{"description":"Adverse events were only recorded/collected as the combined total from participants per study phase. Adverse events were not collected per dose level and thus cannot be reported per dose level.\n\nFor Phase 1, adverse events were collected from the 26 participants who received the study interventions and completed the study.","eventGroups":[{"deathsNumAffected":11,"deathsNumAtRisk":26,"description":"Phase 1 is to determine the maximum tolerated dose (MTD) and dose limiting toxicity (DLT) of the combinations of oral 5-azacitidine and romidepsin in patients with lymphoma. Patients will be administered the study drugs in a 3 + 3 dose-escalation study.\n\nRomidepsin is an anti-cancer (\"antineoplastic\" or \"cytotoxic\") chemotherapy drug. Romidepsin is classified as a \"Histone Deacetylase Inhibitor\". Dose escalation: 10, 14 mg/m2\n\nOral 5-Azacitidine is a pyrimidine nucleoside analogue of cytidine with antineoplastic activity. Dose escalation: 100, 200, 300 mg","id":"EG000","otherNumAffected":26,"otherNumAtRisk":26,"seriousNumAffected":11,"seriousNumAtRisk":26,"title":"Phase 1"},{"deathsNumAffected":0,"deathsNumAtRisk":25,"description":"Patients will be treated with oral 5-azacytidine and romidepsin at the MTD. The treatment will be administered as follows: oral 5-azacytidine 300 mg (flat dose) on Days 1-14 and romidepsin 14 mg/m2 (flat dose) on Days 8, 15, and 22 on a 35-day cycle.","id":"EG001","otherNumAffected":25,"otherNumAtRisk":25,"seriousNumAffected":12,"seriousNumAtRisk":25,"title":"Phase 2"}],"frequencyThreshold":"5","otherEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":26},{"groupId":"EG001","numAffected":13,"numAtRisk":25}],"term":"Fatigue"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","stats":[{"groupId":"EG000","numAffected":14,"numAtRisk":26},{"groupId":"EG001","numAffected":15,"numAtRisk":25}],"term":"Nausea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","stats":[{"groupId":"EG000","numAffected":12,"numAtRisk":26},{"groupId":"EG001","numAffected":10,"numAtRisk":25}],"term":"Vomiting"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":26},{"groupId":"EG001","numAffected":10,"numAtRisk":25}],"term":"Creatinine elevation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":26},{"groupId":"EG001","numAffected":12,"numAtRisk":25}],"term":"Diarrhea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":26},{"groupId":"EG001","numAffected":7,"numAtRisk":25}],"term":"Fever"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":26},{"groupId":"EG001","numAffected":3,"numAtRisk":25}],"term":"Hypercalcemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","stats":[{"groupId":"EG000","numAffected":13,"numAtRisk":26},{"groupId":"EG001","numAffected":11,"numAtRisk":25}],"term":"Hypoalbuminemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":26},{"groupId":"EG001","numAffected":7,"numAtRisk":25}],"term":"Hypocalcemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":26},{"groupId":"EG001","numAffected":3,"numAtRisk":25}],"term":"Hypoglycemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Endocrine disorders","stats":[{"groupId":"EG000","numAffected":21,"numAtRisk":26},{"groupId":"EG001","numAffected":14,"numAtRisk":25}],"term":"Hyperglycemia (Grade 1 and 2)"}],"seriousEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":26},{"groupId":"EG001","numAffected":0,"numAtRisk":25}],"term":"Alkaline phosphatase elevation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":26},{"groupId":"EG001","numAffected":4,"numAtRisk":25}],"term":"Anemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":26},{"groupId":"EG001","numAffected":3,"numAtRisk":25}],"term":"Febrile neutropenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Endocrine disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":26},{"groupId":"EG001","numAffected":1,"numAtRisk":25}],"term":"Hyperglycemia (Grade 3 and 4)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":26},{"groupId":"EG001","numAffected":0,"numAtRisk":25}],"term":"Hypermagnesemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":26},{"groupId":"EG001","numAffected":0,"numAtRisk":25}],"term":"Hypokalemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":26},{"groupId":"EG001","numAffected":0,"numAtRisk":25}],"term":"Hyponatremia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":26},{"groupId":"EG001","numAffected":0,"numAtRisk":25}],"term":"Hypotension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Immune system disorders","stats":[{"groupId":"EG000","numAffected":11,"numAtRisk":26},{"groupId":"EG001","numAffected":8,"numAtRisk":25}],"term":"Lymphocyte count decrease"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Immune system disorders","stats":[{"groupId":"EG000","numAffected":11,"numAtRisk":26},{"groupId":"EG001","numAffected":10,"numAtRisk":25}],"term":"Neutrophil count decrease"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Immune system disorders","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":26},{"groupId":"EG001","numAffected":12,"numAtRisk":25}],"term":"Platelet count decrease"}],"timeFrame":"1.5 years"}