3.2 Safety Results
The
adverse events (AEs) recorded during the entire study were mild to
moderate and well controlled, and most were recovered without treatment.
The incidence of adverse events had no statistically difference (P =
0.62) between the test (20 of 34 subjects) and placebo groups (5 of 10
subjects) in the single-dose study. In total, 51 AEs were reported from
20 of the 34 subjects in test group and fourteen of these were
considered to be related to the EH by the investigator (Table 2). The
incidence of AEs was notably higher in the continuous administration
dose study than in the single-dose study. 68 AEs were reported from 17
of the 18 subjects in the continuous administration dose study, and 58
out of the 68 reported AEs were considered by the investigator to be
related to EH (Table 3). Hypohemoglobinemia was the main AEs recorded in
the single-dose study, while the increase of D-dimer, reticulocyte and
activated partial thromboplastin time (APTT) were the main AEs reported
in the continuous administration study. However, no treatment or
dose-related trend in the incidence of AEs was observed. There were no
serious adverse events (SAEs) reported, no subjects were withdrawn due
to AEs, and there were no AEs leading to death.