Patient disposition and study treatment exposure
| . | Group 1: ibrutinib → ofatumumab (N = 27) . | Group 2: ibrutinib/ofatumumab (N = 20) . | Group 3: ofatumumab → ibrutinib (N = 24) . |
|---|---|---|---|
| Received study treatment, n (%) | 27 (100) | 20 (100) | 24 (100) |
| Enrolled into extension study, n (%)* | 19 (70) | 16 (80) | 19 (79)* |
| Discontinued treatment, n (%) | |||
| Adverse event | 2 (7) | 3 (15) | 2 (8) |
| Progressive disease | 4 (15) | 0 (0) | 5 (21) |
| Underwent stem cell transplant | 1 (4) | 1 (5) | 0 (0) |
| Noncompliance with study drug | 1 (4) | 0 (0) | 0 (0) |
| Median duration of treatment with ibrutinib (range), months | 15.8 (4.5-19.5) | 11.3 (0.4-14.9) | 9.2 (0.7-11.6) |
| Median duration of treatment with ofatumumab (range), months | 5.6 (1.4-9.6) | 5.6 (0-7.4) | 5.6 (0-8.8) |
| Median number of infusions with ofatumumab (range) | 12 (7-12) | 10.5 (1-12) | 12 (1-12) |
| . | Group 1: ibrutinib → ofatumumab (N = 27) . | Group 2: ibrutinib/ofatumumab (N = 20) . | Group 3: ofatumumab → ibrutinib (N = 24) . |
|---|---|---|---|
| Received study treatment, n (%) | 27 (100) | 20 (100) | 24 (100) |
| Enrolled into extension study, n (%)* | 19 (70) | 16 (80) | 19 (79)* |
| Discontinued treatment, n (%) | |||
| Adverse event | 2 (7) | 3 (15) | 2 (8) |
| Progressive disease | 4 (15) | 0 (0) | 5 (21) |
| Underwent stem cell transplant | 1 (4) | 1 (5) | 0 (0) |
| Noncompliance with study drug | 1 (4) | 0 (0) | 0 (0) |
| Median duration of treatment with ibrutinib (range), months | 15.8 (4.5-19.5) | 11.3 (0.4-14.9) | 9.2 (0.7-11.6) |
| Median duration of treatment with ofatumumab (range), months | 5.6 (1.4-9.6) | 5.6 (0-7.4) | 5.6 (0-8.8) |
| Median number of infusions with ofatumumab (range) | 12 (7-12) | 10.5 (1-12) | 12 (1-12) |
Includes 2 patients in group 3 who discontinued ofatumumab during the ofatumumab lead-in period due to disease progression, then started on ibrutinib monotherapy, and later enrolled into the extension study.