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DECREASED"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (15.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":176},{"groupId":"EG001","numAffected":0,"numAtRisk":175}],"term":"WEIGHT DECREASED"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA (15.1)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":176},{"groupId":"EG001","numAffected":0,"numAtRisk":175}],"term":"CHOLELITHIASIS"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA (15.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":176},{"groupId":"EG001","numAffected":0,"numAtRisk":175}],"term":"CHOLECYSTITIS ACUTE NOS"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA (15.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":176},{"groupId":"EG001","numAffected":0,"numAtRisk":175}],"term":"HEPATIC FAILURE"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Endocrine disorders","sourceVocabulary":"MedDRA (15.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":176},{"groupId":"EG001","numAffected":1,"numAtRisk":175}],"term":"ACQUIRED HYPOTHYROIDISM"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Endocrine disorders","sourceVocabulary":"MedDRA (15.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":176},{"groupId":"EG001","numAffected":1,"numAtRisk":175}],"term":"ADRENAL INSUFFICIENCY NOS"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA (15.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":176},{"groupId":"EG001","numAffected":0,"numAtRisk":175}],"term":"CORNEAL ULCER"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA (15.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":176},{"groupId":"EG001","numAffected":1,"numAtRisk":175}],"term":"EXOPHTHALMOS NOS"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"MedDRA (15.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":176},{"groupId":"EG001","numAffected":0,"numAtRisk":175}],"term":"BREAST MICROCALCIFICATION"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA (15.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":176},{"groupId":"EG001","numAffected":0,"numAtRisk":175}],"term":"LUNG SQUAMOUS CELL CARCINOMA, STAGE UNSPECIFIED"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (15.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":176},{"groupId":"EG001","numAffected":0,"numAtRisk":175}],"term":"LEUKOPLAKIA NOS"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA (15.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":176},{"groupId":"EG001","numAffected":0,"numAtRisk":175}],"term":"PHLEBOTHROMBOSIS"}],"timeFrame":"From first dose of study drug to 30 days after the last visit. Up to 25 Jun 2013 (90 Months)."}