Nonhematologic AEs observed in at least 20% of patients in any arm
| . | Prior IMiD . | Prior BTZ + IMiD . | ≥2 prior regimens including BTZ and an IMiD . | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| PAN-BTZ-Dex (n = 241) . | Pbo-BTZ-Dex (n = 239) . | PAN-BTZ-Dex (n = 92) . | Pbo-BTZ-Dex (n = 99) . | PAN-BTZ-Dex (n = 72) . | Pbo-BTZ-Dex (n = 73) . | |||||||
| AE, n (%) . | All . | Grade 3/4 . | All . | Grade 3/4 . | All . | Grade 3/4 . | All . | Grade 3/4 . | All . | Grade 3/4 . | All . | Grade 3/4 . |
| Diarrhea | 167 (69) | 63 (26) | 97 (41) | 19 (8) | 67 (73) | 28 (30) | 46 (47) | 13 (13) | 55 (76) | 24 (33) | 34 (47) | 11 (15) |
| Fatigue/asthenia | 144 (60) | 61 (25) | 93 (39) | 28 (12) | 55 (60) | 23 (25) | 44 (44) | 12 (12) | 43 (60) | 19 (26) | 36 (49) | 10 (14) |
| Peripheral neuropathy | 149 (62) | 41 (17) | 160 (67) | 34 (14) | 51 (55) | 14 (15) | 52 (53) | 9 (9) | 42 (58) | 12 (17) | 39 (53) | 5 (7) |
| Nausea | 89 (37) | 14 (6) | 54 (23) | 2 (1) | 35 (38) | 8 (9) | 21 (21) | 1 (1) | 27 (38) | 8 (11) | 16 (22) | 1 (1) |
| Peripheral edema | 70 (29) | 4 (2) | 48 (20) | 0 | 18 (20) | 2 (2) | 18 (18) | 0 | 16 (22) | 2 (3) | 11 (15) | 0 |
| Vomiting | 65 (27) | 17 (7) | 32 (13) | 4 (2) | 24 (26) | 6 (7) | 10 (10) | 2 (2) | 18 (25) | 4 (6) | 7 (10) | 2 (3) |
| Hypokalemia | 65 (27) | 47 (20) | 30 (13) | 11 (5) | 24 (26) | 19 (21) | 17 (17) | 6 (6) | 18 (25) | 15 (21) | 12 (16) | 5 (7) |
| Decreased appetite | 62 (26) | 6 (3) | 30 (13) | 3 (1) | 21 (23) | 1 (1) | 13 (13) | 0 | 16 (22) | 1 (1) | 10 (14) | 0 |
| Upper respiratory tract infection | 60 (25) | 7 (3) | 40 (17) | 4 (2) | 30 (33) | 4 (4) | 17 (17) | 0 | 21 (29) | 4 (6) | 12 (16) | 0 |
| Pyrexia | 62 (26) | 3 (1) | 34 (14) | 5 (2) | 14 (15) | 0 | 13 (13) | 3 (3) | 10 (14) | 0 | 10 (14) | 3 (4) |
| Constipation | 59 (25) | 3 (1) | 73 (31) | 3 (1) | 25 (27) | 2 (2) | 32 (32) | 2 (2) | 19 (26) | 2 (3) | 20 (27) | 2 (3) |
| Cough | 54 (22) | 1 (0.4) | 46 (19) | 0 | 22 (24) | 0 | 20 (20) | 0 | 19 (26) | 0 | 15 (21) | 0 |
| Abdominal pain | 40 (17) | 5 (2) | 28 (12) | 3 (1) | 21 (23) | 2 (2) | 11 (11) | 2 (2) | 17 (24) | 1 (1) | 8 (11) | 2 (3) |
| . | Prior IMiD . | Prior BTZ + IMiD . | ≥2 prior regimens including BTZ and an IMiD . | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| PAN-BTZ-Dex (n = 241) . | Pbo-BTZ-Dex (n = 239) . | PAN-BTZ-Dex (n = 92) . | Pbo-BTZ-Dex (n = 99) . | PAN-BTZ-Dex (n = 72) . | Pbo-BTZ-Dex (n = 73) . | |||||||
| AE, n (%) . | All . | Grade 3/4 . | All . | Grade 3/4 . | All . | Grade 3/4 . | All . | Grade 3/4 . | All . | Grade 3/4 . | All . | Grade 3/4 . |
| Diarrhea | 167 (69) | 63 (26) | 97 (41) | 19 (8) | 67 (73) | 28 (30) | 46 (47) | 13 (13) | 55 (76) | 24 (33) | 34 (47) | 11 (15) |
| Fatigue/asthenia | 144 (60) | 61 (25) | 93 (39) | 28 (12) | 55 (60) | 23 (25) | 44 (44) | 12 (12) | 43 (60) | 19 (26) | 36 (49) | 10 (14) |
| Peripheral neuropathy | 149 (62) | 41 (17) | 160 (67) | 34 (14) | 51 (55) | 14 (15) | 52 (53) | 9 (9) | 42 (58) | 12 (17) | 39 (53) | 5 (7) |
| Nausea | 89 (37) | 14 (6) | 54 (23) | 2 (1) | 35 (38) | 8 (9) | 21 (21) | 1 (1) | 27 (38) | 8 (11) | 16 (22) | 1 (1) |
| Peripheral edema | 70 (29) | 4 (2) | 48 (20) | 0 | 18 (20) | 2 (2) | 18 (18) | 0 | 16 (22) | 2 (3) | 11 (15) | 0 |
| Vomiting | 65 (27) | 17 (7) | 32 (13) | 4 (2) | 24 (26) | 6 (7) | 10 (10) | 2 (2) | 18 (25) | 4 (6) | 7 (10) | 2 (3) |
| Hypokalemia | 65 (27) | 47 (20) | 30 (13) | 11 (5) | 24 (26) | 19 (21) | 17 (17) | 6 (6) | 18 (25) | 15 (21) | 12 (16) | 5 (7) |
| Decreased appetite | 62 (26) | 6 (3) | 30 (13) | 3 (1) | 21 (23) | 1 (1) | 13 (13) | 0 | 16 (22) | 1 (1) | 10 (14) | 0 |
| Upper respiratory tract infection | 60 (25) | 7 (3) | 40 (17) | 4 (2) | 30 (33) | 4 (4) | 17 (17) | 0 | 21 (29) | 4 (6) | 12 (16) | 0 |
| Pyrexia | 62 (26) | 3 (1) | 34 (14) | 5 (2) | 14 (15) | 0 | 13 (13) | 3 (3) | 10 (14) | 0 | 10 (14) | 3 (4) |
| Constipation | 59 (25) | 3 (1) | 73 (31) | 3 (1) | 25 (27) | 2 (2) | 32 (32) | 2 (2) | 19 (26) | 2 (3) | 20 (27) | 2 (3) |
| Cough | 54 (22) | 1 (0.4) | 46 (19) | 0 | 22 (24) | 0 | 20 (20) | 0 | 19 (26) | 0 | 15 (21) | 0 |
| Abdominal pain | 40 (17) | 5 (2) | 28 (12) | 3 (1) | 21 (23) | 2 (2) | 11 (11) | 2 (2) | 17 (24) | 1 (1) | 8 (11) | 2 (3) |