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v27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":217,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":102,"numEvents":0}],"term":"Cholecystitis acute"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Immune system disorders","sourceVocabulary":"MedDRA v27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":217,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":102,"numEvents":0}],"term":"Cytokine release syndrome"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Product Issues","sourceVocabulary":"MedDRA v27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":217,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":102,"numEvents":1}],"term":"Device extrusion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA v27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":217,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":102,"numEvents":0}],"term":"Confusional state"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA v27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":217,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":102,"numEvents":0}],"term":"Angioedema"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Social circumstances","sourceVocabulary":"MedDRA v27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":217,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":102,"numEvents":0}],"term":"Loss of personal independence in daily activities"}],"timeFrame":"All-cause mortality, Non-Serious Adverse Events (non-SAEs) and Serious Adverse Events (SAEs) were collected up to approximately 263 weeks. The results presented are based on data cut-off date 22 April 2025."}