Table 2.
Reported adverse effects of decitabine
| Adverse event | Grade 1%–2% affected | Grade 3%–4% affected | Reference |
|---|---|---|---|
| Neutropenia | 1 | 31, 86* | 9, 28 |
| Thrombocytopenia | 2 | 18, 85* | 9, 28 |
| Anemia | 5 | 12* | 9, 28 |
| Bleeding | 46 | 7 | 25 |
| Febrile neutropenia, fever of unknown origin | 3 | 6, 14, 20, 23*, 33 | 6, 9, 25, 28, 34, 46 |
| Leukopenia | 22* | 9 | |
| Pyrexia | 6* | 9 | |
| Liver dysfunction | 2, 10, 11 | 1, 1, 4, 6* | 6, 9, 25, 26, 34 |
| Pneumonia | 1 | 2, 11, 15*, 20 | 6, 9, 25, 28, 34 |
| Nausea | 2, 17, 26 | 0, 1*, 7 | 6, 9, 25, 26, 28, 34 |
| Pyrexia | 17 | 0 | 28 |
| Constipation | 11 | 0, 2* | 9, 28 |
| Chills | 10 | 0 | 28 |
| Diarrhea | 1, 2, 12 | 0* | 9, 25, 26, 28, 34 |
| Abdominal pain | 2* | 9 | |
| Bone aches | 0, 4, 10 | 2, 5 | 25, 26, 34 |
| Skin rash | 0, 1 | 0 | 25, 26, 34 |
| Fatigue | 1, 6, 26 | 0, 5 | 25, 28, 34 |
| Cardiovascular | 8 | 6 | |
| Mucositis | 4 | 6 | |
| Anorexia | 12 | 0, 1 | 6, 28 |
| Sleep disorder | 1 | 6 | |
| Alopecia | 1 | 6 | |
| Anaphylactic reaction | 1 | 6 | |
| Deafness | 1 | 6 | |
| Headache | 1 | 6 |
*
Grade 3 and 4 data from the Phase III Decitabine study9 were combined for the purposes of this review.