Table 2:
Adverse events
| Toxicity | Events | Patients | ||||
|---|---|---|---|---|---|---|
| Grade 3/4 | Any grade | Grade 3/4 | Any grade | |||
| n | % | n | % | |||
| Most likely related to Erdafitinib | ||||||
| Oral mucositis | 5 | 58 | 5 | 14% | 27 | 77% |
| Hyperphosphatemia | 0 | 56 | 0 | 0% | 29 | 83% |
| Palmar-plantar erythrodysesthesia syndrome | 4 | 36 | 3 | 9% | 18 | 51% |
| Diarrhea | 0 | 30 | 0 | 0% | 14 | 40% |
| Constipation | 0 | 25 | 0 | 0% | 19 | 54% |
| Dysgeusia | 0 | 25 | 0 | 0% | 19 | 54% |
| Dry mouth | 0 | 22 | 0 | 0% | 18 | 51% |
| Nail alterations | 0 | 19 | 0 | 0% | 13 | 37% |
| Sore throat | 1 | 18 | 1 | 3% | 8 | 23% |
| Alopecia | 0 | 16 | 0 | 0% | 13 | 37% |
| Elevated AST | 4 | 14 | 2 | 6% | 7 | 20% |
| Dry skin | 0 | 13 | 0 | 0% | 12 | 34% |
| Epistaxis | 0 | 12 | 0 | 0% | 9 | 26% |
| Anorexia | 0 | 11 | 0 | 0% | 7 | 20% |
| Dry eye | 1 | 11 | 1 | 3% | 10 | 29% |
| Skin ulceration | 9 | 10 | 2 | 6% | 2 | 6% |
| Elevated ALT | 4 | 8 | 2 | 6% | 5 | 14% |
| Vision changes/alterations | 1 | 7 | 1 | 3% | 6 | 17% |
| Abdominal pain | 0 | 5 | 0 | 0% | 5 | 14% |
| Dizziness | 0 | 5 | 0 | 0% | 3 | 9% |
| Gastroesophageal reflux disease | 0 | 5 | 0 | 0% | 5 | 14% |
| Hypotension | 2 | 4 | 1 | 3% | 3 | 9% |
| Colitis | 2 | 2 | 1 | 3% | 1 | 3% |
| Esophagitis | 1 | 2 | 1 | 3% | 2 | 6% |
| Eye keratopathy | 1 | 2 | 1 | 3% | 1 | 3% |
| Hyperkeratosis | 1 | 1 | 1 | 3% | 1 | 3% |
| Syncope | 1 | 1 | 1 | 3% | 1 | 3% |
| Most likely related to Palbociclib | ||||||
| Neutropenia | 44 | 74 | 22 | 63% | 25 | 71% |
| Leucopenia | 9 | 30 | 8 | 23% | 15 | 43% |
| Anemia | 3 | 23 | 3 | 9% | 12 | 34% |
| Thrombocytopenia | 4 | 21 | 12 | 34% | 2 | 6% |
| Lymphopenia | 1 | 7 | 1 | 3% | 4 | 11% |
| Febrile neutropenia | 1 | 1 | 1 | 3% | 1 | 3% |
| Neutrophilia | 1 | 1 | 1 | 3% | 1 | 3% |
| Thromboembolic event | 1 | 1 | 1 | 3% | 1 | 3% |
| Likely related to the combination | ||||||
| Fatigue | 1 | 50 | 1 | 3% | 23 | 66% |
| Nausea | 0 | 7 | 0 | 0% | 6 | 17% |
| Vomiting | 0 | 7 | 0 | 0% | 6 | 17% |
Grade 1, 2, 3 and 4 toxicities were recorded by the treating investigators, no grade 5 toxicities were experienced in this trial.