Table 3.
Treatment-emergent adverse events (TEAEs) reported in ≥15% of patients
| Adverse Event* | Patients, n (%) | |||
|---|---|---|---|---|
| 140 mg/day (n = 34) | 100 mg/day (n = 118) | |||
| All Grades | Grade 3/4 | All Grades | Grade 3/4 | |
| Any TEAE | 34 (100) | 27 (79.4) | 118 (100) | 100 (84.7) |
| Fatigue | 27 (79.4) | 13 (38.2) | 89 (75.4) | 22 (18.6) |
| Diarrhea | 23 (67.6) | 2 (5.9) | 72 (61.0) | 8 (6.8) |
| Decreased appetite | 18 (52.9) | 1 (2.9) | 54 (45.8) | 5 (4.2) |
| PPES | 14 (41.2) | 3 (8.8) | 46 (39.0) | 11 (9.3) |
| Nausea | 12 (35.3) | 2 (5.9) | 47 (39.8) | 3 (2.5) |
| Headache | 16 (47.1) | 5 (14.7) | 40 (33.9) | 7 (5.9) |
| Constipation | 17 (50.0) | 0 | 35 (29.7) | 0 |
| Hypertension | 12 (35.3) | 1 (2.9) | 37 (31.4) | 9 (7.6) |
| Weight decreased | 9 (26.5) | 0 | 39 (33.1) | 7 (5.9) |
| Dysphonia | 13 (38.2) | 0 | 34 (28.8) | 0 |
| AST increased | 11 (32.4) | 1 (2.9) | 35 (29.7) | 3 (2.5) |
| ALT increased | 11 (32.4) | 3 (8.8) | 33 (28.0) | 10 (8.5) |
| Convulsion | 12 (35.3) | 3 (8.8) | 29 (24.6) | 12 (10.2) |
| LDH increased | 8 (23.5) | 0 | 33 (28.0) | 3 (2.5) |
| Hypophosphatemia | 6 (17.6) | 3 (8.8) | 35 (29.7) | 17 (14.4) |
| Confusional state | 8 (23.5) | 4 (11.8) | 31 (26.3) | 2 (1.7) |
| Stomatitis | 13 (38.2) | 1 (2.9) | 26 (22.0) | 3 (2.5) |
| Vomiting | 10 (29.4) | 1 (2.9) | 25 (21.2) | 4 (3.4) |
| Abdominal pain | 10 (29.4) | 1 (2.9) | 24 (20.3) | 3 (2.5) |
| Thrombocytopenia | 1 (2.9) | 0 | 33 (28.0) | 8 (6.8) |
| Pain in extremity | 8 (23.5) | 0 | 25 (21.2) | 2 (1.7) |
| Insomnia | 11 (32.4) | 0 | 21 (17.8) | 0 |
| Gait disturbance | 9 (26.5) | 2 (5.9) | 23 (19.5) | 7 (5.9) |
| Hair color changes | 8 (23.5) | 0 | 23 (19.5) | 0 |
| Leukopenia | 1 (2.9) | 1 (2.9) | 30 (25.4) | 11 (9.3) |
| Lipase increased | 4 (11.8) | 3 (8.8) | 26 (22.0) | 12 (10.2) |
| Cough | 7 (20.6) | 0 | 21 (17.8) | 0 |
| Dysgeusia | 6 (17.6) | 0 | 22 (18.6) | 0 |
| Anxiety | 6 (17.6) | 0 | 21 (17.8) | 0 |
| Oral pain | 4 (11.8) | 2 (5.9) | 23 (19.5) | 3 (2.5) |
| Depression | 4 (11.8) | 0 | 22 (18.6) | 1 (0.8) |
| Dry skin | 12 (35.3) | 0 | 14 (11.9) | 0 |
| Hemiparesis | 3 (8.8) | 0 | 23 (19.5) | 10 (8.5) |
| Dyspepsia | 5 (14.7) | 0 | 20 (16.9) | 0 |
| Edema peripheral | 4 (11.8) | 0 | 21 (17.8) | 0 |
| Oropharyngeal pain | 9 (26.5) | 0 | 16 (13.6) | 0 |
| Rash | 6 (17.6) | 0 | 19 (16.1) | 1 (0.8) |
| Hypokalemia | 5 (14.7) | 1 (2.9) | 19 (16.1) | 7 (5.9) |
| Neutropenia | 5 (14.7) | 2 (5.9) | 19 (16.1) | 5 (4.2) |
| Dyspnea | 4 (11.8) | 0 | 18 (15.3) | 1 (0.8) |
| Dizziness | 10 (29.4) | 1 (2.9) | 11 (9.3) | 0 |
| Cognitive disorder | 7 (20.6) | 1 (2.9) | 13 (11.0) | 1 (0.8) |
| Lymphopenia | 7 (20.6) | 3 (8.8) | 13 (11.0) | 4 (3.4) |
| Proteinuria | 8 (23.5) | 0 | 12 (10.2) | 1 (0.8) |
| Aphasia | 6 (17.6) | 1 (2.9) | 9 (7.6) | 2 (1.7) |
| Vision blurred | 7 (20.6) | 0 | 7 (5.9) | 0 |
| Bilirubin increased | 6 (17.6) | 2 (5.9) | 7 (5.9) | 1 (0.8) |
| Epistaxis | 6 (17.6) | 0 | 6 (5.1) | 0 |
| Skin discoloration | 6 (17.6) | 0 | 1 (0.8) | 0 |
Abbreviations: ALT, alanine aminotransferase; AST, aspartate aminotransferase; CTCAE, Common Terminology Criteria for Adverse Events; LDH, lactate dehydrogenase; MedDRA, Medical Dictionary for Regulatory Activities; PPES, palmar-plantar erythrodysesthesia syndrome.
*MedDRA v. 15 Preferred Terms (converted to US spelling), CTCAE v. 3.0 grading.