Table 4.

Overall adverse event profile during treatment with molidustat or placebo/active comparator during DIALOGUEs 1, 2, and 4

TEAEsDIALOGUE 1DIALOGUE 2DIALOGUE 4
Molidustata (n=101)Placebo (n=20)Molidustata (n=92)Darbepoetin (n=32)Molidustata (n=157)Epoetin (n=42)
Any TEAE67 (66)16 (80)64 (70)17 (53)126 (80)32 (76)
Any study drug-related TEAE12 (12)2 (10)8 (9)041 (26)4 (10)
Maximum intensity for any TEAE
 Mild44 (44)7 (35)30 (33)7 (22)50 (32)12 (29)
 Moderate18 (18)8 (40)29 (32)6 (19)43 (27)13 (31)
 Severe5 (5)1 (5)5 (5)4 (13)33 (21)7 (17)
Any serious TEAE14 (14)5 (25)19 (21)6 (19)34 (22)7 (17)
Any study drug-related serious TEAE001 (1)02 (1)0
Any TEAE resulting in death001 (1)1 (3)1 (1)0
Any study drug-related TEAE resulting in death000000
  • All data are given as n (%). All TEAEs reported were determined by the investigator. DIALOGUE, DaIly orAL treatment increasing endOGenoUs Erythropoietin; TEAE, treatment-emergent adverse event.

  • a Combined-dose groups.