Table 3.
Treatment-related treatment-emergent adverse events (safety-assessable population)
| Events |
FGFR2 fusions or rearrangements (n = 108) |
Other FGF/FGFR alterations (n = 20) |
No FGF/FGFR alterations (n = 17) |
Total (N = 147)a |
||||
|---|---|---|---|---|---|---|---|---|
| Any grade | Grade ≥3 | Any grade | Grade ≥3 | Any grade | Grade ≥3 | Any grade | Grade ≥3 | |
| Any treatment-related TEAE, n (%)b | 102 (94.4) | 40 (37.0) | 17 (85.0) | 6 (30.0) | 14 (82.4) | 1 (5.9) | 135 (91.8) | 48 (32.7) |
| Hyperphosphatemia | 55 (50.9) | 0 | 11 (55.0) | 0 | 12 (70.6) | 0 | 79 (53.7) | 0 |
| Alopecia | 61 (56.5) | 0 | 3 (15.0) | 0 | 2 (11.8) | 0 | 68 (46.3) | 0 |
| Diarrhea | 44 (40.7) | 4 (3.7) | 5 (25.0) | 0 | 4 (23.5) | 1 (5.9) | 53 (36.1) | 5 (3.4) |
| Stomatitis | 43 (39.8) | 9 (8.3) | 4 (20.0) | 0 | 3 (17.6) | 0 | 51 (34.7) | 9 (6.1) |
| Dysgeusia | 42 (38.9) | 0 | 3 (15.0) | 0 | 3 (17.6) | 0 | 50 (34.0) | 0 |
| Fatigue | 38 (35.2) | 2 (1.9) | 4 (20.0) | 0 | 6 (35.3) | 0 | 48 (32.7) | 2 (1.4) |
| Dry mouth | 38 (35.2) | 0 | 2 (10.0) | 0 | 1 (5.9) | 0 | 43 (29.3) | 0 |
| Nausea | 32 (29.6) | 2 (1.9) | 2 (10.0) | 0 | 3 (17.6) | 0 | 38 (25.9) | 2 (1.4) |
| Decreased appetite | 25 (23.1) | 0 | 5 (25.0) | 1 (5.0) | 4 (23.5) | 0 | 35 (23.8) | 1 (0.7) |
| Dry eye | 33 (30.6) | 0 | 0 | 0 | 0 | 0 | 34 (23.1) | 1 (0.7) |
| Dry skin | 24 (22.2) | 1 (0.9) | 0 | 0 | 0 | 0 | 26 (17.7) | 1 (0.7) |
| Arthralgia | 21 (19.4) | 5 (4.6) | 2 (10.0) | 1 (5.0) | 0 | 0 | 23 (15.6) | 6 (4.1) |
| Palmar–plantar erythrodysesthesia syndrome | 22 (20.4) | 6 (5.6) | 1 (5.0) | 0 | 0 | 0 | 23 (15.6) | 6 (4.1) |
| Constipation | 21 (19.4) | 0 | 1 (5.0) | 0 | 0 | 0 | 22 (15.0) | 0 |
| Hypophosphatemia | 17 (15.7) | 11 (10.2) | 2 (10.0) | 2 (10.0) | 0 | 0 | 19 (12.9) | 13 (8.8) |
| Vomiting | 15 (13.9) | 1 (0.9) | 1 (5.0) | 0 | 1 (5.9) | 0 | 17 (11.6) | 1 (0.7) |
| Pain in extremity | 15 (13.9) | 0 | 0 | 0 | 0 | 0 | 15 (10.2) | 0 |
| Weight decreased | 11 (10.2) | 1 (0.9) | 3 (15.0) | 0 | 0 | 0 | 14 (9.5) | 1 (0.7) |
| Hyponatremia | 3 (2.8) | 1 (0.9) | 3 (15.0) | 3 (15.0) | 2 (11.8) | 0 | 8 (5.4) | 4 (2.7) |
FGF, fibroblast growth factor; FGFR, FGF receptor; TEAE, treatment-emergent adverse event.
a
Total number includes two patients who did not have confirmed FGF/FGFR status by central laboratory testing and were not assigned to any cohort.
b
All any-grade TEAEs occurring in ≥10% and grade ≥3 TEAEs occurring in ≥2% of the total population are shown.