{"description":"* SAEs, AEs and all-cause mortality were not collected on donors.\n* The protocol contains the selected AEs that were collected for those in the pilot and expansion phase.\n* SAEs and AEs were collected on any patient who received at least one dose of itacitinib.\n* All-cause morality was collected for any patient who completed were compliant with the assigned treatment.","eventGroups":[{"deathsNumAffected":3,"deathsNumAtRisk":20,"description":"* Will undergo institutionally standard myeloablative or reduced intensity chemotherapy or chemoradiotherapy\n* Stem cell transplantation on Day 0\n* Itacitinib 200 mg/day from Day -3 to Day 100. After Day 100, for patients at a dose of 200 mg daily, reduce to 100 mg daily for 1 month, then every other day for one month, then discontinue OR after day 100, for patients already dose reduced to 100 mg daily, reduce to 100 mg every other day then discontinue OR after day 100, for patients on study drug hold, discontinue permanently\n* To address concerns of engraftment failure using itacitinib throughout the transplant period, for the first three patients the investigators will consent the donor for a second CD34+ collection to use as a rescue in the case of engraftment failure.","id":"EG000","otherNumAffected":20,"otherNumAtRisk":20,"seriousNumAffected":14,"seriousNumAtRisk":20,"title":"Pilot Study: Itacitinib"},{"deathsNumAffected":8,"deathsNumAtRisk":25,"description":"* Will undergo institutionally standard myeloablative or reduced intensity chemotherapy or chemoradiotherapy\n* Stem cell transplantation on Day 0\n* Itacitinib 200 mg/day from Day -3 to Day 180. After Day 180, for patients at a dose of 200 mg daily, reduce to 100 mg daily for 1 month, then every other day for one month, then discontinue OR after day 180, for patients already dose reduced to 100 mg daily, reduce to 100 mg every other day then discontinue OR after day 180, for patients on study drug hold, discontinue permanently","id":"EG001","otherNumAffected":26,"otherNumAtRisk":26,"seriousNumAffected":24,"seriousNumAtRisk":26,"title":"Expansion Phase: Itacitinib"},{"deathsNumAffected":0,"deathsNumAtRisk":0,"description":"-Donors were consented for the patients enrolled in the Safety Lead-In Phase (planned 3 patients). Donors were consented for a second CD34+ collection to use as a rescue in the case of engraftment failure and for collection of a research blood specimen prior to mobilization.","id":"EG002","otherNumAffected":0,"otherNumAtRisk":0,"seriousNumAffected":0,"seriousNumAtRisk":0,"title":"Donors"}],"frequencyThreshold":"0","otherEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE (Unspecified)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":20},{"groupId":"EG001","numAffected":3,"numAtRisk":26},{"groupId":"EG002","numAtRisk":0}],"term":"Anemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE (Unspecified)","stats":[{"groupId":"EG000","numAffected":13,"numAtRisk":20},{"groupId":"EG001","numAffected":13,"numAtRisk":26},{"groupId":"EG002","numAtRisk":0}],"term":"Febrile neutropenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"CTCAE (Unspecified)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":20},{"groupId":"EG001","numAffected":1,"numAtRisk":26},{"groupId":"EG002","numAtRisk":0}],"term":"Supraventricular tachycardia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (Unspecified)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":20},{"groupId":"EG001","numAffected":0,"numAtRisk":26},{"groupId":"EG002","numAtRisk":0}],"term":"Colitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (Unspecified)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":20},{"groupId":"EG001","numAffected":1,"numAtRisk":26},{"groupId":"EG002","numAtRisk":0}],"term":"Dysphagia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (Unspecified)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":20},{"groupId":"EG001","numAffected":1,"numAtRisk":26},{"groupId":"EG002","numAtRisk":0}],"term":"Esophagitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (Unspecified)","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":20},{"groupId":"EG001","numAffected":5,"numAtRisk":26},{"groupId":"EG002","numAtRisk":0}],"term":"Mucositis oral"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (Unspecified)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":20},{"groupId":"EG001","numAffected":1,"numAtRisk":26},{"groupId":"EG002","numAtRisk":0}],"term":"Nausea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (Unspecified)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":20},{"groupId":"EG001","numAffected":1,"numAtRisk":26},{"groupId":"EG002","numAtRisk":0}],"term":"Rectal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Immune system disorders","sourceVocabulary":"CTCAE (Unspecified)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":20},{"groupId":"EG001","numAffected":0,"numAtRisk":26},{"groupId":"EG002","numAtRisk":0}],"term":"Cytokine release syndrome"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (Unspecified)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":20},{"groupId":"EG001","numAffected":0,"numAtRisk":26},{"groupId":"EG002","numAtRisk":0}],"term":"BK virus"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (Unspecified)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":20},{"groupId":"EG001","numAffected":1,"numAtRisk":26},{"groupId":"EG002","numAtRisk":0}],"term":"Enterococcus faecium bacteremia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (Unspecified)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":20},{"groupId":"EG001","numAffected":1,"numAtRisk":26},{"groupId":"EG002","numAtRisk":0}],"term":"Enterocolitis infectious"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (Unspecified)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":20},{"groupId":"EG001","numAffected":1,"numAtRisk":26},{"groupId":"EG002","numAtRisk":0}],"term":"Lung infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (Unspecified)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":20},{"groupId":"EG001","numAffected":0,"numAtRisk":26},{"groupId":"EG002","numAtRisk":0}],"term":"Paronychia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (Unspecified)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":20},{"groupId":"EG001","numAffected":2,"numAtRisk":26},{"groupId":"EG002","numAtRisk":0}],"term":"Sepsis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (Unspecified)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":20},{"groupId":"EG001","numAffected":1,"numAtRisk":26},{"groupId":"EG002","numAtRisk":0}],"term":"Urinary tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE (Unspecified)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":20},{"groupId":"EG001","numAffected":4,"numAtRisk":26},{"groupId":"EG002","numAtRisk":0}],"term":"Alanine aminotransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE (Unspecified)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":20},{"groupId":"EG001","numAffected":2,"numAtRisk":26},{"groupId":"EG002","numAtRisk":0}],"term":"Alkaline phosphatase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE (Unspecified)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":20},{"groupId":"EG001","numAffected":3,"numAtRisk":26},{"groupId":"EG002","numAtRisk":0}],"term":"Aspartate aminotransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE (Unspecified)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":20},{"groupId":"EG001","numAffected":1,"numAtRisk":26},{"groupId":"EG002","numAtRisk":0}],"term":"Creatinine increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE (Unspecified)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":20},{"groupId":"EG001","numAffected":2,"numAtRisk":26},{"groupId":"EG002","numAtRisk":0}],"term":"Electrocardiogram QT corrected interval prolonged"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE (Unspecified)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":20},{"groupId":"EG001","numAffected":13,"numAtRisk":26},{"groupId":"EG002","numAtRisk":0}],"term":"Lymphocyte count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE (Unspecified)","stats":[{"groupId":"EG000","numAffected":19,"numAtRisk":20},{"groupId":"EG001","numAffected":18,"numAtRisk":26},{"groupId":"EG002","numAtRisk":0}],"term":"Neutrophil count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE (Unspecified)","stats":[{"groupId":"EG000","numAffected":19,"numAtRisk":20},{"groupId":"EG001","numAffected":16,"numAtRisk":26},{"groupId":"EG002","numAtRisk":0}],"term":"Platelet count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE (Unspecified)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":20},{"groupId":"EG001","numAffected":2,"numAtRisk":26},{"groupId":"EG002","numAtRisk":0}],"term":"Weight loss"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE (Unspecified)","stats":[{"groupId":"EG000","numAffected":20,"numAtRisk":20},{"groupId":"EG001","numAffected":17,"numAtRisk":26},{"groupId":"EG002","numAtRisk":0}],"term":"White blood cell decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (Unspecified)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":20},{"groupId":"EG001","numAffected":1,"numAtRisk":26},{"groupId":"EG002","numAtRisk":0}],"term":"Anorexia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (Unspecified)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":20},{"groupId":"EG001","numAffected":0,"numAtRisk":26},{"groupId":"EG002","numAtRisk":0}],"term":"Hyperglycemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (Unspecified)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":20},{"groupId":"EG001","numAffected":0,"numAtRisk":26},{"groupId":"EG002","numAtRisk":0}],"term":"Hypernatremia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (Unspecified)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":20},{"groupId":"EG001","numAffected":1,"numAtRisk":26},{"groupId":"EG002","numAtRisk":0}],"term":"Hyperphosphatemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (Unspecified)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":20},{"groupId":"EG001","numAffected":5,"numAtRisk":26},{"groupId":"EG002","numAtRisk":0}],"term":"Hypertriglyceridemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (Unspecified)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":20},{"groupId":"EG001","numAffected":1,"numAtRisk":26},{"groupId":"EG002","numAtRisk":0}],"term":"Hypocalcemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (Unspecified)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":20},{"groupId":"EG001","numAffected":2,"numAtRisk":26},{"groupId":"EG002","numAtRisk":0}],"term":"Hypokalemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (Unspecified)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":20},{"groupId":"EG001","numAffected":2,"numAtRisk":26},{"groupId":"EG002","numAtRisk":0}],"term":"Hypomagnesemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (Unspecified)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":20},{"groupId":"EG001","numAffected":0,"numAtRisk":26},{"groupId":"EG002","numAtRisk":0}],"term":"Hyponatremia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"CTCAE (Unspecified)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":20},{"groupId":"EG001","numAffected":1,"numAtRisk":26},{"groupId":"EG002","numAtRisk":0}],"term":"Generalized muscle weakness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE (Unspecified)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":20},{"groupId":"EG001","numAffected":1,"numAtRisk":26},{"groupId":"EG002","numAtRisk":0}],"term":"Encephalopathy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE (Unspecified)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":20},{"groupId":"EG001","numAffected":1,"numAtRisk":26},{"groupId":"EG002","numAtRisk":0}],"term":"Headache"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE (Unspecified)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":20},{"groupId":"EG001","numAffected":0,"numAtRisk":26},{"groupId":"EG002","numAtRisk":0}],"term":"Tremor"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"CTCAE (Unspecified)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":20},{"groupId":"EG001","numAffected":3,"numAtRisk":26},{"groupId":"EG002","numAtRisk":0}],"term":"Insomnia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"CTCAE (Unspecified)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":20},{"groupId":"EG001","numAffected":1,"numAtRisk":26},{"groupId":"EG002","numAtRisk":0}],"term":"Acute kidney injury"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"CTCAE (Unspecified)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":20},{"groupId":"EG001","numAffected":0,"numAtRisk":26},{"groupId":"EG002","numAtRisk":0}],"term":"Renal calculi"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"CTCAE (Unspecified)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":20},{"groupId":"EG001","numAffected":1,"numAtRisk":26},{"groupId":"EG002","numAtRisk":0}],"term":"Hypotension"}],"seriousEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE (Unspecified)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":20},{"groupId":"EG001","numAffected":1,"numAtRisk":26},{"groupId":"EG002","numAtRisk":0}],"term":"Anemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE (Unspecified)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":20},{"groupId":"EG001","numAffected":2,"numAtRisk":26},{"groupId":"EG002","numAtRisk":0}],"term":"Febrile neutropenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (Unspecified)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":20},{"groupId":"EG001","numAffected":0,"numAtRisk":26},{"groupId":"EG002","numAtRisk":0}],"term":"Diarrhea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (Unspecified)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":20},{"groupId":"EG001","numAffected":0,"numAtRisk":26},{"groupId":"EG002","numAtRisk":0}],"term":"Enterocolitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (Unspecified)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":20},{"groupId":"EG001","numAffected":2,"numAtRisk":26},{"groupId":"EG002","numAtRisk":0}],"term":"Nausea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE (Unspecified)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":20},{"groupId":"EG001","numAffected":4,"numAtRisk":26},{"groupId":"EG002","numAtRisk":0}],"term":"Fever"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (Unspecified)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":20},{"groupId":"EG001","numAffected":0,"numAtRisk":26},{"groupId":"EG002","numAtRisk":0}],"term":"Adenovirus"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (Unspecified)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":20},{"groupId":"EG001","numAffected":0,"numAtRisk":26},{"groupId":"EG002","numAtRisk":0}],"term":"CMV viremia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (Unspecified)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":20},{"groupId":"EG001","numAffected":1,"numAtRisk":26},{"groupId":"EG002","numAtRisk":0}],"term":"COVID-19 infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (Unspecified)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":20},{"groupId":"EG001","numAffected":1,"numAtRisk":26},{"groupId":"EG002","numAtRisk":0}],"term":"Enterococcus bacteremia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (Unspecified)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":20},{"groupId":"EG001","numAffected":3,"numAtRisk":26},{"groupId":"EG002","numAtRisk":0}],"term":"Enterocolitis infectious"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (Unspecified)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":20},{"groupId":"EG001","numAffected":0,"numAtRisk":26},{"groupId":"EG002","numAtRisk":0}],"term":"HSV stomatitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (Unspecified)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":20},{"groupId":"EG001","numAffected":5,"numAtRisk":26},{"groupId":"EG002","numAtRisk":0}],"term":"Lung infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (Unspecified)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":20},{"groupId":"EG001","numAffected":1,"numAtRisk":26},{"groupId":"EG002","numAtRisk":0}],"term":"MSSA bacteremia septic arthritis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (Unspecified)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":20},{"groupId":"EG001","numAffected":1,"numAtRisk":26},{"groupId":"EG002","numAtRisk":0}],"term":"RSV infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (Unspecified)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":20},{"groupId":"EG001","numAffected":2,"numAtRisk":26},{"groupId":"EG002","numAtRisk":0}],"term":"Sepsis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (Unspecified)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":20},{"groupId":"EG001","numAffected":2,"numAtRisk":26},{"groupId":"EG002","numAtRisk":0}],"term":"Skin infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (Unspecified)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":20},{"groupId":"EG001","numAffected":1,"numAtRisk":26},{"groupId":"EG002","numAtRisk":0}],"term":"Hyperkalemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (Unspecified)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":20},{"groupId":"EG001","numAffected":1,"numAtRisk":26},{"groupId":"EG002","numAtRisk":0}],"term":"Hyponatremia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"CTCAE (Unspecified)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":20},{"groupId":"EG001","numAffected":0,"numAtRisk":26},{"groupId":"EG002","numAtRisk":0}],"term":"Flank pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"CTCAE (Unspecified)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":20},{"groupId":"EG001","numAffected":3,"numAtRisk":26},{"groupId":"EG002","numAtRisk":0}],"term":"Relapsed disease"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE (Unspecified)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":20},{"groupId":"EG001","numAffected":1,"numAtRisk":26},{"groupId":"EG002","numAtRisk":0}],"term":"Reversible posterior leukoencephalopathy syndrome"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"CTCAE (Unspecified)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":20},{"groupId":"EG001","numAffected":2,"numAtRisk":26},{"groupId":"EG002","numAtRisk":0}],"term":"Acute kidney injury"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"CTCAE (Unspecified)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":20},{"groupId":"EG001","numAffected":1,"numAtRisk":26},{"groupId":"EG002","numAtRisk":0}],"term":"Cystitis noninfective"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"CTCAE (Unspecified)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":20},{"groupId":"EG001","numAffected":0,"numAtRisk":26},{"groupId":"EG002","numAtRisk":0}],"term":"Hematuria"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"CTCAE (Unspecified)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":20},{"groupId":"EG001","numAffected":0,"numAtRisk":26},{"groupId":"EG002","numAtRisk":0}],"term":"Renal colic"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (Unspecified)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":20},{"groupId":"EG001","numAffected":0,"numAtRisk":26},{"groupId":"EG002","numAtRisk":0}],"term":"Dyspnea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (Unspecified)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":20},{"groupId":"EG001","numAffected":0,"numAtRisk":26},{"groupId":"EG002","numAtRisk":0}],"term":"Epistaxis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (Unspecified)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":20},{"groupId":"EG001","numAffected":1,"numAtRisk":26},{"groupId":"EG002","numAtRisk":0}],"term":"Hypoxia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (Unspecified)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":20},{"groupId":"EG001","numAffected":1,"numAtRisk":26},{"groupId":"EG002","numAtRisk":0}],"term":"Respiratory failure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"CTCAE (Unspecified)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":20},{"groupId":"EG001","numAffected":1,"numAtRisk":26},{"groupId":"EG002","numAtRisk":0}],"term":"Rash maculo-papular"}],"timeFrame":"- Adverse events (AEs) were tracked from start of itacitinib through 30 days after last dose (median length of follow-up 166 days, full range 16-287 days). - All-cause mortality was collected from start of itacitinib through completion of follow-up (up to day 365)."}