Table 6 Summary of adverse events in the Itraconazole + FHND9041 group (SS)
System organ classification Preferred terminology | Monotherapy Phase with FHND9041 | Monotherapy Phase with Itraconazole | Co-administration phase | Total |
|---|---|---|---|---|
N | 15 | 14 | 14 | 15 |
TEAE | 6 (40.0%)[8] | 6 (42.9%)[7] | 8 (57.1%)[8] | 11 (73.3%)[23] |
Hypertriglyceridemia | 4 (26.7%)[4] | 3 (21.4%)[3] | 2 (14.3%)[2] | 7 (46.7%)[9] |
Hypoglycaemia | 0 (0.0%)[0] | 3 (21.4%)[3] | 0 (0.0%)[0] | 3 (20.0%)[3] |
Hyperglycaemia | 0 (0.0%)[0] | 0 (0.0%)[0] | 1 (7.1%)[1] | 1 (6.7%)[1] |
Elevated blood bilirubin | 0 (0.0%)[0] | 0 (0.0%)[0] | 2 (14.3%)[2] | 2 (13.3%)[2] |
C Elevated reactive proteins | 1 (6.7%)[1] | 0 (0.0%)[0] | 0 (0.0%)[0] | 1 (6.7%)[1] |
Elevated gamma-glutamyltransferase | 0 (0.0%)[0] | 0 (0.0%)[0] | 1 (7.1%)[1] | 1 (6.7%)[1] |
Elevated alanine aminotransferase | 0 (0.0%)[0] | 0 (0.0%)[0] | 1 (7.1%)[1] | 1 (6.7%)[1] |
Carbon dioxide reduction | 0 (0.0%)[0] | 1 (7.1%)[1] | 0 (0.0%)[0] | 1 (6.7%)[1] |
Elevated blood alkaline phosphatase | 0 (0.0%)[0] | 0 (0.0%)[0] | 1 (7.1%)[1] | 1 (6.7%)[1] |
Abnormal liver function | 1 (6.7%)[1] | 0 (0.0%)[0] | 0 (0.0%)[0] | 1 (6.7%)[1] |
Have a high temperature | 1 (6.7%)[1] | 0 (0.0%)[0] | 0 (0.0%)[0] | 1 (6.7%)[1] |
Diarrhoea | 1 (6.7%)[1] | 0 (0.0%)[0] | 0 (0.0%)[0] | 1 (6.7%)[1] |