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Other, specify"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":27,"numEvents":1}],"term":"Sinusitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":27,"numEvents":1}],"term":"Alanine aminotransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":27,"numEvents":2}],"term":"Alkaline phosphatase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":27,"numEvents":1}],"term":"CPK increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":27,"numEvents":23}],"term":"Lymphocyte count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":23,"numAtRisk":27,"numEvents":133}],"term":"Neutrophil count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":18,"numAtRisk":27,"numEvents":85}],"term":"Platelet count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":27,"numEvents":12}],"term":"Weight loss"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":19,"numAtRisk":27,"numEvents":107}],"term":"White blood cell decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":27,"numEvents":4}],"term":"Anorexia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":27,"numEvents":1}],"term":"Dehydration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":27,"numEvents":19}],"term":"Arthralgia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":27,"numEvents":16}],"term":"Musculoskeletal and connective tissue disorder - Other, specify"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":19,"numAtRisk":27,"numEvents":146}],"term":"Myalgia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":12,"numAtRisk":27,"numEvents":44}],"term":"Dysgeusia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":27,"numEvents":3}],"term":"Headache"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":20,"numAtRisk":27,"numEvents":187}],"term":"Peripheral sensory neuropathy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":27,"numEvents":1}],"term":"Cough"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":27,"numEvents":11}],"term":"Alopecia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":27,"numEvents":2}],"term":"Dry skin"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":14,"numAtRisk":27,"numEvents":29}],"term":"Rash maculo-papular"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":27,"numEvents":3}],"term":"Skin and subcutaneous tissue disorders - Other, specify"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":27,"numEvents":7}],"term":"Hot flashes"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":27,"numEvents":1}],"term":"Hypertension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":27,"numEvents":10}],"term":"Thromboembolic event"}],"seriousEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":27,"numEvents":1}],"term":"Febrile neutropenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":27,"numEvents":1}],"term":"Nausea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":27,"numEvents":1}],"term":"Lung infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":27,"numEvents":1}],"term":"Syncope"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":27,"numEvents":1}],"term":"Acute kidney injury"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":27,"numEvents":1}],"term":"Hematuria"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":27,"numEvents":1}],"term":"Thromboembolic event"}],"timeFrame":"Adverse events were collected at the end of each 28-day cycle, for up to 18 cycles."}