{"description":"Although the protocol stated Part B participants would begin treatment at the MTD determined by Part A (45 mg), the conduct of Part B permitted participants to stay in the study even though they had many dose reductions and dosing interruptions. Dosing/exposure for participants varied greatly and there were few participants which remained at any given dose for most of the study. Due to this, there was no analysis of Part B data available according to dose.","eventGroups":[{"deathsNumAffected":0,"deathsNumAtRisk":1,"description":"Participants received a single dose of 7.5 mg CC-223 on Day -1, then daily dosing of 7.5 mg CC-223 for 28 days beginning on Day 1. Participants received subsequent cycles consisting of 28-day continuous dosing without rest between cycles for as long as they derived benefit from treatment as judged by the investigator.","id":"EG000","otherNumAffected":1,"otherNumAtRisk":1,"seriousNumAffected":0,"seriousNumAtRisk":1,"title":"Part A: CC-223 7.5 mg"},{"deathsNumAffected":0,"deathsNumAtRisk":2,"description":"Participants received a single dose of 15 mg CC-223 on Day -1, then daily dosing of 15 mg CC-223 for 28 days beginning on Day 1. Participants received subsequent cycles consisting of 28-day continuous dosing without rest between cycles for as long as they derived benefit from treatment as judged by the investigator.","id":"EG001","otherNumAffected":2,"otherNumAtRisk":2,"seriousNumAffected":0,"seriousNumAtRisk":2,"title":"Part A: CC-223 15 mg"},{"deathsNumAffected":2,"deathsNumAtRisk":9,"description":"Participants received a single dose of 30 mg CC-223 on Day -1, then daily dosing of 30 mg CC-223 for 28 days beginning on Day 1. Participants received subsequent cycles consisting of 28-day continuous dosing without rest between cycles for as long as they derived benefit from treatment as judged by the investigator.","id":"EG002","otherNumAffected":8,"otherNumAtRisk":9,"seriousNumAffected":4,"seriousNumAtRisk":9,"title":"Part A: CC-223 30 mg"},{"deathsNumAffected":3,"deathsNumAtRisk":9,"description":"Participants received a single dose of 45 mg CC-223 on Day -1, then daily dosing of 45 mg CC-223 for 28 days beginning on Day 1. Participants received subsequent cycles consisting of 28-day continuous dosing without rest between cycles for as long as they derived benefit from treatment as judged by the investigator.","id":"EG003","otherNumAffected":9,"otherNumAtRisk":9,"seriousNumAffected":4,"seriousNumAtRisk":9,"title":"Part A: CC-223 45 mg"},{"deathsNumAffected":1,"deathsNumAtRisk":7,"description":"Participants received a single dose of 60 mg CC-223 on Day -1, then daily dosing of 60 mg CC-223 for 28 days beginning on Day 1. Participants received subsequent cycles consisting of 28-day continuous dosing without rest between cycles for as long as they derived benefit from treatment as judged by the investigator.","id":"EG004","otherNumAffected":7,"otherNumAtRisk":7,"seriousNumAffected":2,"seriousNumAtRisk":7,"title":"Part A: CC-223 60 mg"},{"deathsNumAffected":10,"deathsNumAtRisk":26,"description":"Participants with NSCLC received CC-223 at a starting dose of 45 mg/day (reduced to 30 mg/day after protocol Amendment 9) orally once a day in 28-day cycles for as long as they derived benefit from treatment as judged by the investigator.","id":"EG005","otherNumAffected":26,"otherNumAtRisk":26,"seriousNumAffected":15,"seriousNumAtRisk":26,"title":"Part B: Non-small Cell Lung Cancer (NSCLC)"},{"deathsNumAffected":3,"deathsNumAtRisk":13,"description":"Participants with GBM received CC-223 at a starting dose of 45 mg/day (reduced to 30 mg/day after protocol Amendment 9) orally once a day in 28-day cycles for as long as they derived benefit from treatment as judged by the investigator.","id":"EG006","otherNumAffected":13,"otherNumAtRisk":13,"seriousNumAffected":6,"seriousNumAtRisk":13,"title":"Part B: Glioblastoma Multiforme (GBM)"},{"deathsNumAffected":24,"deathsNumAtRisk":53,"description":"Participants with HCC received CC-223 at a starting dose of 45 mg/day (reduced to 30 mg/day after protocol Amendment 9) orally once a day in 28-day cycles for as long as they derived benefit from treatment as judged by the investigator.","id":"EG007","otherNumAffected":53,"otherNumAtRisk":53,"seriousNumAffected":29,"seriousNumAtRisk":53,"title":"Part B: Hepatocellular Carcinoma (HCC)"},{"deathsNumAffected":2,"deathsNumAtRisk":47,"description":"Participants with NET received CC-223 at a starting dose of 45 mg/day (reduced to 30 mg/day after protocol Amendment 9) orally once a day in 28-day cycles for as long as they derived benefit from treatment as judged by the investigator.","id":"EG008","otherNumAffected":47,"otherNumAtRisk":47,"seriousNumAffected":23,"seriousNumAtRisk":47,"title":"Part B: Neuroendocrine Tumor (NET)"},{"deathsNumAffected":5,"deathsNumAtRisk":28,"description":"Participants with DLBCL received CC-223 at a starting dose of 45 mg/day (reduced to 30 mg/day after protocol Amendment 9) orally once a day in 28-day cycles for as long as they derived benefit from treatment as judged by the investigator.","id":"EG009","otherNumAffected":28,"otherNumAtRisk":28,"seriousNumAffected":17,"seriousNumAtRisk":28,"title":"Part B: Diffuse Large B-cell Lymphoma (DLBCL)"},{"deathsNumAffected":2,"deathsNumAtRisk":14,"description":"Participants with MM received CC-223 at a starting dose of 45 mg/day (reduced to 30 mg/day after protocol Amendment 9) orally once a day in 28-day cycles for as long as they derived benefit from treatment as judged by the investigator.","id":"EG010","otherNumAffected":14,"otherNumAtRisk":14,"seriousNumAffected":6,"seriousNumAtRisk":14,"title":"Part B: Multiple Myeloma (MM)"},{"deathsNumAffected":4,"deathsNumAtRisk":17,"description":"Participants with HRPBC received CC-223 at a starting dose of 45 mg/day (reduced to 30 mg/day after protocol Amendment 9) orally once a day in 28-day cycles for as long as they derived benefit from treatment as judged by the investigator.","id":"EG011","otherNumAffected":17,"otherNumAtRisk":17,"seriousNumAffected":11,"seriousNumAtRisk":17,"title":"Part B: Hormone Receptor Positive Breast Cancer (HRPBC)"}],"frequencyThreshold":"5","otherEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":8,"numAtRisk":26,"numEvents":12},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":5,"numAtRisk":53,"numEvents":5},{"groupId":"EG008","numAffected":3,"numAtRisk":47,"numEvents":3},{"groupId":"EG009","numAffected":8,"numAtRisk":28,"numEvents":9},{"groupId":"EG010","numAffected":7,"numAtRisk":14,"numEvents":24},{"groupId":"EG011","numAffected":5,"numAtRisk":17,"numEvents":10}],"term":"Anaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":26,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":53,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":1,"numAtRisk":14,"numEvents":1},{"groupId":"EG011","numAffected":0,"numAtRisk":17,"numEvents":0}],"term":"Eosinophilia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":2,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":26,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":53,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG011","numAffected":0,"numAtRisk":17,"numEvents":0}],"term":"Iron deficiency anaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":26,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":3,"numAtRisk":53,"numEvents":3},{"groupId":"EG008","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG011","numAffected":1,"numAtRisk":17,"numEvents":1}],"term":"Leukocytosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":26,"numEvents":0},{"groupId":"EG006","numAffected":3,"numAtRisk":13,"numEvents":6},{"groupId":"EG007","numAffected":0,"numAtRisk":53,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG011","numAffected":0,"numAtRisk":17,"numEvents":0}],"term":"Leukopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":26,"numEvents":0},{"groupId":"EG006","numAffected":2,"numAtRisk":13,"numEvents":4},{"groupId":"EG007","numAffected":0,"numAtRisk":53,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG011","numAffected":2,"numAtRisk":17,"numEvents":2}],"term":"Lymphopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":26,"numEvents":0},{"groupId":"EG006","numAffected":3,"numAtRisk":13,"numEvents":5},{"groupId":"EG007","numAffected":0,"numAtRisk":53,"numEvents":0},{"groupId":"EG008","numAffected":3,"numAtRisk":47,"numEvents":8},{"groupId":"EG009","numAffected":6,"numAtRisk":28,"numEvents":12},{"groupId":"EG010","numAffected":4,"numAtRisk":14,"numEvents":18},{"groupId":"EG011","numAffected":3,"numAtRisk":17,"numEvents":9}],"term":"Neutropenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":9,"numEvents":1},{"groupId":"EG003","numAffected":2,"numAtRisk":9,"numEvents":3},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":4,"numAtRisk":26,"numEvents":7},{"groupId":"EG006","numAffected":2,"numAtRisk":13,"numEvents":2},{"groupId":"EG007","numAffected":16,"numAtRisk":53,"numEvents":30},{"groupId":"EG008","numAffected":5,"numAtRisk":47,"numEvents":14},{"groupId":"EG009","numAffected":11,"numAtRisk":28,"numEvents":23},{"groupId":"EG010","numAffected":7,"numAtRisk":14,"numEvents":29},{"groupId":"EG011","numAffected":6,"numAtRisk":17,"numEvents":9}],"term":"Thrombocytopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":9,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":26,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":53,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG011","numAffected":0,"numAtRisk":17,"numEvents":0}],"term":"Angina pectoris"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":2,"numAtRisk":26,"numEvents":2},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":53,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG011","numAffected":0,"numAtRisk":17,"numEvents":0}],"term":"Atrial fibrillation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":26,"numEvents":0},{"groupId":"EG006","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG007","numAffected":0,"numAtRisk":53,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG011","numAffected":0,"numAtRisk":17,"numEvents":0}],"term":"Cardiomyopathy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":2,"numAtRisk":26,"numEvents":4},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":53,"numEvents":0},{"groupId":"EG008","numAffected":3,"numAtRisk":47,"numEvents":4},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG011","numAffected":0,"numAtRisk":17,"numEvents":0}],"term":"Palpitations"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":26,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":53,"numEvents":0},{"groupId":"EG008","numAffected":3,"numAtRisk":47,"numEvents":3},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG011","numAffected":0,"numAtRisk":17,"numEvents":0}],"term":"Pericardial effusion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":26,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":53,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG011","numAffected":1,"numAtRisk":17,"numEvents":1}],"term":"Tachycardia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":26,"numEvents":0},{"groupId":"EG006","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG007","numAffected":0,"numAtRisk":53,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG011","numAffected":0,"numAtRisk":17,"numEvents":0}],"term":"Ventricular arrhythmia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":26,"numEvents":0},{"groupId":"EG006","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG007","numAffected":0,"numAtRisk":53,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG011","numAffected":0,"numAtRisk":17,"numEvents":0}],"term":"Ventricular extrasystoles"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":26,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":53,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG011","numAffected":1,"numAtRisk":17,"numEvents":1}],"term":"Ventricular tachycardia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Ear and labyrinth disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":26,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":53,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG011","numAffected":1,"numAtRisk":17,"numEvents":1}],"term":"Cerumen impaction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Ear and labyrinth disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":2,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":26,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":53,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG011","numAffected":0,"numAtRisk":17,"numEvents":0}],"term":"Deafness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Ear and labyrinth disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":26,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":53,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":2,"numAtRisk":14,"numEvents":2},{"groupId":"EG011","numAffected":0,"numAtRisk":17,"numEvents":0}],"term":"Vertigo"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Endocrine disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":26,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":53,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG011","numAffected":2,"numAtRisk":17,"numEvents":2}],"term":"Adrenal insufficiency"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Endocrine disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":26,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":53,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG011","numAffected":1,"numAtRisk":17,"numEvents":1}],"term":"Goitre"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Endocrine disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":9,"numEvents":1},{"groupId":"EG003","numAffected":1,"numAtRisk":9,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":26,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":53,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG011","numAffected":1,"numAtRisk":17,"numEvents":1}],"term":"Hyperthyroidism"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":9,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":26,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":53,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG011","numAffected":0,"numAtRisk":17,"numEvents":0}],"term":"Blindness unilateral"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":26,"numEvents":0},{"groupId":"EG006","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG007","numAffected":0,"numAtRisk":53,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG011","numAffected":0,"numAtRisk":17,"numEvents":0}],"term":"Eye haemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":9,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":26,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":53,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG011","numAffected":0,"numAtRisk":17,"numEvents":0}],"term":"Eye pruritus"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":26,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":53,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG011","numAffected":1,"numAtRisk":17,"numEvents":1}],"term":"Eyelid oedema"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":7,"numEvents":1},{"groupId":"EG005","numAffected":2,"numAtRisk":26,"numEvents":2},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":53,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG011","numAffected":0,"numAtRisk":17,"numEvents":0}],"term":"Periorbital oedema"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":26,"numEvents":0},{"groupId":"EG006","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG007","numAffected":0,"numAtRisk":53,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG011","numAffected":0,"numAtRisk":17,"numEvents":0}],"term":"Scintillating scotoma"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":9,"numEvents":2},{"groupId":"EG003","numAffected":1,"numAtRisk":9,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":26,"numEvents":0},{"groupId":"EG006","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG007","numAffected":5,"numAtRisk":53,"numEvents":5},{"groupId":"EG008","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":1,"numAtRisk":14,"numEvents":1},{"groupId":"EG011","numAffected":0,"numAtRisk":17,"numEvents":0}],"term":"Vision blurred"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":26,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":53,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG011","numAffected":1,"numAtRisk":17,"numEvents":1}],"term":"Visual acuity reduced"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":26,"numEvents":0},{"groupId":"EG006","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG007","numAffected":0,"numAtRisk":53,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":1,"numAtRisk":14,"numEvents":1},{"groupId":"EG011","numAffected":0,"numAtRisk":17,"numEvents":0}],"term":"Visual impairment"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":26,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":4,"numAtRisk":53,"numEvents":4},{"groupId":"EG008","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG011","numAffected":1,"numAtRisk":17,"numEvents":1}],"term":"Abdominal discomfort"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":26,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":5,"numAtRisk":53,"numEvents":5},{"groupId":"EG008","numAffected":4,"numAtRisk":47,"numEvents":4},{"groupId":"EG009","numAffected":2,"numAtRisk":28,"numEvents":3},{"groupId":"EG010","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG011","numAffected":1,"numAtRisk":17,"numEvents":1}],"term":"Abdominal distension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":26,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":53,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":1,"numAtRisk":14,"numEvents":1},{"groupId":"EG011","numAffected":0,"numAtRisk":17,"numEvents":0}],"term":"Abdominal hernia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":2,"numAtRisk":7,"numEvents":3},{"groupId":"EG005","numAffected":3,"numAtRisk":26,"numEvents":3},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":14,"numAtRisk":53,"numEvents":20},{"groupId":"EG008","numAffected":15,"numAtRisk":47,"numEvents":24},{"groupId":"EG009","numAffected":5,"numAtRisk":28,"numEvents":8},{"groupId":"EG010","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG011","numAffected":3,"numAtRisk":17,"numEvents":5}],"term":"Abdominal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":9,"numEvents":1},{"groupId":"EG003","numAffected":1,"numAtRisk":9,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":3,"numAtRisk":26,"numEvents":3},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":5,"numAtRisk":53,"numEvents":5},{"groupId":"EG008","numAffected":7,"numAtRisk":47,"numEvents":7},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG011","numAffected":1,"numAtRisk":17,"numEvents":1}],"term":"Abdominal pain upper"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":26,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":53,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG011","numAffected":1,"numAtRisk":17,"numEvents":1}],"term":"Abdominal rigidity"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":26,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":53,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":4,"numAtRisk":14,"numEvents":5},{"groupId":"EG011","numAffected":3,"numAtRisk":17,"numEvents":5}],"term":"Aphthous ulcer"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":26,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":3,"numAtRisk":53,"numEvents":3},{"groupId":"EG008","numAffected":5,"numAtRisk":47,"numEvents":9},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG011","numAffected":2,"numAtRisk":17,"numEvents":4}],"term":"Ascites"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":9,"numEvents":1},{"groupId":"EG004","numAffected":2,"numAtRisk":7,"numEvents":2},{"groupId":"EG005","numAffected":9,"numAtRisk":26,"numEvents":10},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":12,"numAtRisk":53,"numEvents":13},{"groupId":"EG008","numAffected":9,"numAtRisk":47,"numEvents":10},{"groupId":"EG009","numAffected":8,"numAtRisk":28,"numEvents":10},{"groupId":"EG010","numAffected":3,"numAtRisk":14,"numEvents":3},{"groupId":"EG011","numAffected":5,"numAtRisk":17,"numEvents":5}],"term":"Constipation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":2,"numEvents":1},{"groupId":"EG002","numAffected":4,"numAtRisk":9,"numEvents":4},{"groupId":"EG003","numAffected":5,"numAtRisk":9,"numEvents":5},{"groupId":"EG004","numAffected":5,"numAtRisk":7,"numEvents":6},{"groupId":"EG005","numAffected":16,"numAtRisk":26,"numEvents":41},{"groupId":"EG006","numAffected":5,"numAtRisk":13,"numEvents":6},{"groupId":"EG007","numAffected":32,"numAtRisk":53,"numEvents":55},{"groupId":"EG008","numAffected":36,"numAtRisk":47,"numEvents":138},{"groupId":"EG009","numAffected":17,"numAtRisk":28,"numEvents":29},{"groupId":"EG010","numAffected":7,"numAtRisk":14,"numEvents":9},{"groupId":"EG011","numAffected":11,"numAtRisk":17,"numEvents":21}],"term":"Diarrhoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":9,"numEvents":1},{"groupId":"EG003","numAffected":2,"numAtRisk":9,"numEvents":2},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":5,"numAtRisk":26,"numEvents":5},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":4,"numAtRisk":53,"numEvents":4},{"groupId":"EG008","numAffected":9,"numAtRisk":47,"numEvents":10},{"groupId":"EG009","numAffected":4,"numAtRisk":28,"numEvents":5},{"groupId":"EG010","numAffected":3,"numAtRisk":14,"numEvents":3},{"groupId":"EG011","numAffected":1,"numAtRisk":17,"numEvents":1}],"term":"Dry mouth"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":3,"numAtRisk":26,"numEvents":3},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":53,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":1,"numAtRisk":14,"numEvents":1},{"groupId":"EG011","numAffected":1,"numAtRisk":17,"numEvents":1}],"term":"Dyspepsia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":5,"numAtRisk":26,"numEvents":8},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":4,"numAtRisk":53,"numEvents":4},{"groupId":"EG008","numAffected":3,"numAtRisk":47,"numEvents":3},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG011","numAffected":2,"numAtRisk":17,"numEvents":3}],"term":"Dysphagia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":9,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":26,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":4,"numAtRisk":53,"numEvents":4},{"groupId":"EG008","numAffected":5,"numAtRisk":47,"numEvents":7},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG011","numAffected":0,"numAtRisk":17,"numEvents":0}],"term":"Flatulence"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":2,"numAtRisk":26,"numEvents":2},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":53,"numEvents":0},{"groupId":"EG008","numAffected":5,"numAtRisk":47,"numEvents":5},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG011","numAffected":1,"numAtRisk":17,"numEvents":2}],"term":"Gastrooesophageal reflux disease"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":26,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":53,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG011","numAffected":0,"numAtRisk":17,"numEvents":0}],"term":"Haematochezia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":26,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":53,"numEvents":0},{"groupId":"EG008","numAffected":7,"numAtRisk":47,"numEvents":8},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":1,"numAtRisk":14,"numEvents":1},{"groupId":"EG011","numAffected":3,"numAtRisk":17,"numEvents":3}],"term":"Haemorrhoids"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":9,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":26,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":53,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG011","numAffected":0,"numAtRisk":17,"numEvents":0}],"term":"Lip dry"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":26,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":53,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":1,"numAtRisk":14,"numEvents":1},{"groupId":"EG011","numAffected":0,"numAtRisk":17,"numEvents":0}],"term":"Mouth haemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":3,"numAtRisk":26,"numEvents":3},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":53,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":1,"numAtRisk":14,"numEvents":1},{"groupId":"EG011","numAffected":2,"numAtRisk":17,"numEvents":7}],"term":"Mouth ulceration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":4,"numAtRisk":9,"numEvents":5},{"groupId":"EG003","numAffected":6,"numAtRisk":9,"numEvents":6},{"groupId":"EG004","numAffected":3,"numAtRisk":7,"numEvents":4},{"groupId":"EG005","numAffected":16,"numAtRisk":26,"numEvents":28},{"groupId":"EG006","numAffected":9,"numAtRisk":13,"numEvents":13},{"groupId":"EG007","numAffected":27,"numAtRisk":53,"numEvents":40},{"groupId":"EG008","numAffected":22,"numAtRisk":47,"numEvents":34},{"groupId":"EG009","numAffected":13,"numAtRisk":28,"numEvents":16},{"groupId":"EG010","numAffected":7,"numAtRisk":14,"numEvents":12},{"groupId":"EG011","numAffected":12,"numAtRisk":17,"numEvents":21}],"term":"Nausea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":2,"numAtRisk":26,"numEvents":2},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":3,"numAtRisk":53,"numEvents":3},{"groupId":"EG008","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG011","numAffected":0,"numAtRisk":17,"numEvents":0}],"term":"Odynophagia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":26,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":53,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG011","numAffected":1,"numAtRisk":17,"numEvents":1}],"term":"Oesophagitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":9,"numEvents":1},{"groupId":"EG003","numAffected":1,"numAtRisk":9,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":2,"numAtRisk":26,"numEvents":2},{"groupId":"EG006","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG007","numAffected":0,"numAtRisk":53,"numEvents":0},{"groupId":"EG008","numAffected":3,"numAtRisk":47,"numEvents":4},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG011","numAffected":2,"numAtRisk":17,"numEvents":2}],"term":"Oral pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":26,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":53,"numEvents":0},{"groupId":"EG008","numAffected":6,"numAtRisk":47,"numEvents":7},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":1,"numAtRisk":14,"numEvents":1},{"groupId":"EG011","numAffected":0,"numAtRisk":17,"numEvents":0}],"term":"Proctalgia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":9,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":26,"numEvents":0},{"groupId":"EG006","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG007","numAffected":0,"numAtRisk":53,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG011","numAffected":0,"numAtRisk":17,"numEvents":0}],"term":"Retching"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":26,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":53,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG011","numAffected":1,"numAtRisk":17,"numEvents":1}],"term":"Small intestinal obstruction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":9,"numEvents":1},{"groupId":"EG003","numAffected":1,"numAtRisk":9,"numEvents":2},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":13,"numAtRisk":26,"numEvents":20},{"groupId":"EG006","numAffected":3,"numAtRisk":13,"numEvents":3},{"groupId":"EG007","numAffected":15,"numAtRisk":53,"numEvents":30},{"groupId":"EG008","numAffected":25,"numAtRisk":47,"numEvents":52},{"groupId":"EG009","numAffected":5,"numAtRisk":28,"numEvents":6},{"groupId":"EG010","numAffected":9,"numAtRisk":14,"numEvents":10},{"groupId":"EG011","numAffected":8,"numAtRisk":17,"numEvents":16}],"term":"Stomatitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":26,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":3,"numAtRisk":53,"numEvents":3},{"groupId":"EG008","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG011","numAffected":0,"numAtRisk":17,"numEvents":0}],"term":"Toothache"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":3,"numAtRisk":9,"numEvents":4},{"groupId":"EG003","numAffected":2,"numAtRisk":9,"numEvents":5},{"groupId":"EG004","numAffected":6,"numAtRisk":7,"numEvents":7},{"groupId":"EG005","numAffected":13,"numAtRisk":26,"numEvents":27},{"groupId":"EG006","numAffected":2,"numAtRisk":13,"numEvents":3},{"groupId":"EG007","numAffected":15,"numAtRisk":53,"numEvents":21},{"groupId":"EG008","numAffected":11,"numAtRisk":47,"numEvents":14},{"groupId":"EG009","numAffected":9,"numAtRisk":28,"numEvents":11},{"groupId":"EG010","numAffected":8,"numAtRisk":14,"numEvents":11},{"groupId":"EG011","numAffected":8,"numAtRisk":17,"numEvents":13}],"term":"Vomiting"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":2,"numAtRisk":2,"numEvents":2},{"groupId":"EG002","numAffected":3,"numAtRisk":9,"numEvents":3},{"groupId":"EG003","numAffected":1,"numAtRisk":9,"numEvents":1},{"groupId":"EG004","numAffected":3,"numAtRisk":7,"numEvents":3},{"groupId":"EG005","numAffected":15,"numAtRisk":26,"numEvents":37},{"groupId":"EG006","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG007","numAffected":14,"numAtRisk":53,"numEvents":23},{"groupId":"EG008","numAffected":18,"numAtRisk":47,"numEvents":31},{"groupId":"EG009","numAffected":7,"numAtRisk":28,"numEvents":10},{"groupId":"EG010","numAffected":8,"numAtRisk":14,"numEvents":13},{"groupId":"EG011","numAffected":5,"numAtRisk":17,"numEvents":14}],"term":"Asthenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":7,"numEvents":1},{"groupId":"EG005","numAffected":0,"numAtRisk":26,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":53,"numEvents":0},{"groupId":"EG008","numAffected":3,"numAtRisk":47,"numEvents":3},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG011","numAffected":0,"numAtRisk":17,"numEvents":0}],"term":"Chest discomfort"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":26,"numEvents":0},{"groupId":"EG006","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG007","numAffected":0,"numAtRisk":53,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG011","numAffected":0,"numAtRisk":17,"numEvents":0}],"term":"Chest pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":9,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":5,"numAtRisk":26,"numEvents":6},{"groupId":"EG006","numAffected":2,"numAtRisk":13,"numEvents":2},{"groupId":"EG007","numAffected":6,"numAtRisk":53,"numEvents":7},{"groupId":"EG008","numAffected":5,"numAtRisk":47,"numEvents":7},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG011","numAffected":1,"numAtRisk":17,"numEvents":1}],"term":"Chills"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":26,"numEvents":0},{"groupId":"EG006","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG007","numAffected":0,"numAtRisk":53,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG011","numAffected":0,"numAtRisk":17,"numEvents":0}],"term":"Discomfort"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":2,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":26,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":3,"numAtRisk":53,"numEvents":3},{"groupId":"EG008","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG011","numAffected":0,"numAtRisk":17,"numEvents":0}],"term":"Face oedema"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":2,"numEvents":2},{"groupId":"EG002","numAffected":4,"numAtRisk":9,"numEvents":7},{"groupId":"EG003","numAffected":6,"numAtRisk":9,"numEvents":8},{"groupId":"EG004","numAffected":7,"numAtRisk":7,"numEvents":10},{"groupId":"EG005","numAffected":17,"numAtRisk":26,"numEvents":38},{"groupId":"EG006","numAffected":4,"numAtRisk":13,"numEvents":7},{"groupId":"EG007","numAffected":32,"numAtRisk":53,"numEvents":63},{"groupId":"EG008","numAffected":33,"numAtRisk":47,"numEvents":68},{"groupId":"EG009","numAffected":11,"numAtRisk":28,"numEvents":17},{"groupId":"EG010","numAffected":2,"numAtRisk":14,"numEvents":2},{"groupId":"EG011","numAffected":8,"numAtRisk":17,"numEvents":25}],"term":"Fatigue"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":26,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":53,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG011","numAffected":1,"numAtRisk":17,"numEvents":1}],"term":"Feeling cold"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":7,"numEvents":1},{"groupId":"EG005","numAffected":0,"numAtRisk":26,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":53,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG011","numAffected":0,"numAtRisk":17,"numEvents":0}],"term":"Feeling jittery"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":26,"numEvents":0},{"groupId":"EG006","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG007","numAffected":0,"numAtRisk":53,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG011","numAffected":0,"numAtRisk":17,"numEvents":0}],"term":"Gait disturbance"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":2,"numAtRisk":7,"numEvents":2},{"groupId":"EG005","numAffected":0,"numAtRisk":26,"numEvents":0},{"groupId":"EG006","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG007","numAffected":0,"numAtRisk":53,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG011","numAffected":1,"numAtRisk":17,"numEvents":1}],"term":"Influenza like illness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":3,"numAtRisk":26,"numEvents":5},{"groupId":"EG006","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG007","numAffected":0,"numAtRisk":53,"numEvents":0},{"groupId":"EG008","numAffected":10,"numAtRisk":47,"numEvents":10},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG011","numAffected":1,"numAtRisk":17,"numEvents":1}],"term":"Malaise"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":26,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":53,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG011","numAffected":1,"numAtRisk":17,"numEvents":1}],"term":"Medical device pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":2,"numEvents":1},{"groupId":"EG002","numAffected":2,"numAtRisk":9,"numEvents":3},{"groupId":"EG003","numAffected":3,"numAtRisk":9,"numEvents":4},{"groupId":"EG004","numAffected":5,"numAtRisk":7,"numEvents":9},{"groupId":"EG005","numAffected":0,"numAtRisk":26,"numEvents":0},{"groupId":"EG006","numAffected":1,"numAtRisk":13,"numEvents":4},{"groupId":"EG007","numAffected":7,"numAtRisk":53,"numEvents":11},{"groupId":"EG008","numAffected":6,"numAtRisk":47,"numEvents":12},{"groupId":"EG009","numAffected":4,"numAtRisk":28,"numEvents":4},{"groupId":"EG010","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG011","numAffected":4,"numAtRisk":17,"numEvents":8}],"term":"Mucosal inflammation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":26,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":5,"numAtRisk":53,"numEvents":5},{"groupId":"EG008","numAffected":5,"numAtRisk":47,"numEvents":7},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":1,"numAtRisk":14,"numEvents":1},{"groupId":"EG011","numAffected":2,"numAtRisk":17,"numEvents":2}],"term":"Non-cardiac chest pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":7,"numEvents":1},{"groupId":"EG005","numAffected":0,"numAtRisk":26,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":53,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG011","numAffected":0,"numAtRisk":17,"numEvents":0}],"term":"Oedema"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":3,"numAtRisk":9,"numEvents":4},{"groupId":"EG003","numAffected":1,"numAtRisk":9,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":5,"numAtRisk":26,"numEvents":6},{"groupId":"EG006","numAffected":2,"numAtRisk":13,"numEvents":4},{"groupId":"EG007","numAffected":11,"numAtRisk":53,"numEvents":14},{"groupId":"EG008","numAffected":14,"numAtRisk":47,"numEvents":30},{"groupId":"EG009","numAffected":2,"numAtRisk":28,"numEvents":2},{"groupId":"EG010","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG011","numAffected":3,"numAtRisk":17,"numEvents":4}],"term":"Oedema peripheral"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":2,"numAtRisk":26,"numEvents":2},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":53,"numEvents":0},{"groupId":"EG008","numAffected":3,"numAtRisk":47,"numEvents":3},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG011","numAffected":0,"numAtRisk":17,"numEvents":0}],"term":"Pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":26,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":53,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG011","numAffected":1,"numAtRisk":17,"numEvents":1}],"term":"Peripheral swelling"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":2,"numEvents":1},{"groupId":"EG002","numAffected":1,"numAtRisk":9,"numEvents":1},{"groupId":"EG003","numAffected":3,"numAtRisk":9,"numEvents":4},{"groupId":"EG004","numAffected":4,"numAtRisk":7,"numEvents":6},{"groupId":"EG005","numAffected":5,"numAtRisk":26,"numEvents":9},{"groupId":"EG006","numAffected":4,"numAtRisk":13,"numEvents":4},{"groupId":"EG007","numAffected":13,"numAtRisk":53,"numEvents":18},{"groupId":"EG008","numAffected":8,"numAtRisk":47,"numEvents":14},{"groupId":"EG009","numAffected":3,"numAtRisk":28,"numEvents":3},{"groupId":"EG010","numAffected":1,"numAtRisk":14,"numEvents":1},{"groupId":"EG011","numAffected":2,"numAtRisk":17,"numEvents":3}],"term":"Pyrexia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":26,"numEvents":0},{"groupId":"EG006","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG007","numAffected":0,"numAtRisk":53,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG011","numAffected":0,"numAtRisk":17,"numEvents":0}],"term":"Thirst decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":26,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":53,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":1,"numAtRisk":14,"numEvents":1},{"groupId":"EG011","numAffected":0,"numAtRisk":17,"numEvents":0}],"term":"Xerosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":26,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":6,"numAtRisk":53,"numEvents":11},{"groupId":"EG008","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG011","numAffected":0,"numAtRisk":17,"numEvents":0}],"term":"Hyperbilirubinaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Immune system disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":26,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":53,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG011","numAffected":1,"numAtRisk":17,"numEvents":1}],"term":"Drug hypersensitivity"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Immune system disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":7,"numEvents":1},{"groupId":"EG005","numAffected":0,"numAtRisk":26,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":53,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG011","numAffected":0,"numAtRisk":17,"numEvents":0}],"term":"Hypersensitivity"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":26,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":53,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":1,"numAtRisk":14,"numEvents":1},{"groupId":"EG011","numAffected":0,"numAtRisk":17,"numEvents":0}],"term":"Angular cheilitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":26,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":53,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG011","numAffected":1,"numAtRisk":17,"numEvents":1}],"term":"Candida infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":9,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":26,"numEvents":0},{"groupId":"EG006","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG007","numAffected":0,"numAtRisk":53,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":1,"numAtRisk":14,"numEvents":1},{"groupId":"EG011","numAffected":1,"numAtRisk":17,"numEvents":1}],"term":"Cellulitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":26,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":53,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG009","numAffected":2,"numAtRisk":28,"numEvents":2},{"groupId":"EG010","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG011","numAffected":0,"numAtRisk":17,"numEvents":0}],"term":"Conjunctivitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":26,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":53,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":1,"numAtRisk":14,"numEvents":1},{"groupId":"EG011","numAffected":1,"numAtRisk":17,"numEvents":1}],"term":"Cystitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":9,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":26,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":53,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG011","numAffected":0,"numAtRisk":17,"numEvents":0}],"term":"Ear infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":26,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":53,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG011","numAffected":1,"numAtRisk":17,"numEvents":1}],"term":"Escherichia urinary tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":26,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":53,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG011","numAffected":1,"numAtRisk":17,"numEvents":1}],"term":"Eyelid infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":26,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":53,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG009","numAffected":2,"numAtRisk":28,"numEvents":3},{"groupId":"EG010","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG011","numAffected":0,"numAtRisk":17,"numEvents":0}],"term":"Folliculitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":2,"numEvents":1},{"groupId":"EG002","numAffected":1,"numAtRisk":9,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":26,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":53,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG011","numAffected":0,"numAtRisk":17,"numEvents":0}],"term":"Fungal infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":26,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":53,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG011","numAffected":1,"numAtRisk":17,"numEvents":3}],"term":"Fungal skin infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":2,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":26,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":53,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG011","numAffected":0,"numAtRisk":17,"numEvents":0}],"term":"Incision site infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":26,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":53,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":1,"numAtRisk":14,"numEvents":1},{"groupId":"EG011","numAffected":0,"numAtRisk":17,"numEvents":0}],"term":"Influenza"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":26,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":53,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG011","numAffected":1,"numAtRisk":17,"numEvents":1}],"term":"Klebsiella infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":26,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":53,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG011","numAffected":1,"numAtRisk":17,"numEvents":1}],"term":"Lower respiratory tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":26,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":53,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":1,"numAtRisk":14,"numEvents":1},{"groupId":"EG011","numAffected":0,"numAtRisk":17,"numEvents":0}],"term":"Oral fungal infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":2,"numAtRisk":26,"numEvents":4},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":53,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG011","numAffected":0,"numAtRisk":17,"numEvents":0}],"term":"Paronychia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":26,"numEvents":0},{"groupId":"EG006","numAffected":1,"numAtRisk":13,"numEvents":2},{"groupId":"EG007","numAffected":0,"numAtRisk":53,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG011","numAffected":0,"numAtRisk":17,"numEvents":0}],"term":"Perineal abscess"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":26,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":53,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":1,"numAtRisk":14,"numEvents":1},{"groupId":"EG011","numAffected":0,"numAtRisk":17,"numEvents":0}],"term":"Pharyngitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":26,"numEvents":0},{"groupId":"EG006","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG007","numAffected":0,"numAtRisk":53,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG011","numAffected":0,"numAtRisk":17,"numEvents":0}],"term":"Pneumonia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":3,"numAtRisk":26,"numEvents":3},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":53,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":1,"numAtRisk":14,"numEvents":1},{"groupId":"EG011","numAffected":0,"numAtRisk":17,"numEvents":0}],"term":"Rhinitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":9,"numEvents":2},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":26,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":53,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG011","numAffected":0,"numAtRisk":17,"numEvents":0}],"term":"Sinusitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":26,"numEvents":0},{"groupId":"EG006","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG007","numAffected":0,"numAtRisk":53,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG011","numAffected":0,"numAtRisk":17,"numEvents":0}],"term":"Skin infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":26,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":53,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":1,"numAtRisk":14,"numEvents":1},{"groupId":"EG011","numAffected":0,"numAtRisk":17,"numEvents":0}],"term":"Tooth abscess"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":26,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":53,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG011","numAffected":1,"numAtRisk":17,"numEvents":2}],"term":"Tooth infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":9,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":26,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":53,"numEvents":0},{"groupId":"EG008","numAffected":7,"numAtRisk":47,"numEvents":8},{"groupId":"EG009","numAffected":3,"numAtRisk":28,"numEvents":4},{"groupId":"EG010","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG011","numAffected":1,"numAtRisk":17,"numEvents":1}],"term":"Upper respiratory tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":2,"numEvents":2},{"groupId":"EG002","numAffected":1,"numAtRisk":9,"numEvents":1},{"groupId":"EG003","numAffected":1,"numAtRisk":9,"numEvents":1},{"groupId":"EG004","numAffected":1,"numAtRisk":7,"numEvents":1},{"groupId":"EG005","numAffected":3,"numAtRisk":26,"numEvents":3},{"groupId":"EG006","numAffected":2,"numAtRisk":13,"numEvents":2},{"groupId":"EG007","numAffected":7,"numAtRisk":53,"numEvents":10},{"groupId":"EG008","numAffected":9,"numAtRisk":47,"numEvents":16},{"groupId":"EG009","numAffected":2,"numAtRisk":28,"numEvents":2},{"groupId":"EG010","numAffected":1,"numAtRisk":14,"numEvents":1},{"groupId":"EG011","numAffected":3,"numAtRisk":17,"numEvents":3}],"term":"Urinary tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":26,"numEvents":0},{"groupId":"EG006","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG007","numAffected":0,"numAtRisk":53,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG011","numAffected":0,"numAtRisk":17,"numEvents":0}],"term":"Excoriation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":2,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":26,"numEvents":0},{"groupId":"EG006","numAffected":3,"numAtRisk":13,"numEvents":3},{"groupId":"EG007","numAffected":0,"numAtRisk":53,"numEvents":0},{"groupId":"EG008","numAffected":4,"numAtRisk":47,"numEvents":7},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG011","numAffected":0,"numAtRisk":17,"numEvents":0}],"term":"Fall"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":26,"numEvents":0},{"groupId":"EG006","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG007","numAffected":0,"numAtRisk":53,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG011","numAffected":0,"numAtRisk":17,"numEvents":0}],"term":"Incision site pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":26,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":53,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":1,"numAtRisk":14,"numEvents":1},{"groupId":"EG011","numAffected":2,"numAtRisk":17,"numEvents":2}],"term":"Overdose"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":26,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":53,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG011","numAffected":1,"numAtRisk":17,"numEvents":1}],"term":"Post procedural haematoma"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":2,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":26,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":53,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG011","numAffected":0,"numAtRisk":17,"numEvents":0}],"term":"Post procedural swelling"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":26,"numEvents":0},{"groupId":"EG006","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG007","numAffected":3,"numAtRisk":53,"numEvents":3},{"groupId":"EG008","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG011","numAffected":0,"numAtRisk":17,"numEvents":0}],"term":"Procedural pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":26,"numEvents":0},{"groupId":"EG006","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG007","numAffected":0,"numAtRisk":53,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG011","numAffected":0,"numAtRisk":17,"numEvents":0}],"term":"Scar"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":9,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":26,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":53,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG011","numAffected":0,"numAtRisk":17,"numEvents":0}],"term":"Traumatic fracture"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":26,"numEvents":0},{"groupId":"EG006","numAffected":2,"numAtRisk":13,"numEvents":2},{"groupId":"EG007","numAffected":0,"numAtRisk":53,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG011","numAffected":0,"numAtRisk":17,"numEvents":0}],"term":"Wound complication"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":26,"numEvents":0},{"groupId":"EG006","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG007","numAffected":0,"numAtRisk":53,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG011","numAffected":0,"numAtRisk":17,"numEvents":0}],"term":"Wound dehiscence"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":2,"numAtRisk":26,"numEvents":2},{"groupId":"EG006","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG007","numAffected":16,"numAtRisk":53,"numEvents":22},{"groupId":"EG008","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG011","numAffected":1,"numAtRisk":17,"numEvents":2}],"term":"Alanine aminotransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":26,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":3,"numAtRisk":53,"numEvents":4},{"groupId":"EG008","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG011","numAffected":0,"numAtRisk":17,"numEvents":0}],"term":"Ammonia increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":26,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":53,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":1,"numAtRisk":14,"numEvents":1},{"groupId":"EG011","numAffected":0,"numAtRisk":17,"numEvents":0}],"term":"Amylase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":3,"numAtRisk":26,"numEvents":3},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":23,"numAtRisk":53,"numEvents":46},{"groupId":"EG008","numAffected":5,"numAtRisk":47,"numEvents":9},{"groupId":"EG009","numAffected":2,"numAtRisk":28,"numEvents":3},{"groupId":"EG010","numAffected":2,"numAtRisk":14,"numEvents":2},{"groupId":"EG011","numAffected":2,"numAtRisk":17,"numEvents":3}],"term":"Aspartate aminotransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":3,"numAtRisk":26,"numEvents":3},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":12,"numAtRisk":53,"numEvents":23},{"groupId":"EG008","numAffected":3,"numAtRisk":47,"numEvents":7},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG011","numAffected":1,"numAtRisk":17,"numEvents":1}],"term":"Blood alkaline phosphatase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":26,"numEvents":0},{"groupId":"EG006","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG007","numAffected":6,"numAtRisk":53,"numEvents":12},{"groupId":"EG008","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":1,"numAtRisk":14,"numEvents":2},{"groupId":"EG011","numAffected":0,"numAtRisk":17,"numEvents":0}],"term":"Blood bilirubin increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":9,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":26,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":53,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG011","numAffected":0,"numAtRisk":17,"numEvents":0}],"term":"Blood cholesterol increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":7,"numEvents":1},{"groupId":"EG005","numAffected":2,"numAtRisk":26,"numEvents":4},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":3,"numAtRisk":53,"numEvents":6},{"groupId":"EG008","numAffected":3,"numAtRisk":47,"numEvents":6},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":3,"numAtRisk":14,"numEvents":11},{"groupId":"EG011","numAffected":3,"numAtRisk":17,"numEvents":4}],"term":"Blood creatine phosphokinase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":9,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":9,"numAtRisk":26,"numEvents":22},{"groupId":"EG006","numAffected":1,"numAtRisk":13,"numEvents":2},{"groupId":"EG007","numAffected":12,"numAtRisk":53,"numEvents":35},{"groupId":"EG008","numAffected":12,"numAtRisk":47,"numEvents":22},{"groupId":"EG009","numAffected":5,"numAtRisk":28,"numEvents":7},{"groupId":"EG010","numAffected":6,"numAtRisk":14,"numEvents":12},{"groupId":"EG011","numAffected":3,"numAtRisk":17,"numEvents":7}],"term":"Blood creatinine increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":9,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":26,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":53,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG009","numAffected":2,"numAtRisk":28,"numEvents":2},{"groupId":"EG010","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG011","numAffected":0,"numAtRisk":17,"numEvents":0}],"term":"Blood lactate dehydrogenase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":9,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":26,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":53,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG011","numAffected":0,"numAtRisk":17,"numEvents":0}],"term":"Blood thyroid stimulating hormone decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":2,"numAtRisk":26,"numEvents":2},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":53,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG011","numAffected":0,"numAtRisk":17,"numEvents":0}],"term":"Blood thyroid stimulating hormone increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":3,"numAtRisk":26,"numEvents":5},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":4,"numAtRisk":53,"numEvents":6},{"groupId":"EG008","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG011","numAffected":0,"numAtRisk":17,"numEvents":0}],"term":"Blood urea increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":26,"numEvents":0},{"groupId":"EG006","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG007","numAffected":0,"numAtRisk":53,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG011","numAffected":0,"numAtRisk":17,"numEvents":0}],"term":"Breath sounds abnormal"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":26,"numEvents":0},{"groupId":"EG006","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG007","numAffected":0,"numAtRisk":53,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG011","numAffected":0,"numAtRisk":17,"numEvents":0}],"term":"Ejection fraction decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":26,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":53,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG011","numAffected":1,"numAtRisk":17,"numEvents":1}],"term":"Escherichia test positive"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":26,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":3,"numAtRisk":53,"numEvents":3},{"groupId":"EG008","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG011","numAffected":2,"numAtRisk":17,"numEvents":2}],"term":"Gamma-glutamyltransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":2,"numAtRisk":9,"numEvents":2},{"groupId":"EG004","numAffected":2,"numAtRisk":7,"numEvents":2},{"groupId":"EG005","numAffected":2,"numAtRisk":26,"numEvents":2},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":53,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG011","numAffected":0,"numAtRisk":17,"numEvents":0}],"term":"Glycosylated haemoglobin increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":26,"numEvents":0},{"groupId":"EG006","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG007","numAffected":3,"numAtRisk":53,"numEvents":5},{"groupId":"EG008","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":1,"numAtRisk":14,"numEvents":6},{"groupId":"EG011","numAffected":1,"numAtRisk":17,"numEvents":3}],"term":"Lipase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":26,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":53,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG011","numAffected":1,"numAtRisk":17,"numEvents":1}],"term":"Lymphocyte count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":26,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":53,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG011","numAffected":1,"numAtRisk":17,"numEvents":1}],"term":"Neutrophil count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":26,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":4,"numAtRisk":53,"numEvents":9},{"groupId":"EG008","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":1,"numAtRisk":14,"numEvents":1},{"groupId":"EG011","numAffected":1,"numAtRisk":17,"numEvents":1}],"term":"Platelet count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":2,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":26,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":53,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG011","numAffected":0,"numAtRisk":17,"numEvents":0}],"term":"Pulse pressure increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":26,"numEvents":0},{"groupId":"EG006","numAffected":2,"numAtRisk":13,"numEvents":2},{"groupId":"EG007","numAffected":0,"numAtRisk":53,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG011","numAffected":0,"numAtRisk":17,"numEvents":0}],"term":"Tandem gait test abnormal"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":9,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":26,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":53,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG011","numAffected":0,"numAtRisk":17,"numEvents":0}],"term":"Thyroxine free increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":2,"numAtRisk":9,"numEvents":2},{"groupId":"EG003","numAffected":2,"numAtRisk":9,"numEvents":2},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":9,"numAtRisk":26,"numEvents":12},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":17,"numAtRisk":53,"numEvents":24},{"groupId":"EG008","numAffected":7,"numAtRisk":47,"numEvents":10},{"groupId":"EG009","numAffected":5,"numAtRisk":28,"numEvents":5},{"groupId":"EG010","numAffected":3,"numAtRisk":14,"numEvents":3},{"groupId":"EG011","numAffected":4,"numAtRisk":17,"numEvents":4}],"term":"Weight decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":26,"numEvents":0},{"groupId":"EG006","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG007","numAffected":0,"numAtRisk":53,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG011","numAffected":0,"numAtRisk":17,"numEvents":0}],"term":"Weight increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":26,"numEvents":0},{"groupId":"EG006","numAffected":1,"numAtRisk":13,"numEvents":2},{"groupId":"EG007","numAffected":0,"numAtRisk":53,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG011","numAffected":0,"numAtRisk":17,"numEvents":0}],"term":"White blood cell count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":26,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":53,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG011","numAffected":1,"numAtRisk":17,"numEvents":3}],"term":"Cell death"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":4,"numAtRisk":9,"numEvents":6},{"groupId":"EG003","numAffected":4,"numAtRisk":9,"numEvents":6},{"groupId":"EG004","numAffected":2,"numAtRisk":7,"numEvents":2},{"groupId":"EG005","numAffected":19,"numAtRisk":26,"numEvents":34},{"groupId":"EG006","numAffected":3,"numAtRisk":13,"numEvents":3},{"groupId":"EG007","numAffected":34,"numAtRisk":53,"numEvents":52},{"groupId":"EG008","numAffected":21,"numAtRisk":47,"numEvents":33},{"groupId":"EG009","numAffected":15,"numAtRisk":28,"numEvents":22},{"groupId":"EG010","numAffected":6,"numAtRisk":14,"numEvents":11},{"groupId":"EG011","numAffected":11,"numAtRisk":17,"numEvents":22}],"term":"Decreased appetite"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":2,"numAtRisk":9,"numEvents":2},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":10,"numAtRisk":26,"numEvents":11},{"groupId":"EG006","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG007","numAffected":13,"numAtRisk":53,"numEvents":18},{"groupId":"EG008","numAffected":14,"numAtRisk":47,"numEvents":30},{"groupId":"EG009","numAffected":2,"numAtRisk":28,"numEvents":2},{"groupId":"EG010","numAffected":1,"numAtRisk":14,"numEvents":1},{"groupId":"EG011","numAffected":4,"numAtRisk":17,"numEvents":8}],"term":"Dehydration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":26,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":3,"numAtRisk":53,"numEvents":3},{"groupId":"EG008","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG011","numAffected":0,"numAtRisk":17,"numEvents":0}],"term":"Fluid retention"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":26,"numEvents":0},{"groupId":"EG006","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG007","numAffected":0,"numAtRisk":53,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":1,"numAtRisk":14,"numEvents":1},{"groupId":"EG011","numAffected":0,"numAtRisk":17,"numEvents":0}],"term":"Hypercholesterolaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":4,"numAtRisk":9,"numEvents":8},{"groupId":"EG003","numAffected":4,"numAtRisk":9,"numEvents":11},{"groupId":"EG004","numAffected":3,"numAtRisk":7,"numEvents":5},{"groupId":"EG005","numAffected":14,"numAtRisk":26,"numEvents":37},{"groupId":"EG006","numAffected":3,"numAtRisk":13,"numEvents":3},{"groupId":"EG007","numAffected":32,"numAtRisk":53,"numEvents":75},{"groupId":"EG008","numAffected":15,"numAtRisk":47,"numEvents":38},{"groupId":"EG009","numAffected":10,"numAtRisk":28,"numEvents":22},{"groupId":"EG010","numAffected":8,"numAtRisk":14,"numEvents":16},{"groupId":"EG011","numAffected":7,"numAtRisk":17,"numEvents":20}],"term":"Hyperglycaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":3,"numAtRisk":26,"numEvents":4},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":3,"numAtRisk":53,"numEvents":10},{"groupId":"EG008","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG011","numAffected":1,"numAtRisk":17,"numEvents":1}],"term":"Hyperkalaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":26,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":53,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG011","numAffected":1,"numAtRisk":17,"numEvents":2}],"term":"Hyperlipasaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":26,"numEvents":0},{"groupId":"EG006","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG007","numAffected":0,"numAtRisk":53,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG011","numAffected":0,"numAtRisk":17,"numEvents":0}],"term":"Hyperphagia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":26,"numEvents":0},{"groupId":"EG006","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG007","numAffected":0,"numAtRisk":53,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG011","numAffected":0,"numAtRisk":17,"numEvents":0}],"term":"Hypertriglyceridaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":2,"numAtRisk":26,"numEvents":2},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":4,"numAtRisk":53,"numEvents":5},{"groupId":"EG008","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG009","numAffected":2,"numAtRisk":28,"numEvents":5},{"groupId":"EG010","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG011","numAffected":1,"numAtRisk":17,"numEvents":1}],"term":"Hypoalbuminaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":3,"numAtRisk":26,"numEvents":4},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":5,"numAtRisk":53,"numEvents":6},{"groupId":"EG008","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":3,"numAtRisk":14,"numEvents":4},{"groupId":"EG011","numAffected":3,"numAtRisk":17,"numEvents":3}],"term":"Hypocalcaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":9,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":26,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":53,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG011","numAffected":0,"numAtRisk":17,"numEvents":0}],"term":"Hypoglycaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":9,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":6,"numAtRisk":26,"numEvents":10},{"groupId":"EG006","numAffected":2,"numAtRisk":13,"numEvents":3},{"groupId":"EG007","numAffected":8,"numAtRisk":53,"numEvents":12},{"groupId":"EG008","numAffected":11,"numAtRisk":47,"numEvents":18},{"groupId":"EG009","numAffected":10,"numAtRisk":28,"numEvents":16},{"groupId":"EG010","numAffected":1,"numAtRisk":14,"numEvents":1},{"groupId":"EG011","numAffected":3,"numAtRisk":17,"numEvents":3}],"term":"Hypokalaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":3,"numAtRisk":26,"numEvents":4},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":5,"numAtRisk":53,"numEvents":7},{"groupId":"EG008","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG009","numAffected":3,"numAtRisk":28,"numEvents":5},{"groupId":"EG010","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG011","numAffected":5,"numAtRisk":17,"numEvents":6}],"term":"Hypomagnesaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":2,"numAtRisk":26,"numEvents":2},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":7,"numAtRisk":53,"numEvents":16},{"groupId":"EG008","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":1,"numAtRisk":14,"numEvents":1},{"groupId":"EG011","numAffected":2,"numAtRisk":17,"numEvents":3}],"term":"Hyponatraemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":7,"numAtRisk":26,"numEvents":12},{"groupId":"EG006","numAffected":2,"numAtRisk":13,"numEvents":3},{"groupId":"EG007","numAffected":11,"numAtRisk":53,"numEvents":28},{"groupId":"EG008","numAffected":3,"numAtRisk":47,"numEvents":3},{"groupId":"EG009","numAffected":5,"numAtRisk":28,"numEvents":9},{"groupId":"EG010","numAffected":2,"numAtRisk":14,"numEvents":4},{"groupId":"EG011","numAffected":3,"numAtRisk":17,"numEvents":5}],"term":"Hypophosphataemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":26,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":53,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":1,"numAtRisk":14,"numEvents":1},{"groupId":"EG011","numAffected":0,"numAtRisk":17,"numEvents":0}],"term":"Malnutrition"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":26,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":53,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG011","numAffected":1,"numAtRisk":17,"numEvents":1}],"term":"Metabolic acidosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":26,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":53,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG011","numAffected":1,"numAtRisk":17,"numEvents":1}],"term":"Metabolic alkalosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":2,"numAtRisk":9,"numEvents":2},{"groupId":"EG004","numAffected":2,"numAtRisk":7,"numEvents":4},{"groupId":"EG005","numAffected":0,"numAtRisk":26,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":4,"numAtRisk":53,"numEvents":5},{"groupId":"EG008","numAffected":6,"numAtRisk":47,"numEvents":11},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":1,"numAtRisk":14,"numEvents":2},{"groupId":"EG011","numAffected":1,"numAtRisk":17,"numEvents":3}],"term":"Arthralgia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":2,"numAtRisk":9,"numEvents":3},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":5,"numAtRisk":26,"numEvents":6},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":4,"numAtRisk":53,"numEvents":4},{"groupId":"EG008","numAffected":10,"numAtRisk":47,"numEvents":12},{"groupId":"EG009","numAffected":4,"numAtRisk":28,"numEvents":4},{"groupId":"EG010","numAffected":4,"numAtRisk":14,"numEvents":4},{"groupId":"EG011","numAffected":2,"numAtRisk":17,"numEvents":2}],"term":"Back pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":26,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":53,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":2,"numAtRisk":14,"numEvents":2},{"groupId":"EG011","numAffected":2,"numAtRisk":17,"numEvents":2}],"term":"Bone pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":9,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":26,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":53,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG011","numAffected":0,"numAtRisk":17,"numEvents":0}],"term":"Flank pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":26,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":53,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG011","numAffected":1,"numAtRisk":17,"numEvents":1}],"term":"Joint stiffness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":7,"numEvents":1},{"groupId":"EG005","numAffected":0,"numAtRisk":26,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":53,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG011","numAffected":0,"numAtRisk":17,"numEvents":0}],"term":"Joint swelling"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":2,"numAtRisk":26,"numEvents":2},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":53,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG011","numAffected":0,"numAtRisk":17,"numEvents":0}],"term":"Muscle atrophy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":26,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":53,"numEvents":0},{"groupId":"EG008","numAffected":5,"numAtRisk":47,"numEvents":7},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":2,"numAtRisk":14,"numEvents":2},{"groupId":"EG011","numAffected":1,"numAtRisk":17,"numEvents":1}],"term":"Muscle spasms"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":9,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":26,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":53,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG011","numAffected":1,"numAtRisk":17,"numEvents":1}],"term":"Muscle twitching"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":2,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":3,"numAtRisk":26,"numEvents":3},{"groupId":"EG006","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG007","numAffected":3,"numAtRisk":53,"numEvents":3},{"groupId":"EG008","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG009","numAffected":2,"numAtRisk":28,"numEvents":2},{"groupId":"EG010","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG011","numAffected":0,"numAtRisk":17,"numEvents":0}],"term":"Muscular weakness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":9,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":3,"numAtRisk":26,"numEvents":4},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":53,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG011","numAffected":1,"numAtRisk":17,"numEvents":1}],"term":"Musculoskeletal chest pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":26,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":53,"numEvents":0},{"groupId":"EG008","numAffected":4,"numAtRisk":47,"numEvents":4},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":1,"numAtRisk":14,"numEvents":1},{"groupId":"EG011","numAffected":1,"numAtRisk":17,"numEvents":1}],"term":"Musculoskeletal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":9,"numEvents":1},{"groupId":"EG003","numAffected":1,"numAtRisk":9,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":2,"numAtRisk":26,"numEvents":2},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":3,"numAtRisk":53,"numEvents":3},{"groupId":"EG008","numAffected":3,"numAtRisk":47,"numEvents":3},{"groupId":"EG009","numAffected":2,"numAtRisk":28,"numEvents":2},{"groupId":"EG010","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG011","numAffected":0,"numAtRisk":17,"numEvents":0}],"term":"Myalgia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":3,"numAtRisk":26,"numEvents":3},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":53,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":1,"numAtRisk":14,"numEvents":1},{"groupId":"EG011","numAffected":0,"numAtRisk":17,"numEvents":0}],"term":"Neck pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":9,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":3,"numAtRisk":26,"numEvents":3},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":53,"numEvents":0},{"groupId":"EG008","numAffected":5,"numAtRisk":47,"numEvents":6},{"groupId":"EG009","numAffected":3,"numAtRisk":28,"numEvents":4},{"groupId":"EG010","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG011","numAffected":4,"numAtRisk":17,"numEvents":4}],"term":"Pain in extremity"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":26,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":53,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG011","numAffected":1,"numAtRisk":17,"numEvents":1}],"term":"Cancer pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":9,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":26,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":53,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG011","numAffected":0,"numAtRisk":17,"numEvents":0}],"term":"Tumour pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":26,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":53,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG011","numAffected":1,"numAtRisk":17,"numEvents":1}],"term":"Ageusia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":26,"numEvents":0},{"groupId":"EG006","numAffected":2,"numAtRisk":13,"numEvents":3},{"groupId":"EG007","numAffected":0,"numAtRisk":53,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG011","numAffected":0,"numAtRisk":17,"numEvents":0}],"term":"Aphasia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":26,"numEvents":0},{"groupId":"EG006","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG007","numAffected":0,"numAtRisk":53,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG011","numAffected":0,"numAtRisk":17,"numEvents":0}],"term":"Ataxia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":26,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":53,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":1,"numAtRisk":14,"numEvents":1},{"groupId":"EG011","numAffected":0,"numAtRisk":17,"numEvents":0}],"term":"Cerebral atrophy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":26,"numEvents":0},{"groupId":"EG006","numAffected":1,"numAtRisk":13,"numEvents":2},{"groupId":"EG007","numAffected":0,"numAtRisk":53,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG011","numAffected":0,"numAtRisk":17,"numEvents":0}],"term":"Cognitive disorder"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":9,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":26,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":53,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG011","numAffected":0,"numAtRisk":17,"numEvents":0}],"term":"Convulsion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":26,"numEvents":0},{"groupId":"EG006","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG007","numAffected":0,"numAtRisk":53,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG011","numAffected":0,"numAtRisk":17,"numEvents":0}],"term":"Coordination abnormal"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":2,"numEvents":1},{"groupId":"EG002","numAffected":2,"numAtRisk":9,"numEvents":2},{"groupId":"EG003","numAffected":1,"numAtRisk":9,"numEvents":1},{"groupId":"EG004","numAffected":1,"numAtRisk":7,"numEvents":3},{"groupId":"EG005","numAffected":6,"numAtRisk":26,"numEvents":8},{"groupId":"EG006","numAffected":3,"numAtRisk":13,"numEvents":4},{"groupId":"EG007","numAffected":7,"numAtRisk":53,"numEvents":7},{"groupId":"EG008","numAffected":13,"numAtRisk":47,"numEvents":17},{"groupId":"EG009","numAffected":3,"numAtRisk":28,"numEvents":3},{"groupId":"EG010","numAffected":1,"numAtRisk":14,"numEvents":1},{"groupId":"EG011","numAffected":2,"numAtRisk":17,"numEvents":3}],"term":"Dizziness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":26,"numEvents":0},{"groupId":"EG006","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG007","numAffected":0,"numAtRisk":53,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG011","numAffected":0,"numAtRisk":17,"numEvents":0}],"term":"Dysarthria"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":2,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":2,"numAtRisk":9,"numEvents":2},{"groupId":"EG004","numAffected":1,"numAtRisk":7,"numEvents":1},{"groupId":"EG005","numAffected":3,"numAtRisk":26,"numEvents":5},{"groupId":"EG006","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG007","numAffected":11,"numAtRisk":53,"numEvents":14},{"groupId":"EG008","numAffected":8,"numAtRisk":47,"numEvents":13},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":1,"numAtRisk":14,"numEvents":1},{"groupId":"EG011","numAffected":2,"numAtRisk":17,"numEvents":2}],"term":"Dysgeusia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":26,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":53,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG011","numAffected":1,"numAtRisk":17,"numEvents":1}],"term":"Dystonia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":26,"numEvents":0},{"groupId":"EG006","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG007","numAffected":0,"numAtRisk":53,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG011","numAffected":0,"numAtRisk":17,"numEvents":0}],"term":"Facial paralysis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":26,"numEvents":0},{"groupId":"EG006","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG007","numAffected":0,"numAtRisk":53,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG011","numAffected":0,"numAtRisk":17,"numEvents":0}],"term":"Facial paresis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":26,"numEvents":0},{"groupId":"EG006","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG007","numAffected":0,"numAtRisk":53,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG011","numAffected":0,"numAtRisk":17,"numEvents":0}],"term":"Head discomfort"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":9,"numEvents":1},{"groupId":"EG003","numAffected":1,"numAtRisk":9,"numEvents":1},{"groupId":"EG004","numAffected":1,"numAtRisk":7,"numEvents":1},{"groupId":"EG005","numAffected":5,"numAtRisk":26,"numEvents":6},{"groupId":"EG006","numAffected":5,"numAtRisk":13,"numEvents":10},{"groupId":"EG007","numAffected":11,"numAtRisk":53,"numEvents":11},{"groupId":"EG008","numAffected":8,"numAtRisk":47,"numEvents":8},{"groupId":"EG009","numAffected":6,"numAtRisk":28,"numEvents":7},{"groupId":"EG010","numAffected":3,"numAtRisk":14,"numEvents":3},{"groupId":"EG011","numAffected":5,"numAtRisk":17,"numEvents":5}],"term":"Headache"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":26,"numEvents":0},{"groupId":"EG006","numAffected":5,"numAtRisk":13,"numEvents":6},{"groupId":"EG007","numAffected":0,"numAtRisk":53,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG011","numAffected":0,"numAtRisk":17,"numEvents":0}],"term":"Hemiparesis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":26,"numEvents":0},{"groupId":"EG006","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG007","numAffected":0,"numAtRisk":53,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG011","numAffected":0,"numAtRisk":17,"numEvents":0}],"term":"Hydrocephalus"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":9,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":26,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":53,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":1,"numAtRisk":14,"numEvents":1},{"groupId":"EG011","numAffected":0,"numAtRisk":17,"numEvents":0}],"term":"Hypoaesthesia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":7,"numEvents":1},{"groupId":"EG005","numAffected":0,"numAtRisk":26,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":53,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG011","numAffected":0,"numAtRisk":17,"numEvents":0}],"term":"Incoherent"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":9,"numEvents":1},{"groupId":"EG003","numAffected":1,"numAtRisk":9,"numEvents":1},{"groupId":"EG004","numAffected":1,"numAtRisk":7,"numEvents":1},{"groupId":"EG005","numAffected":3,"numAtRisk":26,"numEvents":3},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":53,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG011","numAffected":0,"numAtRisk":17,"numEvents":0}],"term":"Lethargy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":26,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":53,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":1,"numAtRisk":14,"numEvents":1},{"groupId":"EG011","numAffected":0,"numAtRisk":17,"numEvents":0}],"term":"Loss of consciousness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":26,"numEvents":0},{"groupId":"EG006","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG007","numAffected":0,"numAtRisk":53,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG011","numAffected":0,"numAtRisk":17,"numEvents":0}],"term":"Memory impairment"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":26,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":53,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG011","numAffected":1,"numAtRisk":17,"numEvents":1}],"term":"Myoclonus"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":9,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":2,"numAtRisk":26,"numEvents":3},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":53,"numEvents":0},{"groupId":"EG008","numAffected":4,"numAtRisk":47,"numEvents":5},{"groupId":"EG009","numAffected":3,"numAtRisk":28,"numEvents":3},{"groupId":"EG010","numAffected":1,"numAtRisk":14,"numEvents":1},{"groupId":"EG011","numAffected":1,"numAtRisk":17,"numEvents":1}],"term":"Neuropathy peripheral"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":9,"numEvents":2},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":26,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":4,"numAtRisk":53,"numEvents":4},{"groupId":"EG008","numAffected":3,"numAtRisk":47,"numEvents":3},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG011","numAffected":0,"numAtRisk":17,"numEvents":0}],"term":"Paraesthesia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":26,"numEvents":0},{"groupId":"EG006","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG007","numAffected":0,"numAtRisk":53,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG011","numAffected":0,"numAtRisk":17,"numEvents":0}],"term":"Peripheral sensory neuropathy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":26,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":53,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":1,"numAtRisk":14,"numEvents":1},{"groupId":"EG011","numAffected":0,"numAtRisk":17,"numEvents":0}],"term":"Presyncope"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":26,"numEvents":0},{"groupId":"EG006","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG007","numAffected":0,"numAtRisk":53,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG011","numAffected":0,"numAtRisk":17,"numEvents":0}],"term":"Quadrantanopia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":9,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":26,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":53,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":1,"numAtRisk":14,"numEvents":1},{"groupId":"EG011","numAffected":0,"numAtRisk":17,"numEvents":0}],"term":"Restless legs syndrome"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":26,"numEvents":0},{"groupId":"EG006","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG007","numAffected":0,"numAtRisk":53,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG011","numAffected":0,"numAtRisk":17,"numEvents":0}],"term":"Seizure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":26,"numEvents":0},{"groupId":"EG006","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG007","numAffected":0,"numAtRisk":53,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG011","numAffected":0,"numAtRisk":17,"numEvents":0}],"term":"Sensory loss"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":3,"numAtRisk":26,"numEvents":4},{"groupId":"EG006","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG007","numAffected":0,"numAtRisk":53,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG011","numAffected":3,"numAtRisk":17,"numEvents":4}],"term":"Somnolence"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":26,"numEvents":0},{"groupId":"EG006","numAffected":2,"numAtRisk":13,"numEvents":2},{"groupId":"EG007","numAffected":0,"numAtRisk":53,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG011","numAffected":0,"numAtRisk":17,"numEvents":0}],"term":"Speech disorder"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":2,"numAtRisk":7,"numEvents":2},{"groupId":"EG005","numAffected":2,"numAtRisk":26,"numEvents":2},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":53,"numEvents":0},{"groupId":"EG008","numAffected":4,"numAtRisk":47,"numEvents":4},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":1,"numAtRisk":14,"numEvents":1},{"groupId":"EG011","numAffected":0,"numAtRisk":17,"numEvents":0}],"term":"Syncope"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":2,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":2,"numAtRisk":7,"numEvents":3},{"groupId":"EG005","numAffected":0,"numAtRisk":26,"numEvents":0},{"groupId":"EG006","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG007","numAffected":3,"numAtRisk":53,"numEvents":4},{"groupId":"EG008","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":1,"numAtRisk":14,"numEvents":1},{"groupId":"EG011","numAffected":1,"numAtRisk":17,"numEvents":2}],"term":"Tremor"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":26,"numEvents":0},{"groupId":"EG006","numAffected":2,"numAtRisk":13,"numEvents":2},{"groupId":"EG007","numAffected":0,"numAtRisk":53,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG011","numAffected":0,"numAtRisk":17,"numEvents":0}],"term":"Upper motor neurone lesion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":26,"numEvents":0},{"groupId":"EG006","numAffected":4,"numAtRisk":13,"numEvents":4},{"groupId":"EG007","numAffected":0,"numAtRisk":53,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG011","numAffected":0,"numAtRisk":17,"numEvents":0}],"term":"Visual field defect"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":26,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":53,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":1,"numAtRisk":14,"numEvents":1},{"groupId":"EG011","numAffected":0,"numAtRisk":17,"numEvents":0}],"term":"White matter lesion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":26,"numEvents":0},{"groupId":"EG006","numAffected":2,"numAtRisk":13,"numEvents":2},{"groupId":"EG007","numAffected":0,"numAtRisk":53,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG011","numAffected":0,"numAtRisk":17,"numEvents":0}],"term":"Affect lability"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":26,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":53,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":1,"numAtRisk":14,"numEvents":1},{"groupId":"EG011","numAffected":0,"numAtRisk":17,"numEvents":0}],"term":"Affective disorder"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":26,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":53,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":1,"numAtRisk":14,"numEvents":1},{"groupId":"EG011","numAffected":0,"numAtRisk":17,"numEvents":0}],"term":"Aggression"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":2,"numAtRisk":26,"numEvents":2},{"groupId":"EG006","numAffected":3,"numAtRisk":13,"numEvents":3},{"groupId":"EG007","numAffected":0,"numAtRisk":53,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":1,"numAtRisk":14,"numEvents":1},{"groupId":"EG011","numAffected":0,"numAtRisk":17,"numEvents":0}],"term":"Agitation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":26,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":53,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG011","numAffected":1,"numAtRisk":17,"numEvents":1}],"term":"Anhedonia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":2,"numEvents":2},{"groupId":"EG002","numAffected":1,"numAtRisk":9,"numEvents":1},{"groupId":"EG003","numAffected":1,"numAtRisk":9,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":3,"numAtRisk":26,"numEvents":3},{"groupId":"EG006","numAffected":2,"numAtRisk":13,"numEvents":3},{"groupId":"EG007","numAffected":0,"numAtRisk":53,"numEvents":0},{"groupId":"EG008","numAffected":3,"numAtRisk":47,"numEvents":4},{"groupId":"EG009","numAffected":3,"numAtRisk":28,"numEvents":3},{"groupId":"EG010","numAffected":2,"numAtRisk":14,"numEvents":2},{"groupId":"EG011","numAffected":2,"numAtRisk":17,"numEvents":2}],"term":"Anxiety"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":9,"numEvents":1},{"groupId":"EG003","numAffected":1,"numAtRisk":9,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":2,"numAtRisk":26,"numEvents":3},{"groupId":"EG006","numAffected":3,"numAtRisk":13,"numEvents":3},{"groupId":"EG007","numAffected":0,"numAtRisk":53,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":1,"numAtRisk":14,"numEvents":1},{"groupId":"EG011","numAffected":2,"numAtRisk":17,"numEvents":2}],"term":"Confusional state"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":26,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":53,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG011","numAffected":1,"numAtRisk":17,"numEvents":1}],"term":"Depressed mood"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":2,"numEvents":1},{"groupId":"EG002","numAffected":2,"numAtRisk":9,"numEvents":2},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":3,"numAtRisk":26,"numEvents":4},{"groupId":"EG006","numAffected":2,"numAtRisk":13,"numEvents":2},{"groupId":"EG007","numAffected":3,"numAtRisk":53,"numEvents":3},{"groupId":"EG008","numAffected":3,"numAtRisk":47,"numEvents":3},{"groupId":"EG009","numAffected":2,"numAtRisk":28,"numEvents":2},{"groupId":"EG010","numAffected":3,"numAtRisk":14,"numEvents":3},{"groupId":"EG011","numAffected":0,"numAtRisk":17,"numEvents":0}],"term":"Depression"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":26,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":3,"numAtRisk":53,"numEvents":3},{"groupId":"EG008","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG011","numAffected":0,"numAtRisk":17,"numEvents":0}],"term":"Disorientation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":9,"numEvents":1},{"groupId":"EG003","numAffected":1,"numAtRisk":9,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":26,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":53,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":1,"numAtRisk":14,"numEvents":1},{"groupId":"EG011","numAffected":0,"numAtRisk":17,"numEvents":0}],"term":"Hallucination"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":2,"numAtRisk":26,"numEvents":2},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":7,"numAtRisk":53,"numEvents":7},{"groupId":"EG008","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":1,"numAtRisk":14,"numEvents":1},{"groupId":"EG011","numAffected":2,"numAtRisk":17,"numEvents":2}],"term":"Insomnia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":26,"numEvents":0},{"groupId":"EG006","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG007","numAffected":0,"numAtRisk":53,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG011","numAffected":0,"numAtRisk":17,"numEvents":0}],"term":"Mania"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":7,"numEvents":1},{"groupId":"EG005","numAffected":0,"numAtRisk":26,"numEvents":0},{"groupId":"EG006","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG007","numAffected":0,"numAtRisk":53,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG011","numAffected":0,"numAtRisk":17,"numEvents":0}],"term":"Mental status changes"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":26,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":53,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":1,"numAtRisk":14,"numEvents":1},{"groupId":"EG011","numAffected":0,"numAtRisk":17,"numEvents":0}],"term":"Nervousness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":26,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":53,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":1,"numAtRisk":14,"numEvents":1},{"groupId":"EG011","numAffected":0,"numAtRisk":17,"numEvents":0}],"term":"Persistent depressive disorder"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":26,"numEvents":0},{"groupId":"EG006","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG007","numAffected":0,"numAtRisk":53,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG011","numAffected":0,"numAtRisk":17,"numEvents":0}],"term":"Psychotic disorder"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":26,"numEvents":0},{"groupId":"EG006","numAffected":1,"numAtRisk":13,"numEvents":2},{"groupId":"EG007","numAffected":0,"numAtRisk":53,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG011","numAffected":0,"numAtRisk":17,"numEvents":0}],"term":"Substance-induced psychotic disorder"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":2,"numAtRisk":26,"numEvents":2},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":53,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":1,"numAtRisk":14,"numEvents":1},{"groupId":"EG011","numAffected":0,"numAtRisk":17,"numEvents":0}],"term":"Acute kidney injury"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":26,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":53,"numEvents":0},{"groupId":"EG008","numAffected":5,"numAtRisk":47,"numEvents":6},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":1,"numAtRisk":14,"numEvents":1},{"groupId":"EG011","numAffected":0,"numAtRisk":17,"numEvents":0}],"term":"Dysuria"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":9,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":26,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":53,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG011","numAffected":0,"numAtRisk":17,"numEvents":0}],"term":"Glycosuria"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":26,"numEvents":0},{"groupId":"EG006","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG007","numAffected":0,"numAtRisk":53,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG011","numAffected":0,"numAtRisk":17,"numEvents":0}],"term":"Hypertonic bladder"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":26,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":53,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG011","numAffected":1,"numAtRisk":17,"numEvents":1}],"term":"Micturition urgency"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":26,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":53,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":1,"numAtRisk":14,"numEvents":1},{"groupId":"EG011","numAffected":0,"numAtRisk":17,"numEvents":0}],"term":"Nephropathy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":26,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":53,"numEvents":0},{"groupId":"EG008","numAffected":3,"numAtRisk":47,"numEvents":4},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG011","numAffected":0,"numAtRisk":17,"numEvents":0}],"term":"Nocturia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":26,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":53,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG011","numAffected":1,"numAtRisk":17,"numEvents":1}],"term":"Oliguria"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":2,"numAtRisk":9,"numEvents":2},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":26,"numEvents":0},{"groupId":"EG006","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG007","numAffected":3,"numAtRisk":53,"numEvents":3},{"groupId":"EG008","numAffected":4,"numAtRisk":47,"numEvents":5},{"groupId":"EG009","numAffected":2,"numAtRisk":28,"numEvents":2},{"groupId":"EG010","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG011","numAffected":0,"numAtRisk":17,"numEvents":0}],"term":"Pollakiuria"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":26,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":7,"numAtRisk":53,"numEvents":15},{"groupId":"EG008","numAffected":5,"numAtRisk":47,"numEvents":7},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":2,"numAtRisk":14,"numEvents":2},{"groupId":"EG011","numAffected":2,"numAtRisk":17,"numEvents":2}],"term":"Proteinuria"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":26,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":53,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG009","numAffected":2,"numAtRisk":28,"numEvents":5},{"groupId":"EG010","numAffected":2,"numAtRisk":14,"numEvents":7},{"groupId":"EG011","numAffected":0,"numAtRisk":17,"numEvents":0}],"term":"Renal failure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":26,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":53,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":1,"numAtRisk":14,"numEvents":1},{"groupId":"EG011","numAffected":0,"numAtRisk":17,"numEvents":0}],"term":"Renal impairment"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":26,"numEvents":0},{"groupId":"EG006","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG007","numAffected":0,"numAtRisk":53,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG009","numAffected":2,"numAtRisk":28,"numEvents":2},{"groupId":"EG010","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG011","numAffected":0,"numAtRisk":17,"numEvents":0}],"term":"Urinary incontinence"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":2,"numEvents":1},{"groupId":"EG002","numAffected":4,"numAtRisk":9,"numEvents":4},{"groupId":"EG003","numAffected":1,"numAtRisk":9,"numEvents":2},{"groupId":"EG004","numAffected":2,"numAtRisk":7,"numEvents":2},{"groupId":"EG005","numAffected":5,"numAtRisk":26,"numEvents":7},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":8,"numAtRisk":53,"numEvents":11},{"groupId":"EG008","numAffected":9,"numAtRisk":47,"numEvents":12},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG011","numAffected":3,"numAtRisk":17,"numEvents":3}],"term":"Cough"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":9,"numEvents":1},{"groupId":"EG003","numAffected":1,"numAtRisk":9,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":2,"numAtRisk":26,"numEvents":2},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":53,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG011","numAffected":0,"numAtRisk":17,"numEvents":0}],"term":"Dysphonia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":3,"numAtRisk":9,"numEvents":4},{"groupId":"EG003","numAffected":2,"numAtRisk":9,"numEvents":2},{"groupId":"EG004","numAffected":2,"numAtRisk":7,"numEvents":2},{"groupId":"EG005","numAffected":15,"numAtRisk":26,"numEvents":29},{"groupId":"EG006","numAffected":1,"numAtRisk":13,"numEvents":3},{"groupId":"EG007","numAffected":10,"numAtRisk":53,"numEvents":13},{"groupId":"EG008","numAffected":10,"numAtRisk":47,"numEvents":15},{"groupId":"EG009","numAffected":3,"numAtRisk":28,"numEvents":3},{"groupId":"EG010","numAffected":1,"numAtRisk":14,"numEvents":1},{"groupId":"EG011","numAffected":7,"numAtRisk":17,"numEvents":9}],"term":"Dyspnoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":9,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":3,"numAtRisk":26,"numEvents":4},{"groupId":"EG006","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG007","numAffected":0,"numAtRisk":53,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG011","numAffected":1,"numAtRisk":17,"numEvents":1}],"term":"Dyspnoea exertional"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":7,"numEvents":1},{"groupId":"EG005","numAffected":2,"numAtRisk":26,"numEvents":2},{"groupId":"EG006","numAffected":2,"numAtRisk":13,"numEvents":2},{"groupId":"EG007","numAffected":3,"numAtRisk":53,"numEvents":4},{"groupId":"EG008","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":5,"numAtRisk":14,"numEvents":5},{"groupId":"EG011","numAffected":0,"numAtRisk":17,"numEvents":0}],"term":"Epistaxis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":9,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":2,"numAtRisk":26,"numEvents":2},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":53,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG011","numAffected":0,"numAtRisk":17,"numEvents":0}],"term":"Haemoptysis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":9,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":26,"numEvents":0},{"groupId":"EG006","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG007","numAffected":0,"numAtRisk":53,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG011","numAffected":0,"numAtRisk":17,"numEvents":0}],"term":"Hiccups"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":9,"numEvents":1},{"groupId":"EG003","numAffected":1,"numAtRisk":9,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":26,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":53,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG011","numAffected":0,"numAtRisk":17,"numEvents":0}],"term":"Hypoxia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":26,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":53,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG011","numAffected":0,"numAtRisk":17,"numEvents":0}],"term":"Laryngeal haemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":9,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":26,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":53,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG011","numAffected":0,"numAtRisk":17,"numEvents":0}],"term":"Nasal congestion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":26,"numEvents":0},{"groupId":"EG006","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG007","numAffected":0,"numAtRisk":53,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG011","numAffected":0,"numAtRisk":17,"numEvents":0}],"term":"Nasal inflammation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":9,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":26,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":53,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG011","numAffected":0,"numAtRisk":17,"numEvents":0}],"term":"Oropharyngeal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":9,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":26,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":53,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG011","numAffected":0,"numAtRisk":17,"numEvents":0}],"term":"Paranasal sinus hypersecretion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":9,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":3,"numAtRisk":26,"numEvents":3},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":53,"numEvents":0},{"groupId":"EG008","numAffected":5,"numAtRisk":47,"numEvents":5},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG011","numAffected":1,"numAtRisk":17,"numEvents":1}],"term":"Pleural effusion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":26,"numEvents":0},{"groupId":"EG006","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG007","numAffected":0,"numAtRisk":53,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG011","numAffected":0,"numAtRisk":17,"numEvents":0}],"term":"Pneumonia aspiration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":26,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":53,"numEvents":0},{"groupId":"EG008","numAffected":3,"numAtRisk":47,"numEvents":4},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG011","numAffected":0,"numAtRisk":17,"numEvents":0}],"term":"Pneumonitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":2,"numAtRisk":9,"numEvents":3},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":4,"numAtRisk":26,"numEvents":4},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":53,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":2,"numAtRisk":14,"numEvents":2},{"groupId":"EG011","numAffected":1,"numAtRisk":17,"numEvents":1}],"term":"Productive cough"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":7,"numEvents":1},{"groupId":"EG005","numAffected":0,"numAtRisk":26,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":53,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG011","numAffected":0,"numAtRisk":17,"numEvents":0}],"term":"Pulmonary congestion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":2,"numAtRisk":26,"numEvents":2},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":53,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG011","numAffected":0,"numAtRisk":17,"numEvents":0}],"term":"Sputum discoloured"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":9,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":26,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":53,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG011","numAffected":0,"numAtRisk":17,"numEvents":0}],"term":"Throat irritation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":26,"numEvents":0},{"groupId":"EG006","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG007","numAffected":0,"numAtRisk":53,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG011","numAffected":0,"numAtRisk":17,"numEvents":0}],"term":"Upper-airway cough syndrome"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":9,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":26,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":53,"numEvents":0},{"groupId":"EG008","numAffected":3,"numAtRisk":47,"numEvents":3},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG011","numAffected":0,"numAtRisk":17,"numEvents":0}],"term":"Wheezing"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":9,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":26,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":53,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":1,"numAtRisk":14,"numEvents":1},{"groupId":"EG011","numAffected":0,"numAtRisk":17,"numEvents":0}],"term":"Decubitus ulcer"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":26,"numEvents":0},{"groupId":"EG006","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG007","numAffected":4,"numAtRisk":53,"numEvents":7},{"groupId":"EG008","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG011","numAffected":1,"numAtRisk":17,"numEvents":1}],"term":"Dermatitis acneiform"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":7,"numEvents":1},{"groupId":"EG005","numAffected":7,"numAtRisk":26,"numEvents":9},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":8,"numAtRisk":53,"numEvents":13},{"groupId":"EG008","numAffected":8,"numAtRisk":47,"numEvents":8},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":2,"numAtRisk":14,"numEvents":2},{"groupId":"EG011","numAffected":4,"numAtRisk":17,"numEvents":4}],"term":"Dry skin"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":26,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":53,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG011","numAffected":1,"numAtRisk":17,"numEvents":1}],"term":"Eczema"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":26,"numEvents":0},{"groupId":"EG006","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG007","numAffected":5,"numAtRisk":53,"numEvents":5},{"groupId":"EG008","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG011","numAffected":1,"numAtRisk":17,"numEvents":1}],"term":"Erythema"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":26,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":53,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":1,"numAtRisk":14,"numEvents":1},{"groupId":"EG011","numAffected":0,"numAtRisk":17,"numEvents":0}],"term":"Hyperkeratosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":9,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":26,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":53,"numEvents":0},{"groupId":"EG008","numAffected":3,"numAtRisk":47,"numEvents":3},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG011","numAffected":1,"numAtRisk":17,"numEvents":2}],"term":"Nail disorder"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":9,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":26,"numEvents":0},{"groupId":"EG006","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG007","numAffected":0,"numAtRisk":53,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG009","numAffected":2,"numAtRisk":28,"numEvents":3},{"groupId":"EG010","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG011","numAffected":1,"numAtRisk":17,"numEvents":1}],"term":"Night sweats"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":7,"numEvents":1},{"groupId":"EG005","numAffected":0,"numAtRisk":26,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":5,"numAtRisk":53,"numEvents":11},{"groupId":"EG008","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG011","numAffected":0,"numAtRisk":17,"numEvents":0}],"term":"Palmar-plantar erythrodysaesthesia syndrome"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":2,"numEvents":2},{"groupId":"EG002","numAffected":1,"numAtRisk":9,"numEvents":1},{"groupId":"EG003","numAffected":2,"numAtRisk":9,"numEvents":2},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":9,"numAtRisk":26,"numEvents":21},{"groupId":"EG006","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG007","numAffected":18,"numAtRisk":53,"numEvents":41},{"groupId":"EG008","numAffected":21,"numAtRisk":47,"numEvents":47},{"groupId":"EG009","numAffected":5,"numAtRisk":28,"numEvents":5},{"groupId":"EG010","numAffected":2,"numAtRisk":14,"numEvents":2},{"groupId":"EG011","numAffected":6,"numAtRisk":17,"numEvents":8}],"term":"Pruritus"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":26,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":53,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG011","numAffected":1,"numAtRisk":17,"numEvents":1}],"term":"Psoriasis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":26,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":53,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":1,"numAtRisk":14,"numEvents":1},{"groupId":"EG011","numAffected":0,"numAtRisk":17,"numEvents":0}],"term":"Purpura"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":2,"numEvents":2},{"groupId":"EG002","numAffected":1,"numAtRisk":9,"numEvents":2},{"groupId":"EG003","numAffected":2,"numAtRisk":9,"numEvents":4},{"groupId":"EG004","numAffected":3,"numAtRisk":7,"numEvents":4},{"groupId":"EG005","numAffected":8,"numAtRisk":26,"numEvents":13},{"groupId":"EG006","numAffected":4,"numAtRisk":13,"numEvents":5},{"groupId":"EG007","numAffected":12,"numAtRisk":53,"numEvents":18},{"groupId":"EG008","numAffected":18,"numAtRisk":47,"numEvents":39},{"groupId":"EG009","numAffected":5,"numAtRisk":28,"numEvents":6},{"groupId":"EG010","numAffected":3,"numAtRisk":14,"numEvents":6},{"groupId":"EG011","numAffected":4,"numAtRisk":17,"numEvents":19}],"term":"Rash"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":26,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":53,"numEvents":0},{"groupId":"EG008","numAffected":4,"numAtRisk":47,"numEvents":6},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG011","numAffected":0,"numAtRisk":17,"numEvents":0}],"term":"Rash erythematous"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":9,"numEvents":1},{"groupId":"EG004","numAffected":1,"numAtRisk":7,"numEvents":1},{"groupId":"EG005","numAffected":0,"numAtRisk":26,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":53,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG011","numAffected":1,"numAtRisk":17,"numEvents":1}],"term":"Rash generalised"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":4,"numAtRisk":26,"numEvents":7},{"groupId":"EG006","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG007","numAffected":0,"numAtRisk":53,"numEvents":0},{"groupId":"EG008","numAffected":7,"numAtRisk":47,"numEvents":26},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG011","numAffected":0,"numAtRisk":17,"numEvents":0}],"term":"Rash macular"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":9,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":7,"numEvents":2},{"groupId":"EG005","numAffected":3,"numAtRisk":26,"numEvents":8},{"groupId":"EG006","numAffected":2,"numAtRisk":13,"numEvents":2},{"groupId":"EG007","numAffected":7,"numAtRisk":53,"numEvents":22},{"groupId":"EG008","numAffected":12,"numAtRisk":47,"numEvents":22},{"groupId":"EG009","numAffected":2,"numAtRisk":28,"numEvents":2},{"groupId":"EG010","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG011","numAffected":1,"numAtRisk":17,"numEvents":1}],"term":"Rash maculo-papular"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":26,"numEvents":0},{"groupId":"EG006","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG007","numAffected":3,"numAtRisk":53,"numEvents":5},{"groupId":"EG008","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG011","numAffected":1,"numAtRisk":17,"numEvents":1}],"term":"Rash papular"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":9,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":2,"numAtRisk":7,"numEvents":3},{"groupId":"EG005","numAffected":0,"numAtRisk":26,"numEvents":0},{"groupId":"EG006","numAffected":2,"numAtRisk":13,"numEvents":7},{"groupId":"EG007","numAffected":3,"numAtRisk":53,"numEvents":7},{"groupId":"EG008","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG011","numAffected":0,"numAtRisk":17,"numEvents":0}],"term":"Rash pruritic"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":26,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":53,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":1,"numAtRisk":14,"numEvents":1},{"groupId":"EG011","numAffected":1,"numAtRisk":17,"numEvents":1}],"term":"Skin exfoliation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":26,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":3,"numAtRisk":53,"numEvents":4},{"groupId":"EG008","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG011","numAffected":1,"numAtRisk":17,"numEvents":1}],"term":"Skin lesion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":26,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":53,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":1,"numAtRisk":14,"numEvents":1},{"groupId":"EG011","numAffected":0,"numAtRisk":17,"numEvents":0}],"term":"Skin plaque"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":26,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":53,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":1,"numAtRisk":14,"numEvents":1},{"groupId":"EG011","numAffected":0,"numAtRisk":17,"numEvents":0}],"term":"Urticaria"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":9,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":26,"numEvents":0},{"groupId":"EG006","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG007","numAffected":0,"numAtRisk":53,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":1,"numAtRisk":14,"numEvents":1},{"groupId":"EG011","numAffected":0,"numAtRisk":17,"numEvents":0}],"term":"Deep vein thrombosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":26,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":53,"numEvents":0},{"groupId":"EG008","numAffected":6,"numAtRisk":47,"numEvents":8},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG011","numAffected":0,"numAtRisk":17,"numEvents":0}],"term":"Flushing"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":26,"numEvents":0},{"groupId":"EG006","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG007","numAffected":0,"numAtRisk":53,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG011","numAffected":0,"numAtRisk":17,"numEvents":0}],"term":"Haematoma"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":26,"numEvents":0},{"groupId":"EG006","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG007","numAffected":3,"numAtRisk":53,"numEvents":15},{"groupId":"EG008","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":1,"numAtRisk":14,"numEvents":1},{"groupId":"EG011","numAffected":0,"numAtRisk":17,"numEvents":0}],"term":"Hypertension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":9,"numEvents":1},{"groupId":"EG004","numAffected":1,"numAtRisk":7,"numEvents":1},{"groupId":"EG005","numAffected":3,"numAtRisk":26,"numEvents":3},{"groupId":"EG006","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG007","numAffected":5,"numAtRisk":53,"numEvents":6},{"groupId":"EG008","numAffected":4,"numAtRisk":47,"numEvents":4},{"groupId":"EG009","numAffected":2,"numAtRisk":28,"numEvents":2},{"groupId":"EG010","numAffected":1,"numAtRisk":14,"numEvents":1},{"groupId":"EG011","numAffected":2,"numAtRisk":17,"numEvents":2}],"term":"Hypotension"}],"seriousEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":26,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":53,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG009","numAffected":1,"numAtRisk":28,"numEvents":1},{"groupId":"EG010","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG011","numAffected":0,"numAtRisk":17,"numEvents":0}],"term":"Lymph node pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":26,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":53,"numEvents":0},{"groupId":"EG008","numAffected":1,"numAtRisk":47,"numEvents":1},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG011","numAffected":1,"numAtRisk":17,"numEvents":1}],"term":"Neutropenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":26,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":1,"numAtRisk":53,"numEvents":1},{"groupId":"EG008","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":1,"numAtRisk":14,"numEvents":1},{"groupId":"EG011","numAffected":1,"numAtRisk":17,"numEvents":2}],"term":"Thrombocytopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":26,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":53,"numEvents":0},{"groupId":"EG008","numAffected":1,"numAtRisk":47,"numEvents":1},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG011","numAffected":0,"numAtRisk":17,"numEvents":0}],"term":"Atrial thrombosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":26,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":53,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG009","numAffected":1,"numAtRisk":28,"numEvents":1},{"groupId":"EG010","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG011","numAffected":0,"numAtRisk":17,"numEvents":0}],"term":"Left ventricular dysfunction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":26,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":1,"numAtRisk":53,"numEvents":1},{"groupId":"EG008","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG011","numAffected":0,"numAtRisk":17,"numEvents":0}],"term":"Myocardial ischaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":1,"numAtRisk":26,"numEvents":1},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":53,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG011","numAffected":0,"numAtRisk":17,"numEvents":0}],"term":"Pericardial effusion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":26,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":1,"numAtRisk":53,"numEvents":2},{"groupId":"EG008","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG011","numAffected":0,"numAtRisk":17,"numEvents":0}],"term":"Supraventricular tachycardia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":1,"numAtRisk":26,"numEvents":1},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":1,"numAtRisk":53,"numEvents":1},{"groupId":"EG008","numAffected":2,"numAtRisk":47,"numEvents":2},{"groupId":"EG009","numAffected":2,"numAtRisk":28,"numEvents":2},{"groupId":"EG010","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG011","numAffected":1,"numAtRisk":17,"numEvents":1}],"term":"Abdominal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":26,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":1,"numAtRisk":53,"numEvents":1},{"groupId":"EG008","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG011","numAffected":0,"numAtRisk":17,"numEvents":0}],"term":"Abdominal pain upper"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":26,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":53,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":1,"numAtRisk":14,"numEvents":1},{"groupId":"EG011","numAffected":0,"numAtRisk":17,"numEvents":0}],"term":"Aphthous ulcer"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":1,"numAtRisk":26,"numEvents":1},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":1,"numAtRisk":53,"numEvents":1},{"groupId":"EG008","numAffected":1,"numAtRisk":47,"numEvents":1},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG011","numAffected":2,"numAtRisk":17,"numEvents":2}],"term":"Ascites"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":26,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":53,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG009","numAffected":1,"numAtRisk":28,"numEvents":1},{"groupId":"EG010","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG011","numAffected":0,"numAtRisk":17,"numEvents":0}],"term":"Autoimmune pancreatitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":9,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":26,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":53,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG011","numAffected":0,"numAtRisk":17,"numEvents":0}],"term":"Colonic obstruction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":26,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":1,"numAtRisk":53,"numEvents":1},{"groupId":"EG008","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG011","numAffected":0,"numAtRisk":17,"numEvents":0}],"term":"Crohn's disease"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":9,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":7,"numEvents":1},{"groupId":"EG005","numAffected":0,"numAtRisk":26,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":53,"numEvents":0},{"groupId":"EG008","numAffected":1,"numAtRisk":47,"numEvents":1},{"groupId":"EG009","numAffected":1,"numAtRisk":28,"numEvents":1},{"groupId":"EG010","numAffected":1,"numAtRisk":14,"numEvents":1},{"groupId":"EG011","numAffected":2,"numAtRisk":17,"numEvents":2}],"term":"Diarrhoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":26,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":1,"numAtRisk":53,"numEvents":1},{"groupId":"EG008","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG011","numAffected":0,"numAtRisk":17,"numEvents":0}],"term":"Dysphagia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":26,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":1,"numAtRisk":53,"numEvents":1},{"groupId":"EG008","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG011","numAffected":0,"numAtRisk":17,"numEvents":0}],"term":"Gastrointestinal haemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":26,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":53,"numEvents":0},{"groupId":"EG008","numAffected":1,"numAtRisk":47,"numEvents":1},{"groupId":"EG009","numAffected":1,"numAtRisk":28,"numEvents":1},{"groupId":"EG010","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG011","numAffected":0,"numAtRisk":17,"numEvents":0}],"term":"Intestinal obstruction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":7,"numEvents":1},{"groupId":"EG005","numAffected":1,"numAtRisk":26,"numEvents":1},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":53,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG011","numAffected":2,"numAtRisk":17,"numEvents":2}],"term":"Nausea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":26,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":1,"numAtRisk":53,"numEvents":1},{"groupId":"EG008","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG009","numAffected":1,"numAtRisk":28,"numEvents":1},{"groupId":"EG010","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG011","numAffected":0,"numAtRisk":17,"numEvents":0}],"term":"Pancreatitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":1,"numAtRisk":26,"numEvents":1},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":1,"numAtRisk":53,"numEvents":1},{"groupId":"EG008","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG011","numAffected":0,"numAtRisk":17,"numEvents":0}],"term":"Pancreatitis acute"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":26,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":1,"numAtRisk":53,"numEvents":1},{"groupId":"EG008","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG011","numAffected":0,"numAtRisk":17,"numEvents":0}],"term":"Peptic ulcer"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":26,"numEvents":0},{"groupId":"EG006","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG007","numAffected":0,"numAtRisk":53,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG011","numAffected":0,"numAtRisk":17,"numEvents":0}],"term":"Retroperitoneal haemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":26,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":53,"numEvents":0},{"groupId":"EG008","numAffected":2,"numAtRisk":47,"numEvents":3},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG011","numAffected":0,"numAtRisk":17,"numEvents":0}],"term":"Small intestinal obstruction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":9,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":7,"numEvents":1},{"groupId":"EG005","numAffected":3,"numAtRisk":26,"numEvents":3},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":53,"numEvents":0},{"groupId":"EG008","numAffected":2,"numAtRisk":47,"numEvents":2},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG011","numAffected":2,"numAtRisk":17,"numEvents":2}],"term":"Vomiting"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":26,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":1,"numAtRisk":53,"numEvents":2},{"groupId":"EG008","numAffected":1,"numAtRisk":47,"numEvents":1},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG011","numAffected":0,"numAtRisk":17,"numEvents":0}],"term":"Asthenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":26,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":53,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG011","numAffected":2,"numAtRisk":17,"numEvents":2}],"term":"Fatigue"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":2,"numAtRisk":9,"numEvents":2},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":7,"numEvents":1},{"groupId":"EG005","numAffected":2,"numAtRisk":26,"numEvents":2},{"groupId":"EG006","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG007","numAffected":3,"numAtRisk":53,"numEvents":3},{"groupId":"EG008","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG011","numAffected":0,"numAtRisk":17,"numEvents":0}],"term":"General physical health deterioration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":26,"numEvents":0},{"groupId":"EG006","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG007","numAffected":0,"numAtRisk":53,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG011","numAffected":0,"numAtRisk":17,"numEvents":0}],"term":"Impaired healing"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":26,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":53,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG011","numAffected":1,"numAtRisk":17,"numEvents":1}],"term":"Mucosal inflammation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":26,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":53,"numEvents":0},{"groupId":"EG008","numAffected":1,"numAtRisk":47,"numEvents":1},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG011","numAffected":0,"numAtRisk":17,"numEvents":0}],"term":"Non-cardiac chest pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":1,"numAtRisk":26,"numEvents":1},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":2,"numAtRisk":53,"numEvents":2},{"groupId":"EG008","numAffected":3,"numAtRisk":47,"numEvents":3},{"groupId":"EG009","numAffected":1,"numAtRisk":28,"numEvents":1},{"groupId":"EG010","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG011","numAffected":0,"numAtRisk":17,"numEvents":0}],"term":"Pyrexia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":26,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":53,"numEvents":0},{"groupId":"EG008","numAffected":1,"numAtRisk":47,"numEvents":1},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG011","numAffected":0,"numAtRisk":17,"numEvents":0}],"term":"Bile duct stenosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":26,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":1,"numAtRisk":53,"numEvents":1},{"groupId":"EG008","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG011","numAffected":0,"numAtRisk":17,"numEvents":0}],"term":"Cholecystitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":26,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":53,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG011","numAffected":1,"numAtRisk":17,"numEvents":1}],"term":"Cholelithiasis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":26,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":1,"numAtRisk":53,"numEvents":1},{"groupId":"EG008","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG011","numAffected":0,"numAtRisk":17,"numEvents":0}],"term":"Hepatocellular injury"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Immune system disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":26,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":53,"numEvents":0},{"groupId":"EG008","numAffected":1,"numAtRisk":47,"numEvents":1},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG011","numAffected":0,"numAtRisk":17,"numEvents":0}],"term":"Hypersensitivity"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":26,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":53,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":1,"numAtRisk":14,"numEvents":1},{"groupId":"EG011","numAffected":0,"numAtRisk":17,"numEvents":0}],"term":"Abdominal sepsis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":26,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":53,"numEvents":0},{"groupId":"EG008","numAffected":1,"numAtRisk":47,"numEvents":1},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG011","numAffected":0,"numAtRisk":17,"numEvents":0}],"term":"Abscess"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":26,"numEvents":0},{"groupId":"EG006","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG007","numAffected":0,"numAtRisk":53,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG011","numAffected":0,"numAtRisk":17,"numEvents":0}],"term":"Brain abscess"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":26,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":53,"numEvents":0},{"groupId":"EG008","numAffected":1,"numAtRisk":47,"numEvents":1},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG011","numAffected":0,"numAtRisk":17,"numEvents":0}],"term":"Campylobacter infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":26,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":53,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG009","numAffected":2,"numAtRisk":28,"numEvents":2},{"groupId":"EG010","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG011","numAffected":0,"numAtRisk":17,"numEvents":0}],"term":"Cellulitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":26,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":53,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG009","numAffected":1,"numAtRisk":28,"numEvents":1},{"groupId":"EG010","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG011","numAffected":0,"numAtRisk":17,"numEvents":0}],"term":"Clostridium difficile infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":26,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":53,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG011","numAffected":1,"numAtRisk":17,"numEvents":1}],"term":"Cystitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":26,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":1,"numAtRisk":53,"numEvents":1},{"groupId":"EG008","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG011","numAffected":0,"numAtRisk":17,"numEvents":0}],"term":"Hepatitis B"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":26,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":53,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG009","numAffected":1,"numAtRisk":28,"numEvents":1},{"groupId":"EG010","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG011","numAffected":0,"numAtRisk":17,"numEvents":0}],"term":"Herpes simplex pneumonia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":9,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":26,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":53,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG011","numAffected":0,"numAtRisk":17,"numEvents":0}],"term":"Incision site infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":26,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":1,"numAtRisk":53,"numEvents":1},{"groupId":"EG008","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG011","numAffected":1,"numAtRisk":17,"numEvents":1}],"term":"Lower respiratory tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":1,"numAtRisk":26,"numEvents":1},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":53,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG011","numAffected":0,"numAtRisk":17,"numEvents":0}],"term":"Lung infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":26,"numEvents":0},{"groupId":"EG006","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG007","numAffected":0,"numAtRisk":53,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG011","numAffected":0,"numAtRisk":17,"numEvents":0}],"term":"Meningitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":26,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":1,"numAtRisk":53,"numEvents":1},{"groupId":"EG008","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG011","numAffected":0,"numAtRisk":17,"numEvents":0}],"term":"Perihepatic abscess"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":26,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":53,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":1,"numAtRisk":14,"numEvents":1},{"groupId":"EG011","numAffected":0,"numAtRisk":17,"numEvents":0}],"term":"Pneumococcal sepsis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":1,"numAtRisk":26,"numEvents":1},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":4,"numAtRisk":53,"numEvents":7},{"groupId":"EG008","numAffected":2,"numAtRisk":47,"numEvents":2},{"groupId":"EG009","numAffected":2,"numAtRisk":28,"numEvents":2},{"groupId":"EG010","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG011","numAffected":0,"numAtRisk":17,"numEvents":0}],"term":"Pneumonia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":9,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":1,"numAtRisk":26,"numEvents":1},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":4,"numAtRisk":53,"numEvents":5},{"groupId":"EG008","numAffected":1,"numAtRisk":47,"numEvents":2},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG011","numAffected":0,"numAtRisk":17,"numEvents":0}],"term":"Sepsis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":26,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":53,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG009","numAffected":1,"numAtRisk":28,"numEvents":1},{"groupId":"EG010","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG011","numAffected":1,"numAtRisk":17,"numEvents":1}],"term":"Septic shock"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":26,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":53,"numEvents":0},{"groupId":"EG008","numAffected":2,"numAtRisk":47,"numEvents":2},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG011","numAffected":0,"numAtRisk":17,"numEvents":0}],"term":"Urinary tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":26,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":53,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG011","numAffected":1,"numAtRisk":17,"numEvents":1}],"term":"Urosepsis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":1,"numAtRisk":26,"numEvents":1},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":53,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG011","numAffected":0,"numAtRisk":17,"numEvents":0}],"term":"Accidental overdose"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":26,"numEvents":0},{"groupId":"EG006","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG007","numAffected":0,"numAtRisk":53,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG011","numAffected":0,"numAtRisk":17,"numEvents":0}],"term":"Fall"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":26,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":53,"numEvents":0},{"groupId":"EG008","numAffected":1,"numAtRisk":47,"numEvents":1},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG011","numAffected":0,"numAtRisk":17,"numEvents":0}],"term":"Hip fracture"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":26,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":53,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG011","numAffected":1,"numAtRisk":17,"numEvents":1}],"term":"Overdose"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":26,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":1,"numAtRisk":53,"numEvents":1},{"groupId":"EG008","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG011","numAffected":0,"numAtRisk":17,"numEvents":0}],"term":"Subdural haematoma"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":26,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":53,"numEvents":0},{"groupId":"EG008","numAffected":1,"numAtRisk":47,"numEvents":1},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG011","numAffected":0,"numAtRisk":17,"numEvents":0}],"term":"Ammonia increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":26,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":1,"numAtRisk":53,"numEvents":1},{"groupId":"EG008","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":1,"numAtRisk":14,"numEvents":1},{"groupId":"EG011","numAffected":0,"numAtRisk":17,"numEvents":0}],"term":"Blood creatinine increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":1,"numAtRisk":26,"numEvents":1},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":53,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG011","numAffected":1,"numAtRisk":17,"numEvents":1}],"term":"Decreased appetite"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":7,"numEvents":1},{"groupId":"EG005","numAffected":0,"numAtRisk":26,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":2,"numAtRisk":53,"numEvents":2},{"groupId":"EG008","numAffected":2,"numAtRisk":47,"numEvents":2},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":1,"numAtRisk":14,"numEvents":1},{"groupId":"EG011","numAffected":2,"numAtRisk":17,"numEvents":2}],"term":"Dehydration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":7,"numEvents":1},{"groupId":"EG005","numAffected":0,"numAtRisk":26,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":53,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG009","numAffected":2,"numAtRisk":28,"numEvents":2},{"groupId":"EG010","numAffected":1,"numAtRisk":14,"numEvents":1},{"groupId":"EG011","numAffected":1,"numAtRisk":17,"numEvents":1}],"term":"Hyperglycaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":26,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":53,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG011","numAffected":1,"numAtRisk":17,"numEvents":1}],"term":"Hypokalaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":9,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":1,"numAtRisk":26,"numEvents":1},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":53,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG011","numAffected":0,"numAtRisk":17,"numEvents":0}],"term":"Hyponatraemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":1,"numAtRisk":26,"numEvents":1},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":53,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG011","numAffected":0,"numAtRisk":17,"numEvents":0}],"term":"Hypophosphataemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":26,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":53,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":1,"numAtRisk":14,"numEvents":1},{"groupId":"EG011","numAffected":0,"numAtRisk":17,"numEvents":0}],"term":"Metabolic acidosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":26,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":1,"numAtRisk":53,"numEvents":1},{"groupId":"EG008","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG011","numAffected":0,"numAtRisk":17,"numEvents":0}],"term":"Myositis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":26,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":53,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG009","numAffected":1,"numAtRisk":28,"numEvents":1},{"groupId":"EG010","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG011","numAffected":0,"numAtRisk":17,"numEvents":0}],"term":"Pain in extremity"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":9,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":26,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":53,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG011","numAffected":0,"numAtRisk":17,"numEvents":0}],"term":"Metastases to central nervous system"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":1,"numAtRisk":26,"numEvents":1},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":53,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG011","numAffected":0,"numAtRisk":17,"numEvents":0}],"term":"Non-small cell lung cancer metastatic"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":26,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":53,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG009","numAffected":1,"numAtRisk":28,"numEvents":1},{"groupId":"EG010","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG011","numAffected":0,"numAtRisk":17,"numEvents":0}],"term":"Tumour pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":26,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":53,"numEvents":0},{"groupId":"EG008","numAffected":1,"numAtRisk":47,"numEvents":1},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG011","numAffected":0,"numAtRisk":17,"numEvents":0}],"term":"Encephalopathy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":26,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":1,"numAtRisk":53,"numEvents":1},{"groupId":"EG008","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG011","numAffected":0,"numAtRisk":17,"numEvents":0}],"term":"Hepatic encephalopathy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":26,"numEvents":0},{"groupId":"EG006","numAffected":2,"numAtRisk":13,"numEvents":2},{"groupId":"EG007","numAffected":0,"numAtRisk":53,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG011","numAffected":0,"numAtRisk":17,"numEvents":0}],"term":"Peripheral motor neuropathy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":26,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":1,"numAtRisk":53,"numEvents":1},{"groupId":"EG008","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG009","numAffected":1,"numAtRisk":28,"numEvents":1},{"groupId":"EG010","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG011","numAffected":0,"numAtRisk":17,"numEvents":0}],"term":"Spinal cord compression"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":26,"numEvents":0},{"groupId":"EG006","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG007","numAffected":0,"numAtRisk":53,"numEvents":0},{"groupId":"EG008","numAffected":3,"numAtRisk":47,"numEvents":4},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG011","numAffected":0,"numAtRisk":17,"numEvents":0}],"term":"Syncope"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":1,"numAtRisk":26,"numEvents":2},{"groupId":"EG006","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG007","numAffected":1,"numAtRisk":53,"numEvents":1},{"groupId":"EG008","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG011","numAffected":0,"numAtRisk":17,"numEvents":0}],"term":"Confusional state"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":26,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":53,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":1,"numAtRisk":14,"numEvents":1},{"groupId":"EG011","numAffected":0,"numAtRisk":17,"numEvents":0}],"term":"Delusional disorder, persecutory type"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":26,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":53,"numEvents":0},{"groupId":"EG008","numAffected":1,"numAtRisk":47,"numEvents":1},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG011","numAffected":0,"numAtRisk":17,"numEvents":0}],"term":"Mania"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":9,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":26,"numEvents":0},{"groupId":"EG006","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG007","numAffected":0,"numAtRisk":53,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG011","numAffected":0,"numAtRisk":17,"numEvents":0}],"term":"Mental status changes"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":1,"numAtRisk":26,"numEvents":1},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":1,"numAtRisk":53,"numEvents":1},{"groupId":"EG008","numAffected":1,"numAtRisk":47,"numEvents":1},{"groupId":"EG009","numAffected":1,"numAtRisk":28,"numEvents":1},{"groupId":"EG010","numAffected":2,"numAtRisk":14,"numEvents":2},{"groupId":"EG011","numAffected":2,"numAtRisk":17,"numEvents":2}],"term":"Acute kidney injury"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":1,"numAtRisk":26,"numEvents":1},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":53,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG011","numAffected":0,"numAtRisk":17,"numEvents":0}],"term":"Haematuria"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":26,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":53,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":2,"numAtRisk":14,"numEvents":2},{"groupId":"EG011","numAffected":0,"numAtRisk":17,"numEvents":0}],"term":"Renal failure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":1,"numAtRisk":26,"numEvents":1},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":53,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG011","numAffected":0,"numAtRisk":17,"numEvents":0}],"term":"Renal tubular necrosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":1,"numAtRisk":26,"numEvents":1},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":53,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG011","numAffected":0,"numAtRisk":17,"numEvents":0}],"term":"Alveolitis allergic"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":9,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":26,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":53,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG011","numAffected":0,"numAtRisk":17,"numEvents":0}],"term":"Cough"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":9,"numEvents":2},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":26,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":53,"numEvents":0},{"groupId":"EG008","numAffected":1,"numAtRisk":47,"numEvents":1},{"groupId":"EG009","numAffected":2,"numAtRisk":28,"numEvents":2},{"groupId":"EG010","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG011","numAffected":1,"numAtRisk":17,"numEvents":1}],"term":"Dyspnoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":26,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":1,"numAtRisk":53,"numEvents":1},{"groupId":"EG008","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG011","numAffected":0,"numAtRisk":17,"numEvents":0}],"term":"Epistaxis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":1,"numAtRisk":26,"numEvents":1},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":1,"numAtRisk":53,"numEvents":1},{"groupId":"EG008","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG011","numAffected":0,"numAtRisk":17,"numEvents":0}],"term":"Haemoptysis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":26,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":53,"numEvents":0},{"groupId":"EG008","numAffected":1,"numAtRisk":47,"numEvents":1},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG011","numAffected":0,"numAtRisk":17,"numEvents":0}],"term":"Pleural effusion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":7,"numEvents":1},{"groupId":"EG005","numAffected":2,"numAtRisk":26,"numEvents":2},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":53,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG011","numAffected":0,"numAtRisk":17,"numEvents":0}],"term":"Pneumonitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":9,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":26,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":53,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG011","numAffected":0,"numAtRisk":17,"numEvents":0}],"term":"Pneumothorax"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":9,"numEvents":1},{"groupId":"EG003","numAffected":1,"numAtRisk":9,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":1,"numAtRisk":26,"numEvents":1},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":53,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG011","numAffected":0,"numAtRisk":17,"numEvents":0}],"term":"Respiratory distress"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":9,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":1,"numAtRisk":26,"numEvents":1},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":1,"numAtRisk":53,"numEvents":1},{"groupId":"EG008","numAffected":1,"numAtRisk":47,"numEvents":1},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG011","numAffected":0,"numAtRisk":17,"numEvents":0}],"term":"Respiratory failure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":26,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":2,"numAtRisk":53,"numEvents":2},{"groupId":"EG008","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG011","numAffected":0,"numAtRisk":17,"numEvents":0}],"term":"Dermatitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":1,"numAtRisk":26,"numEvents":1},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":53,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG011","numAffected":0,"numAtRisk":17,"numEvents":0}],"term":"Dermatitis acneiform"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":26,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":53,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG011","numAffected":1,"numAtRisk":17,"numEvents":1}],"term":"Rash"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":26,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":53,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG009","numAffected":1,"numAtRisk":28,"numEvents":1},{"groupId":"EG010","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG011","numAffected":0,"numAtRisk":17,"numEvents":0}],"term":"Rash macular"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":1,"numAtRisk":26,"numEvents":1},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":53,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG011","numAffected":0,"numAtRisk":17,"numEvents":0}],"term":"Rash maculo-papular"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":26,"numEvents":0},{"groupId":"EG006","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG007","numAffected":1,"numAtRisk":53,"numEvents":1},{"groupId":"EG008","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG011","numAffected":0,"numAtRisk":17,"numEvents":0}],"term":"Deep vein thrombosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":26,"numEvents":0},{"groupId":"EG006","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG007","numAffected":2,"numAtRisk":53,"numEvents":2},{"groupId":"EG008","numAffected":1,"numAtRisk":47,"numEvents":1},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG011","numAffected":0,"numAtRisk":17,"numEvents":0}],"term":"Hypotension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":1,"numAtRisk":26,"numEvents":1},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":53,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG011","numAffected":0,"numAtRisk":17,"numEvents":0}],"term":"Jugular vein thrombosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":9,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":7,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":26,"numEvents":0},{"groupId":"EG006","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG007","numAffected":0,"numAtRisk":53,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":47,"numEvents":0},{"groupId":"EG009","numAffected":0,"numAtRisk":28,"numEvents":0},{"groupId":"EG010","numAffected":0,"numAtRisk":14,"numEvents":0},{"groupId":"EG011","numAffected":0,"numAtRisk":17,"numEvents":0}],"term":"Thrombosis"}],"timeFrame":"All-Cause Mortality: From first dose through the course of the trial (up to approximately 6 years). Part A SAEs and AEs: From first dose to 100 days post last dose (up to approximately 14 months). Part B SAEs and AEs: From first dose to 100 days post last dose (up to approximately 49 months)."}