{"description":"AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.","eventGroups":[{"deathsNumAffected":3,"deathsNumAtRisk":4,"description":"Subjects received durvalumab (1500 mg IV every 4 weeks \\[Q4W\\] for 12 cycles). Poly-ICLC (1 mg) was administered intratumorally on days 1, 3, 5, 8, 10 and 15 and intramuscularly on days 17, 22, and 24 of Cycle 1 as well as intramuscularly on days 1, 3, 8, 10, 15, 17, 22 and 24 of Cycle 2 and on days 1 and 4 of Cycle 3.\n\nDurvalumab\n\nPoly-ICLC","id":"EG000","otherNumAffected":4,"otherNumAtRisk":4,"seriousNumAffected":0,"seriousNumAtRisk":4,"title":"Phase 1, Cohort 1A"},{"deathsNumAffected":5,"deathsNumAtRisk":5,"description":"Subjects received durvalumab (1500 mg IV Q4W for 12 cycles) and tremelimumab (75 mg IV Q4W for the first 4 cycles).\n\nPoly-ICLC (1 mg) was administered intratumorally on days 1, 3, 5, 8, 10 and 15 and intramuscularly on days 17, 22, and 24 of Cycle 1 as well as intramuscularly on days 1, 3, 8, 10, 15, 17, 22 and 24 of Cycle 2 and on days 1 and 4 of Cycle 3.\n\nDurvalumab\n\nTremelimumab\n\nPoly-ICLC","id":"EG001","otherNumAffected":5,"otherNumAtRisk":5,"seriousNumAffected":3,"seriousNumAtRisk":5,"title":"Phase 1, Cohort 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intratumorally on days 1, 3, 5, 8, 10 and 15 and intramuscularly on days 17, 22, and 24 of Cycle 1 as well as intramuscularly on days 1, 3, 8, 10, 15, 17, 22 and 24 of Cycle 2 and on days 1 and 4 of Cycle 3.\n\nDurvalumab\n\nTremelimumab\n\nPoly-ICLC","id":"EG003","otherNumAffected":15,"otherNumAtRisk":15,"seriousNumAffected":4,"seriousNumAtRisk":15,"title":"Cohort 1C + Phase 2; Locally Recurrent or Metastatic Breast Cancer"},{"deathsNumAffected":6,"deathsNumAtRisk":7,"description":"Subjects received durvalumab (1500 mg IV Q4W for 12 cycles) and tremelimumab (10 mg) intratumorally on days 1, 8, and 15 of Cycle 1, days 1 and 15 of Cycle 2 and day 1 of Cycles 3 and 4.\n\nPoly-ICLC (1 mg) was administered intratumorally on days 1, 3, 5, 8, 10 and 15 and intramuscularly on days 17, 22, and 24 of Cycle 1 as well as intramuscularly on days 1, 3, 8, 10, 15, 17, 22 and 24 of Cycle 2 and on days 1 and 4 of Cycle 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tremelimumab (10 mg) intratumorally on days 1, 8, and 15 of Cycle 1, days 1 and 15 of Cycle 2 and day 1 of Cycles 3 and 4.\n\nPoly-ICLC (1 mg) was administered intratumorally on days 1, 3, 5, 8, 10 and 15 and intramuscularly on days 17, 22, and 24 of Cycle 1 as well as intramuscularly on days 1, 3, 8, 10, 15, 17, 22 and 24 of Cycle 2 and on days 1 and 4 of Cycle 3.\n\nDurvalumab\n\nTremelimumab\n\nPoly-ICLC","id":"EG006","otherNumAffected":10,"otherNumAtRisk":10,"seriousNumAffected":3,"seriousNumAtRisk":10,"title":"Cohort 1C + Phase 2; Melanoma After Failure of Available Therapies"},{"deathsNumAffected":3,"deathsNumAtRisk":3,"description":"Subjects received durvalumab (1500 mg IV Q4W for 12 cycles) and tremelimumab (10 mg) intratumorally on days 1, 8, and 15 of Cycle 1, days 1 and 15 of Cycle 2 and day 1 of Cycles 3 and 4.\n\nPoly-ICLC (1 mg) was administered intratumorally on days 1, 3, 5, 8, 10 and 15 and intramuscularly on days 17, 22, and 24 of Cycle 1 as well as intramuscularly on days 1, 3, 8, 10, 15, 17, 22 and 24 of Cycle 2 and on days 1 and 4 of Cycle 3.\n\nDurvalumab\n\nTremelimumab\n\nPoly-ICLC","id":"EG007","otherNumAffected":3,"otherNumAtRisk":3,"seriousNumAffected":2,"seriousNumAtRisk":3,"title":"Cohort 1C + Phase 2; Genitourinary Cancers With Accessible Metastases"},{"deathsNumAffected":6,"deathsNumAtRisk":7,"description":"Subjects received durvalumab (1500 mg IV Q4W for 12 cycles) and tremelimumab (10 mg) intratumorally on days 1, 8, and 15 of Cycle 1, days 1 and 15 of Cycle 2 and day 1 of Cycles 3 and 4.\n\nPoly-ICLC (1 mg) was administered intratumorally on days 1, 3, 5, 8, 10 and 15 and intramuscularly on days 17, 22, and 24 of Cycle 1 as well as intramuscularly on days 1, 3, 8, 10, 15, 17, 22 and 24 of Cycle 2 and on days 1 and 4 of Cycle 3.\n\nDurvalumab\n\nTremelimumab\n\nPoly-ICLC","id":"EG008","otherNumAffected":7,"otherNumAtRisk":7,"seriousNumAffected":2,"seriousNumAtRisk":7,"title":"Cohort 1C + Phase 2; Solid Tumors With Accessible Masses"}],"frequencyThreshold":"0","otherEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":4},{"groupId":"EG001","numAffected":3,"numAtRisk":5},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":2,"numAtRisk":15},{"groupId":"EG004","numAffected":3,"numAtRisk":7},{"groupId":"EG005","numAffected":1,"numAtRisk":4},{"groupId":"EG006","numAffected":3,"numAtRisk":10},{"groupId":"EG007","numAffected":1,"numAtRisk":3},{"groupId":"EG008","numAffected":1,"numAtRisk":7}],"term":"Anaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 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(19.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4},{"groupId":"EG001","numAffected":0,"numAtRisk":5},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":1,"numAtRisk":15},{"groupId":"EG004","numAffected":0,"numAtRisk":7},{"groupId":"EG005","numAffected":0,"numAtRisk":4},{"groupId":"EG006","numAffected":0,"numAtRisk":10},{"groupId":"EG007","numAffected":0,"numAtRisk":3},{"groupId":"EG008","numAffected":0,"numAtRisk":7}],"term":"Lymph node pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 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(19.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4},{"groupId":"EG001","numAffected":0,"numAtRisk":5},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":1,"numAtRisk":15},{"groupId":"EG004","numAffected":0,"numAtRisk":7},{"groupId":"EG005","numAffected":1,"numAtRisk":4},{"groupId":"EG006","numAffected":0,"numAtRisk":10},{"groupId":"EG007","numAffected":0,"numAtRisk":3},{"groupId":"EG008","numAffected":0,"numAtRisk":7}],"term":"Eye swelling"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 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