2.3 Safety assessment
The following clinical safety assessments were included in the study: a
physical examination, the vital signs (height, weight, blood pressure,
heart rate, axillary temperature and respiratory rate), clinical
laboratory tests (full blood count, urine routine, blood chemistry,
coagulation function, stool routine & occult blood, 12-lead ECG cardiac
monitoring, chest X-ray examination) and recording of the adverse
events. Adverse experiences were monitored throughout the
study. The investigators evaluated
all the clinical adverse events in terms of the intensity (mild,
moderate or severe), duration, severity, outcome and relationship to the
study drug.