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consciousness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":51},{"groupId":"EG001","numAffected":0,"numAtRisk":53},{"groupId":"EG002","numAffected":0,"numAtRisk":53}],"term":"Acute kidney injury"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":51},{"groupId":"EG001","numAffected":1,"numAtRisk":53},{"groupId":"EG002","numAffected":0,"numAtRisk":53}],"term":"Urinary tract obstruction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 26.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":51},{"groupId":"EG001","numAffected":0,"numAtRisk":53},{"groupId":"EG002","numAffected":0,"numAtRisk":53}],"term":"Dyspnoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":51},{"groupId":"EG001","numAffected":0,"numAtRisk":53},{"groupId":"EG002","numAffected":0,"numAtRisk":53}],"term":"Pleuritic pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 26.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":51},{"groupId":"EG001","numAffected":1,"numAtRisk":53},{"groupId":"EG002","numAffected":0,"numAtRisk":53}],"term":"Pulmonary embolism"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":51},{"groupId":"EG001","numAffected":0,"numAtRisk":53},{"groupId":"EG002","numAffected":1,"numAtRisk":53}],"term":"Dermatitis acneiform"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":51},{"groupId":"EG001","numAffected":0,"numAtRisk":53},{"groupId":"EG002","numAffected":0,"numAtRisk":53}],"term":"Palmar-plantar erythrodysaesthesia syndrome"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":51},{"groupId":"EG001","numAffected":1,"numAtRisk":53},{"groupId":"EG002","numAffected":0,"numAtRisk":53}],"term":"Thrombosis"}],"timeFrame":"All-cause mortality: from randomization to min(max (death, EOS), DCO); median (min, max) time was 6.23 (0.1, 14.0) months. Adverse events includes events onset after first dose until min(last dose + 30 days, EOS, DCO); median (min, max) time was 4.70 (1.0, 13.4) months."}