Table 2.
Study drug-related AEs (safety population)
| DIALOGUE 3 | Molidustat (n = 118) | Darbepoetin (n = 42) | Total (n = 160) |
|---|---|---|---|
| Number (%) of patients with >1 such AE | 8 (6.8) | 2 (4.8) | 10 (6.3) |
| Atrial tachycardia | 1 (0.8) | 0 | 1 (0.6) |
| Melena | 1 (0.8) | 0 | 1 (0.6) |
| Blood creatine phosphokinase increase | 1 (0.8) | 0 | 1 (0.6) |
| Blood pressure increase | 1 (0.8) | 0 | 1 (0.6) |
| Glycosylated hemoglobin increase | 1 (0.8) | 0 | 1 (0.6) |
| Hemoglobin increase (as judged by the investigator) | 1 (0.8) | 0 | 1 (0.6) |
| Metabolic disorder | 1 (0.8) | 0 | 1 (0.6) |
| Intestinal adenocarcinoma | 1 (0.8) | 0 | 1 (0.6) |
| Iron-deficiency anemia | 0 | 1 (2.4) | 1 (0.6) |
| Vascular disorder | 0 | 1 (2.4) | 1 (0.6) |
| DIALOGUE 5 | Molidustat (n = 57) | Epoetin (n = 30) | Total (n = 87) |
|---|---|---|---|
| Number (%) of patients with >1 such AE | 11 (19.3) | 4 (13.3) | 15 (17.2) |
| Hemoglobin increase (as judged by the investigator) | 3 (5.3) | 1 (3.3) | 4 (4.6) |
| Anemia | 1 (1.8) | 0 | 1 (1.1) |
| Nephrogenic anemia | 1 (1.8) | 0 | 1 (1.1) |
| Bundle branch block left | 1 (1.8) | 0 | 1 (1.1) |
| Diarrhea | 1 (1.8) | 1 (3.3) | 2 (2.3) |
| Abdominal tenderness | 1 (1.8) | 0 | 1 (1.1) |
| Arteriovenous graft thrombosis | 1 (1.8) | 0 | 1 (1.1) |
| Vascular access site thrombosis | 1 (1.8) | 0 | 1 (1.1) |
| Electrocardiogram QT prolonged | 1 (1.8) | 0 | 1 (1.1) |
| Lipase increase | 1 (1.8) | 0 | 1 (1.1) |
| Weight decrease | 1 (1.8) | 0 | 1 (1.1) |
| Balance disorder | 1 (1.8) | 0 | 1 (1.1) |
| Cerebrovascular accident | 1 (1.8) | 0 | 1 (1.1) |
| Dizziness | 1 (1.8) | 0 | 1 (1.1) |
| Dyspnea | 1 (1.8) | 0 | 1 (1.1) |
| Hypertension | 1 (1.8) | 1 (3.3) | 2 (2.3) |
| Blood pressure increase | 0 | 1 (3.3) | 1 (1.1) |
Medical Dictionary for Regulatory Activities version 19.1 was used for coding AEs. A patient with multiple AEs was counted a single time for that system organ class or preferred term. An AE was defined as an event that occurred between the first dose date (regardless of phase) and the end-of-treatment date +3 days in the extension study. Data shown are for the safety population. AE, adverse event.