Table II.
Most frequent non-hematologic adverse events*
| Arm A (N= 38) |
Arm B (N= 11) |
|||
|---|---|---|---|---|
| Toxic effects | n (%) | |||
| Any Grade | Grade 3–4 | Any Grade | Grade 3–4 | |
| Diarrhea | 17 (45) | 2 (5) | 3 (27) | 1 (9) |
| Fatigue | 9 (24) | 2 (5) | 1 (9) | 0 (0) |
| Peripheral edema | 9 (24) | 1 (3) | 3 (27) | 0 (0) |
| Rash | 9 (24) | 0 (0) | 3 (27) | 0 (0) |
| Pneumonia | 8 (21) | 8 (21) | 6 (55) | 6 (55) |
| Urinary tract infection | 8 (21) | 6 (16) | 0 (0) | 0 (0) |
| Nausea | 7 (18) | 1 (3) | 3 (27) | 1 (9) |
| Headache | 6 (16) | 2 (5) | 0 (0) | 0 (0) |
| Stomatitis | 6 (16) | 1 (3) | 6 (55) | 4 (36) |
| Dermatitis, bullous | 2 (5) | 0 (0) | 2 (18) | 1 (9) |
| Sepsis | 3 (8) | 3 (8) | 2 (18) | 2 (18) |
| Hyperbilirubinemia | 3 (8) | 2 (5) | 2 (18) | 1 (9) |
| Cough | 2 (5) | 0 (0) | 2 (18) | 0 (0) |
| Epistaxis | 1 (3) | 0 (0) | 2 (18) | 0 (0) |
| Multi-organ failure | 0 (0) | 0 (0) | 2 (18) | 2 (18) |
| Most frequent hematologic adverse events effects | ||||
|
Arm A (N= 38) |
Arm B (N= 11) |
|||
| Toxic effects | Any Grade | Grade 3–4 | Any Grade | Grade 3–4 |
| Neutropenic fever | 17 (45) | 17 (45) | 2 (18) | 2 (18) |
| Thrombocytopenia | 2 (5) | 2 (5) | 0 (0) | 0 (0) |
| Anemia | 3 (8) | 3 (8) | 0 (0) | 0 (0) |
Arm A; Daily IV evofosfamide administration, Arm B; continuous evofosfamide administration
*
≥15% of patients in either Arm