Table 1.
Demographic and baseline clinical characteristics (safety analysis set)a
| Safety analysis set (N = 248) | |
|---|---|
| Age, years, median (range) | 74.0 (26.0–91.0) |
| Age category, n (%) | |
| < 70 years | 76 (30.6) |
| ≥ 70 years | 172 (69.4) |
| Sex, male, n (%) | 193 (77.8) |
| Indication for ibrutinib, n (%) | |
| Refractory MCL | 73 (29.4) |
| Relapsed MCL | 175 (70.6) |
| t(11;14) translocation, n (%) | |
| Yes | 117 (47.2) |
| No | 29 (11.7) |
| Unknownb | 102 (41.1) |
| Expression of cyclin D1, n (%) | |
| Yes | 185 (74.6) |
| No | 10 (4.0) |
| Unknownb | 53 (21.4) |
| Ann Arbor stage, n (%) | |
| I | 11 (4.4) |
| II | 24 (9.7) |
| III | 34 (13.7) |
| IV | 173 (69.8) |
| Unknown | 6 (2.4) |
| ECOG PS, n (%) | |
| 0 | 85 (34.3) |
| 1–2 | 141 (56.9) |
| 3–4 | 20 (8.1) |
| Unknown | 2 (0.8) |
| Number of prior therapies, median (range) | 3.0 (1.0–12.0) |
| Number of prior therapies, n (%) | |
| 1 | 43 (17.3) |
| 2 | 51 (20.6) |
| 3 | 56 (22.6) |
| ≥ 4 | 98 (39.5) |
| Bulky disease (≥ 10 cm), n (%) | |
| Yes | 31 (12.5) |
| No | 216 (87.1) |
| Unknown | 1 (0.4) |
| Time from diagnosis, years, median (range) | 3.7 (0.1–25.3) |
ECOG PS Eastern Cooperative Oncology Group Performance Status, MCL mantle cell lymphoma, n number of patients
aBaseline was the time point at which treatment with ibrutinib was initiated
bIncludes patients who were tested but for whom there were no test results, and patients who were not tested