Table 4.
Adverse events of special interest.
| Safety topic,a n (%) | All patients N = 48 |
|
|---|---|---|
| All grades | Grade ≥ 3 | |
| Gastrointestinal toxicity | 23 (47.9) | 5 (10.4) |
| Hypersensitivityb | 13 (27.1) | 0 |
| Hepatotoxicity (including laboratory terms)c | 13 (27.1) | 5 (10.4) |
| Myelosuppressiond | 12 (25.0) | 10 (20.8) |
| Thrombocytopenia | 9 (18.8) | 8 (16.7) |
| Leukopenia | 7 (14.6) | 6 (12.5) |
| Erythropenia (anemia) | 5 (10.4) | 3 (6.3) |
| Cytopenias affecting >1 lineage | 1 (2.1) | 1 (2.1) |
| Pancreatic toxicity (including laboratory terms) | 15 (31.3) | 11 (22.9) |
| Pancreatic toxicity (clinical events) | 1 (2.1) | 0 |
| Edema and fluid retention | 8 (16.7) | 3 (6.3) |
| Hemorrhage | 9 (18.8) | 1 (2.1) |
| Ischemic heart and CNS conditions | 5 (10.4) | 2 (4.2) |
| Ischemic CNS vascular conditions | 3 (6.3) | 1 (2.1) |
| Ischemic heart disease | 3 (6.3) | 1 (2.1) |
| Arterial occlusive event | 4 (8.3) | 2 (4.2) |
| Phototoxicity | 1 (2.1) | 0 |
| QTc prolongation | 1 (2.1) | 1 (2.1) |
CNS central nervous system.
aNumbers (n) represent counts of patients. A patient with multiple severity grades for an adverse event is only counted under the maximum grade. MedDRA version 23.1, CTCAE version 4.03, Case Retrieval Strategy version released February 25, 2021.
bMainly mild dermatologic events, including rash, rash maculopapular, dermatitis acneiform, eczema, and urticaria. One event of allergic rhinitis was also observed.
cMainly enzyme elevations.
dMyelosuppression includes anemia, leukopenia, thrombocytopenia, and cytopenias affecting >1 lineage.