Treatment-emergent adverse events (TEAEs) reported in ≥15% of patients in the 100 mg group
| Adverse Event* . | Patients, n (%) . | |||
|---|---|---|---|---|
| 140 mg/day (n = 12) . | 100 mg/day (n = 58) . | |||
| All Grades . | Grade 3/4 . | All Grades . | Grade 3/4 . | |
| Any TEAE | 12 (100.0) | 12 (100.0) | 58 (100.0) | 42 (72.4) |
| Fatigue | 8 (66.7) | 3 (25.0) | 44 (75.9) | 12 (20.7) |
| Diarrhea | 8 (66.7) | 2 (16.7) | 25 (43.1) | 2 (3.4) |
| ALT increased | 4 (33.3) | 2 (16.7) | 22 (37.9) | 4 (6.9) |
| Headache | 4 (33.3) | 1 (8.3) | 21 (36.2) | 5 (8.6) |
| Nausea | 5 (41.7) | 0 | 20 (34.5) | 0 |
| Hypertension | 6 (50.0) | 2 (16.7) | 19 (32.8) | 4 (6.9) |
| Constipation | 5 (41.7) | 1 (8.3) | 19 (32.8) | 1 (1.7) |
| AST increased | 5 (41.7) | 2 (16.7) | 16 (27.6) | 3 (5.2) |
| Blood LDH increased | 3 (25.0) | 0 | 16 (27.6) | 1 (1.7) |
| Dysphonia | 5 (41.7) | 0 | 15 (25.9) | 0 |
| Memory impairment | 3 (25.0) | 0 | 15 (25.9) | 0 |
| Convulsion | 2 (16.7) | 1 (8.3) | 15 (25.9) | 3 (5.2) |
| Proteinuria | 5 (41.7) | 0 | 14 (24.1) | 2 (3.4) |
| Confusional state | 3 (25.0) | 0 | 14 (24.1) | 5 (8.6) |
| Cognitive disorder | 2 (16.7) | 1 (8.3) | 13 (22.4) | 0 |
| Decreased appetite | 4 (33.3) | 0 | 12 (20.7) | 1 (1.7) |
| Gait disturbance | 3 (25.0) | 1 (8.3) | 12 (20.7) | 3 (5.2) |
| PPES | 3 (25.0) | 0 | 11 (19.0) | 3 (5.2) |
| Rash | 3 (25.0) | 0 | 11 (19.0) | 0 |
| Depression | 1 (8.3) | 0 | 11 (19.0) | 0 |
| Speech disorder | 1 (8.3) | 1 (8.3) | 10 (17.2) | 4 (6.9) |
| Thrombocytopenia | 0 | 0 | 9 (15.5) | 5 (8.6) |
| Adverse Event* . | Patients, n (%) . | |||
|---|---|---|---|---|
| 140 mg/day (n = 12) . | 100 mg/day (n = 58) . | |||
| All Grades . | Grade 3/4 . | All Grades . | Grade 3/4 . | |
| Any TEAE | 12 (100.0) | 12 (100.0) | 58 (100.0) | 42 (72.4) |
| Fatigue | 8 (66.7) | 3 (25.0) | 44 (75.9) | 12 (20.7) |
| Diarrhea | 8 (66.7) | 2 (16.7) | 25 (43.1) | 2 (3.4) |
| ALT increased | 4 (33.3) | 2 (16.7) | 22 (37.9) | 4 (6.9) |
| Headache | 4 (33.3) | 1 (8.3) | 21 (36.2) | 5 (8.6) |
| Nausea | 5 (41.7) | 0 | 20 (34.5) | 0 |
| Hypertension | 6 (50.0) | 2 (16.7) | 19 (32.8) | 4 (6.9) |
| Constipation | 5 (41.7) | 1 (8.3) | 19 (32.8) | 1 (1.7) |
| AST increased | 5 (41.7) | 2 (16.7) | 16 (27.6) | 3 (5.2) |
| Blood LDH increased | 3 (25.0) | 0 | 16 (27.6) | 1 (1.7) |
| Dysphonia | 5 (41.7) | 0 | 15 (25.9) | 0 |
| Memory impairment | 3 (25.0) | 0 | 15 (25.9) | 0 |
| Convulsion | 2 (16.7) | 1 (8.3) | 15 (25.9) | 3 (5.2) |
| Proteinuria | 5 (41.7) | 0 | 14 (24.1) | 2 (3.4) |
| Confusional state | 3 (25.0) | 0 | 14 (24.1) | 5 (8.6) |
| Cognitive disorder | 2 (16.7) | 1 (8.3) | 13 (22.4) | 0 |
| Decreased appetite | 4 (33.3) | 0 | 12 (20.7) | 1 (1.7) |
| Gait disturbance | 3 (25.0) | 1 (8.3) | 12 (20.7) | 3 (5.2) |
| PPES | 3 (25.0) | 0 | 11 (19.0) | 3 (5.2) |
| Rash | 3 (25.0) | 0 | 11 (19.0) | 0 |
| Depression | 1 (8.3) | 0 | 11 (19.0) | 0 |
| Speech disorder | 1 (8.3) | 1 (8.3) | 10 (17.2) | 4 (6.9) |
| Thrombocytopenia | 0 | 0 | 9 (15.5) | 5 (8.6) |
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. 15.0 Preferred Terms (converted to US spelling), CTCAE v. 3.0 grading.
Treatment-emergent adverse events (TEAEs) reported in ≥15% of patients in the 100 mg group
| Adverse Event* . | Patients, n (%) . | |||
|---|---|---|---|---|
| 140 mg/day (n = 12) . | 100 mg/day (n = 58) . | |||
| All Grades . | Grade 3/4 . | All Grades . | Grade 3/4 . | |
| Any TEAE | 12 (100.0) | 12 (100.0) | 58 (100.0) | 42 (72.4) |
| Fatigue | 8 (66.7) | 3 (25.0) | 44 (75.9) | 12 (20.7) |
| Diarrhea | 8 (66.7) | 2 (16.7) | 25 (43.1) | 2 (3.4) |
| ALT increased | 4 (33.3) | 2 (16.7) | 22 (37.9) | 4 (6.9) |
| Headache | 4 (33.3) | 1 (8.3) | 21 (36.2) | 5 (8.6) |
| Nausea | 5 (41.7) | 0 | 20 (34.5) | 0 |
| Hypertension | 6 (50.0) | 2 (16.7) | 19 (32.8) | 4 (6.9) |
| Constipation | 5 (41.7) | 1 (8.3) | 19 (32.8) | 1 (1.7) |
| AST increased | 5 (41.7) | 2 (16.7) | 16 (27.6) | 3 (5.2) |
| Blood LDH increased | 3 (25.0) | 0 | 16 (27.6) | 1 (1.7) |
| Dysphonia | 5 (41.7) | 0 | 15 (25.9) | 0 |
| Memory impairment | 3 (25.0) | 0 | 15 (25.9) | 0 |
| Convulsion | 2 (16.7) | 1 (8.3) | 15 (25.9) | 3 (5.2) |
| Proteinuria | 5 (41.7) | 0 | 14 (24.1) | 2 (3.4) |
| Confusional state | 3 (25.0) | 0 | 14 (24.1) | 5 (8.6) |
| Cognitive disorder | 2 (16.7) | 1 (8.3) | 13 (22.4) | 0 |
| Decreased appetite | 4 (33.3) | 0 | 12 (20.7) | 1 (1.7) |
| Gait disturbance | 3 (25.0) | 1 (8.3) | 12 (20.7) | 3 (5.2) |
| PPES | 3 (25.0) | 0 | 11 (19.0) | 3 (5.2) |
| Rash | 3 (25.0) | 0 | 11 (19.0) | 0 |
| Depression | 1 (8.3) | 0 | 11 (19.0) | 0 |
| Speech disorder | 1 (8.3) | 1 (8.3) | 10 (17.2) | 4 (6.9) |
| Thrombocytopenia | 0 | 0 | 9 (15.5) | 5 (8.6) |
| Adverse Event* . | Patients, n (%) . | |||
|---|---|---|---|---|
| 140 mg/day (n = 12) . | 100 mg/day (n = 58) . | |||
| All Grades . | Grade 3/4 . | All Grades . | Grade 3/4 . | |
| Any TEAE | 12 (100.0) | 12 (100.0) | 58 (100.0) | 42 (72.4) |
| Fatigue | 8 (66.7) | 3 (25.0) | 44 (75.9) | 12 (20.7) |
| Diarrhea | 8 (66.7) | 2 (16.7) | 25 (43.1) | 2 (3.4) |
| ALT increased | 4 (33.3) | 2 (16.7) | 22 (37.9) | 4 (6.9) |
| Headache | 4 (33.3) | 1 (8.3) | 21 (36.2) | 5 (8.6) |
| Nausea | 5 (41.7) | 0 | 20 (34.5) | 0 |
| Hypertension | 6 (50.0) | 2 (16.7) | 19 (32.8) | 4 (6.9) |
| Constipation | 5 (41.7) | 1 (8.3) | 19 (32.8) | 1 (1.7) |
| AST increased | 5 (41.7) | 2 (16.7) | 16 (27.6) | 3 (5.2) |
| Blood LDH increased | 3 (25.0) | 0 | 16 (27.6) | 1 (1.7) |
| Dysphonia | 5 (41.7) | 0 | 15 (25.9) | 0 |
| Memory impairment | 3 (25.0) | 0 | 15 (25.9) | 0 |
| Convulsion | 2 (16.7) | 1 (8.3) | 15 (25.9) | 3 (5.2) |
| Proteinuria | 5 (41.7) | 0 | 14 (24.1) | 2 (3.4) |
| Confusional state | 3 (25.0) | 0 | 14 (24.1) | 5 (8.6) |
| Cognitive disorder | 2 (16.7) | 1 (8.3) | 13 (22.4) | 0 |
| Decreased appetite | 4 (33.3) | 0 | 12 (20.7) | 1 (1.7) |
| Gait disturbance | 3 (25.0) | 1 (8.3) | 12 (20.7) | 3 (5.2) |
| PPES | 3 (25.0) | 0 | 11 (19.0) | 3 (5.2) |
| Rash | 3 (25.0) | 0 | 11 (19.0) | 0 |
| Depression | 1 (8.3) | 0 | 11 (19.0) | 0 |
| Speech disorder | 1 (8.3) | 1 (8.3) | 10 (17.2) | 4 (6.9) |
| Thrombocytopenia | 0 | 0 | 9 (15.5) | 5 (8.6) |
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. 15.0 Preferred Terms (converted to US spelling), CTCAE v. 3.0 grading.
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