Exposure-adjusted incidence rates for AEIs by category*
| Category . | All grades . | All patients with eventn (%) . | Grade ≥3 . | All patients with eventn (%) . |
|---|---|---|---|---|
| Infections | 9.6 | 590 (76) | 1.4 | 214 (27) |
| Opportunistic infections | 0.1 | 23 (3) | 0.1 | 15 (2) |
| Hemorrhage† | 4.8 | 428 (55) | 0.2 | 28 (4) |
| Major hemorrhage | 0.2 | 31 (4) | 0.2 | 28 (4) |
| Neutropenia‡ | 2.1 | 277 (36) | 1.2 | 183 (23) |
| Thrombocytopenia§ | 1.1 | 167 (21) | 0.3 | 61 (8) |
| Anemiaǁ | 0.8 | 137 (18) | 0.04 | 63 (8) |
| Second primary malignancies¶ | 0.6 | 102 (13)ǁ | 0.2 | 40 (5) |
| Skin cancers | 0.4 | 69 (9) | 0.1 | 13 (2) |
| Hypertension | 0.6 | 95 (12) | 0.2 | 41 (5) |
| Atrial fibrillation and flutter | 0.1 | 22 (3) | 0.03 | 6 (1) |
| Tumor lysis syndrome# | 0.02 | 3 (0.4) | 0.02 | 3 (0.4) |
| Category . | All grades . | All patients with eventn (%) . | Grade ≥3 . | All patients with eventn (%) . |
|---|---|---|---|---|
| Infections | 9.6 | 590 (76) | 1.4 | 214 (27) |
| Opportunistic infections | 0.1 | 23 (3) | 0.1 | 15 (2) |
| Hemorrhage† | 4.8 | 428 (55) | 0.2 | 28 (4) |
| Major hemorrhage | 0.2 | 31 (4) | 0.2 | 28 (4) |
| Neutropenia‡ | 2.1 | 277 (36) | 1.2 | 183 (23) |
| Thrombocytopenia§ | 1.1 | 167 (21) | 0.3 | 61 (8) |
| Anemiaǁ | 0.8 | 137 (18) | 0.04 | 63 (8) |
| Second primary malignancies¶ | 0.6 | 102 (13)ǁ | 0.2 | 40 (5) |
| Skin cancers | 0.4 | 69 (9) | 0.1 | 13 (2) |
| Hypertension | 0.6 | 95 (12) | 0.2 | 41 (5) |
| Atrial fibrillation and flutter | 0.1 | 22 (3) | 0.03 | 6 (1) |
| Tumor lysis syndrome# | 0.02 | 3 (0.4) | 0.02 | 3 (0.4) |
Exposure-adjusted incidence rate is calculated as the first occurrence of each adverse event of interest per 100 person- months of zanubrutinib exposure.
Inclusive of major hemorrhage.
Includes clinical AEs reported under the preferred terms (PTs) neutropenia (n = 97), neutrophil count decreased (n = 178), febrile neutropenia (n = 14), and neutropenic sepsis (n = 1).
Includes clinical AEs reported under the PTs thrombocytopenia (n = 58) and platelet count decreased (n = 97).
Includes clinical AEs reported under the PTs anemia (n = 125) and hemoglobin decreased (n = 6).
Inclusive of skin cancers.
#Two cases of tumor lysis syndrome occurred >30 d after discontinuation of zanubrutinib for disease progression; both were assessed as grade ≥3 and serious. In 1 patient, the event occurred in association with venetoclax exposure, a known precipitant of tumor lysis syndrome.35 A third patient experienced an event with onset 9 d after discontinuation of zanubrutinib for progression of MCL on study day 150, which was unresponsive to medical management. The patient died 3 d after onset from complications of acute kidney injury.