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23.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":160},{"groupId":"EG001","numAffected":1,"numAtRisk":167}],"term":"Bronchospasm"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 23.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":160},{"groupId":"EG001","numAffected":0,"numAtRisk":167}],"term":"Idiopathic pneumonia syndrome"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 23.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":160},{"groupId":"EG001","numAffected":0,"numAtRisk":167}],"term":"Lung infiltration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 23.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":160},{"groupId":"EG001","numAffected":2,"numAtRisk":167}],"term":"Pneumonitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 23.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":160},{"groupId":"EG001","numAffected":1,"numAtRisk":167}],"term":"Pulmonary embolism"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 23.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":160},{"groupId":"EG001","numAffected":1,"numAtRisk":167}],"term":"Pulmonary toxicity"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 23.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":160},{"groupId":"EG001","numAffected":1,"numAtRisk":167}],"term":"Pruritus"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 23.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":160},{"groupId":"EG001","numAffected":1,"numAtRisk":167}],"term":"Rash"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 23.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":160},{"groupId":"EG001","numAffected":1,"numAtRisk":167}],"term":"Pelvic venous thrombosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 23.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":160},{"groupId":"EG001","numAffected":1,"numAtRisk":167}],"term":"Hypotension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 23.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":160},{"groupId":"EG001","numAffected":1,"numAtRisk":167}],"term":"Radiation myelopathy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 23.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":160},{"groupId":"EG001","numAffected":0,"numAtRisk":167}],"term":"Metastases to spine"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 23.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":160},{"groupId":"EG001","numAffected":1,"numAtRisk":167}],"term":"Myelodysplastic syndrome"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 23.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":160},{"groupId":"EG001","numAffected":2,"numAtRisk":167}],"term":"Dermatitis allergic"}],"timeFrame":"Non-serious adverse events were followed for up to 15 months. Serious adverse event data were collected for up to approximately 10 years (116 months)."}