{"description":"Safety Analysis set included all participants who received at least 1 dose of study drug. Participants who received placebo and crossed over to golimumab were included in placebo then golimumab 2 mg/kg arm and who received at least 1 dose of golimumab were included in placebo then golimumab 2 mg/kg and golimumab 2 mg/kg arms for safety analysis.","eventGroups":[{"description":"Participants who received placebo only (at least 1 dose) through Week 16. Follow-up was based on the period the participant was receiving placebo (from Week 0) up to the first golimumab 2 mg/kg dose for this treatment group.","id":"EG000","otherNumAffected":3,"otherNumAtRisk":103,"seriousNumAffected":0,"seriousNumAtRisk":103,"title":"Placebo"},{"description":"Participants who received placebo were crossed over to golimumab 2 mg/kg at Week 16. Participants may have also inadvertently received golimumab 2 mg/kg prior to Week 16. Participants may have missed one or more golimumab doses. Follow-up started from the first golimumab 2 mg/kg dose for this treatment group. Participants who inadvertently received golimumab 2 mg/kg prior to Week 16 were applicable to include in this group.","id":"EG001","otherNumAffected":16,"otherNumAtRisk":99,"seriousNumAffected":1,"seriousNumAtRisk":99,"title":"Placebo Then Golimumab 2 mg/kg"},{"description":"Participants who received at least one dose of 2 mg/kg golimumab from Week 0 onward. Follow-up started from the first golimumab 2 mg/kg dose for this treatment group.","id":"EG002","otherNumAffected":32,"otherNumAtRisk":105,"seriousNumAffected":6,"seriousNumAtRisk":105,"title":"Golimumab 2 mg/kg"}],"frequencyThreshold":"5","otherEvents":[{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA Version 19.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":103},{"groupId":"EG001","numAffected":7,"numAtRisk":99},{"groupId":"EG002","numAffected":17,"numAtRisk":105}],"term":"Nasopharyngitis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA Version 19.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":103},{"groupId":"EG001","numAffected":3,"numAtRisk":99},{"groupId":"EG002","numAffected":12,"numAtRisk":105}],"term":"Upper respiratory tract infection"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA Version 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":103},{"groupId":"EG001","numAffected":5,"numAtRisk":99},{"groupId":"EG002","numAffected":7,"numAtRisk":105}],"term":"Alanine aminotransferase increased"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA Version 19.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":103},{"groupId":"EG001","numAffected":1,"numAtRisk":99},{"groupId":"EG002","numAffected":6,"numAtRisk":105}],"term":"Headache"}],"seriousEvents":[{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA Version 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":103},{"groupId":"EG001","numAffected":0,"numAtRisk":99},{"groupId":"EG002","numAffected":1,"numAtRisk":105}],"term":"Sinus tachycardia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA Version 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":103},{"groupId":"EG001","numAffected":0,"numAtRisk":99},{"groupId":"EG002","numAffected":1,"numAtRisk":105}],"term":"Pancreatitis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA Version 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":103},{"groupId":"EG001","numAffected":0,"numAtRisk":99},{"groupId":"EG002","numAffected":1,"numAtRisk":105}],"term":"Non-alcoholic steatohepatitis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA Version 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":103},{"groupId":"EG001","numAffected":0,"numAtRisk":99},{"groupId":"EG002","numAffected":1,"numAtRisk":105}],"term":"Appendicitis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA Version 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":103},{"groupId":"EG001","numAffected":0,"numAtRisk":99},{"groupId":"EG002","numAffected":1,"numAtRisk":105}],"term":"Pneumonia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA Version 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":103},{"groupId":"EG001","numAffected":0,"numAtRisk":99},{"groupId":"EG002","numAffected":1,"numAtRisk":105}],"term":"Pulmonary tuberculosis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA Version 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":103},{"groupId":"EG001","numAffected":1,"numAtRisk":99},{"groupId":"EG002","numAffected":0,"numAtRisk":105}],"term":"Wrist fracture"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA Version 19.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":103},{"groupId":"EG001","numAffected":0,"numAtRisk":99},{"groupId":"EG002","numAffected":1,"numAtRisk":105}],"term":"Henoch-Schonlein purpura"}],"timeFrame":"Up to 60 weeks"}