TABLE 3.
ADR number and report rate of 20 SOCs of Two DNA Methylation Inhibitors.
| System organ class | Azacitidine (N = 17,925) | Decitabine (N = 5,838) |
|---|---|---|
| Blood and lymphatic system disorders | 6,403 (35.72%) | 2,565 (43.94%) |
| Cardiac disorders | 974 (5.43%) | 234 (4.01%) |
| Congenital familial and genetic disorders | 59 (0.33%) | 17 (0.29%) |
| Ear and labyrinth disorders | 66 (0.37%) | 28 (0.48%) |
| Endocrine disorders | 36 (0.2%) | 5 (0.09%) |
| Eye disorders | 113 (0.63%) | 60 (1.03%) |
| Gastrointestinal disorders | 2,568 (14.33%) | 994 (17.03%) |
| General disorders and administration site conditions | 4,457 (24.86%) | 1,327 (22.73%) |
| Hepatobiliary disorders | 354 (1.97%) | 100 (1.71%) |
| Immune system disorders | 273 (1.52%) | 75 (1.28%) |
| Infections and infestations | 4,213 (23.5%) | 1,166 (19.97%) |
| Injury poisoning and procedural complications | 1,117 (6.23%) | 487 (8.34%) |
| Investigations | 2,585 (14.42%) | 778 (13.33%) |
| Metabolism and nutrition disorders | 862 (4.81%) | 444 (7.61%) |
| Musculoskeletal and connective tissue disorders | 530 (2.96%) | 243 (4.16%) |
| Neoplasms benign malignant and unspecified incl cysts and polyps | 1836 (10.24%) | 373 (6.39%) |
| Nervous system disorders | 1,037 (5.79%) | 392 (6.71%) |
| Pregnancy puerperium and perinatal conditions | 5 (0.03%) | 2 (0.03%) |
| Product issues | 74 (0.41%) | 3 (0.05%) |
| Psychiatric disorders | 287 (1.6%) | 121 (2.07%) |
| Renal and urinary disorders | 682 (3.8%) | 207 (3.55%) |
| Reproductive system and breast disorders | 54 (0.3%) | 22 (0.38%) |
| Respiratory thoracic and mediastinal disorders | 1,602 (8.94%) | 558 (9.56%) |
| Skin and subcutaneous tissue disorders | 1,317 (7.35%) | 330 (5.65%) |
| Social circumstances | 68 (0.38%) | 14 (0.24%) |
| Surgical and medical procedures | 104 (0.58%) | 38 (0.65%) |
| Vascular disorders | 628 (3.5%) | 194 (3.32%) |