Table 1.
Patient disposition and treatment exposure during study treatment
| 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 |
a
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.
b
Planned duration of treatment with ofatumumab was up to 24 weeks.