{"analyses":[{"ciLowerLimit":"3.32","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimitComment":"infinity","groupIds":["OG000","OG002"],"nonInferiorityType":"SUPERIORITY","pValue":"0.0006","paramType":"Odds Ratio (OR)","paramValue":"16.63","statisticalComment":"An exact logistic regression model that adjusts for the randomization stratification factors was used to test the null hypothesis.","statisticalMethod":"Regression, Logistic"},{"ciLowerLimit":"4.72","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimitComment":"infinity","groupIds":["OG001","OG002"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.0001","paramType":"Odds Ratio (OR)","paramValue":"23.03","statisticalComment":"An exact logistic regression model that adjusts for the randomization stratification factors was used to test the null hypothesis.","statisticalMethod":"Regression, Logistic"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"7.63","upperLimit":"26.48","value":"15.4"},{"groupId":"OG001","lowerLimit":"11.10","upperLimit":"31.77","value":"20.0"},{"groupId":"OG002","lowerLimit":"0","upperLimit":"5.28","value":"0"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"65"},{"groupId":"OG001","value":"65"},{"groupId":"OG002","value":"68"}],"units":"Participants"}],"description":"The primary objective of this study was to compare the percentage of patients achieving biochemical control (defined as mean GH levels \\<2.5 µg/L and normalization of sex- and age- adjusted IGF-1) at 24 weeks with pasireotide LAR 40 mg and pasireotide LAR 60 mg separately versus continued treatment with octreotide LAR 30 mg or lanreotide autogel (ATG) 120 mg. The primary efficacy variable is the proportion of patients with a reduction of mean GH levels to \\< 2.5 µg/L and normalization of sex- and age-adjusted IGF-1 at 24 weeks.","dispersionType":"95% Confidence Interval","groups":[{"description":"Supplied in blinded fashion as 20 and 40 mg powder in vials and 2 mL vehicle in ampoule (for reconstitution) for intramuscular administration every 28 days","id":"OG000","title":"Pasireotide LAR 40 mg"},{"description":"Supplied in blinded fashion as 20 and 40 mg powder in vials and 2 mL vehicle in ampoule (for reconstitution) for intramuscular administration every 28 days","id":"OG001","title":"Pasireotide LAR 60 mg"},{"description":"Open label octreotide LAR 30 mg or lanreotide ATG 120 mg supplied either locally or from designated depot. Administered intramuscular every 28 days","id":"OG002","title":"Control Arm (Octreotide or Lanreotide)"}],"paramType":"NUMBER","reportingStatus":"POSTED","timeFrame":"At 24 weeks","title":"Percentage of Participants With a Reduction of Mean GH Levels to < 2.5 µg/L and Normalization of Sex- and Age-adjusted IGF-1.","type":"PRIMARY","unitOfMeasure":"percentage of participants"}