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hyperplasia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"MedDRA Version 22.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":113},{"groupId":"EG001","numAffected":0,"numAtRisk":115}],"term":"Uterine prolapse"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA Version 22.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":113},{"groupId":"EG001","numAffected":1,"numAtRisk":115}],"term":"Acute respiratory failure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA Version 22.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":113},{"groupId":"EG001","numAffected":0,"numAtRisk":115}],"term":"Bronchitis chronic"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA Version 22.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":113},{"groupId":"EG001","numAffected":0,"numAtRisk":115}],"term":"Haemoptysis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA Version 22.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":113},{"groupId":"EG001","numAffected":0,"numAtRisk":115}],"term":"Pleural effusion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA Version 22.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":113},{"groupId":"EG001","numAffected":0,"numAtRisk":115}],"term":"Productive cough"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA Version 22.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":113},{"groupId":"EG001","numAffected":1,"numAtRisk":115}],"term":"Pulmonary embolism"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA Version 22.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":113},{"groupId":"EG001","numAffected":1,"numAtRisk":115}],"term":"Respiratory failure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA Version 22.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":113},{"groupId":"EG001","numAffected":1,"numAtRisk":115}],"term":"Hypertension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA Version 22.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":113},{"groupId":"EG001","numAffected":0,"numAtRisk":115}],"term":"Peripheral ischaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA Version 22.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":113},{"groupId":"EG001","numAffected":1,"numAtRisk":115}],"term":"Venous thrombosis limb"}],"timeFrame":"From first dose of study drug up to 30 days after the last dose of study drug. Median treatment duration for the IBR+OB arm was 42.3 (IBR) and 4.6 (OB) months. Median treatment duration for the CLB+OB arm was 5.1 (CLB) and 4.6 (OB) months. Final analysis data (data cutoff date: 17 October 2019)."}