{"description":"Only 389 subjects (including one subject with 3 placebo injections) received study drug (Safety set). Subjects who received more than one active dose were counted in each treatment group, leading to an artificial safety set of 399 subjects.","eventGroups":[{"description":"Patients on this arm received 150 mg subcutaneously (s.c.) at randomization and upon new flare. The doses were provided as pre-filled syringes. The patients were given 3 injections: two placebo and one active drug.","id":"EG000","otherNumAffected":0,"otherNumAtRisk":133,"seriousNumAffected":6,"seriousNumAtRisk":133,"title":"Canakinumab, Pre-filled Syringes (PFS)"},{"description":"The patients on this arm received 150 mg s.c. at randomization and upon new flare. The doses were provided as lyophilized power and had to be reconstituted with water for injection before application. The patients were given 3 injections: two placebo and one active drug.","id":"EG001","otherNumAffected":0,"otherNumAtRisk":133,"seriousNumAffected":6,"seriousNumAtRisk":133,"title":"Canakinumab, Lyophilizate (LYO)"},{"description":"The patients on this arm received 40 mg intramuscular (i.m.) at randomization and upon new flare. The patients were given 3 injections: two placebo and one active drug.","id":"EG002","otherNumAffected":0,"otherNumAtRisk":133,"seriousNumAffected":5,"seriousNumAtRisk":133,"title":"Triamcinolone Acetonide"}],"frequencyThreshold":"5","seriousEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 14.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":133},{"groupId":"EG001","numAffected":1,"numAtRisk":133},{"groupId":"EG002","numAffected":0,"numAtRisk":133}],"term":"Angina unstable"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 14.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":133},{"groupId":"EG001","numAffected":1,"numAtRisk":133},{"groupId":"EG002","numAffected":0,"numAtRisk":133}],"term":"Cardiac failure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 14.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":133},{"groupId":"EG001","numAffected":1,"numAtRisk":133},{"groupId":"EG002","numAffected":0,"numAtRisk":133}],"term":"Coronary artery disease"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 14.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":133},{"groupId":"EG001","numAffected":0,"numAtRisk":133},{"groupId":"EG002","numAffected":1,"numAtRisk":133}],"term":"Myocardial infarction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 14.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":133},{"groupId":"EG001","numAffected":0,"numAtRisk":133},{"groupId":"EG002","numAffected":1,"numAtRisk":133}],"term":"Constipation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 14.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":133},{"groupId":"EG001","numAffected":0,"numAtRisk":133},{"groupId":"EG002","numAffected":1,"numAtRisk":133}],"term":"Chest pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 14.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":133},{"groupId":"EG001","numAffected":0,"numAtRisk":133},{"groupId":"EG002","numAffected":1,"numAtRisk":133}],"term":"Drug ineffective"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 14.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":133},{"groupId":"EG001","numAffected":1,"numAtRisk":133},{"groupId":"EG002","numAffected":0,"numAtRisk":133}],"term":"Respiratory tract infection viral"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 14.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":133},{"groupId":"EG001","numAffected":1,"numAtRisk":133},{"groupId":"EG002","numAffected":0,"numAtRisk":133}],"term":"Staphylococcal bacteraemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 14.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":133},{"groupId":"EG001","numAffected":0,"numAtRisk":133},{"groupId":"EG002","numAffected":0,"numAtRisk":133}],"term":"Viral infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 14.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":133},{"groupId":"EG001","numAffected":0,"numAtRisk":133},{"groupId":"EG002","numAffected":0,"numAtRisk":133}],"term":"Wound infection staphylococcal"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 14.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":133},{"groupId":"EG001","numAffected":0,"numAtRisk":133},{"groupId":"EG002","numAffected":0,"numAtRisk":133}],"term":"Muscle rupture"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 14.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":133},{"groupId":"EG001","numAffected":0,"numAtRisk":133},{"groupId":"EG002","numAffected":0,"numAtRisk":133}],"term":"Migraine"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 14.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":133},{"groupId":"EG001","numAffected":0,"numAtRisk":133},{"groupId":"EG002","numAffected":0,"numAtRisk":133}],"term":"Delirium"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 14.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":133},{"groupId":"EG001","numAffected":0,"numAtRisk":133},{"groupId":"EG002","numAffected":1,"numAtRisk":133}],"term":"Depression"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 14.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":133},{"groupId":"EG001","numAffected":0,"numAtRisk":133},{"groupId":"EG002","numAffected":0,"numAtRisk":133}],"term":"Calculus ureteric"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 14.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":133},{"groupId":"EG001","numAffected":0,"numAtRisk":133},{"groupId":"EG002","numAffected":0,"numAtRisk":133}],"term":"Obstructive uropathy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 14.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":133},{"groupId":"EG001","numAffected":1,"numAtRisk":133},{"groupId":"EG002","numAffected":0,"numAtRisk":133}],"term":"Asthma"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 14.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":133},{"groupId":"EG001","numAffected":1,"numAtRisk":133},{"groupId":"EG002","numAffected":0,"numAtRisk":133}],"term":"Aortitis"}],"timeFrame":"12 weeks"}