{"analyses":[{"groupIds":["OG000"],"nonInferiorityComment":"Non-inferiority was defined as response rates which were sufficiently similar (p\\>0.20 by Fisher's exact test).","nonInferiorityType":"NON_INFERIORITY","pValue":"0.6143","pValueComment":"The p value was calculated and was 0.6143 which is \\> 0.2 (pre-defined threshold).","statisticalMethod":"Fisher Exact"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"2"}]}],"title":"Complete Response"},{"categories":[{"measurements":[{"groupId":"OG000","value":"7"}]}],"title":"Partial Response"},{"categories":[{"measurements":[{"groupId":"OG000","value":"10"}]}],"title":"Progressive Disease"},{"categories":[{"measurements":[{"groupId":"OG000","value":"9"}]}],"title":"Stable Disease"},{"categories":[{"measurements":[{"groupId":"OG000","value":"1"}]}],"title":"Not Evaluable"}],"denoms":[{"counts":[{"groupId":"OG000","value":"29"}],"units":"Participants"}],"description":"Response based on adequate similarity defined as P-value \\> 0.2 with Fisher's exact test of results in cohorts 1 and 2 was compared with a two-sided Fishers exact test, and response was measured by the response evaluation criteria in solid tumors (RECIST)version 1.1. Complete response (CR) is disappearance of all target lesions. Partial response (PR) is at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Progressive disease is at least a 20% increase in the sum of diameters of target lesions, or appearance of one or more new lesions. Stable disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD).","groups":[{"description":"Participants with anal cancer, non-neuroendocrine cervical cancer, P16 positive (P16+) oropharyngeal cancers, and other rare HPV associated tumors (e.g., squamous cell rectal, vulvar, vaginal, penile cancer, neuroendocrine cervical) naïve to checkpoint inhibition treated with M7824 at a flat dose of 1,200 mg intravenous (IV) once every 2 weeks until confirmed progressive disease, death, unacceptable toxicity, or study withdrawal.","id":"OG000","title":"Participants Naïve to Checkpoint Inhibition - M7824 1,200 mg Intravenous Once Every 2 Weeks"}],"paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"Only cohorts 1 and 2 was evaluable for this outcome measure.","reportingStatus":"POSTED","timeFrame":"median of 2 years","title":"Number of Checkpoint Inhibitor Naive Participants With Response Based on Adequate Similarity (Defined as P-value > 0.2 With Fisher's Exact Test) of Results in Cohorts 1 and 2","type":"SECONDARY","unitOfMeasure":"Participants"}