TEAEs of clinical relevance and special interest
| TEAE . | Luspatercept (N = 96) . | Placebo (N = 49) . | Crossover∗ (N = 38) . | |||
|---|---|---|---|---|---|---|
| All grades . | Grade 3/4 . | All grades . | Grade 3/4 . | All grades . | Grade 3/4 . | |
| TEAEs of clinical relevance | ||||||
| Hypertension† | 21 (21.9) | 3 (3.1) | 1 (2.0) | 0 | 7 (18.4) | 0 |
| Bone pain‡ | 42 (43.8) | 3 (3.1) | 3 (6.1) | 0 | 8 (21.1) | 0 |
| TEAEs of special interest | ||||||
| TEE | 2 (2.1) | 1 (1.0) | 0 | 0 | 2 (5.3) | 1 (2.6) |
| EMH | 10 (10.4) | 0 | 2 (4.1) | 1 (2.0) | 2 (5.3) | 0 |
| Malignancies | 0 | 0 | 2 (4.1) | 2 (4.1) | 0 | 0 |
| Premalignant disorders | 2 (2.1) | 0 | 1 (2.0) | 0 | 0 | 0 |
| TEAE . | Luspatercept (N = 96) . | Placebo (N = 49) . | Crossover∗ (N = 38) . | |||
|---|---|---|---|---|---|---|
| All grades . | Grade 3/4 . | All grades . | Grade 3/4 . | All grades . | Grade 3/4 . | |
| TEAEs of clinical relevance | ||||||
| Hypertension† | 21 (21.9) | 3 (3.1) | 1 (2.0) | 0 | 7 (18.4) | 0 |
| Bone pain‡ | 42 (43.8) | 3 (3.1) | 3 (6.1) | 0 | 8 (21.1) | 0 |
| TEAEs of special interest | ||||||
| TEE | 2 (2.1) | 1 (1.0) | 0 | 0 | 2 (5.3) | 1 (2.6) |
| EMH | 10 (10.4) | 0 | 2 (4.1) | 1 (2.0) | 2 (5.3) | 0 |
| Malignancies | 0 | 0 | 2 (4.1) | 2 (4.1) | 0 | 0 |
| Premalignant disorders | 2 (2.1) | 0 | 1 (2.0) | 0 | 0 | 0 |