Table 2. Adverse Events.
Adverse events | No. (%) | |||||
---|---|---|---|---|---|---|
Cisplatin/gemcitabine plus berzosertib | Cisplatin/gemcitabine alone Arm B | |||||
Grade 1/2 | Grade 3 | Grade 4 | Grade 1/2 | Grade 3 | Grade 4 | |
No. | 46 | 41 | ||||
Decreased | ||||||
Platelet count | 8 (17) | 10 (22) | 17 (37) | 12 (29) | 9 (22) | 7 (17) |
Neutrophil count | 8 (17) | 9 (20) | 8 (17) | 10 (24) | 9 (22) | 2 (5) |
White blood cell | 6 (13) | 9 (20) | 2 (4) | 13 (32) | 2 (5) | NA |
Lymphocyte count | 9 (20) | 4 (9) | 1 (2) | 10 (24) | 3 (7) | NA |
Hyperglycemia | 2 (4) | 1 (2) | 1 (2) | 1 (2) | 2 (5) | NA |
Hyponatremia | 12 (26) | 4 (9) | NA | 12 (29) | 4 (10) | 1 (2) |
Acute kidney injury | 2 (4) | 1 (2) | NA | 2 (5) | 2 (5) | 1 (2) |
Anemia | 12 (26) | 26 (57) | NA | 19 (46) | 10 (24) | NA |
Hypokalemia | 2 (4) | 5 (11) | NA | 7 (17) | 2 (5) | NA |
Urinary tract infection | 3 (7) | 4 (9) | NA | NA | NA | NA |
Dehydration | 2 (4) | 3 (7) | NA | 4 (10) | NA | |
Dyspnea | 5 (11) | 2 (4) | NA | 5 (12) | 1 (2) | NA |
Thromboembolic event | 1 (2) | 2 (4) | NA | 2 (5) | 1 (2) | NA |
Fatigue | 26 (57) | 1 (2) | NA | 20 (49) | 4 (10) | NA |
Abdominal pain | 3 (7) | 1 (2) | NA | 3 (7) | 1 (2) | NA |
Hypomagnesemia | 10 (22) | 1 (2) | NA | 9 (22) | NA | NA |
Edema limbs | 7 (15) | 1 (2) | NA | 1 (2) | NA | NA |
Hypoalbuminemia | 5 (11) | 1 (2) | NA | 7 (17) | NA | NA |
Nausea/Vomiting | 27 (59) | NA | NA | 20 (49) | 4 (10) | NA |
Anorexia | 9 (20) | NA | NA | 9 (22) | 1 (2) | NA |
Generalized muscle weakness | 7 (15) | NA | NA | 4 (10) | 1 (2) | NA |
Hyperkalemia | 4 (9) | NA | NA | 2 (5) | 1 (2) | NA |
Hypertension | 2 (4) | NA | NA | 2 (5) | 1 (2) | NA |
Abbreviation: NA, not applicable.