Pooled analysis of AEs associated with luspatercept use in patients with LR-MDS
| AE . | Source type . | Pooled estimate (95% CI), % . | I2, % . | k . | n . | P value . |
|---|---|---|---|---|---|---|
| Back Pain | CT | 16.1 (9.2-26.8) | 76.7 | 2 | 335 | |
| Fatigue | Combined | 11.4 (5.4-22.6) | 93.6 | 5 | 1100 | |
| Fatigue | CT | 17.0 (8.4-31.6) | 89.7 | 3 | 443 | .021 |
| Fatigue | RW | 6.9 (5.2-9.1) | 0 | 2 | 657 | |
| Dyspnea | Combined | 2.1 (0.3-14.6) | 92.4 | 3 | 927 | |
| Dyspnea | CT | 5.1 (1.0-22.7) | 87.3 | 2 | 335 | .011 |
| Dyspnea | RW | 2.1 (0.3-14.6) | 0 | 1 | 592 | |
| Asthenia | Combined | 5.3 (1.9-14.1) | 78.6 | 5 | 507 | |
| Asthenia | CT | 7.7 (2.1-24.3) | 80 | 3 | 359 | .262 |
| Asthenia | RW | 3.1 (1.2-7.8) | 0 | 2 | 148 | |
| Dizziness | Combined | 12.3 (6.6-21.9) | 79.0 | 4 | 448 | |
| Dizziness | CT | 15.8 (9.2-25.6) | 71.9 | 3 | 365 | .029 |
| Dizziness | RW | 4.8 (9.2-25.6) | 0 | 1 | 83 | |
| Nausea | CT | 3.6 (0.2-45.7) | 89.6 | 2 | 335 | |
| Headache | Combined | 11.2 (6.1-19.5) | 74.9 | 3 | 448 | |
| Headache | CT | 14.1 (8.7-22.0) | 74.9 | 2 | 365 | .043 |
| Headache | RW | 4.9 (1.8-12.2) | 0 | 1 | 83 | |
| Hypertension | Combined | 3.0 (0.6-12.6) | 90.4 | 4 | 947 | |
| Hypertension | CT | 7.4 (2.2-22.2) | 81.8 | 2 | 290 | .104 |
| Hypertension | RW | 1.1 (0.14-7.8) | 78.2 | 2 | 657 | |
| Diarrhea | CT | 15.6 (8.2-27.7) | 85.6% | 4 | 473 | |
| Peripheral Edema | CT | 17.8 (11.4-26.8) | 65.9 | 3 | 365 | |
| Arthralgia | Combined | 5.6 (2.2-13.5) | 90.6 | 5 | 1118 | |
| Arthralgia | CT | 7.5 (3.5-15.2) | 76.7 | 3 | 443 | .666 |
| Arthralgia | RW | 4.0 (0.2-44.1) | 96.9 | 2 | 675 | |
| SAE | Combined | 28.0 (12.8-50.7) | 97.2 | 5 | 1088 | .691 |
| SAE | CT | 32.1 (15.5-54.8) | 93.7 | 3 | 413 | |
| SAE | RW | 22.9 (3.5-70.6) | 98.5 | 2 | 675 |
| AE . | Source type . | Pooled estimate (95% CI), % . | I2, % . | k . | n . | P value . |
|---|---|---|---|---|---|---|
| Back Pain | CT | 16.1 (9.2-26.8) | 76.7 | 2 | 335 | |
| Fatigue | Combined | 11.4 (5.4-22.6) | 93.6 | 5 | 1100 | |
| Fatigue | CT | 17.0 (8.4-31.6) | 89.7 | 3 | 443 | .021 |
| Fatigue | RW | 6.9 (5.2-9.1) | 0 | 2 | 657 | |
| Dyspnea | Combined | 2.1 (0.3-14.6) | 92.4 | 3 | 927 | |
| Dyspnea | CT | 5.1 (1.0-22.7) | 87.3 | 2 | 335 | .011 |
| Dyspnea | RW | 2.1 (0.3-14.6) | 0 | 1 | 592 | |
| Asthenia | Combined | 5.3 (1.9-14.1) | 78.6 | 5 | 507 | |
| Asthenia | CT | 7.7 (2.1-24.3) | 80 | 3 | 359 | .262 |
| Asthenia | RW | 3.1 (1.2-7.8) | 0 | 2 | 148 | |
| Dizziness | Combined | 12.3 (6.6-21.9) | 79.0 | 4 | 448 | |
| Dizziness | CT | 15.8 (9.2-25.6) | 71.9 | 3 | 365 | .029 |
| Dizziness | RW | 4.8 (9.2-25.6) | 0 | 1 | 83 | |
| Nausea | CT | 3.6 (0.2-45.7) | 89.6 | 2 | 335 | |
| Headache | Combined | 11.2 (6.1-19.5) | 74.9 | 3 | 448 | |
| Headache | CT | 14.1 (8.7-22.0) | 74.9 | 2 | 365 | .043 |
| Headache | RW | 4.9 (1.8-12.2) | 0 | 1 | 83 | |
| Hypertension | Combined | 3.0 (0.6-12.6) | 90.4 | 4 | 947 | |
| Hypertension | CT | 7.4 (2.2-22.2) | 81.8 | 2 | 290 | .104 |
| Hypertension | RW | 1.1 (0.14-7.8) | 78.2 | 2 | 657 | |
| Diarrhea | CT | 15.6 (8.2-27.7) | 85.6% | 4 | 473 | |
| Peripheral Edema | CT | 17.8 (11.4-26.8) | 65.9 | 3 | 365 | |
| Arthralgia | Combined | 5.6 (2.2-13.5) | 90.6 | 5 | 1118 | |
| Arthralgia | CT | 7.5 (3.5-15.2) | 76.7 | 3 | 443 | .666 |
| Arthralgia | RW | 4.0 (0.2-44.1) | 96.9 | 2 | 675 | |
| SAE | Combined | 28.0 (12.8-50.7) | 97.2 | 5 | 1088 | .691 |
| SAE | CT | 32.1 (15.5-54.8) | 93.7 | 3 | 413 | |
| SAE | RW | 22.9 (3.5-70.6) | 98.5 | 2 | 675 |
P values represent the statistical significance of differences in AE rates between CT and RW sources when applicable. Only pooled estimates with stratified source analysis (CT vs RW) are accompanied by a P value. Combined represents combined CT and RW data.
CT, clinical trial; RW, real-world study.