{"description":"An Adverse Event is any untoward medical occurrence temporally associated with the use of a medical product in a patient, whether or not the event is considered causally related to the medical product.26 An AE can be a new occurrence or an existing process that increases significantly in intensity or frequency.","eventGroups":[{"deathsNumAffected":0,"deathsNumAtRisk":5,"description":"Subcutaneous injection of IMO-8400 0.6mg/kg/wk or 1.2 mg/kg twice weekly per Protocol 8400-401","id":"EG000","otherNumAffected":4,"otherNumAtRisk":5,"seriousNumAffected":0,"seriousNumAtRisk":5,"title":"IMO-8400 at 0.6 mg/kg/wk or 1.2 mg/kg 2xwk"}],"frequencyThreshold":"5","otherEvents":[{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (16.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":5}],"term":"Lymphadenopathy"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA (16.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":5}],"term":"Conjunctival hemorrhage"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (16.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":5}],"term":"Abdominal pain lower"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (16.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":5}],"term":"Gastroesophageal reflux disease"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (16.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":5}],"term":"Vomiting"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (16.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":5}],"term":"Asthenia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (16.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":5}],"term":"Influenza like illness"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (16.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":5}],"term":"Injection site bruising"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (16.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":5}],"term":"Injection site discoloration"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (16.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":5}],"term":"Injection site erythema"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (16.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":5}],"term":"Edema peripheral"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (16.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":5}],"term":"Pneumonia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (16.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":5}],"term":"Upper respiratory tract infection"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA (16.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":5}],"term":"Arthropod bite"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA (16.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":5}],"term":"Excoriation"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA (16.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":5}],"term":"Infusion related reaction"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (16.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":5}],"term":"Dehydration"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (16.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":5}],"term":"Bone pain"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (16.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":5}],"term":"Flank pain"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (16.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":5}],"term":"Neuropathy peripheral"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (16.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":5}],"term":"Joint swelling"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (16.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":5}],"term":"Dizziness"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (16.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":5}],"term":"Headache"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"MedDRA (16.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":5}],"term":"Benign prostatic hyperplasia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (16.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":5}],"term":"Pleurisy"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (16.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":5}],"term":"Panniculitis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (16.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":5}],"term":"Pigmentation disorder"}],"timeFrame":"During receipt of study treatment on the trial."}