{"description":"Any untoward medicinal occurrence in a patient administered a medicinal product and which does not necessarily have a causal relationship with this treatment (Directive 2001/83/EC amended by Directive 2010/ 84/ EU). An AE can therefore be any unfavourable and unintended sign (e.g., abnormal laboratory finding), symptom or disease temporally associated with the use of a medicinal product, whether or not it is considered causally related to the medicinal product.","eventGroups":[{"deathsNumAffected":5,"deathsNumAtRisk":70,"description":"Adult oncology patients who have been treated for ≥ 1 episode of hyponatraemia secondary to the SIADH (defined as a serum sodium level \\<135 mmol/L)","id":"EG000","otherNumAffected":7,"otherNumAtRisk":70,"seriousNumAffected":10,"seriousNumAtRisk":70,"title":"Oncology Patients With Hyponatraemia"}],"frequencyThreshold":"2","otherEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDra (18.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":70,"numEvents":2}],"term":"Constipation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDra (18.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":70,"numEvents":2}],"term":"Pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDra (18.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":70,"numEvents":3}],"term":"Asthenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDra (18.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":70,"numEvents":2}],"term":"Respiratory failure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDra (18.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":70,"numEvents":2}],"term":"Anaemia"}],"seriousEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDra (18.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":70,"numEvents":2}],"term":"Pleural effusion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDra (18.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":70,"numEvents":1}],"term":"Ascites"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDra (18.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":70,"numEvents":1}],"term":"Listless"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDra (18.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":70,"numEvents":1}],"term":"Oesophageal stenosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDra (18.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":70,"numEvents":1}],"term":"Tachycardia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDra (18.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":70,"numEvents":3}],"term":"Dyspnoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDra (18.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":70,"numEvents":2}],"term":"Death"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDra (18.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":70,"numEvents":1}],"term":"Delirium"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDra (18.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":70,"numEvents":1}],"term":"General physical health deterioriation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDra (18.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":70,"numEvents":1}],"term":"Oedema peripheral"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDra (18.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":70,"numEvents":1}],"term":"Haemoptysis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDra (18.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":70,"numEvents":1}],"term":"Pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDra (18.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":70,"numEvents":1}],"term":"Acute respiratory failure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDra (18.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":70,"numEvents":1}],"term":"Seizure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDra (18.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":70,"numEvents":1}],"term":"Headache"}],"timeFrame":"From the onset of the hyponatraemia episode until 6 weeks afterwards"}