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.