Table 2.
Incidence and severity of AEs (n = 1179).
| MedDRA classification system preferred term | All grades | Severity | ||||
|---|---|---|---|---|---|---|
| Grade 1 | Grade 2 | Grade 3 | Grade 4 | Grade 5 | ||
| Leukopenia | 944 (80.1) | 99 (8.4) | 380 (32.2) | 372 (31.6) | 93 (7.9) | 0 |
| Neutropenia | 893 (75.7) | 109 (9.2) | 267 (22.6) | 292 (24.8) | 225 (19.1) | 0 |
| Anemia | 797 (67.6) | 144 (12.2) | 443 (37.6) | 171 (14.5) | 39 (3.3) | 0 |
| Thrombopenia | 604 (51.2) | 200 (17.0) | 195 (16.5) | 142 (12.0) | 67 (5.7) | 0 |
| Nausea | 361 (30.6) | 295 (25.0) | 60 (5.1) | 6 (0.5) | 0 | 0 |
| AST increased | 258 (21.9) | 194 (16.5) | 50 (4.2) | 10 (0.8) | 4 (0.3) | 0 |
| ALT increased | 241 (20.4) | 180 (15.3) | 52 (4.4) | 8 (0.7) | 1 (0.1) | 0 |
| Fatigue | 228 (19.3) | 185 (15.7) | 43 (3.6) | 0 | 0 | 0 |
| Vomiting | 186 (15.8) | 118 (10.0) | 45 (3.8) | 23 (2.0) | 0 | 0 |
| Pain | 155 (13.1) | 102 (8.7) | 42 (3.6) | 11 (0.9) | 0 | 0 |
| Loss of appetite | 141 (12.0) | 117 (9.9) | 24 (2.0) | 0 | 0 | 0 |
| Blood glucose increased | 83 (7.0) | 60 (5.1) | 21 (1.8) | 2 (0.2) | 0 | 0 |
| Hypocalcemia | 75 (6.5) | 58 (4.9) | 16 (1.4) | 2 (0.2) | 1 (0.1) | 0 |
| Albumin decreased | 76 (6.4) | 72 (6.1) | 4 (0.3) | 0 | 0 | 0 |
| Fever | 75 (6.4) | 58 (4.9) | 13 (1.1) | 1 (0.1) | 3 (0.3) | 0 |
| Anorexia and bulimia syndrome | 61 (5.2) | 56 (4.7) | 5 (0.4) | 0 | 0 | 0 |
| Hypoalbuminemia | 61 (5.2) | 50 (4.2) | 11 (0.9) | 0 | 0 | 0 |
| Blood bilirubin increased | 59 (5.0) | 29 (2.5) | 23 (2.0) | 6 (0.5) | 1 (0.1) | 0 |
| Hypokalemia | 54 (4.6) | 43 (3.6) | 2 (0.2) | 9 (0.8) | 0 | 0 |
| Cough | 52 (4.4) | 40 (3.4) | 12 (1.0) | 0 | 0 | 0 |
| Blood uric acid increased | 50 (4.2) | 49 (4.2) | 1 (0.1) | 0 | 0 | 0 |
| Hyponatremia | 41 (3.5) | 32 (2.7) | 1 (0.1) | 7 (0.6) | 1 (0.1) | 0 |
| Hemoglobin decreased | 38 (3.2) | 12 (1.0) | 20 (1.7) | 6 (0.5) | 0 | 0 |
| Insomnia | 37 (3.1) | 32 (2.7) | 5 (0.4) | 0 | 0 | 0 |
Data were expressed as n (%).
AEs, adverse events; ALT, alanine aminotransferase; AST, aspartate aminotransferase.