Baseline demographics and pretreatment characteristics
| . | Ofatumumab 500 mg (n = 30) . | Ofatumumab 1000 mg (n = 86) . | Total (N = 116) . |
|---|---|---|---|
| Median age, y (range) | 59.5 (39-78) | 61.5 (37-82) | 61.0 (37-82) |
| Median prior regimens, n (range) | 4.0 (1-15) | 3.5 (1-12) | 4.0 (1-15) |
| Median time from diagnosis, y (range) | 5.0 (0.6-16.7) | 4.1 (0.5-16.4) | 4.3 (0.5-16.7) |
| Ann Arbor stage III/IV at screening, n (%) | 27 (90) | 73 (85) | 100 (86) |
| Qualifying rituximab-refractory regimen, n (%) | |||
| Monotherapy | 6 (20) | 21 (24) | 27 (23) |
| Maintenance | 11 (37) | 34 (40) | 45 (39) |
| Chemotherapy combination | 13 (43) | 31 (36) | 44 (38) |
| Refractory to any prior chemotherapy, n (%) | 20 (67) | 55 (64) | 75 (65) |
| Prior chemotherapy, n (%) | 30 (100) | 81 (94) | 111 (96) |
| FLIPI score at screening, n (%) | 7 (23) | ||
| Low risk (0-1) | 10 (33) | 19 (22) | 26 (22) |
| Intermediate risk (2) | 12 (40) | 22 (26) | 32 (28) |
| High risk (3-5) | 43 (50) | 55 (47) | |
| ECOG performance status, n (%)* | |||
| 0 | 14 (47) | 57 (66) | 71 (61) |
| 1-2 | 15 (50) | 29 (34) | 44 (38) |
| . | Ofatumumab 500 mg (n = 30) . | Ofatumumab 1000 mg (n = 86) . | Total (N = 116) . |
|---|---|---|---|
| Median age, y (range) | 59.5 (39-78) | 61.5 (37-82) | 61.0 (37-82) |
| Median prior regimens, n (range) | 4.0 (1-15) | 3.5 (1-12) | 4.0 (1-15) |
| Median time from diagnosis, y (range) | 5.0 (0.6-16.7) | 4.1 (0.5-16.4) | 4.3 (0.5-16.7) |
| Ann Arbor stage III/IV at screening, n (%) | 27 (90) | 73 (85) | 100 (86) |
| Qualifying rituximab-refractory regimen, n (%) | |||
| Monotherapy | 6 (20) | 21 (24) | 27 (23) |
| Maintenance | 11 (37) | 34 (40) | 45 (39) |
| Chemotherapy combination | 13 (43) | 31 (36) | 44 (38) |
| Refractory to any prior chemotherapy, n (%) | 20 (67) | 55 (64) | 75 (65) |
| Prior chemotherapy, n (%) | 30 (100) | 81 (94) | 111 (96) |
| FLIPI score at screening, n (%) | 7 (23) | ||
| Low risk (0-1) | 10 (33) | 19 (22) | 26 (22) |
| Intermediate risk (2) | 12 (40) | 22 (26) | 32 (28) |
| High risk (3-5) | 43 (50) | 55 (47) | |
| ECOG performance status, n (%)* | |||
| 0 | 14 (47) | 57 (66) | 71 (61) |
| 1-2 | 15 (50) | 29 (34) | 44 (38) |
One patient in the ofatumumab 500-mg group had an Eastern Cooperative Oncology Group (ECOG) performance status of 3 and did not meet the inclusion criteria.