Most commonly reported grade ≥3 TEAEs using the 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) . | |
| Cardiac failure | 17 (13) | 26 (20) | 5 (13) | 11 (28) |
| Pneumonia | 14 (11) | 12 (9) | 4 (11) | 1 (3) |
| Congestive cardiac failure | 13 (10) | 9 (7) | 5 (13) | 3 (8) |
| Syncope | 13 (10) | 17 (13) | 6 (16) | 6 (15) |
| Peripheral edema | 8 (6) | 10 (8) | 1 (3) | 5 (13) |
| Diarrhea | 6 (5) | 7 (5) | 2 (5) | 5 (13) |
| Hypokalemia | 5 (4) | 7 (5) | 2 (5) | 4 (10) |
| Lymphopenia | 5 (4) | 8 (6) | 4 (11) | 3 (8) |
| Hypotension | 4 (3) | 7 (5) | 1 (3) | 5 (13) |
| . | 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) . | |
| Cardiac failure | 17 (13) | 26 (20) | 5 (13) | 11 (28) |
| Pneumonia | 14 (11) | 12 (9) | 4 (11) | 1 (3) |
| Congestive cardiac failure | 13 (10) | 9 (7) | 5 (13) | 3 (8) |
| Syncope | 13 (10) | 17 (13) | 6 (16) | 6 (15) |
| Peripheral edema | 8 (6) | 10 (8) | 1 (3) | 5 (13) |
| Diarrhea | 6 (5) | 7 (5) | 2 (5) | 5 (13) |
| Hypokalemia | 5 (4) | 7 (5) | 2 (5) | 4 (10) |
| Lymphopenia | 5 (4) | 8 (6) | 4 (11) | 3 (8) |
| Hypotension | 4 (3) | 7 (5) | 1 (3) | 5 (13) |
Occurring in ≥10% patients in either treatment group (overall population or patients with Mayo stage IV AL amyloidosis) and ordered from highest to lower percent in the birtamimab overall study population (all patients). Patients reporting >1 TEAE are counted only once using the closest relationship to study drug, as assessed by the investigator.