{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"12.2","upperLimit":"20.4","value":"16.6"},{"comment":"Upper limit of 95% CI was not estimable due to low number of participants with events.","groupId":"OG001","lowerLimit":"11.1","upperLimit":"NA","value":"15.2"},{"groupId":"OG002","lowerLimit":"6.9","upperLimit":"16.9","value":"12.3"},{"groupId":"OG003","lowerLimit":"9.3","upperLimit":"15.1","value":"12.7"},{"groupId":"OG004","lowerLimit":"5.6","upperLimit":"14.0","value":"7.5"},{"groupId":"OG005","lowerLimit":"8.9","upperLimit":"15.5","value":"12.9"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"121"},{"groupId":"OG001","value":"98"},{"groupId":"OG002","value":"77"},{"groupId":"OG003","value":"170"},{"groupId":"OG004","value":"43"},{"groupId":"OG005","value":"141"}],"units":"Participants"}],"description":"DOR was calculated, as the time from the date of first documented response (CR or PR) to the first documented progression or death due to underlying cancer. DOR was estimated for responders (i.e. participants achieving at least once CR or PR) only using a Kaplan-Meier method. CR was defined as disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to \\<10 mm. PR was defined as at least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters. If a participant with a CR or PR had no progression or death due to underlying disease, the participant was censored at the date of last adequate tumor assessment. Results are based on confirmed BIRC response. 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":"Analysis population included all the participants who achieved at least once confirmed CR or PR. It was planned to report combined result data of Part 1 and Part 2 for LGX818 300 mg arm.","reportingStatus":"POSTED","timeFrame":"From randomization until disease progression, censoring date or death, whichever 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: Duration of Response (DOR)","type":"SECONDARY","unitOfMeasure":"Months"}