Table 3.
Treatment-emergent AEs in >10% of patients, grade ≥3 adverse events in ≥2 patients, and AEs of interest.
| BGB-3111–214 (MAGNOLIA study) | ||
|---|---|---|
| (N = 68) | ||
| AE, n (%) | Any-grade AE | Grade ≥3 AE |
| Patients with ≥1 AE | 65 (95.6) | 27 (39.7) |
| Diarrhea | 15 (22.1) | 2 (2.9) |
| Contusion | 14 (20.6) | 0 |
| Constipation | 10 (14.7) | 0 |
| Pyrexia | 9 (13.2) | 2 (2.9) |
| Abdominal pain | 8 (11.8) | |
| Upper respiratory tract infection | 8 (11.8) | 1 (1.5) |
| Back pain | 7 (10.3) | 0 |
| Nausea | 7 (10.3) | 0 |
| COVID-19 pneumonia | 4 (5.9) | 3 (4.4) |
| Pneumonia | 2 (2.9) | 2 (2.9) |
| AE of interest | ||
| Bleeding | 25 (36.8) | 0 |
| Major hemorrhagea | 0 | 0 |
| Atrial fibrillation/flutter | 2 (2.9) | 1 (1.5) |
| Hypertensionb | 2 (2.9) | 1 (1.5) |
| Second primary malignanciesc | 5 (7.4) | 3 (4.4) |
| Skin cancers | 2 (2.9) | 0 |
| Infections | 31 (45.6) | 11 (16.2)f |
| Opportunistic infections | 2 (2.9) | 1 (1.5) |
| Tumor lysis syndrome | 0 | 0 |
| Anemia | 4 (5.9) | 2 (2.9) |
| Neutropeniad | 9 (13.2) | 7 (10.3) |
| Thrombocytopeniae | 10 (14.7) | 3 (4.4) |
Abbreviation: MedDRA, Medical Dictionary for Regulatory Activities.
aDefined as any serious or grade ≥3 bleed at any site, or central nervous system bleed of any grade.
bIncludes the MedDRA-preferred terms “hypertension” and “prehypertension.”
cIncludes BCC and SCC of skin (in 2 patients with prior history of skin cancer), acute myeloid leukemia (in a patient with prior exposure to an alkylating agent), bladder cancer recurrent, and papillary thyroid cancer (in a patient with pre-existing thyroid nodule).
dIncludes the MedDRA-preferred terms “neutropenia,” and “neutrophil count decreased.”
eIncludes the MedDRA-preferred terms “thrombocytopenia” and “platelet count decreased.”
fCOVID-19 pneumonia and pneumonia are the only grade ≥3 infections occurring in more than one patient.