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Table 2 Most common AEs by treatment cycle in patients with best response of SD to romidepsin
| Drug related/non-drug related, n | Treatment cycle | |||||||
|---|---|---|---|---|---|---|---|---|
| Any (n = 32) | 1 (n = 32) | 2 (n = 28) | 3 (n = 25) | 4 (n = 21) | 5 (n = 14) | 6 (n = 11) | >6 (n = 5) | |
| Any grade AEs reported in > 20 % of patients with best response of SD | ||||||||
| Nausea | 22/2 | 18/2 | 6/0 | 5/0 | 5/1 | 5/0 | 0/0 | 1/0 |
| Asthenia/fatigue | 19/1 | 13/0 | 6/0 | 4/0 | 4/0 | 3/1 | 2/1 | 1/0 |
| Infections SOC | 6/11 | 4/6 | 1/3 | 1/2 | 0/5 | 1/1 | 1/2 | 1/2 |
| Dysgeusia | 14/0 | 8/0 | 7/0 | 1/0 | 2/0 | 0/0 | 0/0 | 0/0 |
| Vomiting | 12/1 | 5/0 | 4/1 | 4/0 | 3/1 | 4/0 | 0/0 | 1/0 |
| Diarrhea | 7/5 | 5/1 | 4/2 | 1/0 | 1/0 | 0/1 | 0/1 | 1/0 |
| Constipation | 5/6 | 3/3 | 0/0 | 2/0 | 0/0 | 1/1 | 0/0 | 0/1 |
| Anorexia | 11/0 | 6/0 | 3/0 | 3/0 | 1/0 | 2/0 | 0/0 | 1/0 |
| Thrombocytopenia | 10/0 | 6/0 | 2/0 | 3/0 | 2/0 | 2/0 | 2/0 | 0/0 |
| Pyrexia | 7/1 | 1/1 | 1/0 | 0/1 | 2/1 | 1/1 | 1/1 | 1/1 |
| Neutropenia | 7/0 | 4/0 | 4/0 | 3/0 | 2/0 | 1/0 | 1/0 | 2/0 |
| Anemia | 6/1 | 1/1 | 2/0 | 1/0 | 1/0 | 0/0 | 1/0 | 2/0 |
| Grade ≥ 3 AEs reported in > 1 patients with best response of SD | ||||||||
| Neutropenia | 7/0 | 4/0 | 3/0 | 2/0 | 1/0 | 1/0 | 0/0 | 2/0 |
| Thrombocytopenia | 6/0 | 3/0 | 1/0 | 1/0 | 1/0 | 1/0 | 1/0 | 0/0 |
| Infections SOC | 2/3 | 1/2 | 0/0 | 0/0 | 0/0 | 0/0 | 1/0 | 0/2 |
| Anemia | 3/0 | 0/0 | 1/0 | 0/0 | 0/0 | 0/0 | 1/0 | 1/0 |
