{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"100.0"},{"groupId":"OG001","value":"100.0"},{"groupId":"OG002","value":"100.0"},{"groupId":"OG003","value":"99.8"}]}],"title":"Adverse Events"},{"categories":[{"measurements":[{"groupId":"OG000","value":"30.6"},{"groupId":"OG001","value":"35.2"},{"groupId":"OG002","value":"42.2"},{"groupId":"OG003","value":"38.8"}]}],"title":"Serious Adverse Events"}],"denoms":[{"counts":[{"groupId":"OG000","value":"108"},{"groupId":"OG001","value":"54"},{"groupId":"OG002","value":"45"},{"groupId":"OG003","value":"495"}],"units":"Participants"}],"description":"Treatment-emergent adverse events (TEAEs) were defined as any adverse events (AEs) that begin or worsen on or after the start of study drug through 30 days after the last dose of study drug. The severity was graded based on the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 4.03. An AE that met one or more of the following outcomes was classified as serious:\n\n* Fatal\n* Life-threatening\n* Disabling/incapacitating\n* Results in hospitalization or prolongs a hospital stay\n* A congenital abnormality\n* Other important medical events may also be considered serious AEs if they may require medical or surgical intervention to prevent one of the outcomes listed above\n\nPer planned analysis, populations to be used for evaluation of this outcome measure were as follows: Triple Negative Breast Cancer (TNBC) Target Population, HR+/HER2- Metastatic Breast Cancer (mBC) Population, Metastatic Urothelial Cancer (mUC) Population, and Overall Safety Population.","groups":[{"description":"Overall 144 participants with TNBC were enrolled in the study and received at least one dose of SG. Of these 144 participants, 108 received at least 2 prior therapies for metastatic disease and were treated with SG at a starting dose of 10mg/kg. These 108 participants were included in the analysis of safety and were referred to as the TNBC Target Population.","id":"OG000","title":"TNBC Target Population"},{"description":"Overall 68 participants with non-TNBC were enrolled in the study and received at least one dose of SG. Of these 68 participants, 54 were confirmed as Hormone receptor-positive/Human epidermal growth factor receptor 2-negative (HR+/HER2-), had progressed on at least one prior hormonal therapy in the metastatic setting, and had received at least one dose of 10 mg/kg SG. These 54 participants were included in the analysis of safety and were referred to as the HR+/HER2- mBC Population.","id":"OG001","title":"HR+/HER2- mBC Population"},{"description":"Overall 49 participants with metastatic urothelial cancer were enrolled in the study and received at least one dose of SG. Of these 49 participants, 45 had either relapsed after or were refractory to at least one prior standard therapeutic regimen and received at least one dose of 10 mg/kg SG. These 45 participants were included in the analysis of safety and were referred to as the mUC Population.","id":"OG002","title":"mUC Population"},{"description":"Overall 495 participants were enrolled in the study and received at least one dose of 10 mg/kg, 8 mg/kg, 12mg/kg, or 18mg/kg SG. These participants were included in the Overall Safety Population and analyzed for safety.","id":"OG003","title":"Overall Safety Population (OSP)"}],"paramType":"NUMBER","populationDescription":"* Target mTNBC: Participants with mTNBC who received at least 2 prior therapies for metastatic disease \\& who received at least 1 dose of 10 mg/kg SG\n* HR+/HER2-mBC: Participants with HR+/HER2- mBC who progressed on at least 1 prior hormonal therapy \\& who received at least 1 dose of 10 mg/kg SG\n* mUC: Participants who had relapsed after or were refractory to at least 1 prior treatments \\& who received at least 1 dose of 10 mg/kg SG\n* OSP: All participants who received at least 1 dose of SG","reportingStatus":"POSTED","timeFrame":"First dose date up to last dose for data cutoff date of 01 March 2019 (maximum duration: 55.2 months) plus 30 days","title":"Percentage of Participants Experiencing Any Treatment Emergent Adverse Events and Serious Treatment Emergent Adverse Events","type":"PRIMARY","unitOfMeasure":"Percentage of participants"}