Table 2.
Overview of common TEAEs (MedDRA Preferred Terms; incidence ≥10%) and select AEs of clinical interest irrespective of frequency.
| Futibatinib dosing | ||||
|---|---|---|---|---|
| Overall population | 20-mg every day | |||
| (n = 469) | (n = 318) | |||
| Patients with TEAEs | Any grade, n (%) | Grade ≥3, n (%) | Any grade, n (%) | Grade ≥3, n (%) |
| Any TEAE | 467 (99.6) | 313 (66.7) | 316 (99.4) | 228 (71.7) |
| Hyperphosphatemia | 385 (82.1) | 88 (18.8) | 280 (88.1) | 75 (23.6) |
| Constipation | 160 (34.1) | 3 (0.6) | 112 (35.2) | 2 (0.6) |
| Diarrhea | 158 (33.7) | 3 (0.6) | 106 (33.3) | 2 (0.6) |
| Nausea | 139 (29.6) | 5 (1.1) | 86 (27.0) | 3 (0.9) |
| Decreased appetite | 119 (25.4) | 11 (2.3) | 79 (24.8) | 8 (2.5) |
| Fatigue | 111 (23.7) | 18 (3.8) | 84 (26.4) | 17 (5.3) |
| AST increased | 108 (23.0) | 28 (6.0) | 83 (26.1) | 22 (6.9) |
| Vomiting | 105 (22.4) | 7 (1.5) | 73 (23.0) | 5 (1.6) |
| Dry mouth | 102 (21.7) | 0 (0) | 70 (22.0) | 0 (0) |
| ALT increased | 96 (20.5) | 30 (6.4) | 72 (22.6) | 25 (7.9) |
| Alopecia | 87 (18.6) | 0 (0) | 70 (22.0) | 0 (0) |
| Anemia | 85 (18.1) | 31 (6.6) | 53 (16.7) | 19 (6.0) |
| Dry skin | 85 (18.1) | 0 | 57 (17.9) | 0 |
| Abdominal pain | 73 (15.6) | 12 (2.6) | 57 (17.9) | 8 (2.5) |
| Blood creatinine increased | 63 (13.4) | 1 (0.2) | 43 (13.5) | 1 (0.3) |
| Weight decreased | 59 (12.6) | 7 (1.5) | 44 (13.8) | 5 (1.6) |
| Arthralgia | 58 (12.4) | 0 | 45 (14.2) | 0 |
| Dysgeusia | 52 (11.1) | 0 | 42 (13.2) | 0 |
| Asthenia | 51 (10.9) | 8 (1.7) | 32 (10.1) | 7 (2.2) |
| Pyrexia | 51 (10.9) | 5 (1.1) | 28 (8.8) | 3 (0.9) |
| Hypercalcemia | 49 (10.4) | 9 (1.9) | 39 (12.3) | 5 (1.6) |
| Back pain | 48 (10.2) | 3 (0.6) | 32 (10.1) | 3 (0.9) |
| Dry eye | 48 (10.2) | 1 (0.2) | 39 (12.3) | 1 (0.3) |
| Urinary tract infection | 48 (10.2) | 6 (1.3) | 34 (10.7) | 4 (1.3) |
| Blood alkaline phosphatase increased | 46 (9.8) | 11 (2.3) | 35 (11.0) | 7 (2.2) |
| Edema peripheral | 41 (8.7) | 1 (0.2) | 32 (10.1) | 0 |
| AECIs | ||||
| Any AECI | 409 (87.2) | 135 (28.8) | 292 (91.8) | 109 (34.3) |
| Hyperphosphatemia | 385 (82.1) | 88 (18.8) | 280 (88.1) | 75 (23.6) |
| Nail disorders | 127 (27.1) | 5 (1.1) | 94 (29.6) | 4 (1.3) |
| Hepatic AEs | 126 (26.9) | 50 (10.7) | 94 (29.6) | 38 (11.9) |
| Stomatitis | 89 (19.0) | 15 (3.2) | 58 (18.2) | 11 (3.5) |
| PPES | 62 (13.2) | 12 (2.6) | 48 (15.1) | 11 (3.5) |
| Rash | 40 (8.5) | 0 (0) | 27 (8.5) | 0 (0) |
| Retinal disorders | 38 (8.1) | 0 (0) | 27 (8.5) | 0 (0) |
| Cataract | 15 (3.9) | 6 (1.3) | 12 (3.8) | 4 (1.3) |
Abbreviations: AE, adverse event; AECI, adverse event of clinical interest; ALT, alanine aminotransferase; AST, aspartate aminotransferase; MedDRA, Medical Dictionary for Regulatory Activities; PPES, palmar-plantar erythrodysesthesia syndrome; TEAE, treatment-emergent adverse event.