{"analyses":[{"ciLowerLimit":"-0.057","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.383","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.112","estimateComment":"The treatment was considered efficacious if the group by time interaction for LVWT/Dz was statistically significant at a two-sided p\\<0.05 and the expected LVWT/Dz was higher for carvedilol than placebo over time.","groupDescription":"The null hypothesis is that change in LVWT/Dz across time do not vary by arm. Assuming a type I error=0.05, 2-sided test, 15% attrition/year, and correlation range of 0.6-0.8 between measurements, we projected that a sample size of 125/arm would provide 80% power to detect an effect size of 0.23-0.32 for LVWT/Dz at 24m.","groupIds":["OG000","OG001"],"nonInferiorityType":"OTHER","pValue":"0.15","paramType":"Slope","paramValue":"0.163","statisticalComment":"The treatment effect was determined by testing the significance of the group by time interaction in GEE using a one degree-of-freedom (df) test.","statisticalMethod":"Generalized Estimating Equation (GEE)"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","spread":"0.1711","value":"-0.1372"},{"groupId":"OG001","spread":"0.1917","value":"-0.0893"}]}],"title":"BL"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"0.167","value":"-0.2167"},{"groupId":"OG001","spread":"0.154","value":"0.3215"}]}],"title":"6m"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"0.1721","value":"-0.2416"},{"groupId":"OG001","spread":"0.1822","value":"-0.2367"}]}],"title":"12m"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"0.21","value":"-0.2375"},{"groupId":"OG001","spread":"0.1976","value":"-0.1974"}]}],"title":"18m"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"0.2353","value":"0.0213"},{"groupId":"OG001","spread":"0.2145","value":"-0.1834"}]}],"title":"24m"}],"denoms":[{"counts":[{"groupId":"OG000","value":"75"},{"groupId":"OG001","value":"76"}],"units":"Participants"}],"description":"Z-score of the ratio of left ventricular (LV) posterior wall dimension of systole to internal LV dimension in diastole, calculated for each subject by subtracting the reference healthy population mean, then dividing by the standard deviation. The Z-score indicates the number of standard deviations away from the mean of the reference population. Negative Z- score indicates worse outcome. The mean is reported by arm at each timepoint with corresponding standard errors.","dispersionType":"Standard Error","groups":[{"description":"Patients received Carvedilol PO delivered at 6.25 mg twice daily (for a total dose of 12.5 mg per day) for 24 months.","id":"OG000","title":"Arm I (Carvedilol)"},{"description":"Patients received Placebo PO delivered at 6.25 mg twice daily (for a total dose of 12.5 mg per day) for 24 months.","id":"OG001","title":"Arm II (Placebo)"}],"paramType":"MEAN","populationDescription":"We excluded 31 participants who did not have a second time point assessment of echocardiography, resulting in 151 analyzable participants.","reportingStatus":"POSTED","timeFrame":"Baseline before treatment, 6 months, 12 months, 18 months, 24 months after treatment initiation","title":"Average Left-Ventricular Wall Thickness-Dimension Ratio Z-score (LVWT/Dz)","type":"PRIMARY","unitOfMeasure":"z-score"}