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disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":50}],"term":"Dyspnoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":50}],"term":"Epistaxis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":50}],"term":"Hypoxia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":50}],"term":"Pleural effusion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":50}],"term":"Pneumonitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":50}],"term":"Lichenoid keratosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":50}],"term":"Pain of skin"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":50}],"term":"Rash maculo-papular"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":50}],"term":"Embolism"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":50}],"term":"Haematoma"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":50}],"term":"Hypotension"}],"timeFrame":"Serious Adverse Events and other (not including serious) adverse events were assessed for up to 36 months. All cause mortality was assessed for up to 60 months."}