Measurement and Statistical MethodsCounts, means, rates, ratios, proportions, and other relevant statistics were calculated using R 3.2.3 statistical software 21 and/or SEER*Stat 8.3.2. 22 Figures were created in R 3.2.3 21 using rgeos, 23 rgdal, 24 maptools, 25 ggplot2, 26 plotrix, 27 and SEER2R. 28 Statistics are suppressed when counts are fewer than 16 within a cell but included in totals except when data are suppressed from only one cell within a category to prevent identification of the number in the suppressed cell. Note that reported percentages may not add up to 100% due to rounding.Population data for each geographic region were obtained from the SEER program website 29 for the purpose of rate calculation.Age-adjusted incidence rates and 95% confidence intervals 30 for malignant and non-malignant tumors and for selected histology groupings by sex, race, Hispanic ethnicity, and pediatric, adolescent, young adult, and adult age groups were estimated per 100,000 population. Age-adjustment was based on one-year age groupings and standardized to the 2000 US standard population. The age distribution of the 2000 US standard population is shown in Appendix A. Combined populations for the regions included in this report are shown in Appendix B and Appendix C.CBTRUS presents statistics on the pediatric and adolescent age group 0-19 years for clinical relevance and describes specific brain and other CNS tumor patterns in age groups 0-4, 5-9, 10-14, and 15-19 years. However, the 0-14 year age group is a standard age category for childhood cancer used by other cancer surveillance organizations and has been included in this report for consistency and comparison purposes. Race categories in this report are all races, White, Black, American Indian/Alaskan Native (AIAN), and Asian/Pacific Islander (API). Other race, unspecified, and unknown race are included in statistics that are not race-specific. Hispanic ethnicity was defined using the NAACCR Hispanic Identification Algorithm, version 2, data element, which utilizes a combination of cancer registry data fields (Spanish/Hispanic Origin data element, birthplace, race, and surnames) to directly and indirectly classify cases as Hispanic or non-Hispanic. 31 When comparing two rates to one another, it is important to consider whether they are truly different or whether the difference in the estimates may be due to random error. There are several methods used in this report for determining whether two values are 'significantly different,' meaning whether the evidence meets a level of strength (usually a 5% chance of error) where the difference can be assumed to not be due to random error. There are two methods that are used to determine whether a difference between rates is statistically significant in this report. The first is through 95% confidence intervals, which are calculated for all presented rates. A 95% confidence interval is a range around an estimate which, if sampling of the population was repeated, should contain the 'true' value for the population 95% of the t...

OBJECTIVE Few studies have been reported that support the efficacy of adjunctive therapy for patients with bipolar I depression who have had an insufficient response to monotherapy with mood-stabilizing agents. The authors investigated the efficacy of lurasidone, a novel antipsychotic agent, as adjunctive therapy with lithium or valproate for the treatment of bipolar I depression. METHOD Patients were randomly assigned to receive 6 weeks of double-blind adjunctive treatment with lurasidone (N=183) or placebo (N=165), added to therapeutic levels of either lithium or valproate. Primary and key secondary endpoints were change from baseline to week 6 on the Montgomery-Åsberg Depression Rating Scale (MADRS) and depression severity score on the Clinical Global Impressions scale for use in bipolar illness (CGI-BP), respectively. RESULTS Lurasidone treatment significantly reduced mean MADRS total score at week 6 compared with the placebo group (-17.1 versus -13.5; effect size=0.34). Similarly, lurasidone treatment resulted in significantly greater endpoint reduction in CGI-BP depression severity scores compared with placebo (-1.96 versus -1.51; effect size=0.36) as well as significantly greater improvement in anxiety symptoms and in patient-reported measures of quality of life and functional impairment. Discontinuation rates due to adverse events were 6.0% and 7.9% in the lurasidone and placebo groups, respectively. Adverse events most frequently reported for lurasidone were nausea, somnolence, tremor, akathisia, and insomnia. Minimal changes in weight, lipids, and measures of glycemic control were observed during treatment with lurasidone. CONCLUSIONS In patients with bipolar I depression, treatment with lurasidone adjunctive to lithium or valproate significantly improved depressive symptoms and was generally well tolerated.

Lurasidone was an effective treatment for patients with acute schizophrenia. Safety assessments indicated a higher frequency of adverse events associated with 120 mg/day of lurasidone compared with 40 mg/day.

Twelve months of treatment with lurasidone met noninferiority criteria, and was associated with higher rates of remission, and reduced risk of hospitalization compared with QXR. No clinically significant effects on weight or metabolic parameters were observed during maintenance treatment with lurasidone.