{"analyses":[{"ciLowerLimit":"1.458","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"2.988","estimateComment":"Two-sided 95% CI estimated using the Wald method.","groupDescription":"A hierarchical test procedure was used to control the Type I error. Testing was performed sequentially for first 4 secondary endpoints in the order they are presented only if both co-primary endpoints achieved non-inferiority and continued when the previous endpoint was statistically significant at 1-sided significance level of 0.025.","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.0001","pValueComment":"Stratified on multiple myeloma (MM) isotype (immunoglobulin G \\[IgG\\] versus non-IgG), body weight (\\<=65 kg, \\>65 to \\<=85 kg, and \\>85 kg), and number of prior lines (1 to 2 versus \\>=3) according to IRT.","paramType":"Odds Ratio (OR)","paramValue":"2.087","statisticalMethod":"Cochran-Mantel-Haenszel"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"54.1"},{"groupId":"OG001","value":"71.1"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"268"},{"groupId":"OG001","value":"263"}],"units":"Participants"}],"description":"The PESQ-FU consisting of 9 items has been designed to follow up on participant experience and satisfaction regarding the injection method (discomfort, pain, side effects, time saving and satisfaction) and study medication (side effects, worth taking, satisfaction and recommendation). This questionnaire has been adapted based on qualitative interviews with oncology participants. The responses to 'satisfaction with injection method' were recorded as 'very satisfied, satisfied, neither satisfied nor dissatisfied, dissatisfied and very dissatisfied' at specified timepoints. The total percentage of participants who were very satisfied and satisfied with the injection method (item-8) at Cycle 5 Day 15 is reported here. Percentages are rounded off to the tenth decimal place.","groups":[{"description":"Participants received isatuximab 10 mg/kg IV infusion QW (i.e. on Days 1, 8, 15 and 22) in Cycle 1 (28 days) and then 10 mg/kg Q2W (i.e. on Days 1 and 15) of each subsequent 28-day cycle along with pomalidomide 4 mg orally on Days 1 to 21 of each 28-day cycle and dexamethasone 40 mg (or 20 mg for participant \\>=75 years) orally on Days 1, 8, 15, and 22 of each cycle until disease progression, unacceptable AEs, participant request to discontinue treatment, or any other reason, whichever came first.","id":"OG000","title":"Isa-IV + Pd"},{"description":"Participants received isatuximab 1400 mg SC injection administered via an OBDS which is an investigational device injector QW (i.e on Days 1, 8, 15 and 22) in Cycle 1 (28 days) and then 1400 mg Q2W (i.e. on Days 1 and 15) of each subsequent 28-day cycle along with pomalidomide 4 mg orally on Days 1 to 21 of each 28-day cycle and dexamethasone 40 mg (or 20 mg for participant \\>=75 years) orally on Days 1, 8, 15, and 22 of each cycle until disease progression, unacceptable AEs, participant request to discontinue treatment, or any other reason, whichever came first.","id":"OG001","title":"Isa-SC + Pd"}],"paramType":"NUMBER","populationDescription":"The ITT population included all randomized population.","reportingStatus":"POSTED","timeFrame":"Cycle 5 Day 15","title":"Percentage of Participants Who Responded Very Satisfied and Satisfied to the 'Patient Experience and Satisfaction Questionnaire (PESQ-FU)': Satisfaction With Injection Method' (Item-8) at Cycle 5 Day 15","type":"SECONDARY","unitOfMeasure":"percentage of participants"}