Table 3:
Select adverse events (AEs) on ibrutinib and comparison to published data
| All patients (N=391) |
RESONATE-2 published data (N=135) All grades AEs not reported if < 15% of patients (NR) |
|||
|---|---|---|---|---|
| Toxicity | All grades | Grade 3-4 | All grades | Grade 3-4 |
| Arthralgia | 21.2% | 1.5% | 16% | 1% |
| Fatigue | 18.7% | 1.8% | 30% | 1% |
| Rash | 17.9% | 1.8% | NR | 3% |
| Bruising | 17.9% | N/A | NR | NR |
| Diarrhea | 17.4% | .3% | 42% | 4% |
| Infection (all sources combined) | 14.8% | 3.8% | URI 17% | Pneumonia 4% Fever & Neutropenia 2% Cellulitis 2% URI 2% |
| Bleeding | 13.2% | 1.8% | NR | 4% |
| Cytopenias, combined | 10.9% | 2.5% | Neutropenia 16% Anemia 19% |
Neutropenia 10% Anemia 6% Thrombocytopenia 2% |
| Atrial fibrillation | 10.2% | 4.1% | 6% | 1.5% |
| Hypertension | 7.7% | 0.5% | 14% | 4% |
| Peripheral edema | 4.3% | 1% | 19% | 1% |
| Pneumonitis | 2.3% | 1% | NR | NR |
| Renal dysfunction | 1.8% | 1.3% | NR | NR |
| Peripheral neuropathy | 1.3% | 0.5% | NR | NR |
| Liver dysfunction | 1.3% | 0.3% | NR | NR |
| Congestive heart failure | 0.7% | 0.3% | NR | NR |