Table 2.
Any-grade treatment-emergent AEs in ≥20% of patients, grade ≥3 treatment-emergent AEs in >5% of patients (in either subgroup), and all AEs of special interest
| Any-grade TEAE in ≥ 20%, n (%) | MZL | FL |
|---|---|---|
| Patients with ≥1 AE | 20 (100) | 32 (97) |
| Diarrhea | 7 (35) | 4 (12.1) |
| Contusion | 7 (35) | 8 (24.2) |
| Rash | 7 (35) | 3 (9.1) |
| Upper respiratory tract infection | 6 (30) | 9 (27.3) |
| Neutropenia | 6 (30) | 6 (18.2) |
| Pyrexia | 5 (25) | 4 (12.1) |
| Nasopharyngitis | 5 (25) | 0 |
| Sinusitis | 4 (20) | 1 (3) |
| Nausea | 4 (20) | 8 (24.2) |
| Fatigue | 4 (20) | 7 (21.2) |
| Musculoskeletal pain | 4 (20) | 0 |
| Cough | 3 (15) | 8 (24.2) |
| Urinary tract infection | 2 (10) | 8 (24.2) |
| Grade ≥ 3 TEAE in > 5% | ||
| Patients with ≥ 1 Grade ≥ 3 AE | 11 (55) | 22 (66.7) |
| Neutropenia | 4 (20) | 6 (18.2) |
| Thrombocytopenia | 2 (10) | 1 (3) |
| Pneumonia | 1 (5) | 3 (9.1) |
| Pyrexia | 2 (10.0) | 0 |
| Hypertension | 1 (5) | 2 (6.1) |
| Anemia | 3 (15) | 5 (15.2) |
| Urinary tract infection | 0 | 6 (18.2) |
| Sepsis | 0 | 2 (6.1) |
| Abdominal pain | 0 | 2 (6.1) |
| Any grade/Grade ≥ 3 AESI, n (%) | ||
| Patients with ≥ 1 AESI | 19 (95)/10 (50) | 28 (84.8)/17 (51.5) |
| Bleeding | 12 (60)/1 (5) | 18 (54.5)/1 (3) |
| Major hemorrhage* | 2 (10)/1 (5) | 1 (3)/1 (3) |
| Atrial fibrillation/flutter | 0/0 | 0/0 |
| Hypertension | 1 (5)/1 (5) | 2 (6.1)/2 (6.1) |
| Second primary malignancies | 3 (15)†/2 (10) | 3 (9.1)/1 (3) |
| Skin cancers | 1 (5)/0 | 1 (3)/0 |
| Infections | 15 (75)/4 (20)‡ | 21 (63.6)/10 (30.3) |
| Opportunistic infections | 1 (5)/0 | 1 (3)/0 |
| Tumor lysis syndrome | 0/0 | 0/0 |
| Anemia§ | 3 (15)/3 (15) | 5 (15.2)/5 (15.2) |
| Neutropeniaǁ | 6 (30)/4 (20) | 6 (18.2)/6 (18.2) |
| Thrombocytopenia | 3 (15)/2 (10) | 3 (9.1)/1 (3) |
AE indicates adverse event (preferred term); AESI, AE of special interest; FL, follicular lymphoma; MedDRA, Medical Dictionary for Regulatory Activities; MZL, marginal zone lymphoma.
Defined as any serious or grade ≥3 bleed at any site, or central nervous system bleed of any grade.
Includes invasive ductal breast carcinoma, lentigo maligna, prostate cancer.
Includes Escherichia urinary tract infection/Escherichia sepsis, influenza/pneumonia, pyelonephritis, skin infection, carbuncle, Clostridium difficile colitis, gastroenteritis.
Includes the MEDRA preferred terms “anaemia” and “haemoglobin decreased”.
Includes the MedDRA preferred terms “neutropenia,” “neutrophil count decreased,” and “febrile neutropenia”.
Includes the MedDRA preferred terms “thrombocytopenia” and “platelet count decreased.”