TABLE 3.
Treatment‐related adverse events (safety population) a
| Adverse event, n (%) | Enfortumab vedotin (n = 36) | Standard chemotherapy (n = 48) | ||
|---|---|---|---|---|
| Any grade | Grade ≥ 3 | Any grade | Grade ≥ 3 | |
| Overall | 33 (91.7) | 23 (63.9) | 47 (97.9) | 36 (75.0) |
| Alopecia | 19 (52.8) | 0 | 18 (37.5) | 0 |
| Dysgeusia | 18 (50.0) | 0 | 6 (12.5) | 0 |
| Peripheral sensory neuropathy | 17 (47.2) | 0 | 15 (31.3) | 0 |
| White blood cell count decreased | 9 (25.0) | 2 (5.6) | 18 (37.5) | 13 (27.1) |
| Decreased appetite | 9 (25.0) | 2 (5.6) | 10 (20.8) | 1 (2.1) |
| Pruritus | 9 (25.0) | 1 (2.8) | 3 (6.3) | 0 |
| Neutrophil count decreased | 8 (22.2) | 5 (13.9) | 24 (50.0) | 22 (45.8) |
| Anemia | 8 (22.2) | 2 (5.6) | 9 (18.8) | 4 (8.3) |
| Rash maculo‐papular | 8 (22.2) | 1 (2.8) | 2 (4.2) | 0 |
| Drug eruption | 6 (16.7) | 4 (11.1) | 1 (2.1) | 1 (2.1) |
| Lymphocyte count decreased | 6 (16.7) | 2 (5.6) | 5 (10.4) | 5 (10.4) |
| Amylase increased | 4 (11.1) | 2 (5.6) | 0 | 0 |
| Malaise | 4 (11.1) | 0 | 15 (31.3) | 0 |
| Pyrexia | 3 (8.3) | 2 (5.6) | 10 (20.8) | 0 |
| Lipase increased | 3 (8.3) | 2 (5.6) | 1 (2.1) | 1 (2.1) |
| Rash erythematous | 2 (5.6) | 2 (5.6) | 1 (2.1) | 0 |
| Febrile neutropenia | 1 (2.8) | 1 (2.8) | 6 (12.5) | 6 (12.5) |
Abbreviation: TRAE, treatment‐related adverse event.
a
TRAEs that occurred in at least 20% of patients in either treatment group or TRAE of grade ≥ 3 that occurred in at least 5% of patients in either treatment group.