Table 2.
Patient Disposition and Treatment Exposure
| Parameter | Acalabrutinib (n = 155) | IdR (n = 119) | BR (n = 36) |
|---|---|---|---|
| Time on study, median (range), mo | 46.5 (0.53–54.2) | 45.7 (0.03–53.0) | 44.5 (0.53–52.6) |
| Patients who discontinued treatment, n (%) | 154 (100) | 118 (100) | 7 (20)a |
| Reasons for treatment discontinuation, n (%) | |||
| Planned study termination by sponsor | 74 (48) | 10 (8) | 0 |
| Adverse eventb | 35 (23) | 73 (62) | 6 (17) |
| Progressive disease | 34 (22) | 22 (19) | 1 (3) |
| Death | 6 (4) | 2 (2) | 0 |
| Investigator discretion | 1 (1) | 6 (5) | 0 |
| Withdrawal of consent | 1 (1) | 1 (1) | 0 |
| Lost to follow-up | 1 (1) | 0 | 0 |
| Other | 2 (1) | 4 (3) | 0 |
| Duration of treatment exposure, median (range),c mo | 44.2 (1.1–54.2) | 11.5 (0.1–52.3)d | 5.6 (1.0–7.1)e |
| Relative dose intensity, median (range),c % | 99.1 (48.3–100.0) | 88.4 (46.6–100.0)d | 96.4 (14.5–102.5)e |
| Received ≥6 IV treatment cycles,c n (%) | NA | 92 (78)f | 29 (83)e |
a80% of patients completed BR treatment.
bData for treatment discontinuations due to adverse events were captured from the treatment termination case report form.
cThree patients were randomized but not treated (acalabrutinib, n = 1; IdR, n = 1; BR, n = 1) and are not included in the treatment exposure calculations.
dIdelalisib only.
eBendamustine only.
fRituximab only.
BR = bendamustine plus rituximab; IdR = idelalisib plus rituximab; IV = intravenous; NA = not applicable.