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. Author manuscript; available in PMC: 2024 Aug 1.
Published in final edited form as: Cancer. 2023 Apr 20;129(15):2308–2320. doi: 10.1002/cncr.34780

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.

a

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.

b

Includes the MedDRA preferred terms thrombocytopenia and platelet count decreased.

c

Includes the MedDRA preferred terms neutropenia and neutrophil count decreased.

d

Includes the MedDRA preferred terms leukopenia and white blood cell count decreased.