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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":"2"},{"groupId":"OG008","value":"0"},{"groupId":"OG009","value":"1"},{"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":"1"},{"groupId":"OG021","value":"1"},{"groupId":"OG022","value":"0"}]}],"title":"Participants with Treatment-Related 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":"0"}]}],"title":"Participants with Treatment-Related 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":"AE was defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of study drug, whether or not related to study drug. Treatment-emergent events were the 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. Treatment related AE was defined as having a \"Possible\" or \"Related\" relationship to study treatment, as assessed by the Investigator. Severity of Treatment-Related TEAEs were graded using 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":"SAF included all participants who have received at least 1 dose of study treatment.","reportingStatus":"POSTED","timeFrame":"Baseline up to Day 2511","title":"Dose Escalation and Expansion Cohorts: Number of Participants With Treatment-Related Treatment-Emergent Adverse Events (TEAEs) and Treatment-Related TEAEs as Per Severity","type":"SECONDARY","unitOfMeasure":"Participants"}