{"description":"Safety analyses were pre-specified to only report the most severe event if the same events were occurred to the same patient.\n\nFor CT-P13 IV 5mg/kg group, the safety analyses were performed ITT population. For CT-P13 SC and Placebo groups, the safety analyses were performed in the safety population. Analysis of safety population were performed based on the actual treatment group and differences from the randomized population accordingly.","eventGroups":[{"deathsNumAffected":0,"deathsNumAtRisk":396,"description":"Patients who administered CT-P13 IV 5mg/kg at Week 0, 2, and 6.","id":"EG000","otherNumAffected":51,"otherNumAtRisk":396,"seriousNumAffected":12,"seriousNumAtRisk":396,"title":"CT-P13 IV 5 mg/kg"},{"deathsNumAffected":1,"deathsNumAtRisk":238,"description":"Patients who administered CT-P13 SC 120 mg every 2 weeks from W10 to Week 54. Patients who received adjusted dose of CT-P13 SC 240mg which is allowed from Week 22 are also included.","id":"EG001","otherNumAffected":75,"otherNumAtRisk":238,"seriousNumAffected":16,"seriousNumAtRisk":238,"title":"CT-P13 SC 120 mg (Including 240 mg)"},{"deathsNumAffected":1,"deathsNumAtRisk":238,"description":"Patients who administered CT-P13 SC 120 mg every 2 weeks from W10 to Week 54. For patients who received adjusted dose of CT-P13 SC 240mg, data collected before initiation of dose adjustment are included.","id":"EG002","otherNumAffected":70,"otherNumAtRisk":238,"seriousNumAffected":15,"seriousNumAtRisk":238,"title":"CT-P13 SC 120 mg"},{"deathsNumAffected":0,"deathsNumAtRisk":45,"description":"Patients who administered CT-P13 SC 120 mg every 2 weeks from W10 and initiated adjusted dose of CT-P13 SC 240mg which is allowed from Week 22.","id":"EG003","otherNumAffected":9,"otherNumAtRisk":45,"seriousNumAffected":1,"seriousNumAtRisk":45,"title":"CT-P13 SC 120 mg to 240 mg"},{"deathsNumAffected":0,"deathsNumAtRisk":105,"description":"Patients who administered Placebo every 2 weeks from W10 to Week 54. For patients who received adjusted dose of CT-P13 SC 240mg, data collected before initiation of dose adjustment are included.","id":"EG004","otherNumAffected":30,"otherNumAtRisk":105,"seriousNumAffected":8,"seriousNumAtRisk":105,"title":"Placebo"}],"frequencyThreshold":"5","otherEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":16,"numAtRisk":396},{"groupId":"EG001","numAffected":13,"numAtRisk":238},{"groupId":"EG002","numAffected":11,"numAtRisk":238},{"groupId":"EG003","numAffected":3,"numAtRisk":45},{"groupId":"EG004","numAffected":5,"numAtRisk":105}],"term":"Anaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":396},{"groupId":"EG001","numAffected":12,"numAtRisk":238},{"groupId":"EG002","numAffected":11,"numAtRisk":238},{"groupId":"EG003","numAffected":1,"numAtRisk":45},{"groupId":"EG004","numAffected":17,"numAtRisk":105}],"term":"Crohn's disease"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":396},{"groupId":"EG001","numAffected":14,"numAtRisk":238},{"groupId":"EG002","numAffected":11,"numAtRisk":238},{"groupId":"EG003","numAffected":3,"numAtRisk":45},{"groupId":"EG004","numAffected":1,"numAtRisk":105}],"term":"Injection site reaction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":396},{"groupId":"EG001","numAffected":27,"numAtRisk":238},{"groupId":"EG002","numAffected":22,"numAtRisk":238},{"groupId":"EG003","numAffected":5,"numAtRisk":45},{"groupId":"EG004","numAffected":5,"numAtRisk":105}],"term":"COVID-19"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":18,"numAtRisk":396},{"groupId":"EG001","numAffected":18,"numAtRisk":238},{"groupId":"EG002","numAffected":18,"numAtRisk":238},{"groupId":"EG003","numAffected":0,"numAtRisk":45},{"groupId":"EG004","numAffected":5,"numAtRisk":105}],"term":"Headache"}],"seriousEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":396},{"groupId":"EG001","numAffected":0,"numAtRisk":238},{"groupId":"EG002","numAffected":0,"numAtRisk":238},{"groupId":"EG003","numAffected":0,"numAtRisk":45},{"groupId":"EG004","numAffected":1,"numAtRisk":105}],"term":"Anaemia (study drug unrelated)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":396},{"groupId":"EG001","numAffected":0,"numAtRisk":238},{"groupId":"EG002","numAffected":0,"numAtRisk":238},{"groupId":"EG003","numAffected":0,"numAtRisk":45},{"groupId":"EG004","numAffected":0,"numAtRisk":105}],"term":"Cardiovascular insufficiency (study drug unrelated)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":396},{"groupId":"EG001","numAffected":3,"numAtRisk":238},{"groupId":"EG002","numAffected":3,"numAtRisk":238},{"groupId":"EG003","numAffected":0,"numAtRisk":45},{"groupId":"EG004","numAffected":1,"numAtRisk":105}],"term":"Crohn's disease (study drug unrelated)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":396},{"groupId":"EG001","numAffected":1,"numAtRisk":238},{"groupId":"EG002","numAffected":0,"numAtRisk":238},{"groupId":"EG003","numAffected":1,"numAtRisk":45},{"groupId":"EG004","numAffected":0,"numAtRisk":105}],"term":"Haemorrhoids (study drug unrelated)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":396},{"groupId":"EG001","numAffected":0,"numAtRisk":238},{"groupId":"EG002","numAffected":0,"numAtRisk":238},{"groupId":"EG003","numAffected":0,"numAtRisk":45},{"groupId":"EG004","numAffected":0,"numAtRisk":105}],"term":"Intestinal obstruction (study drug unrelated)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":396},{"groupId":"EG001","numAffected":0,"numAtRisk":238},{"groupId":"EG002","numAffected":0,"numAtRisk":238},{"groupId":"EG003","numAffected":0,"numAtRisk":45},{"groupId":"EG004","numAffected":1,"numAtRisk":105}],"term":"Intestinal perforation (study drug unrelated)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":396},{"groupId":"EG001","numAffected":1,"numAtRisk":238},{"groupId":"EG002","numAffected":1,"numAtRisk":238},{"groupId":"EG003","numAffected":0,"numAtRisk":45},{"groupId":"EG004","numAffected":0,"numAtRisk":105}],"term":"Subileus (study drug unrelated)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":396},{"groupId":"EG001","numAffected":1,"numAtRisk":238},{"groupId":"EG002","numAffected":1,"numAtRisk":238},{"groupId":"EG003","numAffected":0,"numAtRisk":45},{"groupId":"EG004","numAffected":0,"numAtRisk":105}],"term":"Accidental death (study drug unrelated)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":396},{"groupId":"EG001","numAffected":0,"numAtRisk":238},{"groupId":"EG002","numAffected":0,"numAtRisk":238},{"groupId":"EG003","numAffected":0,"numAtRisk":45},{"groupId":"EG004","numAffected":0,"numAtRisk":105}],"term":"Abdominal abscess (study drug unrelated)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":396},{"groupId":"EG001","numAffected":0,"numAtRisk":238},{"groupId":"EG002","numAffected":0,"numAtRisk":238},{"groupId":"EG003","numAffected":0,"numAtRisk":45},{"groupId":"EG004","numAffected":0,"numAtRisk":105}],"term":"Abdominal sepsis (study drug unrelated)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":396},{"groupId":"EG001","numAffected":0,"numAtRisk":238},{"groupId":"EG002","numAffected":0,"numAtRisk":238},{"groupId":"EG003","numAffected":0,"numAtRisk":45},{"groupId":"EG004","numAffected":0,"numAtRisk":105}],"term":"Abdominal wall abscess (study drug unrelated)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":396},{"groupId":"EG001","numAffected":1,"numAtRisk":238},{"groupId":"EG002","numAffected":1,"numAtRisk":238},{"groupId":"EG003","numAffected":0,"numAtRisk":45},{"groupId":"EG004","numAffected":0,"numAtRisk":105}],"term":"Abscess intestinal (study drug unrelated)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":396},{"groupId":"EG001","numAffected":1,"numAtRisk":238},{"groupId":"EG002","numAffected":1,"numAtRisk":238},{"groupId":"EG003","numAffected":0,"numAtRisk":45},{"groupId":"EG004","numAffected":0,"numAtRisk":105}],"term":"Anal abscess (study drug unrelated)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":396},{"groupId":"EG001","numAffected":1,"numAtRisk":238},{"groupId":"EG002","numAffected":1,"numAtRisk":238},{"groupId":"EG003","numAffected":0,"numAtRisk":45},{"groupId":"EG004","numAffected":0,"numAtRisk":105}],"term":"Appendicitis (study drug unrelated)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":396},{"groupId":"EG001","numAffected":1,"numAtRisk":238},{"groupId":"EG002","numAffected":1,"numAtRisk":238},{"groupId":"EG003","numAffected":0,"numAtRisk":45},{"groupId":"EG004","numAffected":0,"numAtRisk":105}],"term":"Arthritis bacterial (study drug related)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":396},{"groupId":"EG001","numAffected":1,"numAtRisk":238},{"groupId":"EG002","numAffected":1,"numAtRisk":238},{"groupId":"EG003","numAffected":0,"numAtRisk":45},{"groupId":"EG004","numAffected":0,"numAtRisk":105}],"term":"Bartholinitis (study drug unrelated)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":396},{"groupId":"EG001","numAffected":1,"numAtRisk":238},{"groupId":"EG002","numAffected":1,"numAtRisk":238},{"groupId":"EG003","numAffected":0,"numAtRisk":45},{"groupId":"EG004","numAffected":0,"numAtRisk":105}],"term":"Bronchiolitis (study drug unrelated)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":396},{"groupId":"EG001","numAffected":0,"numAtRisk":238},{"groupId":"EG002","numAffected":0,"numAtRisk":238},{"groupId":"EG003","numAffected":0,"numAtRisk":45},{"groupId":"EG004","numAffected":0,"numAtRisk":105}],"term":"Cytomegalovirus colitis (study drug related)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":396},{"groupId":"EG001","numAffected":0,"numAtRisk":238},{"groupId":"EG002","numAffected":0,"numAtRisk":238},{"groupId":"EG003","numAffected":0,"numAtRisk":45},{"groupId":"EG004","numAffected":0,"numAtRisk":105}],"term":"Intestinal tuberculosis (study drug related)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":396},{"groupId":"EG001","numAffected":0,"numAtRisk":238},{"groupId":"EG002","numAffected":0,"numAtRisk":238},{"groupId":"EG003","numAffected":0,"numAtRisk":45},{"groupId":"EG004","numAffected":0,"numAtRisk":105}],"term":"Orchitis (study drug unrelated)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":396},{"groupId":"EG001","numAffected":0,"numAtRisk":238},{"groupId":"EG002","numAffected":0,"numAtRisk":238},{"groupId":"EG003","numAffected":0,"numAtRisk":45},{"groupId":"EG004","numAffected":1,"numAtRisk":105}],"term":"Peritonitis (study drug unrelated)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":396},{"groupId":"EG001","numAffected":1,"numAtRisk":238},{"groupId":"EG002","numAffected":1,"numAtRisk":238},{"groupId":"EG003","numAffected":0,"numAtRisk":45},{"groupId":"EG004","numAffected":0,"numAtRisk":105}],"term":"Urinary tract infection (study drug related)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":396},{"groupId":"EG001","numAffected":0,"numAtRisk":238},{"groupId":"EG002","numAffected":0,"numAtRisk":238},{"groupId":"EG003","numAffected":0,"numAtRisk":45},{"groupId":"EG004","numAffected":1,"numAtRisk":105}],"term":"Humerus fracture (study drug unrelated)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":396},{"groupId":"EG001","numAffected":0,"numAtRisk":238},{"groupId":"EG002","numAffected":0,"numAtRisk":238},{"groupId":"EG003","numAffected":0,"numAtRisk":45},{"groupId":"EG004","numAffected":0,"numAtRisk":105}],"term":"Infusion related reaction (study drug related)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":396},{"groupId":"EG001","numAffected":1,"numAtRisk":238},{"groupId":"EG002","numAffected":1,"numAtRisk":238},{"groupId":"EG003","numAffected":0,"numAtRisk":45},{"groupId":"EG004","numAffected":0,"numAtRisk":105}],"term":"Skin laceration (study drug unrelated)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":396},{"groupId":"EG001","numAffected":0,"numAtRisk":238},{"groupId":"EG002","numAffected":0,"numAtRisk":238},{"groupId":"EG003","numAffected":0,"numAtRisk":45},{"groupId":"EG004","numAffected":1,"numAtRisk":105}],"term":"Blood creatine phosphokinase increased (study drug related)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 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25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":396},{"groupId":"EG001","numAffected":1,"numAtRisk":238},{"groupId":"EG002","numAffected":1,"numAtRisk":238},{"groupId":"EG003","numAffected":0,"numAtRisk":45},{"groupId":"EG004","numAffected":0,"numAtRisk":105}],"term":"Altered state of consciousness (study drug unrelated)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":396},{"groupId":"EG001","numAffected":1,"numAtRisk":238},{"groupId":"EG002","numAffected":1,"numAtRisk":238},{"groupId":"EG003","numAffected":0,"numAtRisk":45},{"groupId":"EG004","numAffected":0,"numAtRisk":105}],"term":"Neurovascular conflict (study drug unrelated)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":396},{"groupId":"EG001","numAffected":1,"numAtRisk":238},{"groupId":"EG002","numAffected":1,"numAtRisk":238},{"groupId":"EG003","numAffected":0,"numAtRisk":45},{"groupId":"EG004","numAffected":0,"numAtRisk":105}],"term":"Mixed anxiety and depressive disorder (study drug unrelated)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":396},{"groupId":"EG001","numAffected":0,"numAtRisk":238},{"groupId":"EG002","numAffected":0,"numAtRisk":238},{"groupId":"EG003","numAffected":0,"numAtRisk":45},{"groupId":"EG004","numAffected":1,"numAtRisk":105}],"term":"Psychotic disorder (study drug unrelated)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":396},{"groupId":"EG001","numAffected":0,"numAtRisk":238},{"groupId":"EG002","numAffected":0,"numAtRisk":238},{"groupId":"EG003","numAffected":0,"numAtRisk":45},{"groupId":"EG004","numAffected":0,"numAtRisk":105}],"term":"Acute respiratory failure (study drug unrelated)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":396},{"groupId":"EG001","numAffected":0,"numAtRisk":238},{"groupId":"EG002","numAffected":0,"numAtRisk":238},{"groupId":"EG003","numAffected":0,"numAtRisk":45},{"groupId":"EG004","numAffected":0,"numAtRisk":105}],"term":"Pulmonary embolism (study drug unrelated)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":396},{"groupId":"EG001","numAffected":1,"numAtRisk":238},{"groupId":"EG002","numAffected":1,"numAtRisk":238},{"groupId":"EG003","numAffected":0,"numAtRisk":45},{"groupId":"EG004","numAffected":0,"numAtRisk":105}],"term":"Acne fulminans (study drug unrelated)"}],"timeFrame":"For CT-P13 SC and Placebo groups, the overall summary of Treatment-Emergent Adverse Events during the maintenance period (from Week 10 to Week 54) was reported. For CT-P13 IV 5mg/kg group, the overall summary of Treatment-Emergent Adverse Events during the induction phase (from Week 0 to prior to Week 10, before initiation of CT-P13 SC administeration) was reported."}