{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"93"},{"groupId":"OG001","value":"96"},{"groupId":"OG002","value":"24"}]}],"title":"Common non-SAE"},{"categories":[{"measurements":[{"groupId":"OG000","value":"43"},{"groupId":"OG001","value":"53"},{"groupId":"OG002","value":"15"}]}],"title":"SAE"},{"categories":[{"measurements":[{"groupId":"OG000","value":"67"},{"groupId":"OG001","value":"74"},{"groupId":"OG002","value":"23"}]}],"title":"Keratopathy"},{"categories":[{"measurements":[{"groupId":"OG000","value":"17"},{"groupId":"OG001","value":"25"},{"groupId":"OG002","value":"6"}]}],"title":"Dry eye events"},{"categories":[{"measurements":[{"groupId":"OG000","value":"24"},{"groupId":"OG001","value":"36"},{"groupId":"OG002","value":"10"}]}],"title":"Blurred vision"},{"categories":[{"measurements":[{"groupId":"OG000","value":"36"},{"groupId":"OG001","value":"56"},{"groupId":"OG002","value":"10"}]}],"title":"Thrombocytopenia"},{"categories":[{"measurements":[{"groupId":"OG000","value":"20"},{"groupId":"OG001","value":"16"},{"groupId":"OG002","value":"4"}]}],"title":"Infusion-related reactions"},{"categories":[{"measurements":[{"groupId":"OG000","value":"68"},{"groupId":"OG001","value":"76"},{"groupId":"OG002","value":"23"}]}],"title":"Corneal events"},{"categories":[{"measurements":[{"groupId":"OG000","value":"14"},{"groupId":"OG001","value":"28"},{"groupId":"OG002","value":"2"}]}],"title":"Neutropenia"}],"denoms":[{"counts":[{"groupId":"OG000","value":"95"},{"groupId":"OG001","value":"99"},{"groupId":"OG002","value":"24"}],"units":"Participants"}],"description":"An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that; results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, other situations judged by physician, is associated with liver injury and impaired liver function. Adverse events which were not Serious were considered as non-serious adverse events. Number of participants who had SAEs and common (\\>=5%) non-SAEs are presented. Number of participants with AESI (keratopathy, dry eye events, blurred vision, thrombocytopenia, infusion-related reactions, corneal events and neutropenia) are also presented.","groups":[{"description":"Participants were administered frozen liquid (30 mg/vial solution in a single use vial) at a dose of 2.5 mg/kg GSK2857916 as IV solution once every three weeks for a maximum of up to 39 cycles (1 cycle= 21 days). Frozen liquid was diluted with 0.9 percent saline.","id":"OG000","title":"Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)"},{"description":"Participants were administered frozen liquid (30 mg/vial solution in a single use vial) at a dose of 3.4 mg/kg GSK2857916 as IV solution once every three weeks for a maximum of up to 32 cycles (1 cycle= 21 days). Frozen liquid was diluted with 0.9 percent saline.","id":"OG001","title":"Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)"},{"description":"Participants were administered lyophilized powder (100 mg/vial in a single use vial) at a dose of 3.4 mg/kg GSK2857916 given IV for a maximum of 35 cycles (1 cycle= 21 days). Lyophilized powder was reconstituted using water for injection.","id":"OG002","title":"Main Study: GSK2857916 3.4 mg/kg (Lyophilized)"}],"paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"Full Safety Population. 3 participants out of 221 participants did not receive any study treatment and thus, were excluded from the Full Safety Population.","reportingStatus":"POSTED","timeFrame":"Up to 186 weeks","title":"Number of Participants With Serious Adverse Events (SAEs), Common (>=5%) Non-serious Adverse Events and Adverse Events of Special Interest (AESI)","type":"SECONDARY","unitOfMeasure":"Participants"}