Background : The safety of newly approved drugs must be assessed using postmarketing surveillance data. One of the difficulties in assessing the hazard rates of adverse events induced by the anti-cancer drug TS-1 was that the time to event was not exactly identified due to the interval censoring. Most patients were outpatients who underwent clinical laboratory tests almost periodically at 1- or 2-week intervals and therefore, the occurrence of an adverse event was confirmed at the time of testing days after the event occurrence.
Objective : The purpose of this study was to propose a new model of hazard functions for each of 4 items of adverse event induced by TS-1 using post-marketing surveillance data considering the interval censoring.
Methods : The data obtained from 3, 294 patients with gastric cancer who received an initial 4-week course of therapy with TS-1 administered orally twice a day, followed by a 4-week second course with a 2-week no-treatment period after the initial course, were used to estimate hazard functions. Four items of adverse event--hemoglobin level (HB), white blood cell (WBC), neutrophil (NEUT) and platelet counts (PLT) --were graded, respectively, using the criteria established by the Japan Society of Clinical Oncology. Slip-mixed log-logistic and slip-mixed Weibull models were proposed as candidate models for estimating hazard functions. The goodness of fit of the two candidate models was evaluated by applying them to the above-mentioned data. The hazard functions for each of 4 items were assessed using the model with the better fit.
Results : The initial occurrence of adverse event was shown to follow the slip-mixed log-logistic model for each of 4 items. Although most events occurred early on in the initial course of therapy, a small peak in HB was also observed in the second course, while no such peak appeared for the other items.

Purpose: This is the first report to compare 3-dimensional computed tomography (3D-CT) images between pediatric patients with enuresis and children without lower urinary tract symptoms who underwent pelvic CT for other reasons. Methods: Forty-seven children (33 boys and 14 girls) with primary enuresis underwent 3D-CT of sacrococcygeal bones. The control group consisted of 138 children (78 boys and 60 girls) who underwent pelvic CT for other reasons. First, we determined the presence or absence of unfused sacral arches at the L4-S3 levels in both cohorts. Subsequently, we compared the fusion of sacral arches in age- and sex-matched children from these 2 groups. Results: Dysplastic sacral arches, characterized by lack of fusion at 1 or more levels of the S1–3 arches, were observed in nearly all patients in the enuresis group. In the control group (n=138), 54 of 79 children over 10 years old (68%) exhibited fused sacral arches at 3 S1–3 levels. All 11 control children under 4 years old displayed at least 2 unfused sacral arches at the S1–3 levels. In a comparative study of age- and sex-matched patients with enuresis and control children aged 5 to 13 years (n=32 for each group, with 21 boys and 11 girls; mean age, 8.0±2.2 years [range, 5–13 years]), only 1 patient (3%) in the enuresis group exhibited fusion of all S1–3 arches. In contrast, 20 of 32 control group participants (63%) had 3 fused sacral arches (P<0.0001). Conclusions Sacral vertebral arches typically fuse by the age of 10 years. However, in this study, children with enuresis exhibited a significantly elevated prevalence of unfused sacral arches, suggesting that dysplastic development of sacral vertebral arches may play a pathological role in enuresis.

Objectives: Despite the fact that the total energy intake of Japanese people has decreased, the percentage of obese people has increased.This suggests that the timing of meals is related to obesity.
The purpose of the study was to investigate the relationship between the timing of meals and obesity, based on analyses of physical measurements, serum biochemical markers, nutrient intake, and lifestyle factors in the context of Chrononutrition.
Participants and Methods: We analyzed data derived from 766 residents of Toon City (286 males and 480 females) aged 30 to 79 years who underwent detailed medical examinations between 2011 and 2013. These medical examinations included. (1) physical measurements (waist circumference, blood pressure, etc.); (2) serum biochemical markers (total cholesterol, etc.); (3) a detailed questionnaire concerning lifestyle factors such as family structure and daily habits (22 issues), exercise and eating habits (28 issues), alcohol intake and smoking habits; (4) a food frequency questionnaire based on food groups (FFQg);and (5) a questionnaire concerning the times at which meals and snacks are consumed.
Results: The values for body mass index (BMI) and waist circumference were higher for participants who ate dinner less than three hours before bedtime (<3-h group) than those who ate more than three hours before bedtime (>3-h group). The Chi-square test showed that there was a significant difference in eating habits, e.g., eating snacks, eating snacks at night, having dinner after 8 p.m., and having dinner after 9 p.m., between the <3-h group and the >3-h group.
Multiple linear regression analysis showed that skipping breakfast significantly influenced both waist circumference (β = 5.271) and BMI (β = 1.440) and that eating dinner <3-h before going to bed only influenced BMI (β = 0.581).
Conclusion: Skipping breakfast had a greater influence on both waist circumference and BMI than eating dinner <3-h before going to bed.

Objective: Despite the fact that the total energy intake of Japanese peoplehas decreased, the percentage of obese people has increased. This suggests that the timingof meals is related to obesity. The purpose of the study was to investigate therelationship between the timing of meals and obesity, based on analyses of physicalmeasurements, serum biochemical markers, nutrient intake, and lifestyle factors in thecontext of Chrononutrition.
Participants and Methods: We analyzed data derived from 766 residents ofToon City (286 males and 480 females) aged 30 to 79 years who underwent detailed medicalexaminations between 2011 and 2013. These medical examinations included. (1) physicalmeasurements (waist circumference, blood pressure, etc.); (2) serum biochemical markers(total cholesterol, etc.); (3) a detailed questionnaire concerning lifestyle factors suchas family structure and daily habits (22 issues), exercise and eating habits (28 issues),alcohol intake and smoking habits; (4) a food frequency questionnaire based on food groups(FFQg); and (5) a questionnaire concerning the times at which meals and snacks areconsumed.
Results: The values for body mass index (BMI) and waist circumference werehigher for participants who ate dinner less than three hours before bedtime (<3-hgroup) than those who ate more than three hours before bedtime (>3-h group). TheChi-square test showed that there was a significant difference in eating habits, e.g.,eating snacks, eating snacks at night, having dinner after 8 p.m., and having dinner after9 p.m., between the <3-h group and the >3-h group. Multiple linear regressionanalysis showed that skipping breakfast significantly influenced both waist circumference(β = 5.271) and BMI (β = 1.440) and that eating dinner <3-h before going to bed onlyinfluenced BMI (β = 0.581).
Conclusion: Skipping breakfast had a greater influence on both waistcircumference and BMI than eating dinner <3-h before going to bed.