Table 4.
Most common (> 10%) grade 3 and 4 TEAEs
| ALCYONE safety population15 | East Asian | Japanese | Korean | |||||
|---|---|---|---|---|---|---|---|---|
| D-VMP (n = 346) |
VMP (n = 354) |
D-VMP (n = 47) |
VMP (n = 44) |
D-VMP (n = 24) |
VMP (n = 26) |
D-VMP (n = 23) |
VMP (n = 18) |
|
| Hematologic, n (%) | ||||||||
| Neutropenia | 138 (39.9) | 137 (38.7) | 26 (55.3) | 23 (52.3) | 14 (58.3) | 16 (61.5) | 12 (52.2) | 7 (38.9) |
| Thrombocytopenia | 119 (34.4) | 133 (37.6) | 26 (55.3) | 20 (45.5) | 14 (58.3) | 12 (46.2) | 12 (52.2) | 8 (44.4) |
| Leukopenia | 28 (8.1) | 30 (8.5) | 15 (31.9) | 12 (27.3) | 15 (62.5) | 11 (42.3) | 0 | 1 (5.6) |
| Lymphopenia | 26 (7.5) | 22 (6.2) | 15 (31.9) | 8 (18.2) | 15 (62.5) | 8 (30.8) | 0 | 0 |
| Anemia | 55 (15.9) | 70 (19.8) | 8 (17.0) | 11 (25.0) | 2 (8.3) | 6 (23.1) | 6 (26.1) | 5 (27.8) |
| Nonhematologic, n (%) | ||||||||
| Pneumonia | 39 (11.3) | 14 (4.0) | 6 (12.8) | 0 | 2 (8.3) | 0 | 4 (17.4) | 0 |
| Increased ALT | 6 (1.7) | 5 (1.4) | 4 (8.5) | 2 (4.5) | 1 (4.2) | 0 | 3 (13.0) | 2 (11.1) |
| Fatigue | 11 (3.2) | 9 (2.5) | 4 (8.5) | 3 (6.8) | 0 | 1 (3.8) | 4 (17.4) | 2 (11.1) |
| Hyponatremia | 8 (2.3) | 9 (2.5) | 3 (6.4) | 3 (6.8) | 3 (12.5) | 1 (3.8) | 0 | 2 (11.1) |
| Diarrhea | 9 (2.6) | 11 (3.1) | 3 (6.4) | 3 (6.8) | 2 (8.3) | 1 (3.8) | 1 (4.3) | 2 (11.1) |
| Increased AST | 5 (1.4) | 4 (1.1) | 2 (4.3) | 2 (4.5) | 0 | 0 | 2 (8.7) | 2 (11.1) |
| Hypertension | 14 (4.0) | 6 (1.7) | 2 (4.3) | 2 (4.5) | 0 | 0 | 2 (8.7) | 2 (11.1) |
| Asthenia | 4 (1.2) | 7 (2.0) | 1 (2.1) | 2 (4.5) | 0 | 0 | 1 (4.3) | 2 (11.1) |
| Increased C-reactive protein | 2 (0.6) | 2 (0.6) | 0 | 2 (4.5) | 0 | 0 | 0 | 2 (11.1) |
| Septic shock | 1 (0.3) | 3 (0.8) | 0 | 2 (4.5) | 0 | 0 | 0 | 2 (11.1) |
TEAE treatment-emergent adverse event, D-VMP daratumumab/bortezomib/melphalan/prednisone, VMP bortezomib/melphalan/prednisone, ALT alanine aminotransferase, AST aspartate aminotransferase