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 There were no serious adverse events (SAEs) reported, no subjects were withdrawn due to AEs, and there were no AEs leading to death.