Safety
diarrhoea, Headache, nausea, abdominal pain, palpitations, dysphoria, paresthesia, TEAEs, constipation, dizziness, sexual dysfunction, insomnia, headache, abortion, depression, deaths, nausea, vomiting
ADVERSE EVENTS, PARESTHESIA, WOUND INFECTION, SPINAL OSTEOARTHRITIS, ECTOPIC PREGNANCY, EVENTS
TEAEs were reported by 137 (74.46%) patients in the ansofaxine 80 mg group, 144 (78.26%) patients in the ansofaxine 160 mg, and 125 (67.93%) patients in the placebo group. Most TEAEs were mild or moderate in severity. Fourteen subjects had severe TEAEs, reported by 4 (2.17%, 5 events), 4 (2.17%, 6 events), and 6 (3.26%, 8 events) in the ansofaxine 80 mg, ansofaxine 160 mg, and placebo groups, respectively. The severe TEAEs in 80 mg group were abdominal pain, diarrhoea, headache, insomnia, and suicidal ideation. The severe TEAEs in 160 mg group were nausea, vomiting, constipation, white blood cells, urine positive, and urine ketone body present. The severe TEAEs in the placebo group were abdominal pain, white blood cells urine positive, blood creatine phosphokinase increased, dizziness, paresthesia, palpitations, dysphoria, and spinal osteoarthritis.A total of 31 subjects withdrew from the trial due to TEAEs; 25 out of the 31 subjects withdrew from the trial due to the study drug as judged by the investigator, including seven patients (3.80%) in the 80 mg ansofaxine group, thirteen patients (7.07%) in the 160 mg ansofaxine group, five patients (2.72%) in the placebo group. Headache (4 cases) and insomnia (3 cases) were the top two TRAEs that resulted in withdrawal in the 80 mg group, whereas nausea (6 cases) and abdominal discomfort (4 cases) were the top two causes of withdrawal in the 160 mg group. Unlike the ansofaxine dose groups, the top two reasons causing withdrawal in the placebo group were dizziness (2 cases) and palpitations (2 cases).The incidence of treatment-related adverse events (TRAEs) was reported to be 59.24% (109 cases, 233 events), 65.22% (120 cases, 296 events), and 45.11% (83 cases, 170 events) in ansofaxine 80 mg, 160 mg, and placebo groups, respectively.TRAEs with an incidence ≥5% in any group, sorted by descending incidence in each System Organ Class (SOC), were shown in Table Treatment-related adverse events with an incidence ≥ 5% in any treatment group during double-blind period (SS).Note: There were 184 patients in each group. A total of 6 cases of serious adverse events (SAE) occurred in 5 subjects throughout the study, including 2 cases in 2 subjects in the 80 mg group (wound infection, arteriosclerosis coronary artery), 3 cases in 2 subjects in the 160 mg group (ectopic pregnancy and abortion induced in 1 subject, depression in the other subject) and 1 case in 1 subject in the placebo group (spinal osteoarthritis), and all of the cases were judged by investigators as unrelated with the study drug. No deaths occurred in this study. The detailed information regarding vital signs, physical examination, laboratory tests, 12-lead ECG, and C-SSRS was described in the supplementary information. After the 8-week treatment, changes from baseline in ASEX total score were (−1.6 ± 4.83), (−1.1 ± 4.70) in ansofaxine 80 mg and 160 mg groups, respectively, and no significant difference was shown vs. placebo (−0.5 ± 4.27). No cases were reporting newly developed sexual dysfunction in this study.