TABLE 3.
Most common adverse events, serious adverse events, and clinical laboratory abnormalities.
| Adverse event MedDRA preferred terma | Cohort A, n = 45, No. (%) | Cohort B, n = 13, No. (%) | All, n = 58, No. (%) |
|---|---|---|---|
|
| |||
| Adverse events of any grade in ≥40% of patients total | |||
| Thrombocytopeniab | 26 (57.8) | 10 (76.9) | 36 (62.1) |
| Neutropeniac | 23 (51.1) | 12 (92.3) | 35 (60.3) |
| Leukopeniad | 22 (48.9) | 12 (92.3) | 34 (58.6) |
| Anemia | 22 (48.9) | 8 (61.5) | 30 (51.7) |
| Febrile neutropenia | 23 (51.1) | 7 (53.8) | 30 (51.7) |
| Nausea | 23 (51.1) | 6 (46.2) | 29 (50.0) |
| Diarrhea | 19 (42.2) | 9 (69.2) | 28 (48.3) |
| Hypokalemia | 21 (46.7) | 5 (38.5) | 26 (44.8) |
| Grade ≥3 treatment-related adverse events in two or more patients | |||
| Febrile neutropenia | 14 (31.1) | 5 (38.5) | 19 (32.8) |
| Anemia | 10 (22.2) | 4 (30.8) | 14 (24.1) |
| Sepsis | 2 (4.4) | 1 (7.7) | 3 (5.2) |
| Lung infection | 2 (4.4) | 0 (0.0) | 2 (3.4) |
| Rash, maculopapular | 2 (4.4) | 0 (0.0) | 2 (3.4) |
| All-cause serious adverse events in two or more patients | |||
| Pneumonia | 8 (17.8) | 1 (7.7) | 9 (15.5) |
| Respiratory failure | 5 (11.1) | 0 (0.0) | 5 (8.6) |
| Atrial fibrillation | 4 (8.9) | 0 (0.0) | 4 (6.9) |
| Sepsis | 3 (6.7) | 2 (15.4) | 5 (8.6) |
| Cellulitis | 3 (6.7) | 0 (0.0) | 3 (5.2) |
| Myocarditis | 2 (4.4) | 0 (0.0) | 2 (3.4) |
| Acute kidney injury | 1 (2.2) | 2 (15.4) | 3 (5.2) |
| Pleural effusion | 2 (4.4) | 0 (0.0) | 2 (3.4) |
| Dehydration | 0 (0.0) | 2 (15.4) | 2 (3.4) |
| Grade ≥3 treatment-related laboratory abnormalities in two or more patients | |||
| Neutropeniac | 13 (28.9) | 4 (30.8) | 17 (29.3) |
| WBC count decreased | 9 (20.0) | 3 (23.1) | 12 (20.7) |
| Lymphocyte count decreased | 8 (17.8) | 2 (15.4) | 10 (17.2) |
| Platelet count decreased | 7 (15.6) | 4 (30.8) | 11 (19.0) |
| Blood bilirubin increased | 5 (11.1) | 1 (7.7) | 6 (10.3) |
| Alanine aminotransferase increased | 3 (6.7) | 1 (7.7) | 4 (6.9) |
| Aspartate aminotransferase increased | 2 (4.4) | 1 (7.7) | 3 (5.2) |
Note: Cohort A, TP53 mutations (identified molecularly) with or without complex karyotype; cohort B, complex karyotype (three or more metaphase abnormalities without TP53 mutation).
Abbreviations: MedDRA, Medical Dictionary for Regulatory Activities; WBC, white blood cell.
All adverse events were graded using the Common Terminology Criteria for Adverse Events (CTCAE), version 4.03, and were coded using MedDRA, version 19.1.
Includes the MedDRA preferred terms thrombocytopenia and platelet count decreased.
Includes the MedDRA preferred terms neutropenia and neutrophil count decreased.
Includes the MedDRA preferred terms leukopenia and white blood cell count decreased.