Table 3.
AEs considered related to treatment occurring during the study (N = 64)
| AE preferred term* | Related TEAE, n (%) | |
|---|---|---|
| Grade 1-2 in ≥2 patients | Grade 3† | |
| Bone pain | 21 (33) | 3 (5) |
| Headache | 16 (25) | 1 (2) |
| Myalgia | 13 (20) | 0 |
| Arthralgia | 12 (19) | 0 |
| Musculoskeletal pain | 10 (16) | 0 |
| Back pain | 7 (11) | 0 |
| Injection site pain | 7 (11) | 0 |
| Asthenia | 6 (9) | 2 (3) |
| Erythroblastosis | 3 (5) | 0 |
| Injection site erythema | 3 (5) | 0 |
| Musculoskeletal chest pain | 3 (5) | 0 |
| Neck pain | 3 (5) | 0 |
| Pain in jaw | 3 (5) | 0 |
| Pyrexia | 3 (5) | 0 |
| Chills | 2 (3) | 0 |
| Influenza | 2 (3) | 0 |
| Injection site pruritus | 2 (3) | 0 |
| Macules | 2 (3) | 0 |
| Muscle spasms | 2 (3) | 0 |
| Nausea | 2 (3) | 0 |
| Pain in extremity | 2 (3) | 0 |
| Paresthesia | 2 (3) | 0 |
Maximum severity reported per patient per preferred term.
TEAE, treatment-emergent AE.
*
Classified according to the Medical Dictionary for Regulatory Activities. Results shown are the numbers of patients reporting the specified TEAEs.
†
No grade 4 AEs considered related to luspatercept treatment were reported.