Table II.
Summary of adverse events.
Adverse event (AE) | Arm A: rituximab (n = 40) | Arm B: rituximab + ABT-263 (n = 38) | Arm C: rituximab + ABT-263 to PD (n = 40) |
---|---|---|---|
Any SAEs, n (%) | 5 (13) | 5 (13) | 4 (10) |
Any AEs, n (%) | 33 (87) | 37 (97) | 40 (100) |
AEs grade ≥ 3 occurring in > 5% of patients, n (%) | |||
Neutropenia | 3 (8) | 11 (29) | 18 (45) |
Thrombocytopenia | 0 (0) | 7 (18) | 13 (33) |
Anemia/worsening of anemia | 2 (5) | 2 (5) | 1 (3) |
Leukopenia | 1 (3) | 2 (5) | 1 (3) |
Liver enzyme increase | 0 (0) | 3 (8) | 10 (25) |
Hyperbilirubinemia | 0 (0) | 2 (5) | 1 (3) |
Diarrhea | 0 (0) | 2 (5) | 1 (3) |
GI and abdominal pain | 0 (0) | 0 (0) | 2 (5) |
Chills | 0 (0) | 2 (5) | 1 (3) |
Asthenia | 0 (0) | 2 (5) | 0 (0) |
Respiratory tract infection | 3 (8) | 1 (3) | 1 (3) |
Procedural complications (infusion-related reactions) | 0 (0) | 3 (8) | 2 (5) |
Vascular hypertensive disorders (hypertension) | 0 (0) | 2 (5) | 1 (3) |
SAE, serious adverse event; GI, gastrointestinal; PD, progressive disease.