{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"203"},{"groupId":"OG001","value":"186"}]}],"title":"Deaths"},{"categories":[{"measurements":[{"groupId":"OG000","value":"66"},{"groupId":"OG001","value":"63"}]}],"title":"Death within 30 Days"},{"categories":[{"measurements":[{"groupId":"OG000","value":"228"},{"groupId":"OG001","value":"236"}]}],"title":"SAEs"},{"categories":[{"measurements":[{"groupId":"OG000","value":"118"},{"groupId":"OG001","value":"114"}]}],"title":"AEs Leading to Discontinuation"},{"categories":[{"measurements":[{"groupId":"OG000","value":"109"},{"groupId":"OG001","value":"137"}]}],"title":"Drug-related Fluid Retention"}],"denoms":[{"counts":[{"groupId":"OG000","value":"304"},{"groupId":"OG001","value":"305"}],"units":"Participants"}],"description":"With protocol Amendment 6, the duration of the study was extended for 2 additional years (7 years total) for participants who continued to have clinical benefit and no feasible alternate access to dasatinib. However, after Year 5 the requirement to follow participants for survival and to collect other efficacy data was removed from the protocol for the remainder of the study. Only AEs and SAEs were collected up to Year 7. On-study AEs and SAEs were graded by severity according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE), version 3.0. The investigator AE terms were coded and grouped by preferred term and system organ class using the Medical Dictionary for Regulatory Activities (MedDRA), version 16.0.","groups":[{"description":"Dasatinib was administered orally at a dose of 140 mg once a day (QD) until disease progression, drug toxicity, withdrawal of consent, investigator or sponsor decision, pregnancy, or decision to do stem cell transplant.","id":"OG000","title":"Dasatinib 140 mg QD"},{"description":"Dasatinib was administered orally at a dose of 70 mg twice a day (BID) until disease progression, drug toxicity, withdrawal of consent, investigator or sponsor decision, pregnancy, or decision to do stem cell transplant..","id":"OG001","title":"Dasatinib 70 mg BID"}],"paramType":"NUMBER","populationDescription":"All participants who received at least one dose of study drug were analyzed. Participants were analyzed based on the treatment they actually received, not what they were randomized to receive.","reportingStatus":"POSTED","timeFrame":"Day 1 to Year 7","title":"Number of Participants With Death, Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Discontinuation and Drug-related Fluid Retention AEs, up to Year 7 in Treated Participants","type":"SECONDARY","unitOfMeasure":"participants"}