{"analyses":[{"groupDescription":"Statistical analysis for number of participants with clinical remission at Week 54 and not receiving concomitant corticosteroids among participants on corticosteroids at Week 0 of maintenance study were summarized using the CMH test stratified by clinical remission status at Week 0 and the induction dose factor.","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.279","pValueComment":"Fixed sequence testing; 100 mg group was tested if it was positive for preceding endpoint, regardless whether 50 mg group was positive;50 mg group was tested if 100 mg group positive for same endpoint and 50 mg group positive for preceding endpoint.","statisticalMethod":"Cochran-Mantel-Haenszel","testedNonInferiority":false},{"groupDescription":"Statistical analysis for number of participants with clinical remission at Week 54 and not receiving concomitant corticosteroids among participants on corticosteroids at Week 0 of maintenance study were summarized using the CMH test stratified by clinical remission status at Week 0 and the induction dose factor.","groupIds":["OG000","OG002"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.423","pValueComment":"Fixed sequence testing; 100 mg group was tested if it was positive for preceding endpoint, regardless whether 50 mg group was positive;50 mg group was tested if 100 mg group positive for same endpoint and 50 mg group positive for preceding endpoint.","statisticalMethod":"Cochran-Mantel-Haenszel","testedNonInferiority":false}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"16"},{"groupId":"OG001","value":"22"},{"groupId":"OG002","value":"19"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"87"},{"groupId":"OG001","value":"78"},{"groupId":"OG002","value":"82"}],"units":"Participants"}],"description":"Clinical remission is defined as a Mayo score of less than or equal to 2, with no individual sub-score greater than 1. The Mayo score is sum of 4 sub-scores (i.e., stool frequency, rectal bleeding, endoscopic findings, and physician's global assessment); each rated on a scale from 0 to 3, with higher scores indicating more severe disease. The total Mayo score value ranges from 0 to 12.","groups":[{"description":"Participants in clinical response to golimumab at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and randomized to placebo subcutaneous (under the skin) injection matching to golimumab administered every 4 weeks through Week 52 in maintenance study C0524T18 (NCT00488631). Participants with loss of clinical response had their dose increased to golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52.","id":"OG000","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). 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":"OG001","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":"OG002","title":"GLM-I-Rsp-Golimumab 100 mg Maintenance"}],"paramType":"NUMBER","populationDescription":"Analysis population included randomly assigned participants in clinical response to golimumab induction who were receiving concomitant corticosteroids at Week 0 of the study. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.","reportingStatus":"POSTED","timeFrame":"Week 54","title":"Number of Participants With Clinical Remission at Week 54 and Not Receiving Concomitant Corticosteroids Among Participants on Corticosteroids at Week 0 of Maintenance Study","type":"SECONDARY","unitOfMeasure":"Participants"}