{"description":"AE documentation included onset/resolution dates, severity using NCI CTCAE (v4.0), seriousness, study drug action taken, treatment, and outcome. In summaries, treatment-related AEs included those with a \"possible\", \"probable\", or \"definite\" relationship to study drug; preferred terms were counted only once per subject at the maximum reported grade.","eventGroups":[{"description":"Includes all subjects who received at least 1 immunization with study drug.","id":"EG000","otherNumAffected":13,"otherNumAtRisk":13,"seriousNumAffected":4,"seriousNumAtRisk":13,"title":"Safety Analysis Set"}],"frequencyThreshold":"0","otherEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (13.1)","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":13}],"term":"Nausea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (13.1)","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":13}],"term":"Fatigue"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 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(13.1)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":13}],"term":"Flushing"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (13.1)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":13}],"term":"Leukopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (13.1)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":13}],"term":"Neuropathy peripheral"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (13.1)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":13}],"term":"Rash"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (13.1)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":13}],"term":"Sinusitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and 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(13.1)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":13}],"term":"Hypocalcaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (13.1)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":13}],"term":"Hypomagnesaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (13.1)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":13}],"term":"Influenza like illness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (13.1)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":13}],"term":"Myalgia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (13.1)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":13}],"term":"Neutropenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (13.1)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":13}],"term":"Oedema peripheral"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (13.1)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":13}],"term":"Oropharyngeal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (13.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":13}],"term":"Acute sinusitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA (13.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":13}],"term":"Agitation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal 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(13.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":13}],"term":"Nodule"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (13.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":13}],"term":"Non-cardiac chest pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (13.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":13}],"term":"Oedema"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (13.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":13}],"term":"Oral pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA (13.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":13}],"term":"Orthostatic hypotension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue 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and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (13.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":13,"numEvents":1}],"term":"Psoriasis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Grade 3, unresolved","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (13.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":13,"numEvents":1}],"term":"Connective tissue disorder"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Grade 3, resolved","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (13.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":13,"numEvents":1}],"term":"Diarrhoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Grade 2, resolved","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (13.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":13,"numEvents":1}],"term":"Vomiting"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Grade 2, 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AEs occurring or worsening after the first dose of study drug were considered treatment emergent (i.e., TEAEs)."}