Overall summary of TEAEs (safety population) and most commonly reported TEAEs using preferred term
| . | All patients (n = 260), n (%) . | Patients with Mayo stage IV AL amyloidosis (n = 77), n (%) . | ||
|---|---|---|---|---|
| Birtamimab + SOC (n = 130) . | Placebo + SOC (n = 130) . | Birtamimab + SOC (n = 38) . | Placebo + SOC (n = 39) . | |
| Patients reporting ≥1 of the following: | ||||
| TEAE∗ | 127 (98) | 130 (100) | 38 (100) | 39 (100) |
| Treatment-related TEAE | 41 (32) | 50 (38) | 12 (32) | 10 (26) |
| TEAE grade ≥3 | 96 (74) | 102 (78) | 30 (79) | 35 (90) |
| Treatment-related TEAE grade ≥3 | 6 (5) | 12 (9) | 1 (3) | 4 (10) |
| Serious TEAE | 88 (68) | 91 (70) | 27 (71) | 29 (74) |
| Treatment-related serious TEAE | 4 (3) | 5 (4) | 1 (3) | 1 (3) |
| TEAE leading to study drug withdrawal | 6 (5) | 14 (11) | 3 (8) | 2 (5) |
| TEAE leading to death | 19 (15) | 28 (22) | 4 (11) | 14 (36) |
| Treatment-related TEAE leading to death | 0 | 0 | 0 | 0 |
| Most commonly reported TEAE using the preferred term† | ||||
| Fatigue | 57 (44) | 52 (40) | 15 (39) | 16 (41) |
| Nausea | 56 (43) | 44 (34) | 16 (42) | 12 (31) |
| Peripheral edema | 56 (43) | 56 (43) | 21 (55) | 19 (49) |
| Constipation | 54 (42) | 55 (42) | 16 (42) | 13 (33) |
| Diarrhea | 52 (40) | 54 (42) | 12 (32) | 17 (44) |
| Dyspnea | 40 (31) | 41 (32) | 16 (42) | 12 (31) |
| Insomnia | 39 (30) | 30 (23) | 12 (32) | 8 (21) |
| Cough | 31 (24) | 27 (21) | 11 (29) | 5 (13) |
| Hypokalemia | 26 (20) | 27 (21) | 12 (32) | 10 (26) |
| Dizziness | 25 (19) | 39 (30) | 3 (8) | 11 (28) |
| Cardiac failure | 24 (18) | 30 (23) | 8 (21) | 12 (31) |
| Hypotension | 19 (15) | 33 (25) | 4 (11) | 12 (31) |
| . | All patients (n = 260), n (%) . | Patients with Mayo stage IV AL amyloidosis (n = 77), n (%) . | ||
|---|---|---|---|---|
| Birtamimab + SOC (n = 130) . | Placebo + SOC (n = 130) . | Birtamimab + SOC (n = 38) . | Placebo + SOC (n = 39) . | |
| Patients reporting ≥1 of the following: | ||||
| TEAE∗ | 127 (98) | 130 (100) | 38 (100) | 39 (100) |
| Treatment-related TEAE | 41 (32) | 50 (38) | 12 (32) | 10 (26) |
| TEAE grade ≥3 | 96 (74) | 102 (78) | 30 (79) | 35 (90) |
| Treatment-related TEAE grade ≥3 | 6 (5) | 12 (9) | 1 (3) | 4 (10) |
| Serious TEAE | 88 (68) | 91 (70) | 27 (71) | 29 (74) |
| Treatment-related serious TEAE | 4 (3) | 5 (4) | 1 (3) | 1 (3) |
| TEAE leading to study drug withdrawal | 6 (5) | 14 (11) | 3 (8) | 2 (5) |
| TEAE leading to death | 19 (15) | 28 (22) | 4 (11) | 14 (36) |
| Treatment-related TEAE leading to death | 0 | 0 | 0 | 0 |
| Most commonly reported TEAE using the preferred term† | ||||
| Fatigue | 57 (44) | 52 (40) | 15 (39) | 16 (41) |
| Nausea | 56 (43) | 44 (34) | 16 (42) | 12 (31) |
| Peripheral edema | 56 (43) | 56 (43) | 21 (55) | 19 (49) |
| Constipation | 54 (42) | 55 (42) | 16 (42) | 13 (33) |
| Diarrhea | 52 (40) | 54 (42) | 12 (32) | 17 (44) |
| Dyspnea | 40 (31) | 41 (32) | 16 (42) | 12 (31) |
| Insomnia | 39 (30) | 30 (23) | 12 (32) | 8 (21) |
| Cough | 31 (24) | 27 (21) | 11 (29) | 5 (13) |
| Hypokalemia | 26 (20) | 27 (21) | 12 (32) | 10 (26) |
| Dizziness | 25 (19) | 39 (30) | 3 (8) | 11 (28) |
| Cardiac failure | 24 (18) | 30 (23) | 8 (21) | 12 (31) |
| Hypotension | 19 (15) | 33 (25) | 4 (11) | 12 (31) |
Patients reporting >1 TEAE are counted only once using the closest relationship to study drug, as assessed by the investigator.
Occurring in ≥25% of patients in either treatment group (overall population or patients with Mayo stage IV AL amyloidosis) and ordered from highest to lowest percentage in the birtamimab overall study population (all patients).