{"description":"At primary completion (cutoff 26JAN2012) blinded patients who received either regorafenib or placebo were reported in \"Regorafenib (DoubleBlindOnly)\" and \"Placebo (DoubleBlindOnly)\" respectively; patients who received regorafenib after unblinding were reported in \"Placebo, OpenLabelOnly(Switch to Regorafenib)\". This safety update (cutoff 15APR2019) was reported in \"Treated with Regorafenib at any time\" and \"Treated with Regorafenib for\\>1 year\".","eventGroups":[{"deathsNumAffected":40,"deathsNumAtRisk":41,"description":"Participants received Regorafenib (Stivarga) 160 mg (4 x 40 mg tablets) per os once daily, 3 weeks on therapy followed by 1 week off therapy to comprise a cycle of 4 weeks","id":"EG000","otherNumAffected":40,"otherNumAtRisk":41,"seriousNumAffected":23,"seriousNumAtRisk":41,"title":"Regorafenib (Double Blind Only)"},{"deathsNumAffected":7,"deathsNumAtRisk":8,"description":"Participants received matching Placebo tablets per os once daily, 3 weeks on therapy followed by 1 week off therapy to comprise a cycle of 4 weeks","id":"EG001","otherNumAffected":7,"otherNumAtRisk":8,"seriousNumAffected":8,"seriousNumAtRisk":8,"title":"Placebo (Double Blind Only)"},{"deathsNumAffected":47,"deathsNumAtRisk":58,"description":"Participants switched to Open-label Regorafenib treatment from Placebo. Participants received Regorafenib (Stivarga) 160 mg (4 x 40 mg tablets) per os once daily, 3 weeks","id":"EG002","otherNumAffected":58,"otherNumAtRisk":58,"seriousNumAffected":31,"seriousNumAtRisk":58,"title":"Placebo, Open Label Only (Switch to Regorafenib)"},{"deathsNumAffected":155,"deathsNumAtRisk":190,"description":"Treated with Regorafenib at any time: At any time, participants received Regorafenib (Stivarga) 160 mg (4 x 40 mg tablets) per os once daily, 3 weeks on therapy followed by 1 week off therapy to comprise a cycle of 4 weeks","id":"EG003","otherNumAffected":189,"otherNumAtRisk":190,"seriousNumAffected":103,"seriousNumAtRisk":190,"title":"Treated With Regorafenib at Any Time"},{"deathsNumAffected":48,"deathsNumAtRisk":75,"description":"Treated with Regorafenib for \\> 1 year: For more than a year, participants received Regorafenib (Stivarga) 160 mg (4 x 40 mg tablets) per os once daily, 3 weeks on therapy followed by 1 week off therapy to comprise a cycle of 4 weeks","id":"EG004","otherNumAffected":75,"otherNumAtRisk":75,"seriousNumAffected":39,"seriousNumAtRisk":75,"title":"Treated With Regorafenib for > 1 Year"}],"frequencyThreshold":"5","otherEvents":[{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Ear and labyrinth disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":41,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":58,"numEvents":1},{"groupId":"EG003","numAffected":7,"numAtRisk":190,"numEvents":7},{"groupId":"EG004","numAffected":5,"numAtRisk":75,"numEvents":5}],"term":"Hearing impaired"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Ear and labyrinth disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":41,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG002","numAffected":4,"numAtRisk":58,"numEvents":4},{"groupId":"EG003","numAffected":7,"numAtRisk":190,"numEvents":7},{"groupId":"EG004","numAffected":4,"numAtRisk":75,"numEvents":4}],"term":"Ear and labyrinth disorders - Other"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":41,"numEvents":7},{"groupId":"EG001","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG002","numAffected":11,"numAtRisk":58,"numEvents":25},{"groupId":"EG003","numAffected":35,"numAtRisk":190,"numEvents":77},{"groupId":"EG004","numAffected":17,"numAtRisk":75,"numEvents":35}],"term":"Anemia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":41,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG002","numAffected":2,"numAtRisk":58,"numEvents":9},{"groupId":"EG003","numAffected":6,"numAtRisk":190,"numEvents":17},{"groupId":"EG004","numAffected":4,"numAtRisk":75,"numEvents":9}],"term":"Blood and lymphatic system disorders - Other"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Endocrine disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":41,"numEvents":4},{"groupId":"EG001","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG002","numAffected":6,"numAtRisk":58,"numEvents":6},{"groupId":"EG003","numAffected":39,"numAtRisk":190,"numEvents":50},{"groupId":"EG004","numAffected":25,"numAtRisk":75,"numEvents":32}],"term":"Hypothyroidism"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":14,"numAtRisk":41,"numEvents":18},{"groupId":"EG001","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG002","numAffected":16,"numAtRisk":58,"numEvents":23},{"groupId":"EG003","numAffected":62,"numAtRisk":190,"numEvents":122},{"groupId":"EG004","numAffected":26,"numAtRisk":75,"numEvents":60}],"term":"Abdominal pain"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":41,"numEvents":2},{"groupId":"EG001","numAffected":1,"numAtRisk":8,"numEvents":1},{"groupId":"EG002","numAffected":2,"numAtRisk":58,"numEvents":2},{"groupId":"EG003","numAffected":6,"numAtRisk":190,"numEvents":8},{"groupId":"EG004","numAffected":1,"numAtRisk":75,"numEvents":3}],"term":"Ascites"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":41,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":58,"numEvents":1},{"groupId":"EG003","numAffected":7,"numAtRisk":190,"numEvents":10},{"groupId":"EG004","numAffected":6,"numAtRisk":75,"numEvents":9}],"term":"Bloating"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":41,"numEvents":14},{"groupId":"EG001","numAffected":5,"numAtRisk":8,"numEvents":6},{"groupId":"EG002","numAffected":16,"numAtRisk":58,"numEvents":30},{"groupId":"EG003","numAffected":63,"numAtRisk":190,"numEvents":101},{"groupId":"EG004","numAffected":28,"numAtRisk":75,"numEvents":52}],"term":"Constipation"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":15,"numAtRisk":41,"numEvents":20},{"groupId":"EG001","numAffected":1,"numAtRisk":8,"numEvents":1},{"groupId":"EG002","numAffected":24,"numAtRisk":58,"numEvents":67},{"groupId":"EG003","numAffected":96,"numAtRisk":190,"numEvents":353},{"groupId":"EG004","numAffected":53,"numAtRisk":75,"numEvents":281}],"term":"Diarrhea"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":41,"numEvents":4},{"groupId":"EG001","numAffected":1,"numAtRisk":8,"numEvents":2},{"groupId":"EG002","numAffected":6,"numAtRisk":58,"numEvents":9},{"groupId":"EG003","numAffected":19,"numAtRisk":190,"numEvents":39},{"groupId":"EG004","numAffected":11,"numAtRisk":75,"numEvents":30}],"term":"Dyspepsia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":41,"numEvents":5},{"groupId":"EG001","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG002","numAffected":5,"numAtRisk":58,"numEvents":6},{"groupId":"EG003","numAffected":15,"numAtRisk":190,"numEvents":16},{"groupId":"EG004","numAffected":5,"numAtRisk":75,"numEvents":6}],"term":"Dry mouth"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":41,"numEvents":4},{"groupId":"EG001","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG002","numAffected":3,"numAtRisk":58,"numEvents":3},{"groupId":"EG003","numAffected":10,"numAtRisk":190,"numEvents":11},{"groupId":"EG004","numAffected":5,"numAtRisk":75,"numEvents":6}],"term":"Flatulence"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":14,"numAtRisk":41,"numEvents":18},{"groupId":"EG001","numAffected":2,"numAtRisk":8,"numEvents":3},{"groupId":"EG002","numAffected":21,"numAtRisk":58,"numEvents":48},{"groupId":"EG003","numAffected":81,"numAtRisk":190,"numEvents":174},{"groupId":"EG004","numAffected":38,"numAtRisk":75,"numEvents":111}],"term":"Mucositis oral"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":41,"numEvents":12},{"groupId":"EG001","numAffected":3,"numAtRisk":8,"numEvents":4},{"groupId":"EG002","numAffected":18,"numAtRisk":58,"numEvents":33},{"groupId":"EG003","numAffected":61,"numAtRisk":190,"numEvents":110},{"groupId":"EG004","numAffected":32,"numAtRisk":75,"numEvents":66}],"term":"Nausea"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":41,"numEvents":4},{"groupId":"EG001","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG002","numAffected":4,"numAtRisk":58,"numEvents":7},{"groupId":"EG003","numAffected":17,"numAtRisk":190,"numEvents":21},{"groupId":"EG004","numAffected":11,"numAtRisk":75,"numEvents":15}],"term":"Gastrointestinal disorders - Other"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":41,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG002","numAffected":2,"numAtRisk":58,"numEvents":2},{"groupId":"EG003","numAffected":7,"numAtRisk":190,"numEvents":7},{"groupId":"EG004","numAffected":5,"numAtRisk":75,"numEvents":5}],"term":"Stomach pain"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":41,"numEvents":11},{"groupId":"EG001","numAffected":3,"numAtRisk":8,"numEvents":5},{"groupId":"EG002","numAffected":12,"numAtRisk":58,"numEvents":24},{"groupId":"EG003","numAffected":48,"numAtRisk":190,"numEvents":85},{"groupId":"EG004","numAffected":21,"numAtRisk":75,"numEvents":54}],"term":"Vomiting"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":41,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG002","numAffected":4,"numAtRisk":58,"numEvents":4},{"groupId":"EG003","numAffected":11,"numAtRisk":190,"numEvents":19},{"groupId":"EG004","numAffected":8,"numAtRisk":75,"numEvents":16}],"term":"Chills"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":41,"numEvents":4},{"groupId":"EG001","numAffected":3,"numAtRisk":8,"numEvents":3},{"groupId":"EG002","numAffected":11,"numAtRisk":58,"numEvents":20},{"groupId":"EG003","numAffected":33,"numAtRisk":190,"numEvents":72},{"groupId":"EG004","numAffected":17,"numAtRisk":75,"numEvents":53}],"term":"Edema limbs"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":18,"numAtRisk":41,"numEvents":32},{"groupId":"EG001","numAffected":3,"numAtRisk":8,"numEvents":4},{"groupId":"EG002","numAffected":32,"numAtRisk":58,"numEvents":83},{"groupId":"EG003","numAffected":104,"numAtRisk":190,"numEvents":251},{"groupId":"EG004","numAffected":46,"numAtRisk":75,"numEvents":137}],"term":"Fatigue"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":41,"numEvents":17},{"groupId":"EG001","numAffected":1,"numAtRisk":8,"numEvents":1},{"groupId":"EG002","numAffected":18,"numAtRisk":58,"numEvents":24},{"groupId":"EG003","numAffected":52,"numAtRisk":190,"numEvents":83},{"groupId":"EG004","numAffected":25,"numAtRisk":75,"numEvents":46}],"term":"Fever"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":41,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG002","numAffected":3,"numAtRisk":58,"numEvents":3},{"groupId":"EG003","numAffected":18,"numAtRisk":190,"numEvents":22},{"groupId":"EG004","numAffected":14,"numAtRisk":75,"numEvents":17}],"term":"Flu like symptoms"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":41,"numEvents":2},{"groupId":"EG001","numAffected":1,"numAtRisk":8,"numEvents":1},{"groupId":"EG002","numAffected":3,"numAtRisk":58,"numEvents":5},{"groupId":"EG003","numAffected":8,"numAtRisk":190,"numEvents":10},{"groupId":"EG004","numAffected":5,"numAtRisk":75,"numEvents":7}],"term":"Localized edema"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":41,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":58,"numEvents":1},{"groupId":"EG003","numAffected":7,"numAtRisk":190,"numEvents":8},{"groupId":"EG004","numAffected":6,"numAtRisk":75,"numEvents":7}],"term":"Non-cardiac chest pain"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":41,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG002","numAffected":4,"numAtRisk":58,"numEvents":5},{"groupId":"EG003","numAffected":10,"numAtRisk":190,"numEvents":11},{"groupId":"EG004","numAffected":5,"numAtRisk":75,"numEvents":6}],"term":"General disorders and administration site conditions - Other"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":41,"numEvents":8},{"groupId":"EG001","numAffected":1,"numAtRisk":8,"numEvents":1},{"groupId":"EG002","numAffected":19,"numAtRisk":58,"numEvents":46},{"groupId":"EG003","numAffected":55,"numAtRisk":190,"numEvents":115},{"groupId":"EG004","numAffected":29,"numAtRisk":75,"numEvents":73}],"term":"Pain"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":41,"numEvents":9},{"groupId":"EG001","numAffected":1,"numAtRisk":8,"numEvents":2},{"groupId":"EG002","numAffected":6,"numAtRisk":58,"numEvents":15},{"groupId":"EG003","numAffected":20,"numAtRisk":190,"numEvents":41},{"groupId":"EG004","numAffected":4,"numAtRisk":75,"numEvents":10}],"term":"Alanine aminotransferase increased"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":41,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":8,"numEvents":1},{"groupId":"EG002","numAffected":3,"numAtRisk":58,"numEvents":6},{"groupId":"EG003","numAffected":11,"numAtRisk":190,"numEvents":21},{"groupId":"EG004","numAffected":3,"numAtRisk":75,"numEvents":4}],"term":"Alkaline phosphatase increased"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":41,"numEvents":9},{"groupId":"EG001","numAffected":2,"numAtRisk":8,"numEvents":2},{"groupId":"EG002","numAffected":8,"numAtRisk":58,"numEvents":15},{"groupId":"EG003","numAffected":23,"numAtRisk":190,"numEvents":58},{"groupId":"EG004","numAffected":6,"numAtRisk":75,"numEvents":24}],"term":"Aspartate aminotransferase increased"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":41,"numEvents":6},{"groupId":"EG001","numAffected":1,"numAtRisk":8,"numEvents":3},{"groupId":"EG002","numAffected":9,"numAtRisk":58,"numEvents":15},{"groupId":"EG003","numAffected":22,"numAtRisk":190,"numEvents":52},{"groupId":"EG004","numAffected":7,"numAtRisk":75,"numEvents":27}],"term":"Blood bilirubin increased"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":41,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":8,"numEvents":2},{"groupId":"EG002","numAffected":2,"numAtRisk":58,"numEvents":2},{"groupId":"EG003","numAffected":4,"numAtRisk":190,"numEvents":4},{"groupId":"EG004","numAffected":1,"numAtRisk":75,"numEvents":1}],"term":"GGT increased"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":41,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG002","numAffected":3,"numAtRisk":58,"numEvents":11},{"groupId":"EG003","numAffected":6,"numAtRisk":190,"numEvents":19},{"groupId":"EG004","numAffected":3,"numAtRisk":75,"numEvents":14}],"term":"Lipase increased"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":41,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG002","numAffected":6,"numAtRisk":58,"numEvents":8},{"groupId":"EG003","numAffected":13,"numAtRisk":190,"numEvents":25},{"groupId":"EG004","numAffected":6,"numAtRisk":75,"numEvents":12}],"term":"Neutrophil count decreased"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":41,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG002","numAffected":2,"numAtRisk":58,"numEvents":14},{"groupId":"EG003","numAffected":14,"numAtRisk":190,"numEvents":49},{"groupId":"EG004","numAffected":10,"numAtRisk":75,"numEvents":28}],"term":"Investigations - Other"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":41,"numEvents":5},{"groupId":"EG001","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG002","numAffected":6,"numAtRisk":58,"numEvents":25},{"groupId":"EG003","numAffected":15,"numAtRisk":190,"numEvents":46},{"groupId":"EG004","numAffected":10,"numAtRisk":75,"numEvents":34}],"term":"Platelet count decreased"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":41,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG002","numAffected":2,"numAtRisk":58,"numEvents":2},{"groupId":"EG003","numAffected":6,"numAtRisk":190,"numEvents":17},{"groupId":"EG004","numAffected":4,"numAtRisk":75,"numEvents":15}],"term":"White blood cell decreased"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":41,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":8,"numEvents":1},{"groupId":"EG002","numAffected":2,"numAtRisk":58,"numEvents":3},{"groupId":"EG003","numAffected":3,"numAtRisk":190,"numEvents":4},{"groupId":"EG004","numAffected":2,"numAtRisk":75,"numEvents":3}],"term":"Weight gain"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":41,"numEvents":5},{"groupId":"EG001","numAffected":2,"numAtRisk":8,"numEvents":2},{"groupId":"EG002","numAffected":11,"numAtRisk":58,"numEvents":20},{"groupId":"EG003","numAffected":40,"numAtRisk":190,"numEvents":72},{"groupId":"EG004","numAffected":22,"numAtRisk":75,"numEvents":44}],"term":"Weight loss"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Immune system disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":41,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":58,"numEvents":1},{"groupId":"EG003","numAffected":4,"numAtRisk":190,"numEvents":4},{"groupId":"EG004","numAffected":4,"numAtRisk":75,"numEvents":4}],"term":"Allergic reaction"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":41,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG002","numAffected":4,"numAtRisk":58,"numEvents":4},{"groupId":"EG003","numAffected":11,"numAtRisk":190,"numEvents":12},{"groupId":"EG004","numAffected":9,"numAtRisk":75,"numEvents":10}],"term":"Bronchial infection"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":41,"numEvents":3},{"groupId":"EG001","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG002","numAffected":5,"numAtRisk":58,"numEvents":7},{"groupId":"EG003","numAffected":21,"numAtRisk":190,"numEvents":39},{"groupId":"EG004","numAffected":13,"numAtRisk":75,"numEvents":26}],"term":"Infections and infestations - Other"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":41,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG002","numAffected":2,"numAtRisk":58,"numEvents":17},{"groupId":"EG003","numAffected":13,"numAtRisk":190,"numEvents":49},{"groupId":"EG004","numAffected":10,"numAtRisk":75,"numEvents":42}],"term":"Rash pustular"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":41,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":58,"numEvents":1},{"groupId":"EG003","numAffected":6,"numAtRisk":190,"numEvents":6},{"groupId":"EG004","numAffected":5,"numAtRisk":75,"numEvents":5}],"term":"Sinusitis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":41,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG002","numAffected":3,"numAtRisk":58,"numEvents":4},{"groupId":"EG003","numAffected":6,"numAtRisk":190,"numEvents":7},{"groupId":"EG004","numAffected":4,"numAtRisk":75,"numEvents":4}],"term":"Skin infection"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":41,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":58,"numEvents":1},{"groupId":"EG003","numAffected":6,"numAtRisk":190,"numEvents":6},{"groupId":"EG004","numAffected":5,"numAtRisk":75,"numEvents":5}],"term":"Tooth infection"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":41,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG002","numAffected":9,"numAtRisk":58,"numEvents":12},{"groupId":"EG003","numAffected":26,"numAtRisk":190,"numEvents":41},{"groupId":"EG004","numAffected":21,"numAtRisk":75,"numEvents":36}],"term":"Upper respiratory infection"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":41,"numEvents":3},{"groupId":"EG001","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG002","numAffected":2,"numAtRisk":58,"numEvents":4},{"groupId":"EG003","numAffected":12,"numAtRisk":190,"numEvents":17},{"groupId":"EG004","numAffected":6,"numAtRisk":75,"numEvents":9}],"term":"Urinary tract infection"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":15,"numAtRisk":41,"numEvents":21},{"groupId":"EG001","numAffected":3,"numAtRisk":8,"numEvents":5},{"groupId":"EG002","numAffected":20,"numAtRisk":58,"numEvents":42},{"groupId":"EG003","numAffected":77,"numAtRisk":190,"numEvents":134},{"groupId":"EG004","numAffected":32,"numAtRisk":75,"numEvents":72}],"term":"Anorexia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":41,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":8,"numEvents":1},{"groupId":"EG002","numAffected":5,"numAtRisk":58,"numEvents":5},{"groupId":"EG003","numAffected":6,"numAtRisk":190,"numEvents":8},{"groupId":"EG004","numAffected":4,"numAtRisk":75,"numEvents":6}],"term":"Dehydration"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":41,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG002","numAffected":3,"numAtRisk":58,"numEvents":3},{"groupId":"EG003","numAffected":9,"numAtRisk":190,"numEvents":10},{"groupId":"EG004","numAffected":2,"numAtRisk":75,"numEvents":2}],"term":"Hypoalbuminemia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":41,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG002","numAffected":3,"numAtRisk":58,"numEvents":8},{"groupId":"EG003","numAffected":9,"numAtRisk":190,"numEvents":15},{"groupId":"EG004","numAffected":4,"numAtRisk":75,"numEvents":4}],"term":"Hypocalcemia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":41,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG002","numAffected":12,"numAtRisk":58,"numEvents":18},{"groupId":"EG003","numAffected":20,"numAtRisk":190,"numEvents":31},{"groupId":"EG004","numAffected":13,"numAtRisk":75,"numEvents":22}],"term":"Hypokalemia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":41,"numEvents":0},{"groupId":"EG001","numAffected":2,"numAtRisk":8,"numEvents":2},{"groupId":"EG002","numAffected":3,"numAtRisk":58,"numEvents":4},{"groupId":"EG003","numAffected":8,"numAtRisk":190,"numEvents":11},{"groupId":"EG004","numAffected":2,"numAtRisk":75,"numEvents":2}],"term":"Hyponatremia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":41,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":58,"numEvents":1},{"groupId":"EG003","numAffected":10,"numAtRisk":190,"numEvents":13},{"groupId":"EG004","numAffected":5,"numAtRisk":75,"numEvents":7}],"term":"Hypophosphatemia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":41,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":8,"numEvents":1},{"groupId":"EG002","numAffected":3,"numAtRisk":58,"numEvents":3},{"groupId":"EG003","numAffected":4,"numAtRisk":190,"numEvents":4},{"groupId":"EG004","numAffected":4,"numAtRisk":75,"numEvents":4}],"term":"Hypercalcemia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":41,"numEvents":3},{"groupId":"EG001","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG002","numAffected":5,"numAtRisk":58,"numEvents":5},{"groupId":"EG003","numAffected":13,"numAtRisk":190,"numEvents":18},{"groupId":"EG004","numAffected":9,"numAtRisk":75,"numEvents":10}],"term":"Hyperglycemia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":41,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":8,"numEvents":1},{"groupId":"EG002","numAffected":2,"numAtRisk":58,"numEvents":2},{"groupId":"EG003","numAffected":7,"numAtRisk":190,"numEvents":7},{"groupId":"EG004","numAffected":2,"numAtRisk":75,"numEvents":2}],"term":"Hyperuricemia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":41,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG002","numAffected":4,"numAtRisk":58,"numEvents":7},{"groupId":"EG003","numAffected":14,"numAtRisk":190,"numEvents":20},{"groupId":"EG004","numAffected":8,"numAtRisk":75,"numEvents":14}],"term":"Arthralgia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":41,"numEvents":2},{"groupId":"EG001","numAffected":1,"numAtRisk":8,"numEvents":1},{"groupId":"EG002","numAffected":4,"numAtRisk":58,"numEvents":6},{"groupId":"EG003","numAffected":21,"numAtRisk":190,"numEvents":29},{"groupId":"EG004","numAffected":14,"numAtRisk":75,"numEvents":20}],"term":"Back pain"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":41,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":58,"numEvents":3},{"groupId":"EG003","numAffected":5,"numAtRisk":190,"numEvents":9},{"groupId":"EG004","numAffected":5,"numAtRisk":75,"numEvents":9}],"term":"Bone pain"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":41,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":58,"numEvents":1},{"groupId":"EG003","numAffected":5,"numAtRisk":190,"numEvents":5},{"groupId":"EG004","numAffected":4,"numAtRisk":75,"numEvents":4}],"term":"Flank pain"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":41,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":8,"numEvents":1},{"groupId":"EG002","numAffected":4,"numAtRisk":58,"numEvents":7},{"groupId":"EG003","numAffected":6,"numAtRisk":190,"numEvents":14},{"groupId":"EG004","numAffected":3,"numAtRisk":75,"numEvents":11}],"term":"Generalized muscle weakness"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":41,"numEvents":5},{"groupId":"EG001","numAffected":3,"numAtRisk":8,"numEvents":3},{"groupId":"EG002","numAffected":10,"numAtRisk":58,"numEvents":17},{"groupId":"EG003","numAffected":34,"numAtRisk":190,"numEvents":76},{"groupId":"EG004","numAffected":17,"numAtRisk":75,"numEvents":49}],"term":"Myalgia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":41,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":8,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":58,"numEvents":0},{"groupId":"EG003","numAffected":2,"numAtRisk":190,"numEvents":2},{"groupId":"EG004","numAffected":1,"numAtRisk":75,"numEvents":1}],"term":"Neck pain"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":41,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG002","numAffected":4,"numAtRisk":58,"numEvents":5},{"groupId":"EG003","numAffected":14,"numAtRisk":190,"numEvents":17},{"groupId":"EG004","numAffected":10,"numAtRisk":75,"numEvents":12}],"term":"Musculoskeletal and connective tissue disorder - Other"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":41,"numEvents":5},{"groupId":"EG001","numAffected":1,"numAtRisk":8,"numEvents":2},{"groupId":"EG002","numAffected":7,"numAtRisk":58,"numEvents":15},{"groupId":"EG003","numAffected":28,"numAtRisk":190,"numEvents":51},{"groupId":"EG004","numAffected":17,"numAtRisk":75,"numEvents":37}],"term":"Pain in extremity"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":41,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":8,"numEvents":1},{"groupId":"EG002","numAffected":1,"numAtRisk":58,"numEvents":1},{"groupId":"EG003","numAffected":6,"numAtRisk":190,"numEvents":16},{"groupId":"EG004","numAffected":6,"numAtRisk":75,"numEvents":16}],"term":"Dizziness"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":41,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG002","numAffected":4,"numAtRisk":58,"numEvents":4},{"groupId":"EG003","numAffected":17,"numAtRisk":190,"numEvents":19},{"groupId":"EG004","numAffected":9,"numAtRisk":75,"numEvents":11}],"term":"Dysgeusia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":41,"numEvents":4},{"groupId":"EG001","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG002","numAffected":11,"numAtRisk":58,"numEvents":21},{"groupId":"EG003","numAffected":37,"numAtRisk":190,"numEvents":72},{"groupId":"EG004","numAffected":23,"numAtRisk":75,"numEvents":55}],"term":"Headache"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":41,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG002","numAffected":3,"numAtRisk":58,"numEvents":5},{"groupId":"EG003","numAffected":11,"numAtRisk":190,"numEvents":19},{"groupId":"EG004","numAffected":9,"numAtRisk":75,"numEvents":13}],"term":"Paresthesia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":41,"numEvents":7},{"groupId":"EG001","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG002","numAffected":4,"numAtRisk":58,"numEvents":8},{"groupId":"EG003","numAffected":16,"numAtRisk":190,"numEvents":22},{"groupId":"EG004","numAffected":6,"numAtRisk":75,"numEvents":7}],"term":"Peripheral sensory neuropathy"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":41,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":8,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":58,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":190,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":75,"numEvents":0}],"term":"Somnolence"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":41,"numEvents":2},{"groupId":"EG001","numAffected":1,"numAtRisk":8,"numEvents":1},{"groupId":"EG002","numAffected":3,"numAtRisk":58,"numEvents":4},{"groupId":"EG003","numAffected":7,"numAtRisk":190,"numEvents":9},{"groupId":"EG004","numAffected":2,"numAtRisk":75,"numEvents":2}],"term":"Tumor pain"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":41,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG002","numAffected":2,"numAtRisk":58,"numEvents":2},{"groupId":"EG003","numAffected":7,"numAtRisk":190,"numEvents":7},{"groupId":"EG004","numAffected":7,"numAtRisk":75,"numEvents":7}],"term":"Blurred vision"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":41,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":58,"numEvents":1},{"groupId":"EG003","numAffected":6,"numAtRisk":190,"numEvents":6},{"groupId":"EG004","numAffected":4,"numAtRisk":75,"numEvents":4}],"term":"Eye disorders - Other"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":41,"numEvents":4},{"groupId":"EG001","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG002","numAffected":3,"numAtRisk":58,"numEvents":4},{"groupId":"EG003","numAffected":9,"numAtRisk":190,"numEvents":10},{"groupId":"EG004","numAffected":4,"numAtRisk":75,"numEvents":5}],"term":"Anxiety"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":41,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":8,"numEvents":1},{"groupId":"EG002","numAffected":1,"numAtRisk":58,"numEvents":1},{"groupId":"EG003","numAffected":2,"numAtRisk":190,"numEvents":2},{"groupId":"EG004","numAffected":0,"numAtRisk":75,"numEvents":0}],"term":"Confusion"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":41,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG002","numAffected":2,"numAtRisk":58,"numEvents":2},{"groupId":"EG003","numAffected":10,"numAtRisk":190,"numEvents":11},{"groupId":"EG004","numAffected":4,"numAtRisk":75,"numEvents":5}],"term":"Depression"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":41,"numEvents":3},{"groupId":"EG001","numAffected":1,"numAtRisk":8,"numEvents":1},{"groupId":"EG002","numAffected":3,"numAtRisk":58,"numEvents":4},{"groupId":"EG003","numAffected":21,"numAtRisk":190,"numEvents":22},{"groupId":"EG004","numAffected":14,"numAtRisk":75,"numEvents":15}],"term":"Insomnia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":41,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":8,"numEvents":1},{"groupId":"EG002","numAffected":11,"numAtRisk":58,"numEvents":18},{"groupId":"EG003","numAffected":27,"numAtRisk":190,"numEvents":44},{"groupId":"EG004","numAffected":15,"numAtRisk":75,"numEvents":32}],"term":"Cough"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":41,"numEvents":6},{"groupId":"EG001","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG002","numAffected":7,"numAtRisk":58,"numEvents":9},{"groupId":"EG003","numAffected":22,"numAtRisk":190,"numEvents":32},{"groupId":"EG004","numAffected":11,"numAtRisk":75,"numEvents":16}],"term":"Dyspnea"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":41,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG002","numAffected":4,"numAtRisk":58,"numEvents":6},{"groupId":"EG003","numAffected":10,"numAtRisk":190,"numEvents":15},{"groupId":"EG004","numAffected":7,"numAtRisk":75,"numEvents":10}],"term":"Epistaxis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":41,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":8,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":58,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":190,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":75,"numEvents":0}],"term":"Hiccups"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":41,"numEvents":8},{"groupId":"EG001","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG002","numAffected":9,"numAtRisk":58,"numEvents":11},{"groupId":"EG003","numAffected":42,"numAtRisk":190,"numEvents":71},{"groupId":"EG004","numAffected":17,"numAtRisk":75,"numEvents":36}],"term":"Hoarseness"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":41,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG002","numAffected":3,"numAtRisk":58,"numEvents":3},{"groupId":"EG003","numAffected":5,"numAtRisk":190,"numEvents":5},{"groupId":"EG004","numAffected":4,"numAtRisk":75,"numEvents":4}],"term":"Pneumonitis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":41,"numEvents":2},{"groupId":"EG001","numAffected":1,"numAtRisk":8,"numEvents":1},{"groupId":"EG002","numAffected":11,"numAtRisk":58,"numEvents":12},{"groupId":"EG003","numAffected":28,"numAtRisk":190,"numEvents":32},{"groupId":"EG004","numAffected":14,"numAtRisk":75,"numEvents":17}],"term":"Voice alteration"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":41,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG002","numAffected":3,"numAtRisk":58,"numEvents":3},{"groupId":"EG003","numAffected":7,"numAtRisk":190,"numEvents":9},{"groupId":"EG004","numAffected":3,"numAtRisk":75,"numEvents":3}],"term":"Hematuria"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":41,"numEvents":3},{"groupId":"EG001","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":58,"numEvents":0},{"groupId":"EG003","numAffected":10,"numAtRisk":190,"numEvents":12},{"groupId":"EG004","numAffected":4,"numAtRisk":75,"numEvents":5}],"term":"Renal and urinary disorders - Other"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":41,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG002","numAffected":6,"numAtRisk":58,"numEvents":11},{"groupId":"EG003","numAffected":23,"numAtRisk":190,"numEvents":58},{"groupId":"EG004","numAffected":9,"numAtRisk":75,"numEvents":21}],"term":"Proteinuria"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":41,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG002","numAffected":2,"numAtRisk":58,"numEvents":2},{"groupId":"EG003","numAffected":7,"numAtRisk":190,"numEvents":8},{"groupId":"EG004","numAffected":4,"numAtRisk":75,"numEvents":5}],"term":"Urinary frequency"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":41,"numEvents":9},{"groupId":"EG001","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG002","numAffected":21,"numAtRisk":58,"numEvents":26},{"groupId":"EG003","numAffected":62,"numAtRisk":190,"numEvents":84},{"groupId":"EG004","numAffected":33,"numAtRisk":75,"numEvents":49}],"term":"Alopecia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":41,"numEvents":3},{"groupId":"EG001","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG002","numAffected":2,"numAtRisk":58,"numEvents":3},{"groupId":"EG003","numAffected":13,"numAtRisk":190,"numEvents":15},{"groupId":"EG004","numAffected":7,"numAtRisk":75,"numEvents":8}],"term":"Dry skin"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":41,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":58,"numEvents":3},{"groupId":"EG003","numAffected":10,"numAtRisk":190,"numEvents":17},{"groupId":"EG004","numAffected":7,"numAtRisk":75,"numEvents":12}],"term":"Erythema multiforme"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":41,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG002","numAffected":4,"numAtRisk":58,"numEvents":5},{"groupId":"EG003","numAffected":9,"numAtRisk":190,"numEvents":11},{"groupId":"EG004","numAffected":6,"numAtRisk":75,"numEvents":6}],"term":"Erythroderma"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":41,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":8,"numEvents":2},{"groupId":"EG002","numAffected":2,"numAtRisk":58,"numEvents":2},{"groupId":"EG003","numAffected":6,"numAtRisk":190,"numEvents":11},{"groupId":"EG004","numAffected":4,"numAtRisk":75,"numEvents":9}],"term":"Hyperhidrosis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":41,"numEvents":3},{"groupId":"EG001","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG002","numAffected":7,"numAtRisk":58,"numEvents":10},{"groupId":"EG003","numAffected":27,"numAtRisk":190,"numEvents":41},{"groupId":"EG004","numAffected":17,"numAtRisk":75,"numEvents":28}],"term":"Skin and subcutaneous tissue disorders - Other"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":41,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":58,"numEvents":1},{"groupId":"EG003","numAffected":9,"numAtRisk":190,"numEvents":39},{"groupId":"EG004","numAffected":6,"numAtRisk":75,"numEvents":36}],"term":"Pain of skin"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":17,"numAtRisk":41,"numEvents":37},{"groupId":"EG001","numAffected":1,"numAtRisk":8,"numEvents":1},{"groupId":"EG002","numAffected":39,"numAtRisk":58,"numEvents":151},{"groupId":"EG003","numAffected":126,"numAtRisk":190,"numEvents":666},{"groupId":"EG004","numAffected":58,"numAtRisk":75,"numEvents":455}],"term":"Palmar-plantar erythrodysesthesia syndrome"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":41,"numEvents":4},{"groupId":"EG001","numAffected":1,"numAtRisk":8,"numEvents":2},{"groupId":"EG002","numAffected":7,"numAtRisk":58,"numEvents":8},{"groupId":"EG003","numAffected":20,"numAtRisk":190,"numEvents":27},{"groupId":"EG004","numAffected":10,"numAtRisk":75,"numEvents":15}],"term":"Pruritus"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":41,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG002","numAffected":3,"numAtRisk":58,"numEvents":3},{"groupId":"EG003","numAffected":12,"numAtRisk":190,"numEvents":12},{"groupId":"EG004","numAffected":7,"numAtRisk":75,"numEvents":7}],"term":"Rash acneiform"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":41,"numEvents":7},{"groupId":"EG001","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG002","numAffected":8,"numAtRisk":58,"numEvents":10},{"groupId":"EG003","numAffected":32,"numAtRisk":190,"numEvents":71},{"groupId":"EG004","numAffected":16,"numAtRisk":75,"numEvents":26}],"term":"Rash maculo-papular"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":41,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":58,"numEvents":1},{"groupId":"EG003","numAffected":7,"numAtRisk":190,"numEvents":8},{"groupId":"EG004","numAffected":4,"numAtRisk":75,"numEvents":5}],"term":"Hypotension"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":18,"numAtRisk":41,"numEvents":32},{"groupId":"EG001","numAffected":3,"numAtRisk":8,"numEvents":3},{"groupId":"EG002","numAffected":37,"numAtRisk":58,"numEvents":97},{"groupId":"EG003","numAffected":124,"numAtRisk":190,"numEvents":697},{"groupId":"EG004","numAffected":62,"numAtRisk":75,"numEvents":552}],"term":"Hypertension"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":41,"numEvents":0},{"groupId":"EG001","numAffected":2,"numAtRisk":8,"numEvents":2},{"groupId":"EG002","numAffected":1,"numAtRisk":58,"numEvents":1},{"groupId":"EG003","numAffected":6,"numAtRisk":190,"numEvents":7},{"groupId":"EG004","numAffected":5,"numAtRisk":75,"numEvents":5}],"term":"Thromboembolic event"}],"seriousEvents":[{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Ear and labyrinth disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":41,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":58,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":190,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":75,"numEvents":0}],"term":"Vertigo"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":41,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":58,"numEvents":2},{"groupId":"EG003","numAffected":2,"numAtRisk":190,"numEvents":3},{"groupId":"EG004","numAffected":0,"numAtRisk":75,"numEvents":0}],"term":"Anemia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Congenital, familial and genetic disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":41,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":58,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":190,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":75,"numEvents":0}],"term":"Congenital, familial and genetic disorders - Other"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":41,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":58,"numEvents":0},{"groupId":"EG003","numAffected":7,"numAtRisk":190,"numEvents":7},{"groupId":"EG004","numAffected":6,"numAtRisk":75,"numEvents":6}],"term":"Acute coronary syndrome"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":41,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":58,"numEvents":1},{"groupId":"EG003","numAffected":1,"numAtRisk":190,"numEvents":1},{"groupId":"EG004","numAffected":1,"numAtRisk":75,"numEvents":1}],"term":"Atrial fibrillation"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":41,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":58,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":190,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":75,"numEvents":0}],"term":"Cardiac arrest"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":41,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":58,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":190,"numEvents":2},{"groupId":"EG004","numAffected":1,"numAtRisk":75,"numEvents":2}],"term":"Chest pain - cardiac"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":41,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":58,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":190,"numEvents":1},{"groupId":"EG004","numAffected":1,"numAtRisk":75,"numEvents":1}],"term":"Conduction disorder"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":41,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":58,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":190,"numEvents":1},{"groupId":"EG004","numAffected":1,"numAtRisk":75,"numEvents":1}],"term":"Heart failure"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":41,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":58,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":190,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":75,"numEvents":0}],"term":"Cardiac disorders - Other"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":41,"numEvents":5},{"groupId":"EG001","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG002","numAffected":2,"numAtRisk":58,"numEvents":2},{"groupId":"EG003","numAffected":9,"numAtRisk":190,"numEvents":10},{"groupId":"EG004","numAffected":1,"numAtRisk":75,"numEvents":1}],"term":"Abdominal pain"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":41,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":58,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":190,"numEvents":1},{"groupId":"EG004","numAffected":1,"numAtRisk":75,"numEvents":1}],"term":"Anal fistula"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":41,"numEvents":4},{"groupId":"EG001","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":58,"numEvents":0},{"groupId":"EG003","numAffected":3,"numAtRisk":190,"numEvents":4},{"groupId":"EG004","numAffected":0,"numAtRisk":75,"numEvents":0}],"term":"Ascites"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":41,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":58,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":190,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":75,"numEvents":0}],"term":"Colonic fistula"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":41,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":58,"numEvents":2},{"groupId":"EG003","numAffected":1,"numAtRisk":190,"numEvents":2},{"groupId":"EG004","numAffected":0,"numAtRisk":75,"numEvents":0}],"term":"Colonic obstruction"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":41,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":58,"numEvents":2},{"groupId":"EG003","numAffected":2,"numAtRisk":190,"numEvents":4},{"groupId":"EG004","numAffected":1,"numAtRisk":75,"numEvents":2}],"term":"Colonic perforation"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":41,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":58,"numEvents":1},{"groupId":"EG003","numAffected":2,"numAtRisk":190,"numEvents":2},{"groupId":"EG004","numAffected":2,"numAtRisk":75,"numEvents":2}],"term":"Constipation"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":41,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":58,"numEvents":0},{"groupId":"EG003","numAffected":3,"numAtRisk":190,"numEvents":4},{"groupId":"EG004","numAffected":2,"numAtRisk":75,"numEvents":3}],"term":"Diarrhea"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":41,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":58,"numEvents":1},{"groupId":"EG003","numAffected":2,"numAtRisk":190,"numEvents":2},{"groupId":"EG004","numAffected":0,"numAtRisk":75,"numEvents":0}],"term":"Gastric hemorrhage"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":41,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":58,"numEvents":0},{"groupId":"EG003","numAffected":3,"numAtRisk":190,"numEvents":3},{"groupId":"EG004","numAffected":0,"numAtRisk":75,"numEvents":0}],"term":"Intra-abdominal hemorrhage"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":41,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":58,"numEvents":1},{"groupId":"EG003","numAffected":2,"numAtRisk":190,"numEvents":2},{"groupId":"EG004","numAffected":0,"numAtRisk":75,"numEvents":0}],"term":"Ileus"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":41,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":58,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":190,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":75,"numEvents":0}],"term":"Lower gastrointestinal hemorrhage"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":41,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":8,"numEvents":1},{"groupId":"EG002","numAffected":1,"numAtRisk":58,"numEvents":1},{"groupId":"EG003","numAffected":2,"numAtRisk":190,"numEvents":2},{"groupId":"EG004","numAffected":1,"numAtRisk":75,"numEvents":1}],"term":"Nausea"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":41,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":58,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":190,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":75,"numEvents":0}],"term":"Obstruction gastric"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":41,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":58,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":190,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":75,"numEvents":0}],"term":"Gastrointestinal disorders - Other"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":41,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":58,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":190,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":75,"numEvents":0}],"term":"Peritoneal necrosis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":41,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":58,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":190,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":75,"numEvents":0}],"term":"Retroperitoneal hemorrhage"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":41,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":58,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":190,"numEvents":2},{"groupId":"EG004","numAffected":1,"numAtRisk":75,"numEvents":2}],"term":"Small intestinal obstruction"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":41,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":58,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":190,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":75,"numEvents":0}],"term":"Upper gastrointestinal hemorrhage"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":41,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":58,"numEvents":1},{"groupId":"EG003","numAffected":2,"numAtRisk":190,"numEvents":2},{"groupId":"EG004","numAffected":1,"numAtRisk":75,"numEvents":1}],"term":"Vomiting"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":41,"numEvents":1},{"groupId":"EG001","numAffected":2,"numAtRisk":8,"numEvents":2},{"groupId":"EG002","numAffected":1,"numAtRisk":58,"numEvents":1},{"groupId":"EG003","numAffected":3,"numAtRisk":190,"numEvents":3},{"groupId":"EG004","numAffected":2,"numAtRisk":75,"numEvents":2}],"term":"Death NOS"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":41,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":58,"numEvents":2},{"groupId":"EG003","numAffected":1,"numAtRisk":190,"numEvents":2},{"groupId":"EG004","numAffected":0,"numAtRisk":75,"numEvents":0}],"term":"Edema limbs"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":41,"numEvents":4},{"groupId":"EG001","numAffected":1,"numAtRisk":8,"numEvents":2},{"groupId":"EG002","numAffected":2,"numAtRisk":58,"numEvents":2},{"groupId":"EG003","numAffected":5,"numAtRisk":190,"numEvents":7},{"groupId":"EG004","numAffected":2,"numAtRisk":75,"numEvents":2}],"term":"Fatigue"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":41,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG002","numAffected":2,"numAtRisk":58,"numEvents":2},{"groupId":"EG003","numAffected":5,"numAtRisk":190,"numEvents":5},{"groupId":"EG004","numAffected":2,"numAtRisk":75,"numEvents":2}],"term":"Fever"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":41,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":58,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":190,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":75,"numEvents":0}],"term":"Malaise"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":41,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":58,"numEvents":1},{"groupId":"EG003","numAffected":2,"numAtRisk":190,"numEvents":2},{"groupId":"EG004","numAffected":0,"numAtRisk":75,"numEvents":0}],"term":"Multi-organ failure"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":41,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":8,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":58,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":190,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":75,"numEvents":0}],"term":"Non-cardiac chest pain"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":41,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":8,"numEvents":1},{"groupId":"EG002","numAffected":2,"numAtRisk":58,"numEvents":3},{"groupId":"EG003","numAffected":5,"numAtRisk":190,"numEvents":6},{"groupId":"EG004","numAffected":3,"numAtRisk":75,"numEvents":3}],"term":"General disorders and administration site conditions - Other"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":41,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG002","numAffected":2,"numAtRisk":58,"numEvents":3},{"groupId":"EG003","numAffected":3,"numAtRisk":190,"numEvents":4},{"groupId":"EG004","numAffected":1,"numAtRisk":75,"numEvents":1}],"term":"Pain"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":41,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":58,"numEvents":1},{"groupId":"EG003","numAffected":2,"numAtRisk":190,"numEvents":2},{"groupId":"EG004","numAffected":1,"numAtRisk":75,"numEvents":1}],"term":"Bile duct stenosis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":41,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":58,"numEvents":0},{"groupId":"EG003","numAffected":2,"numAtRisk":190,"numEvents":2},{"groupId":"EG004","numAffected":2,"numAtRisk":75,"numEvents":2}],"term":"Cholecystitis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":41,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":58,"numEvents":1},{"groupId":"EG003","numAffected":3,"numAtRisk":190,"numEvents":4},{"groupId":"EG004","numAffected":0,"numAtRisk":75,"numEvents":0}],"term":"Hepatic failure"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":41,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":58,"numEvents":0},{"groupId":"EG003","numAffected":2,"numAtRisk":190,"numEvents":3},{"groupId":"EG004","numAffected":1,"numAtRisk":75,"numEvents":1}],"term":"Hepatic hemorrhage"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":41,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":8,"numEvents":1},{"groupId":"EG002","numAffected":1,"numAtRisk":58,"numEvents":1},{"groupId":"EG003","numAffected":2,"numAtRisk":190,"numEvents":2},{"groupId":"EG004","numAffected":1,"numAtRisk":75,"numEvents":1}],"term":"Hepatobiliary disorders - Other"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":41,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":58,"numEvents":1},{"groupId":"EG003","numAffected":1,"numAtRisk":190,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":75,"numEvents":0}],"term":"Portal vein thrombosis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":41,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":58,"numEvents":2},{"groupId":"EG003","numAffected":3,"numAtRisk":190,"numEvents":6},{"groupId":"EG004","numAffected":1,"numAtRisk":75,"numEvents":3}],"term":"Alanine aminotransferase increased"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":41,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":58,"numEvents":1},{"groupId":"EG003","numAffected":1,"numAtRisk":190,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":75,"numEvents":0}],"term":"Aspartate aminotransferase increased"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":41,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG002","numAffected":2,"numAtRisk":58,"numEvents":2},{"groupId":"EG003","numAffected":3,"numAtRisk":190,"numEvents":3},{"groupId":"EG004","numAffected":1,"numAtRisk":75,"numEvents":1}],"term":"Blood bilirubin increased"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":41,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":58,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":190,"numEvents":2},{"groupId":"EG004","numAffected":0,"numAtRisk":75,"numEvents":0}],"term":"Creatinine increased"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":41,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":58,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":190,"numEvents":1},{"groupId":"EG004","numAffected":1,"numAtRisk":75,"numEvents":1}],"term":"INR increased"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":41,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":58,"numEvents":1},{"groupId":"EG003","numAffected":1,"numAtRisk":190,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":75,"numEvents":0}],"term":"Neutrophil count decreased"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":41,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":58,"numEvents":0},{"groupId":"EG003","numAffected":2,"numAtRisk":190,"numEvents":2},{"groupId":"EG004","numAffected":0,"numAtRisk":75,"numEvents":0}],"term":"Investigations - Other"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":41,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":58,"numEvents":2},{"groupId":"EG003","numAffected":1,"numAtRisk":190,"numEvents":2},{"groupId":"EG004","numAffected":0,"numAtRisk":75,"numEvents":0}],"term":"Platelet count decreased"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":41,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":58,"numEvents":0},{"groupId":"EG003","numAffected":2,"numAtRisk":190,"numEvents":2},{"groupId":"EG004","numAffected":0,"numAtRisk":75,"numEvents":0}],"term":"Abdominal infection"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":41,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":58,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":190,"numEvents":1},{"groupId":"EG004","numAffected":1,"numAtRisk":75,"numEvents":1}],"term":"Appendicitis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":41,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":58,"numEvents":0},{"groupId":"EG003","numAffected":2,"numAtRisk":190,"numEvents":3},{"groupId":"EG004","numAffected":1,"numAtRisk":75,"numEvents":2}],"term":"Bronchial infection"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":41,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":58,"numEvents":2},{"groupId":"EG003","numAffected":1,"numAtRisk":190,"numEvents":2},{"groupId":"EG004","numAffected":0,"numAtRisk":75,"numEvents":0}],"term":"Catheter related infection"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":41,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG002","numAffected":2,"numAtRisk":58,"numEvents":3},{"groupId":"EG003","numAffected":2,"numAtRisk":190,"numEvents":3},{"groupId":"EG004","numAffected":1,"numAtRisk":75,"numEvents":2}],"term":"Enterocolitis infectious"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":41,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":58,"numEvents":1},{"groupId":"EG003","numAffected":2,"numAtRisk":190,"numEvents":2},{"groupId":"EG004","numAffected":1,"numAtRisk":75,"numEvents":1}],"term":"Lung infection"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":41,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG002","numAffected":4,"numAtRisk":58,"numEvents":4},{"groupId":"EG003","numAffected":8,"numAtRisk":190,"numEvents":9},{"groupId":"EG004","numAffected":3,"numAtRisk":75,"numEvents":4}],"term":"Infections and infestations - Other"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":41,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG002","numAffected":2,"numAtRisk":58,"numEvents":2},{"groupId":"EG003","numAffected":3,"numAtRisk":190,"numEvents":3},{"groupId":"EG004","numAffected":1,"numAtRisk":75,"numEvents":1}],"term":"Sepsis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":41,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":58,"numEvents":0},{"groupId":"EG003","numAffected":3,"numAtRisk":190,"numEvents":3},{"groupId":"EG004","numAffected":3,"numAtRisk":75,"numEvents":3}],"term":"Upper respiratory infection"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":41,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":58,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":190,"numEvents":1},{"groupId":"EG004","numAffected":1,"numAtRisk":75,"numEvents":1}],"term":"Urinary tract infection"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":41,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":58,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":190,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":75,"numEvents":0}],"term":"Wound infection"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":41,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":58,"numEvents":2},{"groupId":"EG003","numAffected":4,"numAtRisk":190,"numEvents":5},{"groupId":"EG004","numAffected":3,"numAtRisk":75,"numEvents":4}],"term":"Fracture"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":41,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":58,"numEvents":1},{"groupId":"EG003","numAffected":1,"numAtRisk":190,"numEvents":1},{"groupId":"EG004","numAffected":1,"numAtRisk":75,"numEvents":1}],"term":"Hip fracture"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":41,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":58,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":190,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":75,"numEvents":0}],"term":"Acidosis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":41,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":58,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":190,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":75,"numEvents":0}],"term":"Anorexia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":41,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":8,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":58,"numEvents":0},{"groupId":"EG003","numAffected":3,"numAtRisk":190,"numEvents":3},{"groupId":"EG004","numAffected":3,"numAtRisk":75,"numEvents":3}],"term":"Dehydration"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":41,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":8,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":58,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":190,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":75,"numEvents":0}],"term":"Hyperglycemia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":41,"numEvents":3},{"groupId":"EG001","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":58,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":190,"numEvents":3},{"groupId":"EG004","numAffected":0,"numAtRisk":75,"numEvents":0}],"term":"Hyperkalemia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":41,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG002","numAffected":2,"numAtRisk":58,"numEvents":2},{"groupId":"EG003","numAffected":2,"numAtRisk":190,"numEvents":2},{"groupId":"EG004","numAffected":1,"numAtRisk":75,"numEvents":1}],"term":"Back pain"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":41,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":58,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":190,"numEvents":1},{"groupId":"EG004","numAffected":1,"numAtRisk":75,"numEvents":1}],"term":"Generalized muscle weakness"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":41,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":58,"numEvents":1},{"groupId":"EG003","numAffected":1,"numAtRisk":190,"numEvents":1},{"groupId":"EG004","numAffected":1,"numAtRisk":75,"numEvents":1}],"term":"Musculoskeletal and connective tissue disorder - Other"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":41,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":58,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":190,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":75,"numEvents":0}],"term":"Muscle weakness right-sided"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":41,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":58,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":190,"numEvents":1},{"groupId":"EG004","numAffected":1,"numAtRisk":75,"numEvents":1}],"term":"Amnesia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":41,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":58,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":190,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":75,"numEvents":0}],"term":"Hypoglossal nerve disorder"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":41,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":58,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":190,"numEvents":1},{"groupId":"EG004","numAffected":1,"numAtRisk":75,"numEvents":1}],"term":"Intracranial hemorrhage"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":41,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG002","numAffected":2,"numAtRisk":58,"numEvents":2},{"groupId":"EG003","numAffected":2,"numAtRisk":190,"numEvents":2},{"groupId":"EG004","numAffected":0,"numAtRisk":75,"numEvents":0}],"term":"Nervous system disorders - Other"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":41,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":58,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":190,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":75,"numEvents":0}],"term":"Paresthesia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":41,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":58,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":190,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":75,"numEvents":0}],"term":"Reversible posterior leukoencephalopathy syndrome"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":41,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":58,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":190,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":75,"numEvents":0}],"term":"Somnolence"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":41,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":58,"numEvents":1},{"groupId":"EG003","numAffected":2,"numAtRisk":190,"numEvents":2},{"groupId":"EG004","numAffected":2,"numAtRisk":75,"numEvents":2}],"term":"Stroke"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":41,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":58,"numEvents":0},{"groupId":"EG003","numAffected":2,"numAtRisk":190,"numEvents":2},{"groupId":"EG004","numAffected":2,"numAtRisk":75,"numEvents":2}],"term":"Transient ischemic attacks"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":41,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG002","numAffected":3,"numAtRisk":58,"numEvents":3},{"groupId":"EG003","numAffected":6,"numAtRisk":190,"numEvents":6},{"groupId":"EG004","numAffected":3,"numAtRisk":75,"numEvents":3}],"term":"Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":41,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG002","numAffected":2,"numAtRisk":58,"numEvents":4},{"groupId":"EG003","numAffected":3,"numAtRisk":190,"numEvents":5},{"groupId":"EG004","numAffected":1,"numAtRisk":75,"numEvents":1}],"term":"Tumor pain"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":41,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":58,"numEvents":1},{"groupId":"EG003","numAffected":1,"numAtRisk":190,"numEvents":1},{"groupId":"EG004","numAffected":1,"numAtRisk":75,"numEvents":1}],"term":"Eye disorders - Other"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":41,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":58,"numEvents":1},{"groupId":"EG003","numAffected":1,"numAtRisk":190,"numEvents":1},{"groupId":"EG004","numAffected":1,"numAtRisk":75,"numEvents":1}],"term":"Confusion"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":41,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":8,"numEvents":4},{"groupId":"EG002","numAffected":0,"numAtRisk":58,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":190,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":75,"numEvents":0}],"term":"Mania"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":41,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":58,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":190,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":75,"numEvents":0}],"term":"Psychiatric disorders - Other"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":41,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":58,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":190,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":75,"numEvents":0}],"term":"Adult respiratory distress syndrome"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":41,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":58,"numEvents":0},{"groupId":"EG003","numAffected":2,"numAtRisk":190,"numEvents":2},{"groupId":"EG004","numAffected":0,"numAtRisk":75,"numEvents":0}],"term":"Dyspnea"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":41,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":58,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":190,"numEvents":1},{"groupId":"EG004","numAffected":1,"numAtRisk":75,"numEvents":1}],"term":"Pleural effusion"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":41,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":58,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":190,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":75,"numEvents":0}],"term":"Pneumonitis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":41,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":58,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":190,"numEvents":1},{"groupId":"EG004","numAffected":1,"numAtRisk":75,"numEvents":1}],"term":"Respiratory failure"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":41,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":58,"numEvents":2},{"groupId":"EG003","numAffected":4,"numAtRisk":190,"numEvents":5},{"groupId":"EG004","numAffected":1,"numAtRisk":75,"numEvents":1}],"term":"Acute kidney injury"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":41,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":58,"numEvents":0},{"groupId":"EG003","numAffected":3,"numAtRisk":190,"numEvents":4},{"groupId":"EG004","numAffected":1,"numAtRisk":75,"numEvents":2}],"term":"Renal and urinary disorders - Other"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":41,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":58,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":190,"numEvents":1},{"groupId":"EG004","numAffected":1,"numAtRisk":75,"numEvents":1}],"term":"Renal colic"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":41,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":58,"numEvents":0},{"groupId":"EG003","numAffected":2,"numAtRisk":190,"numEvents":2},{"groupId":"EG004","numAffected":1,"numAtRisk":75,"numEvents":1}],"term":"Urinary retention"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":41,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":58,"numEvents":1},{"groupId":"EG003","numAffected":1,"numAtRisk":190,"numEvents":1},{"groupId":"EG004","numAffected":1,"numAtRisk":75,"numEvents":1}],"term":"Rash maculo-papular"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Surgical and medical procedures","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":41,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":58,"numEvents":1},{"groupId":"EG003","numAffected":4,"numAtRisk":190,"numEvents":4},{"groupId":"EG004","numAffected":2,"numAtRisk":75,"numEvents":2}],"term":"Surgical and medical procedures - Other"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":41,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":58,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":190,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":75,"numEvents":0}],"term":"Hypertension"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":41,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":58,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":190,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":75,"numEvents":0}],"term":"Vascular disorders - Other"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":41,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":58,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":190,"numEvents":1},{"groupId":"EG004","numAffected":1,"numAtRisk":75,"numEvents":1}],"term":"Peripheral ischemia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":41,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":8,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":58,"numEvents":2},{"groupId":"EG003","numAffected":4,"numAtRisk":190,"numEvents":5},{"groupId":"EG004","numAffected":0,"numAtRisk":75,"numEvents":0}],"term":"Thromboembolic event"}],"timeFrame":"From first administration of treatment till 30 days after last dose of treatment."}