Table 3.
Treatment-emergent adverse events in at least 20% of patients on either treatment schedule, by preferred term and frequency
| AE MedDRA preferred term | Schedule A* (N = 32) | Schedule B† (N = 36) |
|---|---|---|
| Patients with ≥1 AE, n (%) | 30 (93.8) | 36 (100) |
| Fatigue | 16 (50.0) | 30 (83.3) |
| Headache | 16 (50.0) | 19 (52.8) |
| Nausea | 13 (40.6) | 17 (47.2) |
| Diarrhea | 11 (34.4) | 14 (38.9) |
| Dizziness | 9 (28.1) | 10 (27.8) |
| Upper respiratory tract infection | 8 (25.0) | 8 (22.2) |
| Constipation | 8 (25.0) | 9 (25.0) |
| Decreased appetite | 2 (6.3) | 9 (25.5) |
| Insomnia | 5 (15.6) | 13 (36.1) |
| Anemia | 5 (15.6) | 12 (33.3) |
| Edema peripheral | 3 (9.4) | 9 (25.0) |
| Pain in extremity | 2 (6.3) | 9 (25.0) |
| Pyrexia | 2 (6.3) | 8 (22.2) |
Patients reporting more than one AE were counted once.
MedDRA, Medical Dictionary for Regulatory Activities v8.1.
*
Schedule A dosing was once weekly (days 1, 8, and 15 of 4-week cycles).
†
Schedule B dosing was twice weekly (days 1, 4, 8, and 11 of 3-week cycles); Schedule B patients could receive low-dose Dex.