{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"82.3","upperLimit":"93.2","value":"87.8"},{"groupId":"OG001","lowerLimit":"79.4","upperLimit":"93.6","value":"86.5"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"139"},{"groupId":"OG001","value":"89"}],"units":"Participants"}],"title":"Worst case scenario"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"92.7","upperLimit":"99.4","value":"96.1"},{"groupId":"OG001","lowerLimit":"80.6","upperLimit":"94.4","value":"87.5"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"127"},{"groupId":"OG001","value":"88"}],"units":"Participants"}],"title":"Day 90 completers"}],"denoms":[{"counts":[{"groupId":"OG000","value":"139"},{"groupId":"OG001","value":"89"}],"units":"Participants"}],"description":"Percentage of SOV2012-F1-treated subjects with a plasma NaF/EDTA plasma testosterone (T) Cavg within the normal range after 90 days of treatment using up- and down-titration as appropriate. Measured by Plasma T concentration using a starting daily dose of 400 mg SOV2012-F1.","dispersionType":"95% Confidence Interval","groups":[{"description":"Patients treated with SOV2012-F1, starting daily dose in MRS-TU-2019EXT is 400 mg - (200 mg with morning meal and 200 mg with evening meal). Dosing is titrated up to a maximum of 800 mg SOV2012-F1 per day (400 mg with morning meal and 400 mg with evening meal) or down to a minimum of 100 mg SOV2012-F1 per day (100 mg with morning meal) based on plasma T after 14 and 42 days of treatment. Patients could be titrated to final daily dose levels of 100 mg, 200 mg (100 mg twice daily), 400 mg (200 mg twice daily), 600 mg (300 me twice daily) or 800 mg (400 mg twice daily). All doses taken with meals.\n\nSOV2012-F1: oral preparation of testosterone undecanoate (TU) in 100 mg, 150 mg and 200 mg strengths.\n\nPatients (n=16) from a single clinical site were excluded from PK-based outcomes due to sample handling errors.","id":"OG000","title":"NaF/EDTA PLASMA"},{"description":"Patients treated with SOV2012-F1, starting daily dose in MRS-TU-2019EXT is 400 mg - (200 mg with morning meal and 200 mg with evening meal). Dosing is titrated up to a maximum of 800 mg SOV2012-F1 per day (400 mg with morning meal and 400 mg with evening meal) or down to a minimum of 100 mg SOV2012-F1 per day (100 mg with morning meal) based on plasma T after 14 and 42 days of treatment. Patients could be titrated to final daily dose levels of 100 mg, 200 mg (100 mg twice daily), 400 mg (200 mg twice daily), 600 mg (300 me twice daily) or 800 mg (400 mg twice daily). All doses taken with meals.\n\nSOV2012-F1: oral preparation of testosterone undecanoate (TU) in 100 mg, 150 mg and 200 mg strengths.\n\nPatients (n=16) from a single clinical site were excluded from PK-based outcomes due to sample handling errors.\n\nPatients were enrolled in the serum sub study.","id":"OG001","title":"SERUM"}],"paramType":"NUMBER","populationDescription":"Modified Extension Treated Set","reportingStatus":"POSTED","timeFrame":"90 days","title":"Plasma and Serum Testosterone Efficacy of Oral SOV2012-F1 With up and Down Titration","type":"PRIMARY","unitOfMeasure":"percentage of participants"}