Table 3.
AEs in patients receiving futibatinib 20 mg once daily
| 20-mg cohort (N = 170), n (%) | ||||||
|---|---|---|---|---|---|---|
| Characteristics | Any grade | Grade 1 | Grade 2 | Grade 3 | Grade 4 | Grade 5 |
| Any TEAE | 168 (98.8) | 12 (7.1) | 34 (20.0) | 97 (57.1) | 9 (5.3) | 16 (9.4)a |
| Any serious TEAE | 82 (48.2) | 1 (0.6) | 10 (5.9) | 49 (28.8) | 6 (3.5) | 16 (9.4) |
| Any treatment-related AE | 162 (95.3) | 27 (15.9) | 62 (36.5) | 72 (42.4) | 1 (0.6) | 0 |
| Action taken because of TEAE | ||||||
| Dosing interruption | 83 (48.8) | 5 (2.9) | 17 (10.0) | 57 (33.5) | 4 (2.4) | 0 |
| Dose reduction | 44 (25.9) | 4 (2.4) | 12 (7.1) | 28 (16.5) | 0 | 0 |
| Treatment discontinuation | 18 (10.6) | 0 | 4 (2.4) | 14 (8.2) | 0 | 0 |
| TEAEsb in ≥10% of patients | ||||||
| Hyperphosphatemia | 138 (81.2) | 26 (15.3) | 74 (43.5) | 38 (22.4) | 0 | 0 |
| Diarrhea | 56 (32.9) | 42 (24.7) | 13 (7.6) | 1 (0.6) | 0 | 0 |
| Constipation | 54 (31.8)b | 39 (22.9) | 12 (7.1) | 2 (1.2) | 0 | 0 |
| Nausea | 48 (28.2) | 32 (18.8) | 16 (9.4) | 0 | 0 | 0 |
| Fatigue | 43 (25.3) | 20 (11.8) | 14 (8.2) | 9 (5.3) | 0 | 0 |
| Vomiting | 43 (25.3) | 30 (17.6) | 11 (6.5) | 2 (1.2) | 0 | 0 |
| AST increased | 41 (24.1) | 19 (11.2) | 13 (7.6) | 9 (5.3) | 0 | 0 |
| ALT increased | 40 (23.5) | 13 (7.6) | 10 (5.9) | 16 (9.4) | 1 (0.6) | 0 |
| Abdominal pain | 33 (19.4) | 16 (9.4) | 12 (7.1) | 5 (2.9) | 0 | 0 |
| Alopecia | 33 (19.4) | 27 (15.9) | 6 (3.5) | 0 | 0 | 0 |
| Decreased appetite | 32 (18.8) | 18 (10.6) | 11 (6.5) | 3 (1.8) | 0 | 0 |
| Dry mouth | 30 (17.6) | 26 (15.3) | 4 (2.4) | 0 | 0 | 0 |
| Asthenia | 27 (15.9) | 12 (7.1) | 8 (4.7) | 7 (4.1) | 0 | 0 |
| Stomatitis | 26 (15.3) | 13 (7.6) | 8 (4.7) | 5 (2.9) | 0 | 0 |
| Anemia | 23 (13.5) | 7 (4.1) | 7 (4.1) | 9 (5.3) | 0 | 0 |
| Dry skin | 22 (12.9) | 21 (12.4) | 1 (0.6) | 0 | 0 | 0 |
| Palmar–plantar erythrodysesthesia | 22 (12.9) | 11 (6.5) | 5 (2.9) | 6 (3.5) | 0 | 0 |
| Increased blood creatinine | 20 (11.8) | 13 (7.6) | 7 (4.1) | 0 | 0 | 0 |
| Arthralgia | 19 (11.2) | 14 (8.2) | 5 (2.9) | 0 | 0 | 0 |
| Hypercalcemia | 19 (11.2) | 14 (8.2) | 3 (1.8) | 2 (1.2) | 0 | 0 |
| Dysgeusia | 18 (10.6) | 13 (7.6) | 5 (2.9) | 0 | 0 | 0 |
| Decreased weight | 17 (10.0) | 10 (5.9) | 6 (3.5) | 1 (0.6) | 0 | 0 |
Abbreviations: ALT, alanine transaminase; AST, aspartate transaminase.
aNone of these TEAEs were considered to be treatment-related.
bGrade was missing for 1 patient.