Table 5.

Treatment-emergent adverse events reported in >10% of patients in any group in DIALOGUEs 1, 2, and 4

TEAEsMolidustat Combined-Dose GroupControl Groupa
DIALOGUE 1n=101n=20
 Hyperparathyroidism, secondary1 (1)3 (15)
 Constipation5 (5)1 (5)
 Diarrhea4 (4)1 (5)
 Vomiting2 (2)1 (5)
 Nasopharyngitis7 (7)2 (10)
 Urinary tract infection4 (4)3 (15)
 Hyperkalemia4 (4)3 (15)
 Dizziness5 (5)3 (15)
 Hypertension10 (10)5 (25)
DIALOGUE 2n=92n=32
 Diarrhea5 (5)1 (3)
 Edema, peripheral8 (9)2 (6)
 CKD10 (11)0
 Hypertension14 (15)4 (13)
DIALOGUE 4n=157n=42
 Diarrhea12 (8)2 (5)
 Nausea8 (5)2 (5)
 Vomiting6 (4)0
 Nasopharyngitis9 (6)1 (2)
 Hemoglobin, decreasedb15 (10)2 (5)
 Hemoglobin, increasedb13 (8)2 (5)
 Hypertension17 (11)8 (19)
  • All data are given as n (%). DIALOGUE, DaIly orAL treatment increasing endOGenoUs Erythropoietin; TEAE, treatment-emergent adverse event.

  • a Patients in the control group received placebo in DIALOGUE 1, continued darbepoetin treatment in DIALOGUE 2, and continued epoetin treatment in DIALOGUE 4.

  • b As judged by the investigator.