{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"-0.99","upperLimit":"0.82","value":"-0.66"},{"comment":"Only one data point, so not amenable to Pearson's correlation coefficient","groupId":"OG001","lowerLimit":"NA","upperLimit":"NA","value":"NA"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"4"},{"groupId":"OG001","value":"1"}],"units":"Participants"}],"title":"ADC vs serum paraprotein"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"-0.79","upperLimit":"0.48","value":"-0.28"},{"comment":"Only three data points, hence 95% confidence interval cannot be reliably calculated.","groupId":"OG001","lowerLimit":"NA","upperLimit":"NA","value":"0.48"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"9"},{"groupId":"OG001","value":"3"}],"units":"Participants"}],"title":"ADC vs serum paraprotein-associated immunoglobulin level"}],"denoms":[{"counts":[{"groupId":"OG000","value":"11"},{"groupId":"OG001","value":"3"}],"units":"Participants"}],"description":"Primary Objective 1: To assess whether the novel magnetic resonance (MR) protocol and exploratory bone biomarkers can improve quantification of tumour burden in patients with new or relapsed myeloma at baseline assessment, compared to paraprotein levels alone.\n\nThis particular section analysed the correlation between the Apparent Diffusion Coefficient (ADC) measurements (from the Diffusion Weighted Magnetic Resonance Imaging (DW-MRI) component of the sequences) of lytic bone lesions, with standard clinical correlates of tumour burden (serum paraprotein, and serum paraprotein-associated immunoglobulin level).\n\nThe measurement of ADC from DW-MRI is further described by Messiou et. al. \\[1\\]\n\n\\[1\\] Messiou, Christina, et al. \"Guidelines for acquisition, interpretation, and reporting of whole-body MRI in myeloma: myeloma response assessment and diagnosis system (MY-RADS).\" Radiology 291.1 (2019): 5-13.","dispersionType":"95% Confidence Interval","groups":[{"description":"All patients with new myeloma at recruitment.","id":"OG000","title":"Group 1a: New Myeloma"},{"description":"All patients with relapsed myeloma at recruitment.","id":"OG001","title":"Group 1b: Relapsed Myeloma"}],"paramType":"NUMBER","populationDescription":"Subset of Group 1a and 1b, on active chemotherapy, with lytic bone lesions identified on baseline novel MR scan, amenable to ADC measurement, and a paired baseline serum paraprotein, or paraprotein-associated immunoglobulin, level available (where measurement was unsuccessful the number analysed is lower than the overall number analysed).\n\nGroup 1c, 2 and 3 participants did not have a lytic bone lesion identified on novel MR scan, and were therefore not included in the analysis.","reportingStatus":"POSTED","timeFrame":"At baseline","title":"Primary Outcome 1: Quantifying Tumour Burden [Correlations With Apparent Diffusion Coefficient (ADC) Measurements]","type":"PRIMARY","unitOfMeasure":"Pearson's correlation coefficient"}