Selected baseline characteristics of the patients (treatment cohort)*
| Characteristics . | Ibrutinib group (n = 182) . | Placebo group (n = 181) . | Total (n = 363) . |
|---|---|---|---|
| Age, y | |||
| Median | 64 | 64 | 64 |
| Range | 38-85 | 36-80 | 36-85 |
| >60, n (%) | 114 (62.6) | 115 (63.5) | 229 (63.1) |
| >70, n (%) | 40 (22.0) | 41 (22.7) | 81 (22.3) |
| Male sex, n (%) | 137 (75.3) | 127 (70.2) | 264 (72.7) |
| Time between first diagnosis and randomization, mo | 182 | 179 | 361 |
| Median | 7.9 | 11.5 | 9.3 |
| Mean | 25.1 | 27.1 | 26.1 |
| Standard deviation | 33.9 | 39.2 | 36.6 |
| Interquartile range | 3.4-35.7 | 2.8-35.7 | 3.1-35.7 |
| Range | 0.7-222.4 | 0.7-285.3 | 0.7-285.3 |
| ECOG performance status, n (%)† | |||
| 0 | 163 (89.6) | 160 (88.4) | 323 (89.0) |
| 1 | 19 (10.4) | 21 (11.6) | 40 (11.0) |
| β2 microglobulin (mg/L) | |||
| ≤1.7 | 10 (5.5) | 16 (8.8) | 26 (7.2) |
| >1.7 ≤ 3.5 | 158 (86.8) | 151 (83.4) | 309 (85.1) |
| >3.5 | 14 (7.7) | 14 (7.7) | 28 (7.7) |
| Thymidine kinase (U/L) | |||
| >10 | 138 (75.8) | 150 (82.9) | 288 (79.3) |
| Cytogenetic subgroup according to hierarchical Döhner classification, n (%)‡ | |||
| Deletion in 17p | 6 (3.3) | 7 (3.9) | 13 (3.6) |
| Deletion in 11q | 21 (11.5) | 19 (10.5) | 40 (11.0) |
| Trisomy in 12 | 24 (13.2) | 28 (15.5) | 52 (14.3) |
| No abnormalities | 36 (19.8) | 30 (16.6) | 66 (18.2) |
| Deletion in 13q alone | 95 (52.2) | 97 (53.6) | 192 (52.9) |
| Mutated TP53, n (%) | 14 (7.7) | 13 (7.2) | 27 (7.4) |
| IGHV mutation status, n (%)§ | 181 | 181 | 362 |
| Mutated | 111 (61.3) | 109 (60.2) | 220 (60.8) |
| Unmutated | 70 (38.7) | 70 (38.7) | 140 (38.7) |
| Not evaluable | 0 (0.0) | 2 (1.1) | 2 (0.6) |
| GCLLSG risk group, n (%) | |||
| Intermediate | 137 (75.3) | 136 (75.1) | 273 (75.2) |
| High | 40 (22.0) | 42 (23.2) | 82 (22.6) |
| Very high | 5 (2.7) | 3 (1.7) | 8 (2.2) |
| CLL-IPI risk group, n (%) | 181 | 181 | 362 |
| Low | 98 (54.1) | 98 (54.1) | 196 (54.1) |
| Intermediate | 59 (32.6) | 58 (32.0) | 117 (32.3) |
| High | 22 (12.2) | 23 (12.7) | 45 (12.4) |
| Very high | 2 (1.1) | 2 (1.1) | 4 (1.1) |
| Characteristics . | Ibrutinib group (n = 182) . | Placebo group (n = 181) . | Total (n = 363) . |
|---|---|---|---|
| Age, y | |||
| Median | 64 | 64 | 64 |
| Range | 38-85 | 36-80 | 36-85 |
| >60, n (%) | 114 (62.6) | 115 (63.5) | 229 (63.1) |
| >70, n (%) | 40 (22.0) | 41 (22.7) | 81 (22.3) |
| Male sex, n (%) | 137 (75.3) | 127 (70.2) | 264 (72.7) |
| Time between first diagnosis and randomization, mo | 182 | 179 | 361 |
| Median | 7.9 | 11.5 | 9.3 |
| Mean | 25.1 | 27.1 | 26.1 |
| Standard deviation | 33.9 | 39.2 | 36.6 |
| Interquartile range | 3.4-35.7 | 2.8-35.7 | 3.1-35.7 |
| Range | 0.7-222.4 | 0.7-285.3 | 0.7-285.3 |
| ECOG performance status, n (%)† | |||
| 0 | 163 (89.6) | 160 (88.4) | 323 (89.0) |
| 1 | 19 (10.4) | 21 (11.6) | 40 (11.0) |
| β2 microglobulin (mg/L) | |||
| ≤1.7 | 10 (5.5) | 16 (8.8) | 26 (7.2) |
| >1.7 ≤ 3.5 | 158 (86.8) | 151 (83.4) | 309 (85.1) |
| >3.5 | 14 (7.7) | 14 (7.7) | 28 (7.7) |
| Thymidine kinase (U/L) | |||
| >10 | 138 (75.8) | 150 (82.9) | 288 (79.3) |
| Cytogenetic subgroup according to hierarchical Döhner classification, n (%)‡ | |||
| Deletion in 17p | 6 (3.3) | 7 (3.9) | 13 (3.6) |
| Deletion in 11q | 21 (11.5) | 19 (10.5) | 40 (11.0) |
| Trisomy in 12 | 24 (13.2) | 28 (15.5) | 52 (14.3) |
| No abnormalities | 36 (19.8) | 30 (16.6) | 66 (18.2) |
| Deletion in 13q alone | 95 (52.2) | 97 (53.6) | 192 (52.9) |
| Mutated TP53, n (%) | 14 (7.7) | 13 (7.2) | 27 (7.4) |
| IGHV mutation status, n (%)§ | 181 | 181 | 362 |
| Mutated | 111 (61.3) | 109 (60.2) | 220 (60.8) |
| Unmutated | 70 (38.7) | 70 (38.7) | 140 (38.7) |
| Not evaluable | 0 (0.0) | 2 (1.1) | 2 (0.6) |
| GCLLSG risk group, n (%) | |||
| Intermediate | 137 (75.3) | 136 (75.1) | 273 (75.2) |
| High | 40 (22.0) | 42 (23.2) | 82 (22.6) |
| Very high | 5 (2.7) | 3 (1.7) | 8 (2.2) |
| CLL-IPI risk group, n (%) | 181 | 181 | 362 |
| Low | 98 (54.1) | 98 (54.1) | 196 (54.1) |
| Intermediate | 59 (32.6) | 58 (32.0) | 117 (32.3) |
| High | 22 (12.2) | 23 (12.7) | 45 (12.4) |
| Very high | 2 (1.1) | 2 (1.1) | 4 (1.1) |
Percentages may not total 100 because of rounding. All but 1 patient of each group had Binet stage A at baseline.
ECOG performance-status scores are assessed on a 5-point scale, with higher scores indicating greater disability.
Cytogenetic subgroups were determined according to the hierarchical model of Döhner et al.31
IGHV mutation status was tested in 362 patients and could be determined in 360 patients.