Table 3.
Most common (> 20%) 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 (%) | ||||||||
| Thrombocytopenia | 169 (48.8) | 190 (53.7) | 31 (66.0) | 25 (56.8) | 18 (75.0) | 16 (61.5) | 13 (56.5) | 9 (50.0) |
| Neutropenia | 172 (49.7) | 186 (52.5) | 27 (57.4) | 23 (52.3) | 15 (62.5) | 16 (61.5) | 12 (52.2) | 7 (38.9) |
| Leukopenia | 46 (13.3) | 53 (15.0) | 17 (36.2) | 14 (31.8) | 17 (70.8) | 13 (50.0) | 0 | 1 (5.6) |
| Lymphopenia | 37 (10.7) | 36 (10.2) | 15 (31.9) | 10 (22.7) | 15 (62.5) | 10 (38.5) | 0 | 0 |
| Anemia | 97 (28.0) | 133 (37.6) | 11 (23.4) | 14 (31.8) | 4 (16.7) | 7 (26.9) | 7 (30.4) | 7 (38.9) |
| Nonhematologic, n (%) | ||||||||
| Diarrhea | 82 (23.7) | 87 (24.6) | 22 (46.8) | 20 (45.5) | 11 (45.8) | 12 (46.2) | 11 (47.8) | 8 (44.4) |
| Pyrexia | 80 (23.1) | 74 (20.9) | 21 (44.7) | 22 (50.0) | 10 (41.7) | 18 (69.2) | 11 (47.8) | 4 (22.2) |
| Constipation | 63 (18.2) | 65 (18.4) | 21 (44.7) | 15 (34.1) | 7 (29.2) | 9 (34.6) | 14 (60.9) | 6 (33.3) |
| Decreased appetite | 40 (11.6) | 46 (13.0) | 19 (40.4) | 17 (38.6) | 8 (33.3) | 12 (46.2) | 11 (47.8) | 5 (27.8) |
| Peripheral sensory neuropathy | 98 (28.3) | 121 (34.2) | 19 (40.4) | 18 (40.9) | 7 (29.2) | 6 (23.1) | 12 (52.2) | 12 (66.7) |
| Nausea | 72 (20.8) | 76 (21.5) | 18 (38.3) | 15 (34.1) | 12 (50.0) | 11 (42.3) | 6 (26.1) | 4 (22.2) |
| Upper respiratory tract infection | 91 (26.3) | 49 (13.8) | 17 (36.2) | 8 (18.2) | 4 (16.7) | 4 (15.4) | 13 (56.5) | 4 (22.2) |
| Vomiting | 59 (17.1) | 55 (15.5) | 12 (25.5) | 6 (13.6) | 9 (37.5) | 4 (15.4) | 3 (13.0) | 2 (11.1) |
| Insomnia | 26 (7.5) | 32 (9.0) | 11 (23.4) | 12 (27.3) | 9 (37.5) | 9 (34.6) | 2 (8.7) | 3 (16.7) |
| Cough | 52 (15.0) | 27 (7.6) | 11 (23.4) | 2 (4.5) | 1 (4.2) | 2 (7.7) | 10 (43.5) | 0 |
| Fatigue | 48 (13.9) | 51 (14.4) | 10 (21.3) | 7 (15.9) | 1 (4.2) | 3 (11.5) | 9 (39.1) | 4 (22.2) |
| Rash | 29 (8.4) | 39 (11.0) | 9 (19.1) | 10 (22.7) | 4 (16.7) | 7 (26.9) | 5 (21.7) | 3 (16.7) |
| Back pain | 48 (13.9) | 42 (11.9) | 9 (19.1) | 2 (4.5) | 2 (8.3) | 2 (7.7) | 7 (30.4) | 0 |
| Nasopharyngitis | 19 (5.5) | 20 (5.6) | 8 (17.0) | 7 (15.9) | 6 (25.0) | 6 (23.1) | 2 (8.7) | 1 (5.6) |
| Dyspepsia | 18 (5.2) | 12 (3.4) | 8 (17.0) | 4 (9.1) | 1 (4.2) | 2 (7.7) | 7 (30.4) | 2 (11.1) |
| Injection-site erythema | 12 (3.5) | 28 (7.9) | 7 (14.9) | 14 (31.8) | 7 (29.2) | 13 (50.0) | 0 | 1 (5.6) |
| Viral upper respiratory tract infection | 14 (4.0) | 3 (0.8) | 7 (14.9) | 1 (2.3) | 5 (20.8) | 1 (3.8) | 2 (8.7) | 0 |
| Chills | 26 (7.5) | 6 (1.7) | 7 (14.9) | 2 (4.5) | 2 (8.3) | 0 | 5 (21.7) | 2 (11.1) |
| Peripheral edema | 62 (17.9) | 39 (11.0) | 6 (12.8) | 4 (9.1) | 6 (25.0) | 3 (11.5) | 0 | 1 (5.6) |
| Increased ALT | 15 (4.3) | 18 (5.1) | 6 (12.8) | 6 (13.6) | 1 (4.2) | 4 (15.4) | 5 (21.7) | 2 (11.1) |
| Increased AST | 13 (3.8) | 15 (4.2) | 5 (10.6) | 6 (13.6) | 0 | 4 (15.4) | 5 (21.7) | 2 (11.1) |
| Malaise | 7 (2.0) | 10 (2.8) | 3 (6.4) | 6 (13.6) | 3 (12.5) | 6 (23.1) | 0 | 0 |
TEAE treatment-emergent adverse event, D-VMP daratumumab/bortezomib/melphalan/prednisone, VMP bortezomib/melphalan/prednisone, ALT alanine aminotransferase, AST aspartate aminotransferase