{"description":"AE is any sign or symptom that occurs during the study treatment plus the 84 days post treatment.\n\nThis is a single-arm study that evaluated the efficacy of Pasireotide LAR 40mmg and 60 mg. The Lanreotide and Octreotide arms were not really arms. These arms represent the drugs that the participants were on before being enrolled in the Pasireotide LAR arm.","eventGroups":[{"deathsNumAffected":0,"deathsNumAtRisk":92,"description":"Patients not achieving biochemical control and were up-titrated to pasireotide LAR 60 mg.","id":"EG000","otherNumAffected":83,"otherNumAtRisk":92,"seriousNumAffected":6,"seriousNumAtRisk":92,"title":"Up-titrated to Pasireotide LAR 60 mg"},{"deathsNumAffected":0,"deathsNumAtRisk":123,"description":"This is the sum total of participants in under the previous treatments in the Core phase: lanreotide 120 mg, octreotide 30 mg or octreotide 40 mg or who were treated with at least one dose of pasireotide LAR in the extension phase","id":"EG001","otherNumAffected":112,"otherNumAtRisk":123,"seriousNumAffected":12,"seriousNumAtRisk":123,"title":"Pasireotide LAR Overall"}],"frequencyThreshold":"2","otherEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":11,"numAtRisk":92},{"groupId":"EG001","numAffected":13,"numAtRisk":123}],"term":"Anaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":92},{"groupId":"EG001","numAffected":9,"numAtRisk":123}],"term":"Sinus bradycardia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":92},{"groupId":"EG001","numAffected":6,"numAtRisk":123}],"term":"Abdominal distension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":92},{"groupId":"EG001","numAffected":12,"numAtRisk":123}],"term":"Abdominal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":16,"numAtRisk":92},{"groupId":"EG001","numAffected":22,"numAtRisk":123}],"term":"Diarrhoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":92},{"groupId":"EG001","numAffected":7,"numAtRisk":123}],"term":"Nausea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":92},{"groupId":"EG001","numAffected":7,"numAtRisk":123}],"term":"Asthenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":92},{"groupId":"EG001","numAffected":8,"numAtRisk":123}],"term":"Fatigue"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":92},{"groupId":"EG001","numAffected":4,"numAtRisk":123}],"term":"Injection site pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":92},{"groupId":"EG001","numAffected":10,"numAtRisk":123}],"term":"Cholelithiasis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":92},{"groupId":"EG001","numAffected":7,"numAtRisk":123}],"term":"Hepatic steatosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":92},{"groupId":"EG001","numAffected":5,"numAtRisk":123}],"term":"Bronchitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":92},{"groupId":"EG001","numAffected":2,"numAtRisk":123}],"term":"Cystitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":92},{"groupId":"EG001","numAffected":11,"numAtRisk":123}],"term":"Influenza"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":92},{"groupId":"EG001","numAffected":8,"numAtRisk":123}],"term":"Upper respiratory tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":92},{"groupId":"EG001","numAffected":11,"numAtRisk":123}],"term":"Viral upper respiratory tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":92},{"groupId":"EG001","numAffected":8,"numAtRisk":123}],"term":"Blood glucose increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":22,"numAtRisk":92},{"groupId":"EG001","numAffected":29,"numAtRisk":123}],"term":"Diabetes mellitus"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":39,"numAtRisk":92},{"groupId":"EG001","numAffected":56,"numAtRisk":123}],"term":"Hyperglycaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":92},{"groupId":"EG001","numAffected":13,"numAtRisk":123}],"term":"Hypoglycaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":92},{"groupId":"EG001","numAffected":7,"numAtRisk":123}],"term":"Impaired fasting glucose"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":92},{"groupId":"EG001","numAffected":7,"numAtRisk":123}],"term":"Arthralgia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":92},{"groupId":"EG001","numAffected":6,"numAtRisk":123}],"term":"Back pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":92},{"groupId":"EG001","numAffected":6,"numAtRisk":123}],"term":"Muscle spasms"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":92},{"groupId":"EG001","numAffected":2,"numAtRisk":123}],"term":"Osteoarthritis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":92},{"groupId":"EG001","numAffected":8,"numAtRisk":123}],"term":"Pain in extremity"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":92},{"groupId":"EG001","numAffected":4,"numAtRisk":123}],"term":"Tendonitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":11,"numAtRisk":92},{"groupId":"EG001","numAffected":14,"numAtRisk":123}],"term":"Headache"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":92},{"groupId":"EG001","numAffected":6,"numAtRisk":123}],"term":"Paraesthesia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":92},{"groupId":"EG001","numAffected":11,"numAtRisk":123}],"term":"Alopecia"}],"seriousEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":92},{"groupId":"EG001","numAffected":1,"numAtRisk":123}],"term":"Neutropenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":92},{"groupId":"EG001","numAffected":1,"numAtRisk":123}],"term":"Stress cardiomyopathy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Endocrine disorders","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":92},{"groupId":"EG001","numAffected":2,"numAtRisk":123}],"term":"Adrenal insufficiency"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":92},{"groupId":"EG001","numAffected":1,"numAtRisk":123}],"term":"Abdominal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":92},{"groupId":"EG001","numAffected":1,"numAtRisk":123}],"term":"Diarrhoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":92},{"groupId":"EG001","numAffected":1,"numAtRisk":123}],"term":"Bile duct stone"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":92},{"groupId":"EG001","numAffected":1,"numAtRisk":123}],"term":"Biliary dilatation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":92},{"groupId":"EG001","numAffected":2,"numAtRisk":123}],"term":"Cholelithiasis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":92},{"groupId":"EG001","numAffected":1,"numAtRisk":123}],"term":"Tonsillitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":92},{"groupId":"EG001","numAffected":1,"numAtRisk":123}],"term":"Hyperglycaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":92},{"groupId":"EG001","numAffected":1,"numAtRisk":123}],"term":"Ketoacidosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":92},{"groupId":"EG001","numAffected":1,"numAtRisk":123}],"term":"Nose deformity"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":92},{"groupId":"EG001","numAffected":1,"numAtRisk":123}],"term":"Breast cancer"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":92},{"groupId":"EG001","numAffected":1,"numAtRisk":123}],"term":"Dermatofibrosarcoma protuberans"}],"timeFrame":"Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 84 days post treatment, up to maximum duration of 76 weeks."}