{"eventGroups":[{"description":"Participants in clinical response to golimumab at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and randomized to placebo subcutaneous injection matching to golimumab administered every 4 weeks through Week 52 in the maintenance study C0524T18 (NCT00488631). Adverse events are presented through Week 54. Participants with loss of clinical response had their dose increased to golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52. For participants with dose adjustment, adverse events are presented from Week 0 up to the time of dose adjustment.","id":"EG000","otherNumAffected":88,"otherNumAtRisk":156,"seriousNumAffected":12,"seriousNumAtRisk":156,"title":"Golimumab Induction Responders (GLM-I-Rsp)-Placebo Maintenance"},{"description":"Participants in clinical response to golimumab at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and randomized to golimumab 50 mg subcutaneous injection administered every 4 weeks through Week 52 in C0524T18 (NCT00488631). Adverse events are presented through Week 54.Participants with loss of clinical response were re-randomized to receive golimumab 50 mg or 100 mg subcutaneous injection administered every 4 weeks through Week 52. For participants with dose adjustment, adverse events are presented from Week 0 up to the time of dose increase.","id":"EG001","otherNumAffected":102,"otherNumAtRisk":154,"seriousNumAffected":13,"seriousNumAtRisk":154,"title":"GLM-I-Rsp-Golimumab 50 mg Maintenance"},{"description":"Participants in clinical response to golimumab at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and randomized to golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52 in maintenance study C0524T18 (NCT00488631). Adverse events are presented through Week 54. Participants with loss of clinical response were re-randomized to receive golimumab 100 mg or 200 mg subcutaneous injection administered every 4 weeks through Week 52 (prior to protocol amendment 3). For participants with dose adjustment, adverse events are presented from Week 0 up to the time of dose increase.","id":"EG002","otherNumAffected":94,"otherNumAtRisk":154,"seriousNumAffected":22,"seriousNumAtRisk":154,"title":"GLM-I-Rsp-Golimumab 100 mg Maintenance"},{"description":"Participants in clinical response to golimumab at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and randomized to placebo every 4 weeks through Week 52 in maintenance study C0524T18 (NCT00488631), and had their dose increased to golimumab 100 mg subcutaneous injection every 4 weeks through Week 52 on loss of clinical response Adverse events are presented from the time of dose adjustment onwards up to Week 54.","id":"EG003","otherNumAffected":44,"otherNumAtRisk":76,"seriousNumAffected":8,"seriousNumAtRisk":76,"title":"GLM-I-Rsp-Placebo Maintenance-Golimumab 100 mg"},{"description":"Participants in clinical response to golimumab at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and randomized to placebo every 4 weeks through Week 52 in maintenance study C0524T18 (NCT00488631), and had their dose increased to golimumab 100 mg subcutaneous injection every 4 weeks through Week 52 on loss of clinical response Adverse events are presented from the time of dose adjustment onwards up to Week 54.","id":"EG004","otherNumAffected":15,"otherNumAtRisk":25,"seriousNumAffected":6,"seriousNumAtRisk":25,"title":"GLM-I-Rsp-Golimumab 50 mg Maintenance-Golimumab 100 mg"},{"description":"Participants in clinical response to golimumab at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and randomized to golimumab 100 mg subcutaneous injection every 4 weeks through Week 52 in the maintenance study C0524T18 (NCT00488631), and had their dose increased to golimumab 200 mg subcutaneous injection every 4 weeks through Week 52 on loss of clinical response. Adverse events are presented from the time of dose adjustment onwards up to Week 54.","id":"EG005","otherNumAffected":10,"otherNumAtRisk":14,"seriousNumAffected":1,"seriousNumAtRisk":14,"title":"GLM-I-Rsp-Golimumab 100 mg Maintenance-Golimumab 200 mg"},{"description":"Participants in clinical response to placebo at Week 6 of an induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and received placebo subcutaneous injection matching to golimumab every 4 weeks through Week 52 in maintenance study C0524T18 (NCT00488631); not randomized. Adverse events are presented through Week 54. Participants with loss of clinical response had their dose increased to golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52. For participants with dose adjustment, adverse events are presented from Week 0 up to the time of dose adjustment.","id":"EG006","otherNumAffected":67,"otherNumAtRisk":129,"seriousNumAffected":7,"seriousNumAtRisk":129,"title":"Placebo Induction Responders (PBO-I-Rsp)-Placebo Maintenance"},{"description":"Participants not in clinical response to placebo at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and received golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52 in maintenance study C0524T18 (NCT00488631); not randomized. Adverse events are presented through Week 54.","id":"EG007","otherNumAffected":140,"otherNumAtRisk":230,"seriousNumAffected":34,"seriousNumAtRisk":230,"title":"PBO-I-nonRsp-Golimumab 100 mg Maintenance"},{"description":"Participants not in clinical response to golimumab at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and received golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52 in maintenance study C0524T18 (NCT00488631); not randomized. Adverse events are presented through Week 54.","id":"EG008","otherNumAffected":247,"otherNumAtRisk":405,"seriousNumAffected":63,"seriousNumAtRisk":405,"title":"GLM-I-nonRsp-Golimumab 100 mg Maintenance"},{"description":"Participants in clinical response to placebo at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and received placebo every 4 weeks through Week 52 in maintenance study C0524T18 (NCT00488631) and had their dose increased to golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52 on loss of clinical response; not randomized. Adverse events are presented from the time of dose adjustment onwards up to Week 54.","id":"EG009","otherNumAffected":30,"otherNumAtRisk":56,"seriousNumAffected":7,"seriousNumAtRisk":56,"title":"PBO-I-Rsp-Placebo Maintenance-Golimumab 100 mg"},{"description":"Participants entered the study extension receiving placebo subcutaneous injection administered every 4 weeks until study unblinding and discontinuation of participants remaining on placebo; those whose UC disease worsened had their dose increased to golimumab 100 mg subcutaneous injection administered every 4 weeks in the study extension. Adverse events are presented from Week 54 up to Week 228 or the time of dose adjustment for subjects who increased dose.","id":"EG010","otherNumAffected":43,"otherNumAtRisk":96,"seriousNumAffected":8,"seriousNumAtRisk":96,"title":"Placebo Extension"},{"description":"Participants entered the study extension receiving golimumab 50 mg subcutaneous injection administered every 4 weeks; those whose UC disease worsened had their dose increased to golimumab 100 mg subcutaneous injection administered every 4 weeks. Adverse events are presented from Week 54 up to Week 228 or the time of dose adjustment for subjects who increased dose.","id":"EG011","otherNumAffected":58,"otherNumAtRisk":93,"seriousNumAffected":11,"seriousNumAtRisk":93,"title":"Golimumab 50 mg Extension Phase"},{"description":"Participants entered the study extension receiving golimumab 100 mg subcutaneous injection administered every 4 weeks; prior to Amendment 3 , those whose UC disease worsened had their dose increased to golimumab 200 mg subcutaneous injection administered every 4 weeks. Adverse events are presented from Week 54 up to Week 228 or the time of dose adjustment for subjects who increased dose.","id":"EG012","otherNumAffected":329,"otherNumAtRisk":469,"seriousNumAffected":91,"seriousNumAtRisk":469,"title":"Golimumab 100 mg Extension"},{"description":"Participants entered the study extension receiving golimumab 200 mg subcutaneous injection administered every 4 weeks. With Amendment 3 participants remaining golimumab 200 mg had their dose descreased to golimumab 100 mg subcutaneous injection administered every 4 weeks. Adverse events are presented from Week 54.","id":"EG013","otherNumAffected":6,"otherNumAtRisk":7,"seriousNumAffected":1,"seriousNumAtRisk":7,"title":"Golimumab 200 mg Extension"},{"description":"A single participant entered the study extension receiving placebo subcutaneous injection administered every 4 weeks; and on worsening of UC disease had their dose increased to golimumab 50 mg subcutaneous injection administered every 4 weeks in the study extension. Adverse events are presented from the time of dose adjustment.","id":"EG014","otherNumAffected":1,"otherNumAtRisk":1,"seriousNumAffected":0,"seriousNumAtRisk":1,"title":"Placebo - 50 mg Extension"},{"description":"Participants entered the study extension receiving placebo subcutaneous injection administered every 4 weeks and had their dose increased to golimumab 100 mg subcutaneous injection administered every 4 weeks upon worsening of UC disease in the study extension. Adverse events are presented from the time of dose adjustment.","id":"EG015","otherNumAffected":19,"otherNumAtRisk":28,"seriousNumAffected":7,"seriousNumAtRisk":28,"title":"Placebo - Golimumab100 mg Extension"},{"description":"Participants entered the study extension receiving golimumab 50 mg subcutaneous injection administered every 4 weeks and had their dose increased to golimumab 100 mg subcutaneous injection administered every 4 weeks upon worsening of UC disease. Adverse events are presented from the time of dose adjustment","id":"EG016","otherNumAffected":11,"otherNumAtRisk":19,"seriousNumAffected":1,"seriousNumAtRisk":19,"title":"Golimumab 50 mg - 100 mg Extension"},{"description":"Participants entered the study extension receiving golimumab 100 mg subcutaneous injection administered every 4 weeks and had their dose increased to golimumab 200 mg subcutaneous injection administered every 4 weeks upon worsening of UC disease. Adverse events are presented from the time of dose adjustment.","id":"EG017","otherNumAffected":7,"otherNumAtRisk":10,"seriousNumAffected":0,"seriousNumAtRisk":10,"title":"Golimumab 100 mg - 200 mg Extension"}],"frequencyThreshold":"5","otherEvents":[{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA Version 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and lymphatic system disorders","sourceVocabulary":"MedDRA Version 17.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":156},{"groupId":"EG001","numAffected":1,"numAtRisk":154},{"groupId":"EG002","numAffected":0,"numAtRisk":154},{"groupId":"EG003","numAffected":0,"numAtRisk":76},{"groupId":"EG004","numAffected":0,"numAtRisk":25},{"groupId":"EG005","numAffected":0,"numAtRisk":14},{"groupId":"EG006","numAffected":0,"numAtRisk":129},{"groupId":"EG007","numAffected":2,"numAtRisk":230},{"groupId":"EG008","numAffected":3,"numAtRisk":405},{"groupId":"EG009","numAffected":1,"numAtRisk":56},{"groupId":"EG010","numAffected":0,"numAtRisk":96},{"groupId":"EG011","numAffected":2,"numAtRisk":93},{"groupId":"EG012","numAffected":7,"numAtRisk":469},{"groupId":"EG013","numAffected":1,"numAtRisk":7},{"groupId":"EG014","numAffected":0,"numAtRisk":1},{"groupId":"EG015","numAffected":0,"numAtRisk":28},{"groupId":"EG016","numAffected":0,"numAtRisk":19},{"groupId":"EG017","numAffected":0,"numAtRisk":10}],"term":"Eosinophilia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA Version 17.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":156},{"groupId":"EG001","numAffected":2,"numAtRisk":154},{"groupId":"EG002","numAffected":5,"numAtRisk":154},{"groupId":"EG003","numAffected":0,"numAtRisk":76},{"groupId":"EG004","numAffected":2,"numAtRisk":25},{"groupId":"EG005","numAffected":0,"numAtRisk":14},{"groupId":"EG006","numAffected":1,"numAtRisk":129},{"groupId":"EG007","numAffected":0,"numAtRisk":230},{"groupId":"EG008","numAffected":7,"numAtRisk":405},{"groupId":"EG009","numAffected":0,"numAtRisk":56},{"groupId":"EG010","numAffected":0,"numAtRisk":96},{"groupId":"EG011","numAffected":0,"numAtRisk":93},{"groupId":"EG012","numAffected":1,"numAtRisk":469},{"groupId":"EG013","numAffected":0,"numAtRisk":7},{"groupId":"EG014","numAffected":0,"numAtRisk":1},{"groupId":"EG015","numAffected":0,"numAtRisk":28},{"groupId":"EG016","numAffected":0,"numAtRisk":19},{"groupId":"EG017","numAffected":0,"numAtRisk":10}],"term":"Leukopenia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Ear and labyrinth disorders","sourceVocabulary":"MedDRA Version 17.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":156},{"groupId":"EG001","numAffected":1,"numAtRisk":154},{"groupId":"EG002","numAffected":0,"numAtRisk":154},{"groupId":"EG003","numAffected":0,"numAtRisk":76},{"groupId":"EG004","numAffected":0,"numAtRisk":25},{"groupId":"EG005","numAffected":1,"numAtRisk":14},{"groupId":"EG006","numAffected":0,"numAtRisk":129},{"groupId":"EG007","numAffected":1,"numAtRisk":230},{"groupId":"EG008","numAffected":2,"numAtRisk":405},{"groupId":"EG009","numAffected":0,"numAtRisk":56},{"groupId":"EG010","numAffected":0,"numAtRisk":96},{"groupId":"EG011","numAffected":0,"numAtRisk":93},{"groupId":"EG012","numAffected":4,"numAtRisk":469},{"groupId":"EG013","numAffected":0,"numAtRisk":7},{"groupId":"EG014","numAffected":0,"numAtRisk":1},{"groupId":"EG015","numAffected":0,"numAtRisk":28},{"groupId":"EG016","numAffected":0,"numAtRisk":19},{"groupId":"EG017","numAffected":0,"numAtRisk":10}],"term":"Ear Pain"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA Version 17.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":156},{"groupId":"EG001","numAffected":0,"numAtRisk":154},{"groupId":"EG002","numAffected":0,"numAtRisk":154},{"groupId":"EG003","numAffected":0,"numAtRisk":76},{"groupId":"EG004","numAffected":0,"numAtRisk":25},{"groupId":"EG005","numAffected":0,"numAtRisk":14},{"groupId":"EG006","numAffected":0,"numAtRisk":129},{"groupId":"EG007","numAffected":1,"numAtRisk":230},{"groupId":"EG008","numAffected":0,"numAtRisk":405},{"groupId":"EG009","numAffected":0,"numAtRisk":56},{"groupId":"EG010","numAffected":0,"numAtRisk":96},{"groupId":"EG011","numAffected":0,"numAtRisk":93},{"groupId":"EG012","numAffected":2,"numAtRisk":469},{"groupId":"EG013","numAffected":0,"numAtRisk":7},{"groupId":"EG014","numAffected":0,"numAtRisk":1},{"groupId":"EG015","numAffected":0,"numAtRisk":28},{"groupId":"EG016","numAffected":1,"numAtRisk":19},{"groupId":"EG017","numAffected":0,"numAtRisk":10}],"term":"Dry Eye"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA Version 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Irritation"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA Version 17.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":156},{"groupId":"EG001","numAffected":0,"numAtRisk":154},{"groupId":"EG002","numAffected":0,"numAtRisk":154},{"groupId":"EG003","numAffected":0,"numAtRisk":76},{"groupId":"EG004","numAffected":0,"numAtRisk":25},{"groupId":"EG005","numAffected":0,"numAtRisk":14},{"groupId":"EG006","numAffected":0,"numAtRisk":129},{"groupId":"EG007","numAffected":0,"numAtRisk":230},{"groupId":"EG008","numAffected":0,"numAtRisk":405},{"groupId":"EG009","numAffected":0,"numAtRisk":56},{"groupId":"EG010","numAffected":0,"numAtRisk":96},{"groupId":"EG011","numAffected":0,"numAtRisk":93},{"groupId":"EG012","numAffected":0,"numAtRisk":469},{"groupId":"EG013","numAffected":1,"numAtRisk":7},{"groupId":"EG014","numAffected":0,"numAtRisk":1},{"groupId":"EG015","numAffected":0,"numAtRisk":28},{"groupId":"EG016","numAffected":0,"numAtRisk":19},{"groupId":"EG017","numAffected":0,"numAtRisk":10}],"term":"Myopia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA Version 17.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":156},{"groupId":"EG001","numAffected":0,"numAtRisk":154},{"groupId":"EG002","numAffected":1,"numAtRisk":154},{"groupId":"EG003","numAffected":0,"numAtRisk":76},{"groupId":"EG004","numAffected":0,"numAtRisk":25},{"groupId":"EG005","numAffected":0,"numAtRisk":14},{"groupId":"EG006","numAffected":0,"numAtRisk":129},{"groupId":"EG007","numAffected":0,"numAtRisk":230},{"groupId":"EG008","numAffected":0,"numAtRisk":405},{"groupId":"EG009","numAffected":0,"numAtRisk":56},{"groupId":"EG010","numAffected":0,"numAtRisk":96},{"groupId":"EG011","numAffected":0,"numAtRisk":93},{"groupId":"EG012","numAffected":0,"numAtRisk":469},{"groupId":"EG013","numAffected":0,"numAtRisk":7},{"groupId":"EG014","numAffected":0,"numAtRisk":1},{"groupId":"EG015","numAffected":0,"numAtRisk":28},{"groupId":"EG016","numAffected":1,"numAtRisk":19},{"groupId":"EG017","numAffected":0,"numAtRisk":10}],"term":"Ocular Hyperaemia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA Version 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Blurred"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA Version 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Discomfort"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA Version 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Pain"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA Version 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Upper"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA Version 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Ulcerative"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA Version 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