{"classes":[{"categories":[{"measurements":[{"comment":"Upper limit of 95% CI was not estimable due to low number of events and longer observation time.","groupId":"OG000","lowerLimit":"11.1","upperLimit":"NA","value":"12.1"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"6"}],"units":"Participants"}],"description":"CDOR was defined as the time from the first observation of a CNS response of CR or PR according to RANO criteria until first observation of CNS progression or death from any cause. An analysis by RANO criteria was performed. Definitions of CR or PR as per RANO was included in description of Outcome Measure 17. As per RANO criteria, progression was defined as 25% or more increase in SPD of measurable enhancing (measurable) compared to the best response after initiation of therapy or Screening; increase (significant) in non-enhancing T2/FLAIR lesions, not attributable to other non-tumor causes; any new lesions; and clinical deterioration (not attributable to other non-tumor causes and not due to steroid decrease) and clear worsening of neurological status with respect to the previous timepoint. The median time to the event was estimated using the methodology of Kaplan-Meier. Brookmeyer-Crowley method was used to calculate 95% CI.","dispersionType":"95% Confidence Interval","groups":[{"description":"Participants received 600 mg alectinib capsules orally BID from Cycle 1 Day 1 for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.","id":"OG000","title":"Alectinib 600 mg (Fed): Phase II"}],"paramType":"MEDIAN","populationDescription":"Phase II safety population. 'Overall Number of Participants Analyzed' = participants evaluable for this outcome measure.","reportingStatus":"POSTED","timeFrame":"Every 6 weeks from Cycle 1 Day 1, at Cycles 2, 4, and 6 between Days 14-21, and every 3 cycles thereafter (assessed up to 194 weeks) (1 cycle = 21 days)","title":"CDOR According to RANO Criteria by IRC: Phase II","type":"SECONDARY","unitOfMeasure":"months"}