{"description":"Adverse events (AEs) were graded using CTCAE v4.0. AEs collected per protocol included a) grade 1 or 2 AEs if attribution was at least possibly related to panobinostat, and b) all grade 3+ AEs on treatment and within 30 days off treatment. All these AEs were summarized in SAE and Other AE tables below. All mortalities on this study were due to disease, except one for upper airway obstruction. Two patients on stratum 2 did not start protocol therapy and were not counted as at risk.","eventGroups":[{"deathsNumAffected":13,"deathsNumAtRisk":13,"description":"Recurrent or progressive DIPG patients received panobinostat orally every other day, 3 times per week at 10 mg/m\\^2/day for three weeks on, one week off (1 course = 28 days) for up to 26 courses in the absence of disease progression or unacceptable toxicity.","id":"EG000","otherNumAffected":13,"otherNumAtRisk":13,"seriousNumAffected":9,"seriousNumAtRisk":13,"title":"Stratum 1, Dose Level 1 (10 mg/m^2)"},{"deathsNumAffected":5,"deathsNumAtRisk":6,"description":"Recurrent or progressive DIPG patients received panobinostat orally every other day, 3 times per week at 16 mg/m\\^2/day for three weeks on, one week off (1 course = 28 days) for up to 26 courses in the absence of disease progression or unacceptable toxicity.","id":"EG001","otherNumAffected":6,"otherNumAtRisk":6,"seriousNumAffected":4,"seriousNumAtRisk":6,"title":"Stratum 1, Dose Level 2 (16 mg/m^2)"},{"deathsNumAffected":3,"deathsNumAtRisk":3,"description":"Non-progressed DIPG or H3K27M+ thalamic DMG patients received panobinostat orally every other day, 3 times per week at 16 mg/m\\^2/day for every other week (1 course = 28 days) for up to 26 courses in the absence of disease progression or unacceptable toxicity.","id":"EG002","otherNumAffected":3,"otherNumAtRisk":3,"seriousNumAffected":0,"seriousNumAtRisk":3,"title":"Stratum 2, Dose Level 1 (16 mg/m^2)"},{"deathsNumAffected":5,"deathsNumAtRisk":11,"description":"Non-progressed DIPG or H3K27M+ thalamic DMG patients received panobinostat orally every other day, 3 times per week at 22 mg/m\\^2/day for every other week (1 course = 28 days) for up to 26 courses in the absence of disease progression or unacceptable toxicity.","id":"EG003","otherNumAffected":11,"otherNumAtRisk":11,"seriousNumAffected":5,"seriousNumAtRisk":11,"title":"Stratum 2, Dose Level 2 (22 mg/m^2)"},{"deathsNumAffected":11,"deathsNumAtRisk":12,"description":"Non-progressed DIPG or H3K27M+ thalamic DMG patients received panobinostat orally every other day, 3 times per week at 28 mg/m\\^2/day for every other week (1course = 28 days) for up to 26 courses in the absence of disease progression or unacceptable toxicity.","id":"EG004","otherNumAffected":12,"otherNumAtRisk":12,"seriousNumAffected":4,"seriousNumAtRisk":12,"title":"Stratum 2, Dose Level 3 (28 mg/m^2)"},{"deathsNumAffected":5,"deathsNumAtRisk":6,"description":"Non-progressed DIPG or H3K27M+ thalamic DMG patients received panobinostat orally every other day, 3 times per week at 36 mg/m\\^2/day for every other week (1course = 28 days) for up to 26 courses in the absence of disease progression or unacceptable toxicity.","id":"EG005","otherNumAffected":6,"otherNumAtRisk":6,"seriousNumAffected":4,"seriousNumAtRisk":6,"title":"Stratum 2, Dose Level 4 (36 mg/m^2)"}],"frequencyThreshold":"5","otherEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":13,"numEvents":3},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG003","numAffected":3,"numAtRisk":11,"numEvents":6},{"groupId":"EG004","numAffected":7,"numAtRisk":12,"numEvents":16},{"groupId":"EG005","numAffected":3,"numAtRisk":6,"numEvents":7}],"term":"Anemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":12,"numEvents":1},{"groupId":"EG005","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Cardiac disorders - other, specify"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Right ventricular dysfunction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":12,"numEvents":1},{"groupId":"EG005","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Sinus bradycardia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":13,"numEvents":2},{"groupId":"EG001","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":11,"numEvents":1},{"groupId":"EG004","numAffected":1,"numAtRisk":12,"numEvents":1},{"groupId":"EG005","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Sinus tachycardia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Extraocular muscle paresis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG002","numAffected":1,"numAtRisk":3,"numEvents":3},{"groupId":"EG003","numAffected":2,"numAtRisk":11,"numEvents":3},{"groupId":"EG004","numAffected":1,"numAtRisk":12,"numEvents":4},{"groupId":"EG005","numAffected":1,"numAtRisk":6,"numEvents":2}],"term":"Abdominal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":3,"numEvents":2},{"groupId":"EG003","numAffected":1,"numAtRisk":11,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG005","numAffected":3,"numAtRisk":6,"numEvents":3}],"term":"Constipation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":13,"numEvents":2},{"groupId":"EG001","numAffected":3,"numAtRisk":6,"numEvents":3},{"groupId":"EG002","numAffected":1,"numAtRisk":3,"numEvents":1},{"groupId":"EG003","numAffected":8,"numAtRisk":11,"numEvents":13},{"groupId":"EG004","numAffected":9,"numAtRisk":12,"numEvents":15},{"groupId":"EG005","numAffected":4,"numAtRisk":6,"numEvents":6}],"term":"Diarrhea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":12,"numEvents":1},{"groupId":"EG005","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Dysphagia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Gastroesophageal reflux disease"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG002","numAffected":2,"numAtRisk":3,"numEvents":3},{"groupId":"EG003","numAffected":1,"numAtRisk":11,"numEvents":1},{"groupId":"EG004","numAffected":1,"numAtRisk":12,"numEvents":1},{"groupId":"EG005","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Gastrointestinal disorders - other, specify"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG005","numAffected":1,"numAtRisk":6,"numEvents":1}],"term":"Mucositis oral"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":13,"numEvents":2},{"groupId":"EG001","numAffected":4,"numAtRisk":6,"numEvents":5},{"groupId":"EG002","numAffected":3,"numAtRisk":3,"numEvents":11},{"groupId":"EG003","numAffected":5,"numAtRisk":11,"numEvents":7},{"groupId":"EG004","numAffected":7,"numAtRisk":12,"numEvents":11},{"groupId":"EG005","numAffected":2,"numAtRisk":6,"numEvents":4}],"term":"Nausea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":13,"numEvents":4},{"groupId":"EG001","numAffected":2,"numAtRisk":6,"numEvents":2},{"groupId":"EG002","numAffected":2,"numAtRisk":3,"numEvents":8},{"groupId":"EG003","numAffected":8,"numAtRisk":11,"numEvents":21},{"groupId":"EG004","numAffected":8,"numAtRisk":12,"numEvents":23},{"groupId":"EG005","numAffected":5,"numAtRisk":6,"numEvents":7}],"term":"Vomiting"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":13,"numEvents":7},{"groupId":"EG001","numAffected":3,"numAtRisk":6,"numEvents":3},{"groupId":"EG002","numAffected":2,"numAtRisk":3,"numEvents":3},{"groupId":"EG003","numAffected":5,"numAtRisk":11,"numEvents":7},{"groupId":"EG004","numAffected":5,"numAtRisk":12,"numEvents":6},{"groupId":"EG005","numAffected":3,"numAtRisk":6,"numEvents":3}],"term":"Fatigue"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":11,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Fever"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Gait disturbance"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Irritability"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Malaise"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Catheter related infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":12,"numEvents":1},{"groupId":"EG005","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Infections and infestations - other, specify"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Mucosal infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":12,"numEvents":1},{"groupId":"EG005","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Paronychia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG005","numAffected":1,"numAtRisk":6,"numEvents":1}],"term":"Skin infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Vaginal infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":11,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Bruising"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":13,"numEvents":10},{"groupId":"EG001","numAffected":2,"numAtRisk":6,"numEvents":3},{"groupId":"EG002","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG003","numAffected":4,"numAtRisk":11,"numEvents":4},{"groupId":"EG004","numAffected":1,"numAtRisk":12,"numEvents":2},{"groupId":"EG005","numAffected":2,"numAtRisk":6,"numEvents":5}],"term":"Alanine aminotransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":13,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Alkaline phosphatase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":13,"numEvents":5},{"groupId":"EG001","numAffected":3,"numAtRisk":6,"numEvents":4},{"groupId":"EG002","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG003","numAffected":4,"numAtRisk":11,"numEvents":4},{"groupId":"EG004","numAffected":2,"numAtRisk":12,"numEvents":2},{"groupId":"EG005","numAffected":2,"numAtRisk":6,"numEvents":3}],"term":"Aspartate aminotransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":13,"numEvents":2},{"groupId":"EG001","numAffected":1,"numAtRisk":6,"numEvents":2},{"groupId":"EG002","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":11,"numEvents":4},{"groupId":"EG004","numAffected":2,"numAtRisk":12,"numEvents":2},{"groupId":"EG005","numAffected":2,"numAtRisk":6,"numEvents":2}],"term":"Blood bilirubin increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG003","numAffected":2,"numAtRisk":11,"numEvents":3},{"groupId":"EG004","numAffected":2,"numAtRisk":12,"numEvents":3},{"groupId":"EG005","numAffected":2,"numAtRisk":6,"numEvents":2}],"term":"Creatinine increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":11,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG005","numAffected":2,"numAtRisk":6,"numEvents":4}],"term":"Electrocardiogram qt corrected interval prolonged"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":13,"numEvents":5},{"groupId":"EG001","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Hemoglobin increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":13,"numEvents":3},{"groupId":"EG001","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG002","numAffected":1,"numAtRisk":3,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":12,"numEvents":1},{"groupId":"EG005","numAffected":2,"numAtRisk":6,"numEvents":2}],"term":"Investigations - other, specify"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":13,"numEvents":17},{"groupId":"EG001","numAffected":6,"numAtRisk":6,"numEvents":7},{"groupId":"EG002","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG003","numAffected":8,"numAtRisk":11,"numEvents":22},{"groupId":"EG004","numAffected":10,"numAtRisk":12,"numEvents":30},{"groupId":"EG005","numAffected":4,"numAtRisk":6,"numEvents":19}],"term":"Lymphocyte count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":13,"numEvents":2},{"groupId":"EG001","numAffected":3,"numAtRisk":6,"numEvents":4},{"groupId":"EG002","numAffected":2,"numAtRisk":3,"numEvents":2},{"groupId":"EG003","numAffected":5,"numAtRisk":11,"numEvents":13},{"groupId":"EG004","numAffected":7,"numAtRisk":12,"numEvents":30},{"groupId":"EG005","numAffected":6,"numAtRisk":6,"numEvents":18}],"term":"Neutrophil count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":13,"numEvents":14},{"groupId":"EG001","numAffected":5,"numAtRisk":6,"numEvents":6},{"groupId":"EG002","numAffected":3,"numAtRisk":3,"numEvents":6},{"groupId":"EG003","numAffected":10,"numAtRisk":11,"numEvents":21},{"groupId":"EG004","numAffected":11,"numAtRisk":12,"numEvents":24},{"groupId":"EG005","numAffected":4,"numAtRisk":6,"numEvents":8}],"term":"Platelet count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG002","numAffected":2,"numAtRisk":3,"numEvents":5},{"groupId":"EG003","numAffected":2,"numAtRisk":11,"numEvents":2},{"groupId":"EG004","numAffected":3,"numAtRisk":12,"numEvents":4},{"groupId":"EG005","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Weight loss"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":13,"numEvents":4},{"groupId":"EG001","numAffected":5,"numAtRisk":6,"numEvents":5},{"groupId":"EG002","numAffected":2,"numAtRisk":3,"numEvents":2},{"groupId":"EG003","numAffected":8,"numAtRisk":11,"numEvents":24},{"groupId":"EG004","numAffected":11,"numAtRisk":12,"numEvents":46},{"groupId":"EG005","numAffected":5,"numAtRisk":6,"numEvents":18}],"term":"White blood cell decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":13,"numEvents":2},{"groupId":"EG001","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG002","numAffected":2,"numAtRisk":3,"numEvents":2},{"groupId":"EG003","numAffected":3,"numAtRisk":11,"numEvents":3},{"groupId":"EG004","numAffected":2,"numAtRisk":12,"numEvents":3},{"groupId":"EG005","numAffected":2,"numAtRisk":6,"numEvents":2}],"term":"Anorexia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":12,"numEvents":1},{"groupId":"EG005","numAffected":2,"numAtRisk":6,"numEvents":2}],"term":"Dehydration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":13,"numEvents":5},{"groupId":"EG001","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":11,"numEvents":2},{"groupId":"EG004","numAffected":1,"numAtRisk":12,"numEvents":2},{"groupId":"EG005","numAffected":1,"numAtRisk":6,"numEvents":1}],"term":"Hyperglycemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":11,"numEvents":1},{"groupId":"EG004","numAffected":3,"numAtRisk":12,"numEvents":3},{"groupId":"EG005","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Hypermagnesemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":11,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Hypernatremia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":13,"numEvents":8},{"groupId":"EG001","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG003","numAffected":3,"numAtRisk":11,"numEvents":3},{"groupId":"EG004","numAffected":1,"numAtRisk":12,"numEvents":1},{"groupId":"EG005","numAffected":1,"numAtRisk":6,"numEvents":1}],"term":"Hypoalbuminemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":13,"numEvents":5},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG003","numAffected":2,"numAtRisk":11,"numEvents":3},{"groupId":"EG004","numAffected":1,"numAtRisk":12,"numEvents":1},{"groupId":"EG005","numAffected":1,"numAtRisk":6,"numEvents":1}],"term":"Hypocalcemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":13,"numEvents":3},{"groupId":"EG001","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":11,"numEvents":2},{"groupId":"EG004","numAffected":1,"numAtRisk":12,"numEvents":1},{"groupId":"EG005","numAffected":1,"numAtRisk":6,"numEvents":1}],"term":"Hypoglycemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":13,"numEvents":2},{"groupId":"EG001","numAffected":2,"numAtRisk":6,"numEvents":2},{"groupId":"EG002","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG003","numAffected":2,"numAtRisk":11,"numEvents":3},{"groupId":"EG004","numAffected":3,"numAtRisk":12,"numEvents":4},{"groupId":"EG005","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Hypokalemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":13,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Hypomagnesemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":11,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG005","numAffected":1,"numAtRisk":6,"numEvents":1}],"term":"Hyponatremia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":13,"numEvents":3},{"groupId":"EG001","numAffected":2,"numAtRisk":6,"numEvents":2},{"groupId":"EG002","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG003","numAffected":6,"numAtRisk":11,"numEvents":6},{"groupId":"EG004","numAffected":5,"numAtRisk":12,"numEvents":6},{"groupId":"EG005","numAffected":2,"numAtRisk":6,"numEvents":3}],"term":"Hypophosphatemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":13,"numEvents":5},{"groupId":"EG001","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":11,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Metabolism and nutrition disorders - other, specify"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Back pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":13,"numEvents":2},{"groupId":"EG001","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Generalized muscle weakness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":12,"numEvents":1},{"groupId":"EG005","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Muscle weakness left-sided"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":13,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Neoplasms benign, malignant and unspecified (incl cysts and polyps) - other, specify"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG001","numAffected":2,"numAtRisk":6,"numEvents":2},{"groupId":"EG002","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":11,"numEvents":1},{"groupId":"EG004","numAffected":1,"numAtRisk":12,"numEvents":1},{"groupId":"EG005","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Ataxia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":3,"numEvents":1},{"groupId":"EG003","numAffected":1,"numAtRisk":11,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Dizziness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Dysarthria"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":3,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":12,"numEvents":1},{"groupId":"EG005","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Dysgeusia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":13,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":3,"numEvents":1},{"groupId":"EG003","numAffected":1,"numAtRisk":11,"numEvents":1},{"groupId":"EG004","numAffected":2,"numAtRisk":12,"numEvents":3},{"groupId":"EG005","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Headache"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":12,"numEvents":1},{"groupId":"EG005","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Intracranial hemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":13,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Insomnia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Renal and urinary disorders - other, specify"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":12,"numEvents":1},{"groupId":"EG005","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Urinary incontinence"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Cough"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":13,"numEvents":2},{"groupId":"EG001","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":11,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Dyspnea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":11,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Epistaxis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Productive cough"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Respiratory, thoracic and mediastinal disorders - other, specify"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Alopecia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Dry skin"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":11,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Rash acneiform"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":11,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Rash maculo-papular"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":13,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Skin and subcutaneous tissue disorders - other, specify"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":3,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Flushing"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":13,"numEvents":5},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG003","numAffected":2,"numAtRisk":11,"numEvents":2},{"groupId":"EG004","numAffected":1,"numAtRisk":12,"numEvents":1},{"groupId":"EG005","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Hypertension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":11,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Superficial thrombophlebitis"}],"seriousEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Abdominal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":13,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Dysphagia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Vomiting"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Fatigue"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Gait disturbance"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Catheter related infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Sepsis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Urinary tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG001","numAffected":2,"numAtRisk":6,"numEvents":3},{"groupId":"EG002","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":11,"numEvents":1},{"groupId":"EG004","numAffected":2,"numAtRisk":12,"numEvents":4},{"groupId":"EG005","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Neutrophil count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG001","numAffected":2,"numAtRisk":6,"numEvents":2},{"groupId":"EG002","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":11,"numEvents":1},{"groupId":"EG004","numAffected":1,"numAtRisk":12,"numEvents":1},{"groupId":"EG005","numAffected":1,"numAtRisk":6,"numEvents":1}],"term":"Platelet count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"White blood cell decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG005","numAffected":1,"numAtRisk":6,"numEvents":1}],"term":"Hypokalemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":11,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Generalized muscle weakness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG005","numAffected":1,"numAtRisk":6,"numEvents":1}],"term":"Muscle weakness left-sided"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Muscle weakness right-sided"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":11,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Trismus"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":13,"numEvents":8},{"groupId":"EG001","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Neoplasms benign, malignant and unspecified (incl cysts and polyps) - other, specify"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Ataxia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":13,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":11,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Depressed level of consciousness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG005","numAffected":1,"numAtRisk":6,"numEvents":1}],"term":"Dizziness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Dysarthria"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Facial muscle weakness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Headache"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG003","numAffected":2,"numAtRisk":11,"numEvents":2},{"groupId":"EG004","numAffected":1,"numAtRisk":12,"numEvents":2},{"groupId":"EG005","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Hydrocephalus"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":13,"numEvents":2},{"groupId":"EG001","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Nervous system disorders - other, specify"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":11,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Reversible posterior leukoencephalopathy syndrome"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Hematuria"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Apnea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Dyspnea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":13,"numEvents":3},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Respiratory failure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":12,"numEvents":2},{"groupId":"EG005","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Respiratory, thoracic and mediastinal disorders - other, specify"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG003","numAffected":2,"numAtRisk":11,"numEvents":2},{"groupId":"EG004","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":6,"numEvents":0}],"term":"Hypertension"}],"timeFrame":"Approximately 2 years after initiation of protocol treatment"}