Objective : The incidence rate is used frequently in drug safety assessment. The incidence rate of adverse events is defined as the number of patients experiencing a certain adverse event divided by the number of patients administered a drug in spite of duration of administration (observation). In post-marketing surveillance, the duration of administration (observation) typically differs by patient and most of the analyses fail to take into account the differences in duration of administration (observation). Therefore, we investigated the usefulness of hazard functions in a drug safety assessment using the interim results from Clinical Experience Investigation of the oral anticancer drug, TS-1.
Methods : About three thousand patients with gastric cancer were enrolled in this Clinical Experience Investigation. TS-1 was administrated orally twice daily. One course consisted of consecutive administration for 28 days and 14 days rest. Administration was repeated in two courses. Hematological measurements, stomatitis, anorexia, nausea/vomiting, diarrhea, malaise were analyzed. Adverse events were evaluated in accordance with the criteria of the Japan Society for Cancer Therapy, which were established based on criteria established by the WHO. Time to occurrence of an adverse event was calculated from the first day of administration until the adverse event was first observed. Hazard functions were estimated by smoothing methods using kernel functions.
Results : The occurrence of adverse events using smoothed hazard functions had one peak around 10 days in the first course and decreased by administration rest. With the resumption of administration, the occurrence increased again. The occurrence in the second course were less than that of the first course.
Conclusion : The occurrence peaks of adverse events were estimated graphically by smoothed hazard functions. We conclude that hazard functions are useful as an analytical tool in drug safety assessment.

In patients with the visceral fat type obesity, there is a high incidence of glucose and lipid metabolic abnormalities and hypertension. We obtained the following results from a study of the relationship between the degree of visceral fat obesity and metabolic and vascular complications in 98 obese patients with various complications.
1. Viceral fat obesity (V/S ratio ≥ 0.4) was found in 74% of the subjects. The incidence was higher in males than females. The highest incidence was observed in both men and women in thier 40s, and there was no increase with age.
2. The V/S ratio was high in patients with hyperlipidemia, diabetes, and fatty liver in that order. In the V/S ≥ 0.4 group, there was a higher incidence of hyperlipidemia and ischemic heart disease than in the V/S<0.4 group.
3. The V/S ratio was higher in the patients with two or more metabolic and vascular complications than in those with only one complication.
4. A questionnaire survey showed that there were many individuals who did almost no exercise and had a long history of obesity in the V/S ≥ 0.4 group.
5. The V/S ≥ 0.4 group had high triglyceride levels. There was a positive correlation between the V/ S ratio or V value and the trigyceride level, but no correlation between S value and triglyceride level.

Tohoku Medical and Pharmaceutical University, Japan, offers “Early Exposure to Medical Practice” in the first semester for first-year medical students to learn about patient-centered care as well as the real-world conditions and issues faced in community medical practice. Owing to the COVID-19 pandemic during the past two years, we planned and implemented online training, including some disability simulations, which mostly aimed to prevent the spread of infection. The students who completed these training courses reported that the online training had certain advantages over hands-on training ; the two activities implemented were not only effective in preventing infection but also had other benefits that only an online environment could provide. Herein, we report the results and some of the merits of these practices in 2021.