3.3 Safety analysis
All the 20 subjects enrolled in this study completed 2 times of
famitinib and 13 times of omeprazole administration as planned.
A total of 9 (45.0%) subjects
had 16 AEs, all of which were treatment-emergent adverse events (TEAEs)
at grade 1 severity according to the Common Terminology Criteria for
Adverse Events (CTCAE) guidelines. No adverse events of grade 2 or above
were reported. Among the total 16 AEs, 9 TEAEs occurred in 6 subjects
(30.0%) in the single administration phase of famitinib; 1 subject
(5.0%) had 1 TEAE in the single administration phase of omeprazole; At
the stage of famitinib combined with omeprazole, 5 subjects (25.0%) had
6 TEAEs. Famitinib was generally well tolerated when administered either
alone or in combination with omeprazole.
A summary of the above TEAEs was shown in Table 3. 5 (25.0%) subjects
had 10 TEAEs related to famitinib including alanine aminotransferase
increased (10%), blood triglycerides increased (10%), gamma-glutamyl
transferase increased (5%), basophil count increased (5%), white blood
cells urine positive (5%), glucose urine present (5%), and blood
glucose increased (5%). 2 (10.0%) subjects had 2 TEAEs related to
omeprazole including
gamma-glutamyl transferase
increased (5%) and increased heart rate. All adverse events occurred
during the study period were recovered / resolved at the end of the
study.