{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"6"},{"groupId":"OG001","value":"6"},{"groupId":"OG002","value":"6"},{"groupId":"OG003","value":"6"},{"groupId":"OG004","value":"6"},{"groupId":"OG005","value":"3"},{"groupId":"OG006","value":"216"}]}],"title":"Participants with an Adverse Event"},{"categories":[{"measurements":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"4"},{"groupId":"OG002","value":"5"},{"groupId":"OG003","value":"5"},{"groupId":"OG004","value":"5"},{"groupId":"OG005","value":"3"},{"groupId":"OG006","value":"140"}]}],"title":"Participants with a Serious Adverse Event"}],"denoms":[{"counts":[{"groupId":"OG000","value":"6"},{"groupId":"OG001","value":"6"},{"groupId":"OG002","value":"6"},{"groupId":"OG003","value":"6"},{"groupId":"OG004","value":"6"},{"groupId":"OG005","value":"3"},{"groupId":"OG006","value":"217"}],"units":"Participants"}],"description":"The overall safety profile of the drug was assessed by reviewing the number of patients with AEs, SAEs and other events. There was no formal statistical analysis. Safety assessments continued for the duration of treatment.","groups":[{"description":"Part 1: Patients received a starting dose of 30 mg QD for 28 days and they were assessed for dose limiting toxicities (DLT). If no DTLs were observed the dose escalation continued.\n\nPatients received avapritinib in continuous 28 day cycles until discontinuation.","id":"OG000","title":"Experimental: Part 1 Avapritinib (Formerly BLU-285) 30 mg QD"},{"description":"Part 1: Patients received a starting dose of 60 mg QD for 28 days and they were assessed for dose limiting toxicities (DLT). If no DTLs were observed the dose escalation continued.\n\nPatients received avapritinib in continuous 28 day cycles until discontinuation.","id":"OG001","title":"Experimental: Part 1 Avapritinib (Formerly BLU-285) 60 mg QD"},{"description":"Part 1: Patients received a starting dose of 90 mg QD for 28 days and they were assessed for dose limiting toxicities (DLT). If no DTLs were observed the dose escalation continued.\n\nPatients received avapritinib in continuous 28 day cycles until discontinuation.","id":"OG002","title":"Experimental: Part 1 Avapritinib (Formerly BLU-285) 90 mg QD"},{"description":"Part 1: Patients received a starting dose of 135 mg QD for 28 days and they were assessed for dose limiting toxicities (DLT). If no DTLs were observed the dose escalation continued.\n\nPatients received avapritinib in continuous 28 day cycles until discontinuation.","id":"OG003","title":"Experimental: Part 1 Avapritinib (Formerly BLU-285) 135 mg QD"},{"description":"Part 1: Patients received a starting dose of 200 mg QD for 28 days and they were assessed for dose limiting toxicities (DLT). If no DTLs were observed the dose escalation continued.\n\nPatients received avapritinib in continuous 28 day cycles until discontinuation. .","id":"OG004","title":"Experimental: Part 1 Avapritinib (Formerly BLU-285) 200 mg QD"},{"description":"Part 1: Patients received a starting dose of 600 mg QD for 28 days and they were assessed for dose limiting toxicities (DLT). If no DTLs were observed the dose escalation continued.\n\nPatients received avapritinib in continuous 28 day cycles until discontinuation.","id":"OG005","title":"Experimental: Part 1 Avapritinib (Formerly BLU-285) 600 mg QD"},{"description":"Part 1 and Part 2: Patients enrolled in Part 1 and Part 2 at a starting dose of 300 or 400 mg QD were included in the Part1/Part 2 safety and efficacy analysis. 13 patients in this group were enrolled in Part 1\n\nPatients received avapritinib in continuous 28 day cycles until discontinuation.","id":"OG006","title":"Experimental: Part 1 and Part 2 Avapritinib (Formerly BLU-285) 300 mg or 400 mg QD"}],"paramType":"NUMBER","populationDescription":"Safety Population - all patients that received at least one dose of avapritinib","reportingStatus":"POSTED","timeFrame":"AEs were collected from the start of study drug until 30 days after the last dose, SAEs were collected from the date of the informed consent signature until 30 days after the last dose of study drug, up to 5 years","title":"Parts 1 and 2: Number of Patients With Adverse Events (AE) and Serious Adverse Events (SAE)","type":"PRIMARY","unitOfMeasure":"participants"}