{"description":"Definition of an adverse event: any harmful manifestation occurring in a person who is amenable to research involving the human person, whether or not the event is related to the research or product to which the research relates.\n\nDefinition of a serious adverse event: any adverse event that causes death, is life-threatening, requires hospitalization or prolongation, causes disability, results in a congenital malformation, and any event considered medically significant.","eventGroups":[{"deathsNumAffected":0,"deathsNumAtRisk":8,"description":"Surgery of the pituitary adenoma via a transoral approach assisted by the da Vinci® Si™ robot","id":"EG000","otherNumAffected":7,"otherNumAtRisk":8,"seriousNumAffected":4,"seriousNumAtRisk":8,"title":"Transoral Surgery"}],"frequencyThreshold":"0","otherEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"polyuro-polydipsic syndrome","organSystem":"Endocrine disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":8,"numEvents":3}],"term":"Diabetes insipidus"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":8,"numEvents":5}],"term":"Headaches"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":8,"numEvents":1}],"term":"Epistaxis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":8,"numEvents":2}],"term":"Nausea/vomiting"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":8,"numEvents":3}],"term":"Laryngeal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":8,"numEvents":3}],"term":"Visual trouble"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":8,"numEvents":1}],"term":"Asthenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":8,"numEvents":1}],"term":"Dysphagia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":8,"numEvents":1}],"term":"Fever"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":8,"numEvents":1}],"term":"Post-lumbar puncture syndrome"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":8,"numEvents":1}],"term":"Anxiety"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":8,"numEvents":1}],"term":"Rash"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":8,"numEvents":1}],"term":"Pneumocephalus"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Endocrine disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":8,"numEvents":1}],"term":"Corticotropin deficiency"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":8,"numEvents":1}],"term":"Constipation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":8,"numEvents":1}],"term":"Paralysis of the nerve III"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":8,"numEvents":1}],"term":"Pain at the incision site"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Ear and labyrinth disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":8,"numEvents":1}],"term":"Vertigo"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":8,"numEvents":1}],"term":"Torticollis"}],"seriousEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Rhinorrhea with cerebrospinal fluid","organSystem":"Surgical and medical procedures","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":8,"numEvents":1}],"term":"Complication of neurological intervention"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Resumption of surgery","organSystem":"Surgical and medical procedures","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":8,"numEvents":2}],"term":"Injury, poisoning and complications of interventions"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Acute coronary syndrome during anesthesia (surgery of excision of the adenoma canceled)","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":8,"numEvents":1}],"term":"Injuries and complications related to an intervention"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Stroke post surgical revision","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":8,"numEvents":1}],"term":"Stroke"}],"timeFrame":"6 months"}