{"classes":[{"categories":[{"measurements":[{"comment":"Median and upper limit of 95% CI were not estimable due to low number of participants with events.","groupId":"OG000","lowerLimit":"22.1","upperLimit":"NA","value":"NA"},{"groupId":"OG001","lowerLimit":"18.4","upperLimit":"30.5","value":"30.5"},{"comment":"Upper limit of 95% CI was not estimable due to low number of participants with events.","groupId":"OG002","lowerLimit":"15.2","upperLimit":"NA","value":"22.1"},{"comment":"Median and 95% CI were not estimable due to low number of participants with events.","groupId":"OG003","lowerLimit":"NA","upperLimit":"NA","value":"NA"},{"comment":"Median and upper limit of 95% CI were not estimable due to low number of participants with events.","groupId":"OG004","lowerLimit":"9.4","upperLimit":"NA","value":"NA"},{"groupId":"OG005","lowerLimit":"16.6","upperLimit":"30.5","value":"20.5"}]}]}],"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":"FACT-M:melanoma specific questionnaire to assess participant health-related quality of life(QoL).Melanoma specific 16 subscale :signs,symptoms,physical/social activities most relevant to participants with advanced-stage melanoma.Other items :physical,functional and social/family well-being(7 items each),emotional well-being(6 items),surgery specific concerns related to melanoma(8 items,not included in this study).Each item range 0(not at all)to 4(very much),combined to produce subscale scores.Total score range for FACT-M excluding surgery specific items is 0 to172,higher scores:better QoL.Melanoma subscale score range from0(worst)to 64(best response),higher score:better QoL.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 pre-specified collection period(i.e.,end of study)are reported for this OM.","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 (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 Function Assessment Cancer Therapy-melanoma (FACT-M) Subscale","type":"SECONDARY","unitOfMeasure":"Months"}