Table 2.
Summary of TEAEs up to week 52 (safety analysis set)
| Molidustat (n = 153) | Darbepoetin (n = 76) | Total (N = 229) | |
|---|---|---|---|
| Any TEAE, n (%) | 146 (95.4) | 72 (94.7) | 218 (95.2) |
| Mild | 93 (60.8) | 54 (71.1) | 147 (64.2) |
| Moderate | 40 (26.1) | 13 (17.1) | 53 (23.1) |
| Severe | 13 (8.5) | 5 (6.6) | 18 (7.9) |
| Any serious TEAE, n (%) | 37 (24.2) | 14 (18.4) | 51 (22.3) |
| TEAE leading to death, n (%) | 2 (1.3) | 2 (2.6) | 4 (1.7) |
| TEAEs by primary system organ class and preferred terma | |||
| GI disorders, n (%) | 79 (51.6) | 59 (77.6) | 138 (60.3) |
| General disorders and administration site conditions, n (%) | 1 (0.7) | 6 (7.9) | 7 (3.1) |
| Infections and infestations, n (%) | 88 (57.5) | 48 (63.2) | 136 (59.4) |
| Injury, poisoning, and procedural complications, n (%) | 49 (32.0) | 25 (32.9) | 74 (32.3) |
| Metabolism and nutrition disorders, n (%) | 3 (2.0) | 4 (5.3) | 7 (3.1) |
| Musculoskeletal and connective tissue disorders, n (%) | 37 (24.2) | 16 (21.1) | 53 (23.1) |
| Nervous system disorders, n (%) | 12 (7.8) | 10 (13.2) | 22 (9.6) |
| Skin and subcutaneous disorders, n (%) | 12 (7.8) | 15 (19.7) | 27 (11.8) |
| Specific TEAEs, n (%) | |||
| Any neoplasms, benign, malignant, and unspecifiedb | 15 (9.8) | 4 (5.3) | 19 (8.3) |
| Malignant tumorsc | 6 (3.9) | 1 (1.4) | 7 (3.1) |
| Nonmalignant tumors | 9 (5.9) | 3 (3.9) | 12 (5.2) |
GI, gastrointestinal; 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.
a
The number of adverse events are the sum of individual TEAEs which were reported in ≥5% of patients in either treatment group. Details are provided in Table S2.
b
Details are provided in Supplementary Table S3.
c
Categorized using the standardized MedDRA Queries (SMQ).