{"calculatePct":false,"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"4"},{"groupId":"OG001","value":"13"},{"groupId":"OG002","value":"15"},{"groupId":"OG003","value":"21"},{"groupId":"OG004","value":"8"},{"groupId":"OG005","value":"182"},{"groupId":"OG006","value":"156"},{"groupId":"OG007","value":"161"},{"groupId":"OG008","value":"60"},{"groupId":"OG009","value":"88"},{"groupId":"OG010","value":"21"},{"groupId":"OG011","value":"17"},{"groupId":"OG012","value":"50"},{"groupId":"OG013","value":"50"},{"groupId":"OG014","value":"53"},{"groupId":"OG015","value":"44"},{"groupId":"OG016","value":"122"},{"groupId":"OG017","value":"62"},{"groupId":"OG018","value":"19"},{"groupId":"OG019","value":"103"},{"groupId":"OG020","value":"204"},{"groupId":"OG021","value":"130"},{"groupId":"OG022","value":"149"}]}],"title":"Participants with TEAEs"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"1"},{"groupId":"OG002","value":"1"},{"groupId":"OG003","value":"2"},{"groupId":"OG004","value":"2"},{"groupId":"OG005","value":"11"},{"groupId":"OG006","value":"3"},{"groupId":"OG007","value":"22"},{"groupId":"OG008","value":"5"},{"groupId":"OG009","value":"14"},{"groupId":"OG010","value":"2"},{"groupId":"OG011","value":"5"},{"groupId":"OG012","value":"1"},{"groupId":"OG013","value":"2"},{"groupId":"OG014","value":"2"},{"groupId":"OG015","value":"3"},{"groupId":"OG016","value":"11"},{"groupId":"OG017","value":"7"},{"groupId":"OG018","value":"1"},{"groupId":"OG019","value":"7"},{"groupId":"OG020","value":"15"},{"groupId":"OG021","value":"2"},{"groupId":"OG022","value":"14"}]}],"title":"Participants with TEAEs with Grade 1 severity"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"4"},{"groupId":"OG002","value":"4"},{"groupId":"OG003","value":"6"},{"groupId":"OG004","value":"3"},{"groupId":"OG005","value":"54"},{"groupId":"OG006","value":"45"},{"groupId":"OG007","value":"58"},{"groupId":"OG008","value":"9"},{"groupId":"OG009","value":"19"},{"groupId":"OG010","value":"9"},{"groupId":"OG011","value":"5"},{"groupId":"OG012","value":"10"},{"groupId":"OG013","value":"17"},{"groupId":"OG014","value":"21"},{"groupId":"OG015","value":"10"},{"groupId":"OG016","value":"52"},{"groupId":"OG017","value":"25"},{"groupId":"OG018","value":"5"},{"groupId":"OG019","value":"30"},{"groupId":"OG020","value":"46"},{"groupId":"OG021","value":"30"},{"groupId":"OG022","value":"43"}]}],"title":"Participants with TEAEs with Grade 2 severity"},{"categories":[{"measurements":[{"groupId":"OG000","value":"2"},{"groupId":"OG001","value":"4"},{"groupId":"OG002","value":"6"},{"groupId":"OG003","value":"11"},{"groupId":"OG004","value":"3"},{"groupId":"OG005","value":"66"},{"groupId":"OG006","value":"68"},{"groupId":"OG007","value":"45"},{"groupId":"OG008","value":"29"},{"groupId":"OG009","value":"41"},{"groupId":"OG010","value":"6"},{"groupId":"OG011","value":"7"},{"groupId":"OG012","value":"25"},{"groupId":"OG013","value":"21"},{"groupId":"OG014","value":"23"},{"groupId":"OG015","value":"18"},{"groupId":"OG016","value":"42"},{"groupId":"OG017","value":"20"},{"groupId":"OG018","value":"10"},{"groupId":"OG019","value":"45"},{"groupId":"OG020","value":"82"},{"groupId":"OG021","value":"51"},{"groupId":"OG022","value":"54"}]}],"title":"Participants with TEAEs with Grade 3 severity"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"2"},{"groupId":"OG003","value":"1"},{"groupId":"OG004","value":"0"},{"groupId":"OG005","value":"19"},{"groupId":"OG006","value":"15"},{"groupId":"OG007","value":"12"},{"groupId":"OG008","value":"7"},{"groupId":"OG009","value":"4"},{"groupId":"OG010","value":"1"},{"groupId":"OG011","value":"0"},{"groupId":"OG012","value":"8"},{"groupId":"OG013","value":"5"},{"groupId":"OG014","value":"3"},{"groupId":"OG015","value":"6"},{"groupId":"OG016","value":"3"},{"groupId":"OG017","value":"6"},{"groupId":"OG018","value":"1"},{"groupId":"OG019","value":"6"},{"groupId":"OG020","value":"16"},{"groupId":"OG021","value":"12"},{"groupId":"OG022","value":"12"}]}],"title":"Participants with TEAEs with Grade 4 severity"},{"categories":[{"measurements":[{"groupId":"OG000","value":"2"},{"groupId":"OG001","value":"4"},{"groupId":"OG002","value":"2"},{"groupId":"OG003","value":"1"},{"groupId":"OG004","value":"0"},{"groupId":"OG005","value":"32"},{"groupId":"OG006","value":"25"},{"groupId":"OG007","value":"24"},{"groupId":"OG008","value":"10"},{"groupId":"OG009","value":"10"},{"groupId":"OG010","value":"3"},{"groupId":"OG011","value":"0"},{"groupId":"OG012","value":"6"},{"groupId":"OG013","value":"5"},{"groupId":"OG014","value":"4"},{"groupId":"OG015","value":"7"},{"groupId":"OG016","value":"14"},{"groupId":"OG017","value":"4"},{"groupId":"OG018","value":"2"},{"groupId":"OG019","value":"15"},{"groupId":"OG020","value":"45"},{"groupId":"OG021","value":"35"},{"groupId":"OG022","value":"25"}]}],"title":"Participants with TEAEs with Grade 5 severity"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"},{"groupId":"OG004","value":"0"},{"groupId":"OG005","value":"0"},{"groupId":"OG006","value":"0"},{"groupId":"OG007","value":"0"},{"groupId":"OG008","value":"0"},{"groupId":"OG009","value":"0"},{"groupId":"OG010","value":"0"},{"groupId":"OG011","value":"0"},{"groupId":"OG012","value":"0"},{"groupId":"OG013","value":"0"},{"groupId":"OG014","value":"0"},{"groupId":"OG015","value":"0"},{"groupId":"OG016","value":"0"},{"groupId":"OG017","value":"0"},{"groupId":"OG018","value":"0"},{"groupId":"OG019","value":"0"},{"groupId":"OG020","value":"0"},{"groupId":"OG021","value":"0"},{"groupId":"OG022","value":"1"}]}],"title":"Participants with TEAEs with missing Grade"}],"denoms":[{"counts":[{"groupId":"OG000","value":"4"},{"groupId":"OG001","value":"13"},{"groupId":"OG002","value":"15"},{"groupId":"OG003","value":"21"},{"groupId":"OG004","value":"8"},{"groupId":"OG005","value":"184"},{"groupId":"OG006","value":"156"},{"groupId":"OG007","value":"168"},{"groupId":"OG008","value":"60"},{"groupId":"OG009","value":"90"},{"groupId":"OG010","value":"21"},{"groupId":"OG011","value":"18"},{"groupId":"OG012","value":"50"},{"groupId":"OG013","value":"51"},{"groupId":"OG014","value":"53"},{"groupId":"OG015","value":"44"},{"groupId":"OG016","value":"125"},{"groupId":"OG017","value":"62"},{"groupId":"OG018","value":"20"},{"groupId":"OG019","value":"103"},{"groupId":"OG020","value":"205"},{"groupId":"OG021","value":"132"},{"groupId":"OG022","value":"153"}],"units":"Participants"}],"description":"Adverse event(AE): any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with use of study drug, whether or not related to study drug. A serious adverse event(SAE) was an AE that resulted in any of following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. Treatment-emergent events were events between first dose of study drug that were absent before treatment or that worsened relative to pre-treatment state up to 30 days after last administration.TEAEs included both Serious TEAEs and non-serious TEAEs. Severity of TEAEs were graded using National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 4.0 toxicity grades, as follows: Grade 1= Mild, Grade 2= Moderate, Grade 3= Severe, Grade 4= Life-threatening and Grade 5= Death.","groups":[{"description":"Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 1.0 milligrams per kilogram (mg/kg) once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or investigational medicinal product (IMP) occurs.","id":"OG000","title":"Dose Escalation Cohort: Avelumab 1.0 mg/kg"},{"description":"Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 3.0 mg/kg once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.","id":"OG001","title":"Dose Escalation Cohort: Avelumab 3.0 mg/kg"},{"description":"Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.","id":"OG002","title":"Dose Escalation Cohort: Avelumab 10.0 mg/kg"},{"description":"Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 20.0 mg/kg once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.","id":"OG003","title":"Dose Escalation Cohort: Avelumab 20.0 mg/kg"},{"description":"Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once weekly for the first 12 weeks and once every 2 weeks starting Week 13 in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.","id":"OG004","title":"Dose Escalation Cohort: Avelumab 10.0 mg/kg Weekly"},{"description":"Participants with non-small cell lung cancer (NSCLC), who had progressed after 1 line of platinum-containing doublet chemotherapy received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.","id":"OG005","title":"Primary Expansion Cohort: NSCLC, Post-platinum Doublet"},{"description":"Participants with non-small cell lung cancer (NSCLC), first line received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.","id":"OG006","title":"Primary Expansion Cohort: NSCLC, First Line"},{"description":"Participants with metastatic breast cancer received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.","id":"OG007","title":"Primary Expansion Cohort: Metastatic Breast Cancer"},{"description":"Participants with gastric and gastroesophageal cancer who progressed on or after first-line chemotherapy received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.","id":"OG008","title":"Primary Expansion Cohort: GC/GEJC Progressed"},{"description":"Participants with gastric and gastroesophageal cancer who non-progressed on or after first-line chemotherapy received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.","id":"OG009","title":"Primary Expansion Cohort: GC/GEJC Non Progressed"},{"description":"Participants with colorectal cancer received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.","id":"OG010","title":"Secondary Expansion Cohort: Colorectal Cancer"},{"description":"Participants with castrate-resistant prostate cancer received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.","id":"OG011","title":"Secondary Expansion Cohort: Castrate-resistant Prostate Cancer"},{"description":"Participants with adrenocortical carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.","id":"OG012","title":"Secondary Expansion Cohort: Adrenocortical Carcinoma"},{"description":"Participants with melanoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.","id":"OG013","title":"Secondary Expansion Cohort: Melanoma"},{"description":"Participants with mesothelioma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.","id":"OG014","title":"Secondary Expansion Cohort: Mesothelioma"},{"description":"Participants with urothelial carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.","id":"OG015","title":"Secondary Expansion Cohort: Urothelial Carcinoma"},{"description":"Participants with ovarian carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.","id":"OG016","title":"Secondary Expansion Cohort: Ovarian Cancer"},{"description":"Participants with Renal cell carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks as a first-line therapy in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.","id":"OG017","title":"Secondary Expansion Cohort: Renal Cell Carcinoma (First Line)"},{"description":"Participants with Renal cell carcinoma who failed 1 prior systemic first-line regimen received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks as a second line treatment in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.","id":"OG018","title":"Secondary Expansion Cohort: Renal Cell Carcinoma (Second Line)"},{"description":"Participants with ovarian carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.","id":"OG019","title":"Efficacy Expansion Cohort: Ovarian Cancer"},{"description":"Participants with urothelial carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.","id":"OG020","title":"Efficacy Expansion Cohort: Urothelial Carcinoma"},{"description":"Participants with gastric (GC) and gastroesophageal junction cancer (GEJC) who have failed both a first-line chemotherapy regimen and subsequent ramucirumab therapy, received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks as a third-line treatment in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.","id":"OG021","title":"Efficacy Expansion Cohort: GC/GEJC, Third Line"},{"description":"Participants with head and neck squamous cell carcinoma (HNSCC) received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.","id":"OG022","title":"Efficacy Expansion Cohort: HNSCC"}],"paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"Safety analysis set (SAF) included all participants who have received at least 1 dose of study treatment.","reportingStatus":"POSTED","timeFrame":"Up to Day 2511","title":"Dose Escalation and Expansion Cohorts: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and TEAEs as Per Severity","type":"SECONDARY","unitOfMeasure":"Participants"}