2.5 Data and statistical analysis
The treatment-emergent adverse events (TEAE) and adverse reactions in each dose group were summarized according to the System Organ Class and the Preferred Term. TEAE means an adverse event that occurred at or after the first medication to 28 days (inclusive) after the last medication. The severity of adverse events was classified using NCI CTCAE 4.03.
For safety data such as laboratory, vital signs, electrocardiogram, physical examination, etc., baseline data, post-dose data, and change from baseline were summarized according to each follow-up and each dose group; Regarding whether the test results were normal or not and whether they were clinically meaningful as classified data, a Shift Table was used to describe the change from baseline to each follow-up after administration.
Using the blood/urine PK concentration analysis set, the blood/urine concentration of each planned time point was descriptively summarized, and for each dose group, the concentration-time curve of each subject and the average concentration-time curve of each group was drawn.
The pharmacokinetic data were processed and graphed using computer programs Excel and origin Pro 8.0. The pharmacokinetic parameters were calculated using the non-compartmental model (NCA) of Phoenix 64 (WinNonlin6.3). Medical history and adverse events were coded using MedDRA and past and combined medications were coded using WHO Drug Dictionary.
Statistical analysis was respectively performed for the single-dose and continuous administration by the SASĀ® version 9.4 software (SAS Institute Inc., Cary, NC, USA) and a P-value of 0.05 was considered statistically significant.