{"description":"All patients enrolled in the Ovarian Cancer (OvC) arm except for one subject enrolled in the Colorectal (CRC) arm. The CRC arm patient was discontinued before efficacy could be assessed. For this reason, this subject was not included in the evaluation for efficacy or safety.","eventGroups":[{"deathsNumAffected":7,"deathsNumAtRisk":25,"description":"* Metastatic platinum-resistant or refractory OvC previously treated with ≥1 line of prior platinum-containing therapy\n* Galinpepimut-S + Montanide + GM-CSF + pembrolizumab","id":"EG000","otherNumAffected":25,"otherNumAtRisk":25,"seriousNumAffected":5,"seriousNumAtRisk":25,"title":"Ovarian Cancer (OvC)"},{"deathsNumAffected":0,"deathsNumAtRisk":0,"description":"Metastatic CRC previously treated with ≥ 2 lines of prior systematic chemotherapies Galinpepimut-S + Montanide + GM-CSF + pembrolizumab","id":"EG001","otherNumAffected":0,"otherNumAtRisk":0,"seriousNumAffected":0,"seriousNumAtRisk":0,"title":"Colorectal Cancer (CRC)"}],"frequencyThreshold":"5","otherEvents":[{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (23.0)","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":25,"numEvents":5},{"groupId":"EG001","numAtRisk":0}],"term":"Anemia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (23.0)","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":25,"numEvents":9},{"groupId":"EG001","numAtRisk":0}],"term":"Vomiting"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (23.0)","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":25,"numEvents":7},{"groupId":"EG001","numAtRisk":0}],"term":"Abdominal pain"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (23.0)","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":25,"numEvents":7},{"groupId":"EG001","numAtRisk":0}],"term":"Nausea"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal 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(23.0)","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":25,"numEvents":5},{"groupId":"EG001","numAtRisk":0}],"term":"Constipation"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (23.0)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":25,"numEvents":4},{"groupId":"EG001","numAtRisk":0}],"term":"Ascites"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (23.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":25,"numEvents":3},{"groupId":"EG001","numAtRisk":0}],"term":"Small intestinal obstruction"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (23.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":25,"numEvents":2},{"groupId":"EG001","numAtRisk":0}],"term":"Abdominal pain upper"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General 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infection"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (23.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":25,"numEvents":2},{"groupId":"EG001","numAtRisk":0}],"term":"Decreased appetite"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (23.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":25,"numEvents":2},{"groupId":"EG001","numAtRisk":0}],"term":"Dehydration"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (23.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":25,"numEvents":3},{"groupId":"EG001","numAtRisk":0}],"term":"Arthralgia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (23.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":25,"numEvents":2},{"groupId":"EG001","numAtRisk":0}],"term":"Back pain"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (23.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":25,"numEvents":2},{"groupId":"EG001","numAtRisk":0}],"term":"Bone pain"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (23.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":25,"numEvents":2},{"groupId":"EG001","numAtRisk":0}],"term":"Myalgia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (23.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":25,"numEvents":2},{"groupId":"EG001","numAtRisk":0}],"term":"Pain in 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(23.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":25,"numEvents":2},{"groupId":"EG001","numAtRisk":0}],"term":"Dyspnea"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (23.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":25,"numEvents":2},{"groupId":"EG001","numAtRisk":0}],"term":"Pleural effusion"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (23.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":25,"numEvents":2},{"groupId":"EG001","numAtRisk":0}],"term":"Pruritus"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (23.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":25,"numEvents":2},{"groupId":"EG001","numAtRisk":0}],"term":"Rash maculo-papular"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA (23.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":25,"numEvents":2},{"groupId":"EG001","numAtRisk":0}],"term":"Hypotension"}],"seriousEvents":[{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (23.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":25,"numEvents":1},{"groupId":"EG001","numAtRisk":0}],"term":"Pneumonitis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA (23.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":25,"numEvents":1},{"groupId":"EG001","numAtRisk":0}],"term":"Acute kidney injury"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA (23.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":25,"numEvents":1},{"groupId":"EG001","numAtRisk":0}],"term":"Hydronephrosis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (23.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":25,"numEvents":1},{"groupId":"EG001","numAtRisk":0}],"term":"Dyspnoea"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (23.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":25,"numEvents":1},{"groupId":"EG001","numAtRisk":0}],"term":"Small intestinal obstruction"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (23.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":25,"numEvents":1},{"groupId":"EG001","numAtRisk":0}],"term":"Fatigue"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (23.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":25,"numEvents":1},{"groupId":"EG001","numAtRisk":0}],"term":"Sepsis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (23.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":25,"numEvents":1},{"groupId":"EG001","numAtRisk":0}],"term":"Back pain"}],"timeFrame":"Adverse event data was collected for 29 months."}