Table 1.
Parameter, n (%) | Ibrutinib (n = 195) | Ofatumumab (n = 196) |
---|---|---|
Duration of treatment, months, median (range) | 41.0 (0.2‐71.1) | 5.3 (0.0‐9.0) |
Disposition of study treatment | ||
Did not receive study drug | 0 | 5 (2.6) |
Completed treatment (ofatumumab arm only) | N/A | 120 (61.2) |
Discontinued | 195 (100.0) | 71 (36.2) |
Progressive disease | 72 (36.9) | 36 (18.4) |
Study terminated by sponsor | 43 (22.1) | 0 |
Adverse event | 32 (16.4) | 7 (3.6) |
Patient withdrawal | 15 (7.7) | 6 (3.1) |
Deatha | 13 (6.7) | 9 (4.6) |
Investigator decision | 20 (10.3) | 13 (6.6) |
Duration of treatment, years (randomized therapy)b | ||
˃0 to 1 | 36 (18.5) | 191 (97.4) |
>1 to 2 | 25 (12.8) | 0 |
>2 to 3 | 31 (15.9) | 0 |
>3 to 4 | 24 (12.3) | 0 |
>4 to 5 | 22 (11.3) | 0 |
>5 to 6 | 57 (29.2) | 0 |
These cases of death included the following: ibrutinib arm, pneumonia (n = 3), sepsis (n = 2), unknown cause (sudden death, n = 2), neutropenic sepsis, terminal bowel cancer, lung infection, cardiac arrest, subdural hematoma, and burns and ensuing complications in one patient each; ofatumumab arm, pneumonia (n = 2), upper respiratory tract infection, squamous cell carcinoma of the neck, influenza A, aggressive squamous cell carcinoma of the scalp, nocardiosis, fever of unknown origin, and bacteremia in one patient each.
Planned duration of treatment with ofatumumab was up to 24 weeks.