Table 2.
Summary of adverse events experienced by at least 10 % of 51 subjects
| Adverse event, n (%) | Grade 1 | Grade 2 | Grade 3 | Grade 4 | Total |
|---|---|---|---|---|---|
| PPE syndrome | 18 (35) | 16 (31) | 5 (10) | 0 | 39 (76) |
| Diarrhea | 26 (51) | 7 (14) | 1 (2) | 0 | 34 (67) |
| Stomatitis | 21 (41) | 0 | 0 | 0 | 21 (41) |
| Rash | 13 (25) | 6 (12) | 1 (2) | 0 | 20 (39) |
| Pruritus | 16 (31) | 1 (2) | 0 | 0 | 17 (33) |
| Nausea | 15 (29) | 2 (4) | 0 | 0 | 17 (33) |
| Fatigue | 16 (31) | 1 (2) | 0 | 0 | 17 (33) |
| Anorexia | 15 (29) | 1 (2) | 1 (2) | 0 | 17 (33) |
| Blood bilirubin increased | 6 (12) | 10 (20) | 0 | 0 | 16 (31) |
| Dry skin | 13 (25) | 1 (2) | 1 (2) | 0 | 15 (29) |
| Alanine aminotransferase increased | 9 (18) | 4 (8) | 1 (2) | 1 (2) | 15 (29) |
| Aspartate aminotransferase increased | 9 (18) | 3 (6) | 3 (6) | 0 | 15 (29) |
| Nasopharyngitis | 14 (27) | 1 (2) | 0 | 0 | 15 (29) |
| White blood cell count decreased | 2 (4) | 10 (20) | 2 (4) | 0 | 14 (27) |
| Paronychia | 11 (22) | 3 (6) | 0 | 0 | 14 (27) |
| Neutrophil count decreased | 3 (6) | 4 (8) | 3 (6) | 1 (2) | 11 (22) |
| Pigmentation disorder | 9 (18) | 0 | 0 | 0 | 9 (18) |
| Pyrexia | 8 (16) | 1 (2) | 0 | 0 | 9 (18) |
| Blood alkaline phosphatase increased | 7 (14) | 0 | 1 (2) | 0 | 8 (16) |
| Red blood cell count decreased | 8 (16) | 0 | 0 | 0 | 8 (16) |
| Cheilitis | 7 (14) | 0 | 0 | 0 | 7 (14) |
| Weight decreased | 4 (8) | 3 (6) | 0 | 0 | 7 (14) |
| Headache | 6 (12) | 1 (2) | 0 | 0 | 7 (14) |
| Skin exfoliation | 6 (12) | 1 (2) | 0 | 0 | 7 (14) |
| Vomiting | 4 (8) | 2 (4) | 0 | 0 | 6 (12) |
| Malaise | 5 (10) | 1 (2) | 0 | 0 | 6 (12) |
| Dizziness | 5 (10) | 0 | 1 (2) | 0 | 6 (12) |
| Cancer pain | 3 (6) | 3 (6) | 0 | 0 | 6 (12) |
| Acne | 3 (6) | 1 (2) | 1 (2) | 0 | 5 (10) |
| Nail disorder | 4 (8) | 1 (2) | 0 | 0 | 5 (10) |
| Constipation | 5 (10) | 0 | 0 | 0 | 5 (10) |
| Blood albumin decreased | 3 (6) | 2 (4) | 0 | 0 | 5 (10) |
Number (percent)
PPE palmar-plantar erythrodysesthesia