{"description":"1/48 participants in cohort 1 was a screening fail.","eventGroups":[{"deathsNumAffected":28,"deathsNumAtRisk":47,"description":"Cohort 1, Arm 1, Treatment Assignment Code (TAC) 1: Participants with HPV associated malignancies will receive human papillomavirus (HPV) vaccine every (q) 4 weeks x6, then q3 months (MO) x2 + NHS-IL12 q 4 weeks (wks) + M7824 q 2 wks.\n\nPDS0101 will be administered on Day (D)1, D15, D29 followed by booster vaccines every 4 weeks for up to a year. Subcutaneous 1.0mL (2.4mg of total peptide and 3 mg of R-DOTAP (Versamune) injection).\n\nM7824 will be administered at a flat dose of 1,200 mg intravenous (IV) (over 1 hour) once every 2 weeks.\n\nNHS-IL12 will be administered by subcutaneous (SC) injection every 4 weeks.","id":"EG000","otherNumAffected":47,"otherNumAtRisk":47,"seriousNumAffected":18,"seriousNumAtRisk":47,"title":"Cohort 1, Arm 1: Human Papillomavirus (HPV) Associated Malignancies"},{"deathsNumAffected":0,"deathsNumAtRisk":3,"description":"Cohort 2, Arm 2, Treatment Assignment Code (TAC) 1: Participants with cervical cancer with prior pelvic radiation and boost brachytherapy will receive human papillomavirus (HPV) vaccine + NHS-IL12 + M7824 (MSB0011359C) at reduced doses.\n\nPDS0101 will be administered on Day (D)1, D15, D29 followed by booster vaccines every 4 weeks for up to a year. Subcutaneous 1.0mL (2.4mg of total peptide and 3 mg of R-DOTAP (Versamune) injection).\n\nM7824 will be administered at a flat dose of 1,200 mg intravenous (IV) (over 1 hour) once every 2 weeks.\n\nNHS-IL12 will be administered by subcutaneous (SC) injection every 4 weeks.","id":"EG001","otherNumAffected":3,"otherNumAtRisk":3,"seriousNumAffected":1,"seriousNumAtRisk":3,"title":"Cohort 2, Arm 2: Cervical Cancer With Prior Pelvic Radiation and Boost Brachytherapy"}],"frequencyThreshold":"0","otherEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (5.0)","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":47,"numEvents":8},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0}],"term":"Abdominal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE (5.0)","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":47,"numEvents":6},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0}],"term":"Activated partial thromboplastin time prolonged"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE (5.0)","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":47,"numEvents":24},{"groupId":"EG001","numAffected":1,"numAtRisk":3,"numEvents":3}],"term":"Alanine aminotransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE (5.0)","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":47,"numEvents":16},{"groupId":"EG001","numAffected":1,"numAtRisk":3,"numEvents":1}],"term":"Alkaline phosphatase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (5.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":47,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0}],"term":"Allergic rhinitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (5.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":47,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0}],"term":"Anal fissure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (5.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":47,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0}],"term":"Anal hemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (5.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":47,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0}],"term":"Anal mucositis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE (5.0)","stats":[{"groupId":"EG000","numAffected":31,"numAtRisk":47,"numEvents":126},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0}],"term":"Anemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (5.0)","stats":[{"groupId":"EG000","numAffected":12,"numAtRisk":47,"numEvents":14},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0}],"term":"Anorexia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"CTCAE (5.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":47,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0}],"term":"Anxiety"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"CTCAE (5.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":47,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0}],"term":"Arterial thromboembolism"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"CTCAE (5.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":47,"numEvents":6},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0}],"term":"Arthralgia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"CTCAE (5.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":47,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0}],"term":"Arthritis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (5.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":47,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0}],"term":"Ascites"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE (5.0)","stats":[{"groupId":"EG000","numAffected":14,"numAtRisk":47,"numEvents":27},{"groupId":"EG001","numAffected":1,"numAtRisk":3,"numEvents":2}],"term":"Aspartate aminotransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"CTCAE (5.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":47,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0}],"term":"Atrial fibrillation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"CTCAE (5.0)","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":47,"numEvents":5},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0}],"term":"Back pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (5.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":47,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0}],"term":"Bloating"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE (5.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":47,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":3,"numEvents":1}],"term":"Blood bilirubin increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE (5.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":47,"numEvents":3},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0}],"term":"Blood lactate dehydrogenase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"CTCAE (5.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":47,"numEvents":3},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0}],"term":"Blurred vision"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"CTCAE (5.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":47,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0}],"term":"Bruising"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE (5.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":47,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0}],"term":"CPK increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"CTCAE (5.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":47,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0}],"term":"Cardiac disorders - Other, Immune mediated myocarditis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE (5.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":47,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0}],"term":"Cardiac troponin I increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"CTCAE (5.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":47,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0}],"term":"Cataract"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE (5.0)","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":47,"numEvents":5},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0}],"term":"Chills"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE (5.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":47,"numEvents":3},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0}],"term":"Cholesterol high"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"CTCAE (5.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":47,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0}],"term":"Confusion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (5.0)","stats":[{"groupId":"EG000","numAffected":15,"numAtRisk":47,"numEvents":20},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0}],"term":"Constipation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (5.0)","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":47,"numEvents":9},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0}],"term":"Cough"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE (5.0)","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":47,"numEvents":11},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0}],"term":"Creatinine increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (5.0)","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":47,"numEvents":10},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0}],"term":"Dehydration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"CTCAE (5.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":47,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0}],"term":"Delirium"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (5.0)","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":47,"numEvents":8},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0}],"term":"Diarrhea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE (5.0)","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":47,"numEvents":8},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0}],"term":"Dizziness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"CTCAE (5.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":47,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0}],"term":"Dry eye"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"CTCAE (5.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":47,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0}],"term":"Dry 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(5.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":47,"numEvents":3},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0}],"term":"Dysphagia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (5.0)","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":47,"numEvents":12},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0}],"term":"Dyspnea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE (5.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":47,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0}],"term":"Edema face"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE (5.0)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":47,"numEvents":6},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0}],"term":"Edema 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(5.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":47,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0}],"term":"Eye disorders - Other, left eye stye"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (5.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":47,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0}],"term":"Eye infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE (5.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":47,"numEvents":3},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0}],"term":"Facial nerve disorder"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE 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