Table 2.
Summary of treatment-emergent adverse events and treatment-emergent adverse events by system organ class reported in <5% of patients in any treatment group - pooled total population
| Treatment-emergent adverse events | Vadadustat (W = 3,686) Exposure = 6,335.3 PY |
Darbepoetin alfa (W = 3,687) Exposure = 6,420.1 PY |
||
|---|---|---|---|---|
| n (%) | Events (events per 100 PY) | n (%) | Events (events per 100 PY) | |
| Summary | ||||
| Any TEAE | 3,277 (88.9) | 27,417 (432.8) | 3,292 (89.3) | 28,340 (441.4) |
| Severity | ||||
| Mild | 589 (16.0) | 12,477 (196.9) | 601 (16.3) | 12,781 (199.1) |
| Moderate | 1,106 (30.0) | 10,361 (163.5) | 1,095 (29.7) | 10,926 (170.2) |
| Severe | 1,582 (42.9) | 4,579 (72.3) | 1,596 (43.3) | 4,633 (72.2) |
| Any drug-related TEAE | 371 (10.1) | 576 (9.1) | 174 (4.7) | 218 (3.4) |
| Any severe TEAE | 1,582 (42.9) | 4,579 (72.3) | 1,596 (43.3) | 4,633 (72.2) |
| Any TE-SAE | 2,139 (58.0) | 6,981 (110.2) | 2,186 (59.3) | 7,159 (111.5) |
| Any drug-related TE-SAE | 66 (1.8) | 75 (1.2) | 55 (1.5) | 64 (1.0) |
| Any TEAE leading to discontinuation | 259 (7.0) | 321 (5.1) | 126 (3.4) | 159 (2.5) |
| Any drug-related TEAE leading to discontinuation | 73 (2.0) | 85 (1.3) | 11 (0.3) | 12 (0.2) |
| Any TEAE leading to death | 593 (16.1) | 593 (9.4) | 596 (16.2) | 597 (9.3) |
| By MedDRA System Organ Class, reported in >5% of patients | ||||
| Any TEAE | 3,277 (88.9) | 432.8 | 3,292 (89.3) | 441.4 |
| Infections and infestations | 1,873 (50.8) | 68.6 | 1,942 (52.7) | 71.6 |
| Gastrointestinal disorders | 1,483 (40.2) | 52.4 | 1,297 (35.2) | 46.7 |
| Metabolism and nutrition disorders | 1,274 (34.6) | 42.3 | 1,336 (36.2) | 42.1 |
| Vascular disorders | 1,140 (30.9) | 30.6 | 1,213 (32.9) | 32.8 |
| Injury, poisoning, and procedural complications | 1,088 (29.5) | 36.8 | 1,132 (30.7) | 39.7 |
| Respiratory, thoracic, and mediastinal disorders | 902 (24.5) | 26.9 | 966 (26.2) | 28.9 |
| General disorders and administration site conditions | 984 (26.7) | 24.1 | 883 (23.9) | 21.9 |
| Nervous system disorders | 880 (23.9) | 23.7 | 892 (24.2) | 22.4 |
| Musculoskeletal and connective tissue disorders | 843 (22.9) | 22.7 | 895 (24.3) | 24.3 |
| Renal and urinary disorders | 872 (23.7) | 19.1 | 860 (23.3) | 18.8 |
MedDRA, Medical Dictionary for Regulatory Activities; PY, patient-years; TEAE, treatment-emergent adverse event; TE-SAE, treatment-emergent serious adverse event.