{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"59"},{"groupId":"OG001","value":"67"},{"groupId":"OG002","value":"19"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"84"},{"groupId":"OG001","value":"92"},{"groupId":"OG002","value":"22"}],"units":"Participants"}],"title":"Blurred Vision, n= 84,92,22"},{"categories":[{"measurements":[{"groupId":"OG000","value":"39"},{"groupId":"OG001","value":"36"},{"groupId":"OG002","value":"12"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"43"},{"groupId":"OG001","value":"42"},{"groupId":"OG002","value":"13"}],"units":"Participants"}],"title":"Chills, n=43,42,13"},{"categories":[{"measurements":[{"groupId":"OG000","value":"42"},{"groupId":"OG001","value":"47"},{"groupId":"OG002","value":"17"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"84"},{"groupId":"OG001","value":"92"},{"groupId":"OG002","value":"22"}],"units":"Participants"}],"title":"Constipation, n=84,92, 22"},{"categories":[{"measurements":[{"groupId":"OG000","value":"60"},{"groupId":"OG001","value":"65"},{"groupId":"OG002","value":"16"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"84"},{"groupId":"OG001","value":"92"},{"groupId":"OG002","value":"22"}],"units":"Participants"}],"title":"Decreased Appetite, n=84,92, 22"},{"categories":[{"measurements":[{"groupId":"OG000","value":"81"},{"groupId":"OG001","value":"87"},{"groupId":"OG002","value":"21"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"84"},{"groupId":"OG001","value":"92"},{"groupId":"OG002","value":"22"}],"units":"Participants"}],"title":"Fatigue, n=84,92, 22"},{"categories":[{"measurements":[{"groupId":"OG000","value":"78"},{"groupId":"OG001","value":"80"},{"groupId":"OG002","value":"19"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"79"},{"groupId":"OG001","value":"80"},{"groupId":"OG002","value":"20"}],"units":"Participants"}],"title":"General Pain, n= 79, 80, 20"},{"categories":[{"measurements":[{"groupId":"OG000","value":"35"},{"groupId":"OG001","value":"33"},{"groupId":"OG002","value":"14"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"37"},{"groupId":"OG001","value":"37"},{"groupId":"OG002","value":"14"}],"units":"Participants"}],"title":"Heart Palpitations, n=37, 37, 14"},{"categories":[{"measurements":[{"groupId":"OG000","value":"28"},{"groupId":"OG001","value":"25"},{"groupId":"OG002","value":"8"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"84"},{"groupId":"OG001","value":"92"},{"groupId":"OG002","value":"22"}],"units":"Participants"}],"title":"Mouth/Throat Sores, n=84,92, 22"},{"categories":[{"measurements":[{"groupId":"OG000","value":"47"},{"groupId":"OG001","value":"50"},{"groupId":"OG002","value":"11"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"48"},{"groupId":"OG001","value":"52"},{"groupId":"OG002","value":"11"}],"units":"Participants"}],"title":"Nausea, n=48, 52, 11"},{"categories":[{"measurements":[{"groupId":"OG000","value":"22"},{"groupId":"OG001","value":"33"},{"groupId":"OG002","value":"6"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"23"},{"groupId":"OG001","value":"33"},{"groupId":"OG002","value":"6"}],"units":"Participants"}],"title":"Nosebleed, n=23, 33, 6"},{"categories":[{"measurements":[{"groupId":"OG000","value":"60"},{"groupId":"OG001","value":"58"},{"groupId":"OG002","value":"17"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"84"},{"groupId":"OG001","value":"92"},{"groupId":"OG002","value":"22"}],"units":"Participants"}],"title":"Shortness Of Breath, n=84,92, 22"},{"categories":[{"measurements":[{"groupId":"OG000","value":"20"},{"groupId":"OG001","value":"28"},{"groupId":"OG002","value":"5"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"21"},{"groupId":"OG001","value":"28"},{"groupId":"OG002","value":"6"}],"units":"Participants"}],"title":"Vomiting, n=21, 28, 6"},{"categories":[{"measurements":[{"groupId":"OG000","value":"50"},{"groupId":"OG001","value":"59"},{"groupId":"OG002","value":"19"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"84"},{"groupId":"OG001","value":"92"},{"groupId":"OG002","value":"22"}],"units":"Participants"}],"title":"Watery Eyes, n=84,92, 22"}],"denoms":[{"counts":[{"groupId":"OG000","value":"84"},{"groupId":"OG001","value":"92"},{"groupId":"OG002","value":"22"}],"units":"Participants"}],"description":"The PRO-CTCAE is a patient-reported outcome measure developed to evaluate symptomatic toxicity in participants on cancer clinical trials. It included symptomatic toxicities drawn from the CTCAE like blurred vision, chills, constipation, decreased appetite, fatigue, general pain, heart palpitations, mouth/throat sores, nausea, nosebleed, shortness of breath, vomiting and watery eyes. Items were scored individually on a 0 to 4 scale for severity, frequency and interference. Number of participants with symptomatic AEs (those who had a maximum post-Baseline rating greater than 0, example; 1, 2, 3, or 4) measured by PRO-CTCAE are 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. only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).","reportingStatus":"POSTED","timeFrame":"Up to 186 weeks","title":"Number of Participants With Symptomatic AEs Measured by Patient-reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)","type":"SECONDARY","unitOfMeasure":"Participants"}