Table 2 |. Most common TRAEs.
| AE | Any grade, n (%) | Grades 3–5, n (%) |
|---|---|---|
| Fatigue | 28 (44) | 3 (5) |
| Diarrhea | 17 (27) | 4 (6) |
| Aspartate aminotransferase increased | 15 (23) | 4 (6) |
| Pruritus | 15 (23) | 0 |
| Alanine aminotransferase increased | 14 (22) | 0 |
| Rash maculo-papular | 12 (19) | 0 |
| Anemia | 11 (17) | 1 (2) |
| Weight loss | 10 (16) | 0 |
| Hypothyroidism | 9 (14) | 0 |
| Dry skin | 8 (13) | 0 |
| Nausea | 8 (13) | 0 |
| Arthralgia | 7 (11) | 2 (3) |
| Pain | 7 (11) | 2 (3) |
| Anorexia | 6 (9) | 0 |
| Alkaline phosphatase increased | 5 (8) | 1 (2) |
| Dyspnea | 4 (6) | 0 |
| Lymphocyte count decreased | 4 (6) | 1 (2) |
| White blood cell count decreased | 4 (6) | 0 |
| Blurred vision | 3 (5) | 0 |
| Cough | 3 (5) | 0 |
| Fever | 3 (5) | 0 |
| Headache | 3 (5) | 0 |
| Hyperglycemia | 3 (5) | 2 (3) |
| Platelet count decreased | 3 (5) | 1 (2) |
| Pneumonitis | 3 (5) | 0 |
| Urticaria | 3 (5) | 0 |
| Vomiting | 3 (5) | 0 |
| Neutrophil count decreased | 3 (5) | 1 (2) |
| Colitis | 2 (3) | 2 (3) |
| Hypophysitis | 2 (3) | 1 (2) |
| Mucositis oral | 2 (3) | 1 (2) |
| Adrenal insufficiency | 1 (2) | 1 (2) |
| Arthritis | 1 (2) | 1 (2) |
| Bone marrow hypocellular | 1 (2) | 1 (2) |
| Creatine phosphokinase increased | 1 (2) | 1 (2) |
| Death NOSa | 1 (2) | 1 (2) |
| Heart failure | 1 (2) | 1 (2) |
| Hyponatremia | 1 (2) | 1 (2) |
| Sepsis | 1 (2) | 1 (2) |
| Syncope | 1 (2) | 1 (2) |
Only TRAEs occurring in more than two total patients and/or grade >2 are included.
a
Unwitnessed death of a patient who had increasing liver function tests and liver metastases in cycle 1 of therapy. This death was designated as PD, but, because it was unwitnessed, it was also attributed as possibly related to study drugs.