Table 4.
Events of Clinical Interesta
| ECI, n (%) | Acalabrutinib (n = 154) | IdR (n = 118) | BR (n = 35) | |||
|---|---|---|---|---|---|---|
| All Grades | Grade ≥3 | All Grades | Grade ≥3 | All Grades | Grade ≥3 | |
| Cardiac events | 24 (16) | 8 (5) | 12 (10) | 6 (5) | 3 (9) | 3 (9) |
| Atrial fibrillation/flutter | 12 (8) | 2 (1) | 4 (3) | 1 (1) | 1 (3) | 1 (3) |
| Hemorrhage | 47 (31) | 4 (3) | 10 (8) | 3 (3) | 2 (6) | 1 (3) |
| Major hemorrhageb | 5 (3) | 4 (3)c | 3 (3) | 3 (3)d | 1 (3) | 1 (3)e |
| Hypertension | 12 (8) | 7 (5) | 7 (6) | 1 (1) | 0 | 0 |
| Infections | 105 (68) | 45 (29) | 86 (73) | 40 (34) | 17 (49) | 4 (11) |
| Second primary malignancies | 28 (18) | 13 (8) | 5 (4) | 1 (1) | 2 (6) | 2 (6) |
| Second primary malignancies excluding non-melanoma skin | 11 (7) | 10 (6) | 2 (2) | 1 (1) | 1 (3) | 1 (3) |
| Tumor lysis syndrome | 1 (1) | 1 (1) | 1 (1) | 1 (1) | 0 | 0 |
aECIs were based on combined AE terms for infections, bleeding events, hypertension, and second primary malignancies excluding non-melanoma skin and on a single AE term for atrial fibrillation or flutter.
AEs were graded according to the Common Toxicity Criteria of the National Cancer Institute, version 4.03 and reported until 30 d after the last dose of study drug or at documented disease progression, whichever was longer.
bMajor hemorrhage was defined as any serious or grade .3 hemorrhage or central nervous system hemorrhage of any grade, excluding immune thrombocytopenic purpura.
cIncludes events of grade 4 gastrointestinal hemorrhage (n = 1), grade 3 gastrointestinal hemorrhage (n = 1), grade 4 immune thrombocytopenic purpura (n = 1), and grade 3 intestinal hemorrhage (n = 1).
dIncludes events of grade 3 gastrointestinal hemorrhage (n = 1), grade 3 and 4 immune thrombocytopenic purpura (n = 1), and grade 3 hematuria (n = 1).
eGrade 3 hemorrhagic anemia and grade 3 tumor hemorrhage (n = 1).
AE = adverse event; BR = bendamustine plus rituximab; ECI = event of clinical interest; IdR = idelalisib plus rituximab.