Table 4 Study subject adverse events (AEs) by severity
AEsa | Number (%) patients | |||||
|---|---|---|---|---|---|---|
Grade | Grade 1 | Grade 2 | Grade 3 | Grade 1 | Grade 2 | Grade 3 |
Study | Combination therapy: utidelone (30 mg/m2) + capecitabine (2000 mg/m2) n = 33 | Monotherapy utidelone (40 mg/m2) n = 70 | ||||
Event of grade 3 or above | 19 (57.6) | 13 (18.6) | ||||
Hematologic toxicity | 7 (24.2) | 5 (15.2) | 2 (6.1) | 8(11.4) | 9 (12.9) | 5 (7.1) |
Neutrophil decreased | 2 (6.1) | 2 (6.1) | 2 (6.1) | 11(15.7) | 3(4.3) | 5 (7.1) |
WBC decreased | 5 (15.2) | 6 (18.2) | 0 | 6 (8.6) | 9 (12.9) | 1(1.4) |
Hemoglobin decreased | 1 (3.0) | 0 | 0 | 1 (1.4) | 2(2.9) | 0 |
Platelet decreased | 0 | 2 (6.1) | 0 | 2 (2.9) | 0 | 0 |
Hepatic and renal function abnormalities | 2 (6.1) | 1 (3.0) | 0 | 8 (8.6) | 3 (4.3) | 0 |
GGT increased | 0 | 0 | 0 | 1 (1.4) | 1 (1.4) | 0 |
ALT increased | 1 (3.0) | 0 | 0 | 7 (10) | 2( 2.9) | 0 |
AST increased | 1 (3.0) | 0 | 0 | 4 (5.7) | 2 (2.9) | 0 |
Total bilirubin increased | 1 (3.0) | 1 (3.0) | 0 | 3 (4.3) | 0 | 0 |
Gastrointestinal toxicity | 10 (30.3) | 17 (51.5) | 0 | 28 (40) | 10 (14.3) | 2 (2.9) |
Decreased appetite | 19 (57.6) | 0 | 0 | 14 (20) | 1 (2.9) | 0 |
Diarrhea | 8 (24.2) | 2 (6.1) | 0 | 9 (12.9) | 5 (7.1) | 2 (2.9) |
Vomiting | 4 (12.2) | 10 (30.3) | 0 | 6 (8.6) | 1 (1.4) | 0 |
Nausea | 10 (30.3) | 16 (48.5) | 0 | 22 (31.4) | 2 (2.9) | 0 |
Neurological toxicity | 2 (12.2) | 13 (39.4) | 17 (51.5) | 28 (40) | 23 (32.9) | 7 (10) |
Peripheral neuropathy | 4 (12.2) | 13 (39.4) | 15 (45.5) | 26 (37.1) | 23 (32.9) | 6 (8.6) |
Insomnia | 10 (30.3) | 0 | 1 (3.0) | 5 (7.1) | 0 | 0 |
Dizziness | 17 (51.5) | 1 (3.0) | 2 (6.1) | 7 (10) | 4 (5.7) | 2 (2.9) |
Hand-foot syndrome | 7 (21.2) | 1 (3.0) | 5 (15.2) | 1 (1.4) | 0 | 0 |
Other | ||||||
Myalgia and arthralgia | 5 (15.2) | 15 (45.5) | 5 (15.2) | 9 (12.9) | 1 (1.4) | 1 (1.4) |
Alopecia | 2 (6.1) | 4 (12.2) | 1 (3.0) | 20 (28.6) | 4 (5.7) | 1 (1.4) |
Fatigue | 13 (39.4) | 6 (18.2) | 1 (3.0) | 8 (11.4) | 9 (12.9) | 5 (7.1) |