Table 2.
Summary of prevalence of TEAEs over time (and overall) occurring in patients in the ibrutinib plus BR arm in the final analysis.
| Ibrutinib treatment duration | ||||||||
|---|---|---|---|---|---|---|---|---|
| n (%) | ≥0–0.5 year (n = 287) |
>0.5–1 year (n = 246) |
>1–2 years (n = 216) |
>2–3 years (n = 188) |
>3–4 years (n = 171) |
>4–5 years (n = 157) |
>5–6 years (n = 129) |
Overall (n = 287) |
| Patients with any grade TEAEs | 271 (94.4) | 216 (87.8) | 180 (83.3) | 141 (75.0) | 121 (70.8) | 114 (72.6) | 49 (38.0) | 282 (98.3) |
| Patients with TEAEs of grade ≥3 | 212 (73.9) | 111 (45.1) | 87 (40.3) | 62 (33.0) | 37 (21.6) | 35 (22.3) | 17 (13.2) | 259 (90.2) |
| Patients with any treatment-related TEAEa | 225 (78.4) | 145 (58.9) | 122 (56.5) | 76 (40.4) | 68 (39.8) | 50 (31.8) | 21 (16.3) | 249 (86.8) |
| Patients with any TESAE | 104 (36.2) | 47 (19.1) | 53 (24.5) | 40 (21.3) | 29 (17.0) | 29 (18.5) | 13 (10.1) | 198 (69.0) |
| Patients with any TEAE leading to ibrutinib discontinuationb | 22 (7.7) | 15 (6.1) | 8 (3.7) | 3 (1.6) | 3 (1.8) | 2 (1.3) | 5 (3.9) | 58 (20.2) |
| Patients with any TEAEs with a fatal outcomec | 10 (3.5) | 4 (1.6) | 11 (5.1) | 3 (1.6) | 1 (0.6) | 1 (0.6) | 3 (2.3) | 33 (11.5) |
BR: bendamustine and rituximab; n: number of patients; TEAEs: treatment-emergent adverse events; TESAE: treatment-emergent serious adverse event.
a
Judged by the investigator to be very likely, probably, possibly, or definitely related to the study drug.
b
Patients who had TEAEs leading to discontinuation of ibrutinib were counted only at the interval when they discontinued ibrutinib.
c
Patients who had TEAE leading to death were counted only at the interval when they died.