Table 3.
AEs of special interest during consolidation and treatment re-initiation phases.
| Adverse event of special interest group | Consolidation phase N = 215, n (%) | Re-initiation phase N = 91, n (%) |
|---|---|---|
| Blood cholesterol increased | 11 (5.1) | 17 (18.7) |
| Blood glucose increased | 3 (1.4) | 11 (12.1) |
| Cardiac failure | 0 | 0 |
| Cardiovascular events | 11 (5.1) | 16 (17.6) |
| Ischemic cerebrovascular events | 3 (1.4) | 3 (3.3) |
| Ischemic heart disease | 3 (1.4) | 8 (8.8) |
| Peripheral arterial occlusive disease | 4 (1.9) | 4 (4.4) |
| Fluid retention | 4 (1.9) | 6 (6.6) |
| Edema and other fluid retentions | 3 (1.4) | 4 (4.4) |
| Severe | 1 (0.5) | 2 (2.2) |
| Hepatotoxicity | 11 (5.1) | 12 (13.2) |
| Drug-induced liver injury | 0 | 1 (1.1) |
| Total transaminase activity and bilirubin elevations | 11 (5.1) | 12 (13.2) |
| Musculoskeletal pain | 33 (15.3) | 18 (19.8) |
| Myelosuppression (Thrombocytopenia) | 2 (0.9) | 0 |
| Pancreatitis, lipase, and amylase elevations | 3 (1.4) | 1 (1.1) |
| QT prolongation | 4 (1.9) | 4 (4.4) |
| Rash | 8 (3.7) | 7 (7.7) |
| Renal events | 0 | 4 (4.4) |
| Significant bleeding | 2 (0.9) | 2 (2.2) |
| Gastrointestinal hemorrhage | 2 (0.9) | 2 (2.2) |
| CNS hemorrhage | 0 | 0 |
AE, adverse event; CNS, central nervous system.