Table 3.
Treatment-related adverse events (TRAEs).
| Patients (n = 86), n (%) | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| TRAEs | Grade 1 | Grade 2 | Grade 3 | Grade 4 | Grade 5 | Any Grade | Interruption | Dose Reduction | Discontinuation |
| Any event | 71 (83) | 57 (66) | 29 (34) | 2 (2) | 2 (2) | 82 (95) | 36 (42) | 44 (51) | 15 (17) |
| Diarrhea a | 20 (23) | 26 (30) | 17 (20) | 1 (1) | 1 (1) | 66 (77) | 20 (23) | 28 (33) | 11 (13) |
| Acneifor rash | 32 (37) | 12 (14) | 7 (8) | 0 (0) | 0 (0) | 51 (59) | 4 (5) | 7 (8) | 1 (1) |
| Dry skin | 20 (8) | 11 (12) | 3 (3) | 0 (0) | 0 (0) | 34 (40) | 0 (0) | 0 (0) | 0 (0) |
| Nausea | 13 (15) | 13 (15) | 3 (3) | 1 (1) | 0 (0) | 30 (35) | 4 (5) | 5 (6) | 4 (5) |
| Fatigue | 15 (17) | 10 (12) | 4 (5) | 0 (0) | 0 (0) | 30 (35) | 0 (0) | 0 (0) | 0 (0) |
| Anorexia (decreased appetite) | 14 (16) | 13 (15) | 2 (2) | 0 (0) | 0 (0) | 29 (34) | 1 (1) | 5 (6) | 1 (1) |
| Paronychia | 15 (17) | 12 (14) | 0 (0) | 0 (0) | 0 (0) | 27 (31) | 2 (2) | 2 (2) | 0 (0) |
| Weight loss | 18 (21) | 1 (3) | 0 (0) | 0 (0) | 0 (0) | 21 (24) | 0 (0) | 1 (1) | 0 (0) |
| Pruritus | 14 (16) | 5 (6) | 2 (2) | 0 (0) | 0 (0) | 21 (24) | 0 (0) | 1 (1) | 0 (0) |
| Elevated creatinine | 10 (12) | 8 (9) | 1 (1) | 0 (0) | 0 (0) | 19 (22) | 4 (5) | 3 (3) | 0 (0) |
| Oral mucositis | 7 (8) | 7 (8) | 4 (5) | 1 (1) | 0 (0) | 19 (22) | 3 (3) | 5 (6) | 3 (3) |
| Vomiting | 10 (12) | 5 (6) | 3 (3) | 1 (1) | 0 (0) | 19 (22) | 4 (5) | 5 (6) | 5 (6) |
| Anemia | 11 (13) | 3 (3) | 0 (0) | 0 (0) | 0 (0) | 14 (16) | 0 (0) | 0 (0) | 0 (0) |
| Elevated ALT (SGPT) and/or AST | 8 (9) | 1 (1) | 2 (2) | 0 (0) | 0 (0) | 12 (14) | 1 (1) | 1 (1) | 1 (1) |
| Skin pain | 4 (5) | 5 (6) | 0 (0) | 0 (0) | 0 (0) | 11 (13) | 0 (0) | 0 (0) | 0 (0) |
| Elevated lipase | 2 (2) | 1 (1) | 2 (2) | 0 (0) | 0 (0) | 5 (6) | 0 (0) | 0 (0) | 0 (0) |
| Rhinorrhea | 4 (5) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 4 (5) | 0 (0) | 0 (0) | 0 (0) |
| Other adverse events b | 14 (16) | 5 (6) | 5 (6) | 0 (0) | 1 (1) | 26 (30) | 5 (6) | 10 (12) | 4 (5) |
Grade of diarrhea, fatigue, liver toxicity, and tachycardia (other) was unknown for one patient each. Grade of skin pain and weight loss was unknown for two patients. In eight patients, lipase was not routinely measured. a One patient died due to grade 5 diarrhea in combination with grade 4 vomiting. b One patient died due to liver toxicity in combination with progression of liver and brain metastases.