{"analyses":[{"ciLowerLimit":"0.026","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.088","estimateComment":"Unstratified odds ratio (Carfilzomib/Bortezomib) was estimated.","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"< 0.0001","pValueComment":"Based on the pre-specified multiplicity adjustment method, secondary endpoints were to be tested only if the results of the primary endpoint were significant. The p-values for all secondary endpoints are descriptive only.","paramType":"Odds Ratio (OR)","paramValue":"0.048","statisticalMethod":"Pearson Chi-Square test"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"30.8","upperLimit":"39.6","value":"35.1"},{"groupId":"OG001","lowerLimit":"1.3","upperLimit":"4.4","value":"2.5"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"470"},{"groupId":"OG001","value":"474"}],"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 in combination with melphalan and prednisone for nine 42-day cycles. Bortezomib was administered either IV or subcutaneously at 1.3 mg/m² during cycles 1 to 4 on days 1, 4, 8, 11, 22, 25, 29, and 32 followed by 1.3 mg/m² during cycles 5 to 9 on days 1, 8, 22, and 29. On days 1 to 4 of each cycle, melphalan was administered at 9 mg/m² and prednisone was administered at 60 mg/m².","id":"OG000","title":"Bortezomib, Melphalan, Prednisone"},{"description":"Participants received carfilzomib administered in combination with melphalan and prednisone for nine 42-day cycles. Carfilzomib was administered as an intravenous (IV) infusion on days 1, 2, 8, 9, 22, 23, 29, and 30 of each 42-day cycle. The carfilzomib dose was at 20 mg/m² on cycle 1, days 1 and 2 followed by 36 mg/m² thereafter. On days 1 to 4, melphalan was administered at 9 mg/m² and prednisone was administered at 60 mg/m².","id":"OG001","title":"Carfilzomib, Melphalan, Prednisone"}],"paramType":"NUMBER","populationDescription":"The safety population included all randomized participants who received at least 1 dose of any study treatment (i.e., carfilzomib, bortezomib, melphalan, or prednisone).","reportingStatus":"POSTED","timeFrame":"From the first dose of any study drug up to 30 days after the last dose of any study drug as of the data cut-off date of 15 July 2016; median duration of treatment was 52 weeks in both treatment groups.","title":"Percentage of Participants With ≥ Grade 2 Peripheral Neuropathy","type":"SECONDARY","unitOfMeasure":"percentage of participants"}