Table 5.
TEAEs resulting in discontinuation of study drug by primary system organ class and preferred term (full analysis set)
| Primary system organ class and preferred term | Molidustat (n = 153) | Darbepoetin (n = 76) | Total (N = 229) |
|---|---|---|---|
| Patients with ≥1 TEAE leading to discontinuation, n (%) | 13 (8.5) | 0 | 13 (5.7) |
| Cardiac disorders, n (%) | 2 (1.3) | 0 | 2 (0.9) |
| Angina pectoris | 1 (0.7) | 0 | 1 (0.4) |
| Angina unstable | 1 (0.7) | 0 | 1 (0.4) |
| Aortic valve stenosis | 1 (0.7) | 0 | 1 (0.4) |
| Arteriosclerosis coronary artery | 1 (0.7) | 0 | 1 (0.4) |
| Infections and infestations, n (%) | 1 (0.7) | 0 | 1 (0.4) |
| Septic shock | 1 (0.7) | 0 | 1 (0.4) |
| Injury, poisoning, and procedural complications, n (%) | 1 (0.7) | 0 | 1 (0.4) |
| Shunt occlusion | 1 (0.7) | 0 | 1 (0.4) |
| Neoplasms benign, malignant, and unspecified, n (%) | 6 (3.9) | 0 | 6 (2.6) |
| Benign cardiac neoplasm | 1 (0.7) | 0 | 1 (0.4) |
| Breast cancer | 1 (0.7) | 0 | 1 (0.4) |
| Gastric cancer | 1 (0.7) | 0 | 1 (0.4) |
| Prostate cancer | 1 (0.7) | 0 | 1 (0.4) |
| Renal cancer | 1 (0.7) | 0 | 1 (0.4) |
| Tumor inflammation | 1 (0.7) | 0 | 1 (0.4) |
| Nervous system disorders, n (%) | 1 (0.7) | 0 | 1 (0.4) |
| Cerebral infarction | 1 (0.7) | 0 | 1 (0.4) |
| Skin and subcutaneous disorders, n (%) | 1 (0.7) | 0 | 1 (0.4) |
| Drug eruption | 1 (0.7) | 0 | 1 (0.4) |
| Vascular disorders, n (%) | 1 (0.7) | 0 | 1 (0.4) |
| Aortic dissection | 1 (0.7) | 0 | 1 (0.4) |
TEAE, treatment-emergent adverse event.
Adverse events are presented by primary system organ class and preferred term. A patient is counted only once within each preferred term or any primary system organ class.