{"analyses":[{"ciLowerLimit":"0.089","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.210","estimateComment":"The odds ratio (carfilzomib/bortezomib) was estimated using the unconditional Cochran-Mantel-Haenszel method.","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER_LEGACY","pValue":"<0.0001","pValueComment":"The multiplicity in testing secondary endpoints was adjusted per group using the sequential Holm procedure to preserve the family-wise error rate at 0.025.","paramType":"Odds Ratio (OR)","paramValue":"0.137","statisticalMethod":"Cochran-Mantel-Haenszel"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"27.7","upperLimit":"36.3","value":"32.0"},{"groupId":"OG001","lowerLimit":"3.9","upperLimit":"8.2","value":"6.0"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"456"},{"groupId":"OG001","value":"463"}],"units":"Participants"}],"description":"Neuropathy events were defined as Grade 2 or higher peripheral neuropathy as specified by peripheral neuropathy Standardised Medical Dictionary for Regulatory Activities (MedDRA) Query, narrow (scope) (SMQN) terms.\n\nPeripheral neuropathy was assessed by neurologic exam and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03:\n\nGrade 1: Asymptomatic; Grade 2: Moderate symptoms, limiting instrumental activities of daily living (ADL) Grade 3: Severe symptoms; limiting self-care ADL; Grade 4: Life-threatening consequences, urgent intervention indicated; Grade 5: Death.","dispersionType":"95% Confidence Interval","groups":[{"description":"Participants received bortezomib 1.3 mg/m² administered intravenously (IV) or subcutaneously (SC) on Days 1, 4, 8, and 11 of a 21-day cycle plus dexamethasone (DEX) 20 mg administered on Days 1, 2, 4, 5, 8, 9, 11, and 12 of each 21-day cycle.","id":"OG000","title":"Bortezomib + DEX"},{"description":"Participants received 20 mg/m² carfilzomib administered by IV infusion on Days 1 and 2 of Cycle 1, followed by 56 mg/m² on Days 8, 9, 15, and 16 of Cycle 1 and for each 28-day cycle thereafter. Additionally, participants received 20 mg dexamethasone on Days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28 day cycle.","id":"OG001","title":"Carfilzomib + DEX"}],"paramType":"NUMBER","populationDescription":"Safety population (all participants who received at least 1 dose of study treatment)","reportingStatus":"POSTED","timeFrame":"From the first dose of study drug up to 30 days after the last dose of study drug as of the data cut-off date of 10 November 2014; median duration of treatment was 27 weeks in the bortezomib group and 40 weeks in the carfilzomib treatment group.","title":"Percentage of Participants With ≥ Grade 2 Peripheral Neuropathy","type":"SECONDARY","unitOfMeasure":"percentage of participants"}