{"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":548,"description":"Patients who administered CT-P13 IV 5mg/kg at Week 0, 2, and 6.","id":"EG000","otherNumAffected":89,"otherNumAtRisk":548,"seriousNumAffected":23,"seriousNumAtRisk":548,"title":"CT-P13 IV 5 mg/kg"},{"deathsNumAffected":0,"deathsNumAtRisk":296,"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":60,"otherNumAtRisk":296,"seriousNumAffected":15,"seriousNumAtRisk":296,"title":"CT-P13 SC 120 mg"},{"deathsNumAffected":0,"deathsNumAtRisk":140,"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":"EG002","otherNumAffected":37,"otherNumAtRisk":140,"seriousNumAffected":4,"seriousNumAtRisk":140,"title":"Placebo"}],"frequencyThreshold":"5","otherEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":34,"numAtRisk":548},{"groupId":"EG001","numAffected":11,"numAtRisk":296},{"groupId":"EG002","numAffected":5,"numAtRisk":140}],"term":"Anaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":13,"numAtRisk":548},{"groupId":"EG001","numAffected":13,"numAtRisk":296},{"groupId":"EG002","numAffected":13,"numAtRisk":140}],"term":"Colitis ulcerative"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":13,"numAtRisk":548},{"groupId":"EG001","numAffected":26,"numAtRisk":296},{"groupId":"EG002","numAffected":9,"numAtRisk":140}],"term":"COVID-19"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":548},{"groupId":"EG001","numAffected":5,"numAtRisk":296},{"groupId":"EG002","numAffected":7,"numAtRisk":140}],"term":"Nasopharyngitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":30,"numAtRisk":548},{"groupId":"EG001","numAffected":15,"numAtRisk":296},{"groupId":"EG002","numAffected":7,"numAtRisk":140}],"term":"Headache"}],"seriousEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":548},{"groupId":"EG001","numAffected":1,"numAtRisk":296},{"groupId":"EG002","numAffected":0,"numAtRisk":140}],"term":"Anaemia (Study drug unrelated)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":548},{"groupId":"EG001","numAffected":1,"numAtRisk":296},{"groupId":"EG002","numAffected":0,"numAtRisk":140}],"term":"Iron deficiency anaemia (study drug unrelated)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":548},{"groupId":"EG001","numAffected":1,"numAtRisk":296},{"groupId":"EG002","numAffected":0,"numAtRisk":140}],"term":"Aortic valve incompetence (study drug unrelated)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":548},{"groupId":"EG001","numAffected":1,"numAtRisk":296},{"groupId":"EG002","numAffected":0,"numAtRisk":140}],"term":"Cardiac failure (study drug unrelated)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":548},{"groupId":"EG001","numAffected":2,"numAtRisk":296},{"groupId":"EG002","numAffected":1,"numAtRisk":140}],"term":"Colitis ulcerative (study drug unrelated)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":548},{"groupId":"EG001","numAffected":0,"numAtRisk":296},{"groupId":"EG002","numAffected":0,"numAtRisk":140}],"term":"Duodenal ulcer (study drug unrelated)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":548},{"groupId":"EG001","numAffected":1,"numAtRisk":296},{"groupId":"EG002","numAffected":0,"numAtRisk":140}],"term":"Duodenal ulcer perforation (study drug unrelated)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":548},{"groupId":"EG001","numAffected":0,"numAtRisk":296},{"groupId":"EG002","numAffected":0,"numAtRisk":140}],"term":"Intestinal obstruction (study drug unrelated)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":548},{"groupId":"EG001","numAffected":0,"numAtRisk":296},{"groupId":"EG002","numAffected":0,"numAtRisk":140}],"term":"Intestinal strangulation (study drug unrelated)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":548},{"groupId":"EG001","numAffected":0,"numAtRisk":296},{"groupId":"EG002","numAffected":0,"numAtRisk":140}],"term":"Large intestine perforation (study drug unrelated)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":548},{"groupId":"EG001","numAffected":0,"numAtRisk":296},{"groupId":"EG002","numAffected":0,"numAtRisk":140}],"term":"Pancreatitis acute (study drug related)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":548},{"groupId":"EG001","numAffected":0,"numAtRisk":296},{"groupId":"EG002","numAffected":1,"numAtRisk":140}],"term":"Rectal haemorrhage (study drug unrelated)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":548},{"groupId":"EG001","numAffected":0,"numAtRisk":296},{"groupId":"EG002","numAffected":0,"numAtRisk":140}],"term":"Appendicitis (study drug unrelated)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":548},{"groupId":"EG001","numAffected":1,"numAtRisk":296},{"groupId":"EG002","numAffected":0,"numAtRisk":140}],"term":"COVID-19 (study drug unrelated)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":548},{"groupId":"EG001","numAffected":2,"numAtRisk":296},{"groupId":"EG002","numAffected":0,"numAtRisk":140}],"term":"COVID-19 pneumonia (study drug unrelated)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":548},{"groupId":"EG001","numAffected":0,"numAtRisk":296},{"groupId":"EG002","numAffected":1,"numAtRisk":140}],"term":"Cellulitis (study drug related)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":548},{"groupId":"EG001","numAffected":1,"numAtRisk":296},{"groupId":"EG002","numAffected":0,"numAtRisk":140}],"term":"Cystitis (study drug unrelated)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":548},{"groupId":"EG001","numAffected":0,"numAtRisk":296},{"groupId":"EG002","numAffected":0,"numAtRisk":140}],"term":"Cytomegalovirus infection (study drug unrelated)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":548},{"groupId":"EG001","numAffected":0,"numAtRisk":296},{"groupId":"EG002","numAffected":0,"numAtRisk":140}],"term":"Peritonitis (study drug unrelated)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":548},{"groupId":"EG001","numAffected":1,"numAtRisk":296},{"groupId":"EG002","numAffected":0,"numAtRisk":140}],"term":"Pneumonia (study drug related)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":548},{"groupId":"EG001","numAffected":1,"numAtRisk":296},{"groupId":"EG002","numAffected":0,"numAtRisk":140}],"term":"Salpingitis (study drug unrelated)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":548},{"groupId":"EG001","numAffected":1,"numAtRisk":296},{"groupId":"EG002","numAffected":0,"numAtRisk":140}],"term":"Urinary tract infection (study drug related)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":548},{"groupId":"EG001","numAffected":0,"numAtRisk":296},{"groupId":"EG002","numAffected":0,"numAtRisk":140}],"term":"Urosepsis (study drug unrelated)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":548},{"groupId":"EG001","numAffected":0,"numAtRisk":296},{"groupId":"EG002","numAffected":0,"numAtRisk":140}],"term":"Anastomic leak (study drug unrelated)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":548},{"groupId":"EG001","numAffected":1,"numAtRisk":296},{"groupId":"EG002","numAffected":0,"numAtRisk":140}],"term":"Clavicle fracture (study drug unrelated)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":548},{"groupId":"EG001","numAffected":0,"numAtRisk":296},{"groupId":"EG002","numAffected":0,"numAtRisk":140}],"term":"Infusion related reaction (study drug related)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":548},{"groupId":"EG001","numAffected":1,"numAtRisk":296},{"groupId":"EG002","numAffected":0,"numAtRisk":140}],"term":"Arthritis (study drug unrelated)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":548},{"groupId":"EG001","numAffected":1,"numAtRisk":296},{"groupId":"EG002","numAffected":0,"numAtRisk":140}],"term":"Colorectal adenoma (study drug unrelated)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":548},{"groupId":"EG001","numAffected":0,"numAtRisk":296},{"groupId":"EG002","numAffected":1,"numAtRisk":140}],"term":"Neuromyopathy (study drug unrelated)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":548},{"groupId":"EG001","numAffected":0,"numAtRisk":296},{"groupId":"EG002","numAffected":0,"numAtRisk":140}],"term":"Ureterolithiasis (study drug unrelated)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":548},{"groupId":"EG001","numAffected":0,"numAtRisk":296},{"groupId":"EG002","numAffected":0,"numAtRisk":140}],"term":"Cervical dysplasia (study drug unrelated)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 25.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":548},{"groupId":"EG001","numAffected":0,"numAtRisk":296},{"groupId":"EG002","numAffected":1,"numAtRisk":140}],"term":"Deep vein thrombosis (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."}