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(19.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":209},{"groupId":"EG001","numAffected":0,"numAtRisk":211},{"groupId":"EG002","numAffected":0,"numAtRisk":28},{"groupId":"EG003","numAffected":1,"numAtRisk":420}],"term":"Dermatosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":209},{"groupId":"EG001","numAffected":0,"numAtRisk":211},{"groupId":"EG002","numAffected":0,"numAtRisk":28},{"groupId":"EG003","numAffected":1,"numAtRisk":420}],"term":"Hyperhidrosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":209},{"groupId":"EG001","numAffected":1,"numAtRisk":211},{"groupId":"EG002","numAffected":0,"numAtRisk":28},{"groupId":"EG003","numAffected":1,"numAtRisk":420}],"term":"Hyperkeratosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":209},{"groupId":"EG001","numAffected":1,"numAtRisk":211},{"groupId":"EG002","numAffected":0,"numAtRisk":28},{"groupId":"EG003","numAffected":1,"numAtRisk":420}],"term":"Skin lesion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":209},{"groupId":"EG001","numAffected":1,"numAtRisk":211},{"groupId":"EG002","numAffected":0,"numAtRisk":28},{"groupId":"EG003","numAffected":1,"numAtRisk":420}],"term":"Skin ulcer"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":209},{"groupId":"EG001","numAffected":1,"numAtRisk":211},{"groupId":"EG002","numAffected":0,"numAtRisk":28},{"groupId":"EG003","numAffected":2,"numAtRisk":420}],"term":"Deep vein thrombosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":209},{"groupId":"EG001","numAffected":0,"numAtRisk":211},{"groupId":"EG002","numAffected":0,"numAtRisk":28},{"groupId":"EG003","numAffected":1,"numAtRisk":420}],"term":"Hypertension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":209},{"groupId":"EG001","numAffected":2,"numAtRisk":211},{"groupId":"EG002","numAffected":1,"numAtRisk":28},{"groupId":"EG003","numAffected":9,"numAtRisk":420}],"term":"Hypotension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":209},{"groupId":"EG001","numAffected":1,"numAtRisk":211},{"groupId":"EG002","numAffected":0,"numAtRisk":28},{"groupId":"EG003","numAffected":1,"numAtRisk":420}],"term":"Hypovolaemic shock"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":209},{"groupId":"EG001","numAffected":1,"numAtRisk":211},{"groupId":"EG002","numAffected":0,"numAtRisk":28},{"groupId":"EG003","numAffected":1,"numAtRisk":420}],"term":"Peripheral ischaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":209},{"groupId":"EG001","numAffected":1,"numAtRisk":211},{"groupId":"EG002","numAffected":0,"numAtRisk":28},{"groupId":"EG003","numAffected":1,"numAtRisk":420}],"term":"Thrombophlebitis superficial"}],"timeFrame":"Adverse events were collected from First Patient First Treatment (FPFT) up to 30 days after study drug discontinuation, for a maximum duration of 77.4 months (treatment duration ranged from 0.1 to 76.4 months). In addition, new malignancies and AEs possibly related to study treatment were collected up to approximately 6 years"}