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24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":21,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":10,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":4,"numEvents":0}],"term":"Platelet count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA version 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":21,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":10,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":4,"numEvents":0}],"term":"Hyperkalaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA version 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":21,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":10,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":4,"numEvents":0}],"term":"Spinal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA version 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":21,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":10,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":4,"numEvents":0}],"term":"Peripheral motor neuropathy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Product Issues","sourceVocabulary":"MedDRA version 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":21,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":10,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":4,"numEvents":0}],"term":"Device issue"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA version 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":21,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":10,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":4,"numEvents":0}],"term":"Delirium"}],"timeFrame":"SAEs were collected from signing of the ICF until 30 days after the last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Maximum treatment durations for Cohorts 1a, 1b & 2a were 127.1, 94.7 and 36.1 weeks respectively. The AE reporting period is estimated to be 30 days longer."}