Table 4.
Adverse events reported during the safety data collection period in the safety evaluable population.
| Incidence (n = 75) | Non-Serious | Serious | Overall | |||
| nevents | n (%) | nevents | n (%) | nevents | n (%) | |
| AEs | 135 | 45 (60.0) | 83 | 36 (48.0) | 218 | 60 (80.0) |
| AEs related to POM | 42 | 23 (30.7) | 31 | 14 (18.7) | 73 | 32 (42.7) |
| AEs leading to POM discontinuation | 6 | 6 (8.0) | 21 | 15 (20.0) | 27 | 21 (28.0) |
| POM-related AEs leading to POM discontinuation | 4 | 4 (5.3) | 3 | 3 (4.0) | 7 | 7 (9.3) |
| Infections/infestations | 18 | 15 (20.0) | 17 | 15 (20.0) | 35 | 28 (37.3) |
| Infections/infestations related to POM | 4 | 3 (4.0) | 4 | 3 (4.0) | ||
| Thrombosis/deep vein thrombosis | 2 | 1 (1.3) | 1 | 1 (1.3) | 3 | 2 (2.7) |
| Deep vein thrombosis related to POM | 1 | 1 (1.3) | 1 | 1 (1.3) | ||
| nevents | n (%) | |||||
| Grade ≥3 POM-related AEs | 22 | 10 (13.3) | ||||
| Grade ≥3 POM-related hematological toxicities | 14 | 6 (8.0) | ||||
| Neutropenia | 3 | 3 (4.0) | ||||
| Anemia Thrombocytopenia |
4 | 2 (2.7) | ||||
| 4 | 2 (2.7) | |||||
| Platelet count decreased | 2 | 1 (1.3) | ||||
| Neutrophil count decreased | 1 | 1 (1.3) | ||||
| Grade ≥3 POM-related non-hematological toxicities | 8 | 4 (5.3) | ||||
| Acute kidney injury/renal impairment | 2 | 2 (2.7) | ||||
| Back pain | 1 | 1 (1.3) | ||||
| Deep vein thrombosis Device (catheter) related infection Diarrhea |
1 | 1 (1.3) | ||||
| 1 | 1 (1.3) | |||||
| 1 | 1 (1.3) | |||||
| Gastric hemorrhage | 1 | 1 (1.3) | ||||
| Renal impairment | 1 | 1 (1.3) | ||||
| Urinary tract infection | 1 | 1 (1.3) | ||||
AE, adverse event; POM, pomalidomide.