Table 5.
Treatment-emergent adverse events reported in >10% of patients in any group in DIALOGUEs 1, 2, and 4
| TEAEs | Molidustat Combined-Dose Group | Control Groupa |
|---|---|---|
| DIALOGUE 1 | n=101 | n=20 |
| Hyperparathyroidism, secondary | 1 (1) | 3 (15) |
| Constipation | 5 (5) | 1 (5) |
| Diarrhea | 4 (4) | 1 (5) |
| Vomiting | 2 (2) | 1 (5) |
| Nasopharyngitis | 7 (7) | 2 (10) |
| Urinary tract infection | 4 (4) | 3 (15) |
| Hyperkalemia | 4 (4) | 3 (15) |
| Dizziness | 5 (5) | 3 (15) |
| Hypertension | 10 (10) | 5 (25) |
| DIALOGUE 2 | n=92 | n=32 |
| Diarrhea | 5 (5) | 1 (3) |
| Edema, peripheral | 8 (9) | 2 (6) |
| CKD | 10 (11) | 0 |
| Hypertension | 14 (15) | 4 (13) |
| DIALOGUE 4 | n=157 | n=42 |
| Diarrhea | 12 (8) | 2 (5) |
| Nausea | 8 (5) | 2 (5) |
| Vomiting | 6 (4) | 0 |
| Nasopharyngitis | 9 (6) | 1 (2) |
| Hemoglobin, decreasedb | 15 (10) | 2 (5) |
| Hemoglobin, increasedb | 13 (8) | 2 (5) |
| Hypertension | 17 (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.