Baseline demographics and disease characteristics of patients in the main study and substudy
| . | Main study (N = 389) . | Substudy (n = 34) . | ||
|---|---|---|---|---|
| VenR (n = 194) . | BR (n = 195) . | Retreatment with VenR (n = 25) . | Crossed over to VenR (n = 9) . | |
| Mean age (SD), y | 63.9 (10.5) | 64.4 (9.6) | 65.8 (8.3) | 62.3 (16.8) |
| Sex, n (%) | ||||
| Male | 136 (70.1) | 151 (77.4) | 19 (76.0) | 9 (100.0) |
| Female | 58 (29.9) | 44 (22.6) | 6 (24.0) | 0 |
| No. of prior cancer therapies, n (%) | ||||
| 1 | 111 (57.2) | 117 (60.0) | 20 (80.0) | 7 (77.8) |
| 2 | 58 (29.9) | 43 (22.1) | 4 (16.0) | 0 |
| ≥3 | 25 (12.9) | 35 (17.9) | 1 (4.0) | 2 (22.2) |
| del(17p) and/or TP53 mutation, n (%) | ||||
| Yes | 72 (37.1) | 75 (38.5) | 9 (36.0) | 0 |
| No | 106 (54.6) | 95 (48.7) | 12 (48.0) | 8 (88.9) |
| Unknown | 16 (8.2) | 25 (12.8) | 4 (16.0) | 1 (11.1) |
| del(17p), n (%) | ||||
| Yes | 46 (23.7) | 46 (23.6) | 4 (16.0) | 0 |
| No | 127 (65.5) | 123 (63.1) | 16 (64.0) | 8 (88.9) |
| Unknown | 21 (10.8) | 26 (13.3) | 5 (20.0) | 1 (11.1) |
| TP53 mutation, n (%) | ||||
| Yes | 48 (24.7) | 51 (26.2) | 7 (28.0) | 0 |
| No | 144 (74.2) | 132 (67.7) | 18 (72.0) | 8 (88.9) |
| Unknown | 2 (1.0) | 12 (6.2) | 0 | 1 (11.1) |
| IGHV, n (%) | ||||
| Mutated | 53 (29.4) | 51 (28.3) | 1 (4.0) | 3 (33.3) |
| Unmutated | 123 (68.3) | 123 (68.3) | 22 (88.0) | 5 (55.6) |
| Unknown | 4 (2.2) | 6 (3.3) | 2 (8.0) | 1 (11.1) |
| GC, n (%) | ||||
| 0-2 | 106 (54.4) | 114 (58.5) | 11 (44.0) | 7 (77.8) |
| 3-4 | 34 (17.4) | 29 (14.9) | 9 (36.0) | 1 (11.1) |
| ≥5 | 14 (7.2) | 17 (8.7) | 2 (8.0) | 0 |
| Unknown | 40 (20.5) | 35 (17.9) | 3 (12.0) | 1 (11.1) |
| . | Main study (N = 389) . | Substudy (n = 34) . | ||
|---|---|---|---|---|
| VenR (n = 194) . | BR (n = 195) . | Retreatment with VenR (n = 25) . | Crossed over to VenR (n = 9) . | |
| Mean age (SD), y | 63.9 (10.5) | 64.4 (9.6) | 65.8 (8.3) | 62.3 (16.8) |
| Sex, n (%) | ||||
| Male | 136 (70.1) | 151 (77.4) | 19 (76.0) | 9 (100.0) |
| Female | 58 (29.9) | 44 (22.6) | 6 (24.0) | 0 |
| No. of prior cancer therapies, n (%) | ||||
| 1 | 111 (57.2) | 117 (60.0) | 20 (80.0) | 7 (77.8) |
| 2 | 58 (29.9) | 43 (22.1) | 4 (16.0) | 0 |
| ≥3 | 25 (12.9) | 35 (17.9) | 1 (4.0) | 2 (22.2) |
| del(17p) and/or TP53 mutation, n (%) | ||||
| Yes | 72 (37.1) | 75 (38.5) | 9 (36.0) | 0 |
| No | 106 (54.6) | 95 (48.7) | 12 (48.0) | 8 (88.9) |
| Unknown | 16 (8.2) | 25 (12.8) | 4 (16.0) | 1 (11.1) |
| del(17p), n (%) | ||||
| Yes | 46 (23.7) | 46 (23.6) | 4 (16.0) | 0 |
| No | 127 (65.5) | 123 (63.1) | 16 (64.0) | 8 (88.9) |
| Unknown | 21 (10.8) | 26 (13.3) | 5 (20.0) | 1 (11.1) |
| TP53 mutation, n (%) | ||||
| Yes | 48 (24.7) | 51 (26.2) | 7 (28.0) | 0 |
| No | 144 (74.2) | 132 (67.7) | 18 (72.0) | 8 (88.9) |
| Unknown | 2 (1.0) | 12 (6.2) | 0 | 1 (11.1) |
| IGHV, n (%) | ||||
| Mutated | 53 (29.4) | 51 (28.3) | 1 (4.0) | 3 (33.3) |
| Unmutated | 123 (68.3) | 123 (68.3) | 22 (88.0) | 5 (55.6) |
| Unknown | 4 (2.2) | 6 (3.3) | 2 (8.0) | 1 (11.1) |
| GC, n (%) | ||||
| 0-2 | 106 (54.4) | 114 (58.5) | 11 (44.0) | 7 (77.8) |
| 3-4 | 34 (17.4) | 29 (14.9) | 9 (36.0) | 1 (11.1) |
| ≥5 | 14 (7.2) | 17 (8.7) | 2 (8.0) | 0 |
| Unknown | 40 (20.5) | 35 (17.9) | 3 (12.0) | 1 (11.1) |
SD, standard deviation.