{"analyses":[{"groupDescription":"Efficacy analysis was based on the Intent-To-Treat-Efficacy (ITT-E) population for the induction period. The ITT-E population was a subpopulation of the ITT population, which consisted of all participants who received at least one SC injection of the study medication during the induction period. Participants who received open-label high induction dose, because they enrolled after Protocol Amendment 4 was released, were excluded from the ITT-E population.","groupIds":["OG002"],"nonInferiorityComment":"one-sample two-sided Chi-square test","nonInferiorityType":"SUPERIORITY","pValue":"< 0.001","pValueComment":"Adjusted p-value from a sequentially rejective multiple test procedure, testing co-primary and ranked secondary endpoints 1st for I-SD+I-HD, then for individual adalimumab dose groups (I-HD, I-SD) against the respective external placebo rate (19.83%)","statisticalComment":"controlling familywise Type I error of 5% in a strong sense","statisticalMethod":"rejective multiple test procedure"},{"groupDescription":"Efficacy analysis was based on the Intent-To-Treat-Efficacy (ITT-E) population for the induction period. The ITT-E population was a subpopulation of the ITT population, which consisted of all participants who received at least one SC injection of the study medication during the induction period. Participants who received open-label high induction dose, because they enrolled after Protocol Amendment 4 was released, were excluded from the ITT-E population.","groupIds":["OG001"],"nonInferiorityComment":"one-sample two-sided Chi-square test","nonInferiorityType":"SUPERIORITY","pValue":"< 0.001","pValueComment":"Adjusted p-value from a sequentially rejective multiple test procedure, testing co-primary and ranked secondary endpoints 1st for I-SD+I-HD, then for individual adalimumab dose groups (I-HD, I-SD) against the respective external placebo rate (19.83%)","statisticalComment":"controlling familywise Type I error of 5% in a strong sense","statisticalMethod":"rejective multiple test procedure"},{"groupDescription":"Efficacy analysis was based on the Intent-To-Treat-Efficacy (ITT-E) population for the induction period. The ITT-E population was a subpopulation of the ITT population, which consisted of all participants who received at least one SC injection of the study medication during the induction period. Participants who received open-label high induction dose, because they enrolled after Protocol Amendment 4 was released, were excluded from the ITT-E population.","groupIds":["OG000"],"nonInferiorityComment":"one-sample two-sided Chi-square test","nonInferiorityType":"SUPERIORITY","pValue":"0.382","pValueComment":"Adjusted p-value from a sequentially rejective multiple test procedure, testing co-primary and ranked secondary endpoints 1st for I-SD+I-HD, then for individual adalimumab dose groups (I-HD, I-SD) against the respective external placebo rate (19.83%)","statisticalComment":"controlling familywise Type I error of 5% in a strong sense","statisticalMethod":"rejective multiple test procedure"},{"groupDescription":"Efficacy analysis was based on the Intent-To-Treat-Efficacy (ITT-E) population for the induction period. The ITT-E population was a subpopulation of the ITT population, which consisted of all participants who received at least one SC injection of the study medication during the induction period. Participants who received open-label high induction dose, because they enrolled after Protocol Amendment 4 was released, were excluded from the ITT-E population.","groupIds":["OG006"],"nonInferiorityComment":"one-sample two-sided Chi-square test","nonInferiorityType":"SUPERIORITY","pValue":"< 0.001","pValueComment":"Adjusted p-value from a sequentially rejective multiple test procedure, testing co-primary and ranked secondary endpoints 1st for I-SD+I-HD, then for individual adalimumab dose groups (I-HD, I-SD) against the respective external placebo rate (19.83%)","statisticalComment":"controlling familywise Type I error of 5% in a strong sense","statisticalMethod":"rejective multiple test procedure"},{"groupDescription":"Efficacy analysis was based on the Intent-To-Treat-Efficacy (ITT-E) population for the induction period. The ITT-E population was a subpopulation of the ITT population, which consisted of all participants who received at least one SC injection of the study medication during the induction period. Participants who received open-label high induction dose, because they enrolled after Protocol Amendment 4 was released, were excluded from the ITT-E population.","groupIds":["OG005"],"nonInferiorityComment":"one-sample two-sided Chi-square test","nonInferiorityType":"SUPERIORITY","pValue":"< 0.001","pValueComment":"Adjusted p-value from a sequentially rejective multiple test procedure, testing co-primary and ranked secondary endpoints 1st for I-SD+I-HD, then for individual adalimumab dose groups (I-HD, I-SD) against the respective external placebo rate (19.83%)","statisticalComment":"controlling familywise Type I error of 5% in a strong sense","statisticalMethod":"rejective multiple test procedure"},{"groupDescription":"Efficacy analysis was based on the Intent-To-Treat-Efficacy (ITT-E) population for the induction period. The ITT-E population was a subpopulation of the ITT population, which consisted of all participants who received at least one SC injection of the study medication during the induction period. Participants who received open-label high induction dose, because they enrolled after Protocol Amendment 4 was released, were excluded from the ITT-E population.","groupIds":["OG004"],"nonInferiorityComment":"one-sample two-sided Chi-square test","nonInferiorityType":"SUPERIORITY","pValue":"0.344","pValueComment":"Adjusted p-value from a sequentially rejective multiple test procedure, testing co-primary and ranked secondary endpoints 1st for I-SD+I-HD, then for individual adalimumab dose groups (I-HD, I-SD) against the respective external placebo rate (19.83%)","statisticalComment":"controlling familywise Type I error of 5% in a strong sense","statisticalMethod":"rejective multiple test procedure"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"25.46","upperLimit":"62.57","value":"43.3"},{"groupId":"OG001","lowerLimit":"44.27","upperLimit":"73.63","value":"59.6"},{"groupId":"OG002","lowerLimit":"41.52","upperLimit":"64.71","value":"53.2"},{"groupId":"OG003","lowerLimit":"41.34","upperLimit":"88.98","value":"68.8"},{"groupId":"OG004","lowerLimit":"23.70","upperLimit":"59.36","value":"40.6"},{"groupId":"OG005","lowerLimit":"44.17","upperLimit":"72.42","value":"58.8"},{"groupId":"OG006","lowerLimit":"40.56","upperLimit":"62.92","value":"51.8"},{"groupId":"OG007","lowerLimit":"40.99","upperLimit":"86.66","value":"66.7"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"30"},{"groupId":"OG001","value":"47"},{"groupId":"OG002","value":"77"},{"groupId":"OG003","value":"16"},{"groupId":"OG004","value":"32"},{"groupId":"OG005","value":"51"},{"groupId":"OG006","value":"83"},{"groupId":"OG007","value":"18"}],"units":"Participants"}],"description":"The Mayo score is a tool designed to measure disease activity for ulcerative colitis. The PMS (Mayo score without endoscopy) ranges from 0 (normal or inactive disease) to 9 (severe disease) and is calculated as the sum of 3 sub scores (stool frequency, rectal bleeding and physician's global assessment), each of which ranges from 0 (normal) to 3 (severe disease). A negative change in PMS indicates improvement. Clinical remission was defined as a PMS ≤ 2 and no individual subscore \\> 1.","dispersionType":"95% Confidence Interval","groups":[{"description":"Participants randomized to receive adalimumab 2.4 mg/kg (maximum dose of 160 mg) at Baseline and matching placebo at Week 1, 1.2 mg/kg (maximum dose of 80 mg) at Week 2, followed by 0.6 mg/kg (maximum dose of 40 mg) at Week 4 and Week 6.","id":"OG000","title":"Main Study: I-SD"},{"description":"Participants randomized to receive adalimumab 2.4 mg/kg (maximum dose of 160 mg) at Baseline and at Week 1, 1.2 mg/kg (maximum dose of 80 mg) at Week 2, followed by 0.6 mg/kg (maximum dose of 40 mg) at Week 4 and Week 6.","id":"OG001","title":"Main Study: I-HD"},{"description":"Combined I-SD + I-HD arms (see above).","id":"OG002","title":"Main Study: I-SD + I-HD"},{"description":"(After Amendment 4) participants assigned to open-label adalimumab 2.4 mg/kg (maximum dose of 160 mg) at Baseline and at Week 1, 1.2 mg/kg (maximum dose of 80 mg) at Week 2, followed by 0.6 mg/kg (maximum dose of 40 mg) at Week 4 and Week 6.","id":"OG003","title":"Main Study: I-HD-OL"},{"description":"Participants randomized to receive adalimumab 2.4 mg/kg (maximum dose of 160 mg) at Baseline and matching placebo at Week 1, 1.2 mg/kg (maximum dose of 80 mg) at Week 2, followed by 0.6 mg/kg (maximum dose of 40 mg) at Week 4 and Week 6.","id":"OG004","title":"Integrated Study (Main + Japan Sub-Study): I-SD"},{"description":"Participants randomized to receive adalimumab 2.4 mg/kg (maximum dose of 160 mg) at Baseline and at Week 1, 1.2 mg/kg (maximum dose of 80 mg) at Week 2, followed by 0.6 mg/kg (maximum dose of 40 mg) at Week 4 and Week 6.","id":"OG005","title":"Integrated Study (Main + Japan Sub-Study): I-HD"},{"description":"Combined I-SD + I-HD arms (see above).","id":"OG006","title":"Integrated Study (Main + Japan Sub-Study): I-SD + I-HD"},{"description":"(After Amendment 4) participants assigned to open-label adalimumab 2.4 mg/kg (maximum dose of 160 mg) at Baseline and at Week 1, 1.2 mg/kg (maximum dose of 80 mg) at Week 2, followed by 0.6 mg/kg (maximum dose of 40 mg) at Week 4 and Week 6.","id":"OG007","title":"Integrated Study (Main + Japan Sub-Study): I-HD-OL"}],"paramType":"NUMBER","populationDescription":"Intent-to-Treat (ITT): all participants who received at least 1 dose of study drug during the Induction period; analyzed as enrolled/randomized. Non-responder imputation (NRI): missing data is imputed as not having met the endpoint.","reportingStatus":"POSTED","timeFrame":"Week 8","title":"Co-Primary Endpoint 1: Percentage of Participants Who Achieved Clinical Remission as Measured by Partial Mayo Score (PMS) at Week 8 - Induction Period","type":"PRIMARY","unitOfMeasure":"percentage of participants"}