Table II.
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