{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"7"}]}],"title":"Any AE"},{"categories":[{"measurements":[{"groupId":"OG000","value":"1"}]}],"title":"Any SAE"}],"denoms":[{"counts":[{"groupId":"OG000","value":"8"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"}],"units":"Participants"}],"description":"An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A SAE is defined as any untoward medical occurrence that, at any dose: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect and other important medical events judged by the investigator that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the participant or may require medical or surgical intervention.","groups":[{"description":"Participants received GSK3039294 600 mg, capsules, orally, under fed condition, QD for 7 days in cohort 3.","id":"OG000","title":"Part B: Cohort 3- GSK3039294 600 mg QD"},{"description":"Participants were planned to receive repeat dose of GSK3039294 for 21 days in cohort 4a. The dose level was to be adjusted once during the 21 days. Cohort 4a was not initiated due to safety reasons during conduct of Part B (Cohort 3).","id":"OG001","title":"Part B: Cohort 4a- GSK3039294"},{"description":"Participants were planned to receive repeat dose of GSK3039294 for 21 days in cohort 4b. The dose level was to be adjusted once during the 21 days. Cohort 4b was not initiated due to safety reasons during conduct of Part B (Cohort 3).","id":"OG002","title":"Part B: Cohort 4b- GSK3039294"}],"paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"Safety population. Data was not collected as study was terminated, due to safety reasons during conduct of Part B (end of Cohort 3) whereas Cohort 4a and 4b were not recruited in Part B.","reportingStatus":"POSTED","timeFrame":"Cohort 3: Up to Day 21; Cohort 4: Up to Day 35","title":"Part B:Number of Participants With AEs and SAEs","type":"PRIMARY","unitOfMeasure":"Participants"}