estimable due to low number of participants with events.","groupId":"OG002","lowerLimit":"11.9","upperLimit":"NA","value":"16.6"},{"groupId":"OG003","lowerLimit":"16.8","upperLimit":"19.1","value":"18.4"},{"comment":"Upper limit of 95% CI was not estimable due to low number of participants with events.","groupId":"OG004","lowerLimit":"5.6","upperLimit":"NA","value":"9.5"},{"groupId":"OG005","lowerLimit":"7.7","upperLimit":"20.2","value":"11.1"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"192"},{"groupId":"OG001","value":"194"},{"groupId":"OG002","value":"191"},{"groupId":"OG003","value":"258"},{"groupId":"OG004","value":"86"},{"groupId":"OG005","value":"280"}],"units":"Participants"}],"description":"EORTC QLQ-C30 is 30 item questionnaire composed of 5 multi-item functional subscales (physical,role,cognitive,emotional,social functioning), 3 multi-item symptom scales (fatigue,nausea/vomiting, and pain),global health/quality of life (QOL) subscale and 6 single items assessing other cancer related symptoms (dyspnea,sleep disturbance, appetite, diarrhea, constipation and financial impact of cancer). It employed twenty-eight 4 point Likert scales with responses from \"not at all\" to \"very much\" and two 7 point Likert scales for global health and overall QOL. Global health status scale score ranged from 0 to 100. Higher score: better level of functioning. Time to definitive 10% deterioration: time from date of randomization to date of event with at least 10% relative to baseline worsening of corresponding scale score with no later improvement or death due to any cause. All collected data up to the pre-specified collection period (i.e., end of study) are reported for this outcome measure.","dispersionType":"95% Confidence Interval","groups":[{"description":"Participants received 450 milligram (mg) of LGX818 orally once daily (QD) along with 45 mg of MEK162 twice daily (BID) for each 28 day treatment cycle until progressive disease (PD) as confirmed by Blinded Independent Review Committee (BIRC), withdrawal of consent, intolerable toxicity, study discontinuation, lost to follow-up or death.","id":"OG000","title":"Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450)"},{"description":"Participants received 300 mg of LGX818 orally once daily for each 28 day treatment cycle until PD as confirmed by BIRC, withdrawal of consent, intolerable toxicity, study discontinuation, lost to follow-up or death.","id":"OG001","title":"Part 1: LGX818 300 mg"},{"description":"Participants received 960 mg of Vemurafenib according to the locally approved prescribing information twice daily for each 28 day treatment cycle until PD as confirmed by BIRC, withdrawal of consent, intolerable toxicity, study discontinuation, lost to follow-up or death.","id":"OG002","title":"Part 1: Vemurafenib 960 mg BID"},{"description":"Participants received 300 mg of LGX818 orally once daily along with 45 mg of MEK162 twice daily for each 28 day treatment cycle until PD as confirmed by BIRC, withdrawal of consent, intolerable toxicity, study discontinuation, lost to follow-up or death.","id":"OG003","title":"Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300)"},{"description":"Participants received 300 mg of LGX818 orally once daily for each 28 day treatment cycle until PD as confirmed by BIRC, withdrawal of consent, intolerable toxicity, study discontinuation, lost to follow-up or death.","id":"OG004","title":"Part 2: LGX818 300 mg"},{"description":"Participants of Part 1 and 2 received 300 mg of LGX818 orally once daily for each 28 day treatment cycle until PD as confirmed by BIRC, withdrawal of consent, intolerable toxicity, and study discontinuation, lost to follow-up or death.","id":"OG005","title":"Part 1 + Part 2: LGX818 300 mg"}],"paramType":"MEDIAN","populationDescription":"FAS included all randomized participants. It was planned to report combined result data of Part 1 and Part 2 for LGX818 300 mg arm.","reportingStatus":"POSTED","timeFrame":"Date of randomization to date of event or death due to any cause, which ever occurred first (maximum up to 29 months for Part 1, excluding Part 1: LGX818 300 mg group; up to 35 months for Part 2 and Part 1 LGX 300 mg group)","title":"Part 1 and Part 2: Time to Definitive 10% Deterioration in the Global Health Status Score of the European Organization for Research and Treatment of Cancer's Core Quality of Life Questionnaire (EORTC QLQ-C30)","type":"SECONDARY","unitOfMeasure":"Months"}