Incidence and severity of adverse events, at least possibly related to intervention (observed in 5% or more of participants or grade 2 or higher toxicity. Presented as number (%) of individuals)
| No. (%) of adverse events | ||||
| Evaluable (N=46) | ||||
| Grade terminology | None | Grade 1 | Grade 2 | Grade 3 |
| Total | 3 (6.5) | 22 (47.8) | 19 (41.3) | 2 (4.3) |
| Rash acneiform/maculopapular | 20 (43.5) | 17 (37.0) | 8 (17.4) | 1 (2.2) |
| Mucositis oral | 43 (93.5) | 1 (2.2) | 2 (4.3) | 0 (0.0) |
| Diarrhoea | 23 (50.0) | 19 (41.3) | 4 (8.7) | 0 (0.0) |
| Nausea | 34 (73.9) | 9 (19.6) | 3 (6.5) | 0 (0.0) |
| Vomiting | 42 (91.3) | 4 (8.7) | 0 (0.0) | 0 (0.0) |
| Dyspepsia | 43 (93.5) | 1 (2.2) | 2 (4.3) | 0 (0.0) |
| Conjunctivitis | 45 (97.8) | 0 (0.0) | 1 (2.2) | 0 (0.0) |
| Dry eye | 44 (95.7) | 2 (4.3) | 0 (0.0) | 0 (0.0) |
| Fatigue | 34 (73.9) | 10 (21.7) | 2 (4.3) | 0 (0.0) |
| Malaise | 43 (93.5) | 3 (6.5) | 0 (0.0) | 0 (0.0) |
| Enterocolitis infectious | 45 (97.8) | 0 (0.0) | 0 (0.0) | 1 (2.2) |
| Infections and infestations | 44 (95.7) | 0 (0.0) | 2 (4.3) | 0 (0.0) |
| Prolapse of intestinal stoma | 45 (97.8) | 0 (0.0) | 1 (2.2) | 0 (0.0) |
| ALT increased | 45 (97.8) | 0 (0.0) | 1 (2.2) | 0 (0.0) |
| Weight gain | 45 (97.8) | 0 (0.0) | 1 (2.2) | 0 (0.0) |
| Anorexia | 43 (93.5) | 3 (6.5) | 0 (0.0) | 0 (0.0) |
| Dizziness | 41 (89.1) | 5 (10.9) | 0 (0.0) | 0 (0.0) |
| Headache | 39 (84.8) | 4 (8.7) | 3 (6.5) | 0 (0.0) |
| Insomnia | 44 (95.7) | 1 (2.2) | 1 (2.2) | 0 (0.0) |
| Alopecia | 42 (91.3) | 3 (6.5) | 1 (2.2) | 0 (0.0) |
| Dry skin | 42 (91.3) | 3 (6.5) | 1 (2.2) | 0 (0.0) |
| Pruritus | 42 (91.3) | 2 (4.3) | 2 (4.3) | 0 (0.0) |
| Scalp pain | 45 (97.8) | 0 (0.0) | 1 (2.2) | 0 (0.0) |
ALT, alanine aminotransferase.