Table 2.
Treatment-Related Adverse Events* (Safety Analysis Population).
| Enfortumab Vedotin Group (N=296) | Chemotherapy Group (N=291) | |||
|---|---|---|---|---|
| Adverse event, n (%) | All Grade | Grade ≥3 | All Grade | Grade ≥3 |
| Any adverse event | 278 (93.9) | 152 (51.4) | 267 (91.8) | 145 (49.8) |
|
| ||||
| Alopecia | 134 (45.3) | 0 | 106 (36.4) | 0 |
|
| ||||
| Peripheral sensory neuropathyꝉ | 100 (33.8) | 9 (3.0) | 62 (21.3) | 6 (2.1) |
|
| ||||
| Pruritus | 95 (32.1) | 4 (1.4) | 13 (4.5) | 0 |
|
| ||||
| Fatigue | 92 (31.1) | 19 (6.4) | 66 (22.7) | 13 (4.5) |
|
| ||||
| Decreased appetite | 91 (30.7) | 9 (3.0) | 68 (23.4) | 5 (1.7) |
|
| ||||
| Diarrhea | 72 (24.3) | 10 (3.4) | 48 (16.5) | 5 (1.7) |
|
| ||||
| Dysgeusia | 72 (24.3) | 0 | 21 (7.2) | 0 |
|
| ||||
| Nausea | 67 (22.6) | 3 (1.0) | 63 (21.6) | 4 (1.4) |
|
| ||||
| Rash maculopapular | 48 (16.2) | 22 (7.4) | 5 (1.7) | 0 |
|
| ||||
| Anemia | 34 (11.5) | 8 (2.7) | 59 (20.3) | 22 (7.6) |
|
| ||||
| Neutrophil count decreased | 30 (10.1) | 18 (6.1) | 49 (16.8) | 39 (13.4) |
|
| ||||
| Neutropenia | 20 (6.8) | 14 (4.7) | 24 (8.2) | 18 (6.2) |
|
| ||||
| WBC decreased | 16 (5.4) | 4 (1.4) | 31 (10.7) | 20 (6.9) |
|
| ||||
| Febrile neutropenia | 2 (0.7) | 2 (0.7) | 16 (5.5) | 16 (5.5) |
*
Treatment-related adverse events occurring in ≥20% of patients in either treatment group or grade ≥3 treatment-related adverse events occurring in ≥5% of patients in either treatment group. “Treatment-related adverse event” indicates reasonable possibility that the event may have been caused by the study treatment as assessed by the investigator. If the relationship is missing, then the adverse event is considered to be treatment-related.
ꝉ
A total of 113 patients (enfortumab vedotin, n=55; chemotherapy, n=58) had pre-existing peripheral neuropathy.
WBC denotes white blood cell.