Any-grade treatment-emergent AEs in ≥15% of patients, grade ≥3 AEs in >2 patients, and all AEs of interest in the safety population (N = 32)
| AE* . | Any-grade AEs . | Grade ≥ 3 AEs . |
|---|---|---|
| Patients with 1 AE | 31 (96.9) | 19 (59.5) |
| Diarrhea | 14 (43.8) | 1 (3.1) |
| Contusion | 12 (37.5) | 0 |
| Constipation | 10 (31.3) | 0 |
| Upper respiratory tract infections | 10 (31.3) | 0 |
| Fatigue | 8 (25.0) | 1 (3.1) |
| Dyspnea | 8 (25.0) | 0 |
| Peripheral edema | 7 (21.9) | 2 (6.3) |
| Back pain | 7 (21.9) | 1 (3.1) |
| Rash | 7 (21.9) | 0 |
| Arthralgia | 6 (18.8) | 0 |
| Cough | 6 (18.8) | 0 |
| Muscle spasms | 5 (15.6) | 0 |
| Pruritis | 5 (15.6) | 0 |
| Localized infection | 5 (15.6) | 0 |
| Urinary tract infection | 5 (15.6) | 0 |
| Pneumonia | 4 (12.5) | 3 (9.4) |
| Myalgia | 3 (9.4) | 3 (9.4) |
| AEs of interest | ||
| Bleeding | 18 (56.3) | 3 (9.4) |
| Major hemorrhage* | 3 (9.4) | 3 (9.4) |
| Atrial fibrillation/flutter | 2 (6.3) grades 2 and 3 | 1 (3.1) |
| Hypertension | 2 (6.3) | 1 (3.1) |
| Second primary malignancies | 6 (18.8) | 1 (3.1) |
| Skin cancers | 5 (15.6) | 1 (3.1) |
| Infections | 22 (68.8) | 6 (18.8) |
| Opportunistic infections | 3 (9.4) | 2 (6.3) |
| Tumor lysis syndrome | 2 (6.3) | 2 (6.3) |
| Anemia | 4 (12.5) | 4 (12.5) |
| Neutropenia† | 4 (12.5) | 3 (9.4) |
| Thrombocytopenia‡ | 4 (12.5) | 2 (6.3) |
| AE* . | Any-grade AEs . | Grade ≥ 3 AEs . |
|---|---|---|
| Patients with 1 AE | 31 (96.9) | 19 (59.5) |
| Diarrhea | 14 (43.8) | 1 (3.1) |
| Contusion | 12 (37.5) | 0 |
| Constipation | 10 (31.3) | 0 |
| Upper respiratory tract infections | 10 (31.3) | 0 |
| Fatigue | 8 (25.0) | 1 (3.1) |
| Dyspnea | 8 (25.0) | 0 |
| Peripheral edema | 7 (21.9) | 2 (6.3) |
| Back pain | 7 (21.9) | 1 (3.1) |
| Rash | 7 (21.9) | 0 |
| Arthralgia | 6 (18.8) | 0 |
| Cough | 6 (18.8) | 0 |
| Muscle spasms | 5 (15.6) | 0 |
| Pruritis | 5 (15.6) | 0 |
| Localized infection | 5 (15.6) | 0 |
| Urinary tract infection | 5 (15.6) | 0 |
| Pneumonia | 4 (12.5) | 3 (9.4) |
| Myalgia | 3 (9.4) | 3 (9.4) |
| AEs of interest | ||
| Bleeding | 18 (56.3) | 3 (9.4) |
| Major hemorrhage* | 3 (9.4) | 3 (9.4) |
| Atrial fibrillation/flutter | 2 (6.3) grades 2 and 3 | 1 (3.1) |
| Hypertension | 2 (6.3) | 1 (3.1) |
| Second primary malignancies | 6 (18.8) | 1 (3.1) |
| Skin cancers | 5 (15.6) | 1 (3.1) |
| Infections | 22 (68.8) | 6 (18.8) |
| Opportunistic infections | 3 (9.4) | 2 (6.3) |
| Tumor lysis syndrome | 2 (6.3) | 2 (6.3) |
| Anemia | 4 (12.5) | 4 (12.5) |
| Neutropenia† | 4 (12.5) | 3 (9.4) |
| Thrombocytopenia‡ | 4 (12.5) | 2 (6.3) |
All data are n (%).
Defined as any serious or grade ≥3 bleed at any site or central nervous system bleed of any grade.
Includes the MedDRA preferred terms neutropenia, neutrophil count decreased, and febrile neutropenia.
Includes the MedDRA preferred terms of thrombocytopenia and platelet count decreased.