Table 7.
Frequency of Adverse Events.
| Entire Study Population (n = 78) |
Frequency of Toxicities by SML | |||||
|---|---|---|---|---|---|---|
| SMI ≤ 5% Decrease to Baseline (n = 54) |
SMI > 5% Decrease to Baseline (n = 24) |
|||||
| Event | Any Grade | Grade ≥ 3 | Any Grade | Grade ≥ 3 | Any Grade | Grade ≥ 3 |
| Any event—no. (%) | 77 (99) | 51 (65) | 54 (100) | 39 (72) | 23 (96) | 12 (50) |
| Stomatitis—no. (%) | 6 (8) | 0 | 3 (6) | 0 | 3 (13) | 0 |
| Hand–foot syndrome—no. (%) | 0 | 0 | 0 | 0 | 0 | 0 |
| Skin lesions—no. (%) | 4 (5) | 0 | 3 (6) | 0 | 1 (4) | 0 |
| Diarrhea—no. (%) | 19 (24) | 1 (1) | 16 (30) | 1 (1) | 3 (13) | 0 |
| Pneumonia—no. (%) | 5 (6) | 0 | 5 (9) | 0 | 0 | 0 |
| Nausea—no. (%) | 16 (21) | 2 (3) | 9 (17) | 0 | 7 (29) | 2 (8) |
| Vomiting—no. (%) | 8 (10) | 2 (3) | 3 (6) | 0 | 5 (21) | 2 (8) |
| Anemia—no. (%) | 64 (82) | 15 (19) | 43 (80) | 9 (17) | 21 (88) | 6 (25) |
| Neutropenia—no. (%) | 54 (69) | 36 (46) | 39 (72) | 30 (56) | 15 (63) | 6 (25) |
| Lymphopenia—no. (%) | 30 (38) | 4 (5) | 21 (39) | 3 (6) | 9 (38) | 1 (4) |
| Thrombocytopenia—no. (%) | 15 (19) | 3 (4) | 10 (19) | 2 (4) | 5 (21) | 1 (4) |
| ALT increased—no. (%) | 27 (35) | 2 (3) | 18 (33) | 1 (1) | 9 (38) | 1 (4) |
| AST increased—no. (%) | 23 (29) | 2 (3) | 19 (35) | 1 (1) | 4 (17) | 1 (4) |
| Fatigue—no. (%) | 52 (67) | 8 (9) | 35 (65) | 4 (7) | 17 (71) | 4 (4) |
| Decreased appetite—no. (%) | 35 (45) | 2 (3) | 22 (41) | 0 | 13 (54) | 2 (8) |
| Constipation—no. (%) | 8 (10) | 0 | 6 (11) | 0 | 2 (8) | 0 |
| Weight loss—no. (%) | 31 (40) | 0 | 17 (31) | 0 | 14 (58) | 0 |