TABLE 2.
TRAEs reported per-patient with incidence ≥10%
| Any grade N (%) | Grade 1–2 N (%) | Grade 3 N (%) | Grade 4 N (%) | |
| Any AE | 60 (76) | 47 (60) | 13 (16) | 2 (3) |
| Gastrointestinal disorders | 39 (49) | 38 (48) | 1 (1) | — |
| Nausea | 17 (22) | 17 (22) | — | — |
| Diarrhea | 10 (13) | 10 (13) | — | — |
| Dyspepsia | 10 (13) | 10 (13) | — | — |
| Vomiting | 9 (11) | 8 (10) | 1 (1) | — |
| Eye disorders | 37 (47) | 36 (46) | 1 (1) | — |
| Dyschromatopsia | 15 (19) | 15 (19) | — | — |
| Vision blurred | 12 (15) | 12 (15) | — | — |
| Visual impairment | 8 (10) | 7 (9) | 1 (1) | — |
| Blood and lymphatic system disorders | 13 (17) | 9 (11) | 4 (5) | — |
| Anemia | 13 (16) | 9 (11) | 4 (5) | — |
| General disorders and administration site conditions | 13 (16) | 9 (11) | 1 (1) | — |
| Fatigue | 9 (11) | 9 (11) | — | — |
| Laboratory investigations | 13 (16) | 8 (10) | 5 (6) | 2a (3) |
| Skin and subcutaneous tissue disorders | 8 (10) | 6 (8) | 2 (3) | — |
NOTE: N = 79 patients included. Grading of adverse events per NCI Common Terminology Criteria for Adverse Events [CTCAE] v4.03.
aThe two TRAEs classified as grade 4 were elevated lipase (one event) and elevated liver function tests (one event).