Table 4.
Related Adverse Events With Ofatumumab Therapy
| Adverse Events* | FA-ref (n = 59) |
BF-ref (n = 79) |
||||||
|---|---|---|---|---|---|---|---|---|
| All Grades |
Grade 3 or 4 |
All Grades |
Grade 3 or 4 |
|||||
| No. of Patients | % | No. of Patients | % | No. of Patients | % | No. of Patients | % | |
| Infection | 12 | 20 | 7 | 12 | 17 | 22 | 6 | 8 |
| Neutropenia | 11 | 19 | 8 | 14 | 6 | 8 | 5 | 6 |
| Fatigue | 3 | 5 | 0 | 0 | 7 | 9 | 0 | 0 |
| Cough | 5 | 8 | 0 | 0 | 4 | 5 | 0 | 0 |
| Anemia | 2 | 3 | 0 | 0 | 7 | 9 | 4 | 5 |
| Diarrhea | 5 | 8 | 0 | 0 | 3 | 4 | 0 | 0 |
| Dyspnea | 5 | 8 | 1 | 2 | 3 | 4 | 0 | 0 |
| Nausea | 3 | 5 | 0 | 0 | 5 | 6 | 0 | 0 |
| Rash | 5 | 8 | 0 | 0 | 2 | 3 | 0 | 0 |
| Fever | 5 | 8 | 1 | 2 | 1 | 1 | 0 | 0 |
Abbreviations: FA-ref, fludarabine and alemtuzumab refractory; BF-ref, bulky fludarabine refractory.
*
Adverse events judged by investigators to be related to ofatumumab among the most common adverse events that occurred in ≥ 10% of patients from the first infusion of ofatumumab to within 30 days of the last infusion.