Table 4.
AEI
| Category of event | Grade 1, n (%) | Grade 2, n (%) | Grade 3, n (%) | Grade 4, n (%) | Grade 5, n (%) | All grade, n (%) | EAIR (all severity grades), events per 100 person-months |
|---|---|---|---|---|---|---|---|
| Patients with ≥1 AEI* | 7 (9.1) | 30 (39.0) | 25 (32.5) | 9 (11.7) | 4 (5.2) | 75 (97.4) | – |
| Bleeding | 40 (51.9) | 5 (6.5) | 3 (3.9) | 0 | 0 | 48 (62.3) | 4.49 |
| Major hemorrhage | 0 | 0 | 3 (3.9) | 0 | 0 | 3 (3.9) | 0.13 |
| Atrial fibrillation/ flutter | 1 (1.3) | 2 (2.6) | 1 (1.3) | 0 | 0 | 4 (5.2) | 0.19 |
| Hypertension | 1 (1.3) | 8 (10.4) | 3 (3.9) | 0 | 0 | 12 (15.6) | 0.61 |
| Second primary malignancies | 3 (3.9) | 6 (7.8) | 7 (9.1) | 2 (2.6) | 1 (1.3) | 19 (24.7) | 0.98 |
| Skin cancers | 2 (2.6) | 7 (9.1) | 4 (5.2) | 0 | 0 | 13 (16.9) | 0.66 |
| Tumor lysis syndrome | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Infections | 4 (5.2) | 45 (58.4) | 17 (22.1) | 1 (1.3) | 3 (3.9) | 70 (90.9) | 11.48 |
| Hepatitis B reactivation* | 1 (1.3) | 0 | 0 | 0 | 0 | 1 (1.3) | – |
| Anemia | 1 (1.3) | 3 (3.9) | 7 (9.1) | 0 | 0 | 11 (14.3) | 0.54 |
| Neutropenia | 0 | 2 (2.6) | 6 (7.8) | 6 (7.8) | 0 | 14 (18.2) | 0.73 |
| Thrombocytopenia | 3 (3.9) | 2 (2.6) | 1 (1.3) | 0 | 0 | 6 (7.8) | 0.28 |
AEI, AEs of interest.
*
EAIR not calculated.