{"calculatePct":false,"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"2"}]}],"title":"Complete response (CR)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"12"}]}],"title":"Partial response (PR)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"46"}]}],"title":"Stable disease (SD)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"67"}]}],"title":"Progressive disease (PD)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"1"}]}],"title":"Non-CR/Non-PD"},{"categories":[{"measurements":[{"groupId":"OG000","value":"25"}]}],"title":"Non-evaluable"}],"denoms":[{"counts":[{"groupId":"OG000","value":"153"}],"units":"Participants"}],"description":"Confirmed BOR was determined according to RECIST 1.1 and as adjudicated by an Independent Endpoint Review Committee (IERC) and defined as best response of any of complete response (CR), partial response (PR), stable disease (SD) and progressive disease (PD) recorded from date of randomization until disease progression/recurrence (taking smallest measurement recorded since start of treatment as reference). CR: Disappearance of all evidence of target/non-target lesions. PR: At least 30%reduction from baseline in sum of longest diameter (SLD) of all lesions. SD: Neither sufficient increase to qualify for PD nor sufficient shrinkage to qualify for PR. PD: at least a 20% increase in SLD, taking as reference smallest SLD recorded from baseline/appearance of 1or more new lesions and unequivocal progression of non-target lesions.","groups":[{"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":"OG000","title":"Efficacy Expansion Cohort: HNSCC"}],"paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"Full analysis set (FAS) included all participants who have received at least 1 dose of study treatment.","reportingStatus":"POSTED","timeFrame":"HNSCC Efficacy Expansion: Baseline up to Day 1072","title":"Efficacy Expansion Cohort (HNSCC): Number of Participants With Confirmed Best Overall Response (BOR) as Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1), as Adjudicated by Independent Endpoint Review Committee (IERC)","type":"PRIMARY","unitOfMeasure":"Participants"}