{"analyses":[{"groupIds":["OG000","OG001","OG002","OG003"],"nonInferiorityType":"OTHER","paramType":"MTD/RDE","paramValue":"510"},{"groupIds":["OG004","OG005","OG006"],"nonInferiorityType":"OTHER","paramType":"MTD/RDE","paramValue":"500"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"1"},{"groupId":"OG004","value":"0"},{"groupId":"OG005","value":"1"},{"groupId":"OG006","value":"0"}]}],"title":"Investigations: Alanine aminotransferase incr."},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"1"},{"groupId":"OG004","value":"0"},{"groupId":"OG005","value":"0"},{"groupId":"OG006","value":"0"}]}],"title":"Gastrointestinal disorders: abdominal pain"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"},{"groupId":"OG004","value":"0"},{"groupId":"OG005","value":"0"},{"groupId":"OG006","value":"1"}]}],"title":"Gastrointestinal disorders: Influenza"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"2"},{"groupId":"OG004","value":"0"},{"groupId":"OG005","value":"1"},{"groupId":"OG006","value":"1"}]}],"title":"Total DLTs"}],"denoms":[{"counts":[{"groupId":"OG000","value":"4"},{"groupId":"OG001","value":"12"},{"groupId":"OG002","value":"6"},{"groupId":"OG003","value":"2"},{"groupId":"OG004","value":"4"},{"groupId":"OG005","value":"4"},{"groupId":"OG006","value":"5"}],"units":"Participants"}],"description":"A DLT is defined as an adverse event or abnormal laboratory value assessed as unrelated to disease, disease progression, inter-current illness, or concomitant therapies that occurs within the first 21 days of treatment with LDK378 and meets a specified defined criteria. A participant with multiple occurrences of DLTs under one treatment is counted only once in the Adverse Event category for that treatment. A participant with multiple DLTs within a primary system organ class is counted only once in the total row.","groups":[{"description":"Participants in the fasted group who took 300 mg of ceritinib","id":"OG000","title":"Fasted: Ceritinib 300 mg/m2"},{"description":"Participants in the fasted group who took 450 mg of ceritinib","id":"OG001","title":"Fasted: Ceritinib 450 mg/m2"},{"description":"Participants in the fasted group who took 510 mg of ceritinib","id":"OG002","title":"Fasted: Ceritinib 510 mg/m2"},{"description":"Participants in the fasted group who took 560 mg of ceritinib","id":"OG003","title":"Fasted: Ceritinib 560 mg/m2"},{"description":"Participants in the fed group who took 320 mg of ceritinib","id":"OG004","title":"Fed: Ceritinib 320 mg/m2"},{"description":"Participants in the fed group who took 400 mg of ceritinib","id":"OG005","title":"Fed: Ceritinib 400 mg/m2"},{"description":"Participants in the fed group who took 500 mg of ceritinib","id":"OG006","title":"Fed: Ceritinib 500 mg/m2"}],"paramType":"NUMBER","populationDescription":"The dose determining analysis set (DDS) consisted of all patients from the Safety set who either met the minimum exposure criterion and had sufficient safety evaluations or discontinued earlier due to DLT in the escalation phase.","reportingStatus":"POSTED","timeFrame":"up to day 21 after the patient's first dose; cycle = within the first 21 days of patient's first dose","title":"Incidence Rate of Dose Limiting Toxicities (DLTs) Occurring During First Cycle of Treatment","type":"PRIMARY","unitOfMeasure":"Participants"}