Table 2.
TRAE in at least 5% of patients by dose group
| 120 3/4 | 160 3/4 | 160 3/4, 2/1w | All patients | |||||
|---|---|---|---|---|---|---|---|---|
| (n = 25) |
(n = 67) |
(n = 27) |
(N = 119) |
|||||
| Preferred term | All grade | Grade 3+ | All grade | Grade 3+ | All grade | Grade 3+ | All grade | Grade 3+ |
| no. (%) | no. (%) | no. (%) | no. (%) | no. (%) | no. (%) | no. (%) | no. (%) | |
| Any event | 23 (92.0) | 8 (32.0) | 58 (86.6) | 32 (47.8) | 24 (88.9) | 7 (25.9) | 105 (88.2) | 47 (39.5) |
| Anemia | 18 (72.0) | 6 (24.0) | 47 (70.1) | 28 (41.8) | 15 (55.6) | 3 (11.1) | 80 (67.2) | 37 (31.1) |
| Fatigue | 8 (32.0) | 1 (4.0) | 21 (31.3) | 2 (3.0) | 7 (25.9) | 0 | 36 (30.3) | 3 (2.5) |
| Neutropenia | 6 (24.0) | 2 (8.0) | 23 (34.3) | 12 (17.9) | 6 (22.2) | 4 (14.8) | 35 (29.4) | 18 (15.2)a |
| Nausea or vomiting | 9 (36.0) | 0 | 17 (25.4) | 0 | 5 (18.5) | 0 | 31 (26.1) | 0 |
| Thrombocytopenia | 4 (16.0) | 1 (4.0) | 13 (19.4) | 6 (9.0) | 8 (29.6) | 0 | 25 (21.0) | 7 (5.8) a |
| Decreased appetite | 9 (36.0) | 0 | 8 (11.9) | 0 | 1 (3.7) | 0 | 18 (15.1) | 0 |
| Diarrhea | 6 (24.0) | 0 | 8 (11.9) | 0 | 5 (18.5) | 0 | 19 (16.0) | 0 |
| Leukopenia | 4 (16.0) | 0 | 7 (10.4) | 4 (6.0) | 3 (11.1) | 1 (3.7) | 14 (11.8) | 5 (4.2) |
| Dyspnea | 1 (4.0) | 0 | 7 (10.4) | 0 | 0 | 0 | 8 (6.7) | 0 |
| Dysgeusia | 2 (8.0) | 0 | 4 (6.0) | 0 | 0 | 0 | 6 (5.0) | 0 |
| Constipation | 2 (8.0) | 0 | 3 (4.5) | 0 | 1 (3.7) | 0 | 6 (5.0) | 0 |
| Rash maculo-papular | 1 (4.0) | 0 | 4 (6.0) | 0 | 1 (3.7) | 0 | 6 (5.0) | 0 |
| ALT or AST increased | 0 | 0 | 3 (4.5) | 0 | 2 (7.4) | 0 | 5 (4.2) | 0 |
| Blood ALP increased | 0 | 0 | 2 (3.0) | 0 | 2 (7.4) | 0 | 4 (3.4) | 0 |
| Weight decreased | 1 (4.0) | 0 | 0 | 0 | 2 (7.4) | 0 | 3 (2.5) | 0 |
a
There were 5 incidences of grade 4 TRAE: 160 3/4 group: grade 4 thrombocytopenia (n = 1), grade 4 neutropenia (n = 3); 160 3/4, 2/1w group: grade 4 neutropenia (n = 1). 2/1w = 2 weeks on, 1 week off; 120 3/4 = 120 mg QD 3 days on, 4 days off; 160 3/4 = 160 mg QD 3 days on, 4 days off; ALT = alanine aminotransferase; AST = aspartate aminotransferase; ALP = alkaline phosphatase; QD = once daily; TRAE = treatment-related adverse events.