Table 2.
Adverse Events. *
| Adverse Event | Ibrutinib (N = 195) | Ofatumumab (N = 191) | ||
|---|---|---|---|---|
| Any Grade | Grade 3 or 4 | Any Grade | Grade 3 or 4 | |
| number of patients (percent) | ||||
| Any adverse event occurring during treatment | 194 (99) | 99 (51) | 187 (98) | 74 (39) |
|
| ||||
| Diarrhea | 93 (48) | 8 (4) | 34 (18) | 3 (2) |
|
| ||||
| Fatigue | 54 (28) | 4 (2) | 57 (30) | 3 (2) |
|
| ||||
| Nausea | 51 (26) | 3 (2) | 35 (18) | 0 |
|
| ||||
| Pyrexia | 46 (24) | 3 (2) | 28 (15) | 2 (1) |
|
| ||||
| Anemia | 44 (23) | 9 (5) | 33 (17) | 15 (8) |
|
| ||||
| Neutropenia | 42 (22) | 32 (16) | 28 (15) | 26 (14) |
|
| ||||
| Cough | 38 (19) | 0 | 44 (23) | 2 (1) |
|
| ||||
| Thrombocytopenia | 33 (17) | 11 (6) | 22 (12) | 8 (4) |
|
| ||||
| Arthralgia | 34 (17) | 2 (1) | 13 (7) | 0 |
|
| ||||
| Upper respiratory tract infection | 31 (16) | 1 (1) | 20 (10) | 3 (2) |
|
| ||||
| Constipation | 30 (15) | 0 | 18 (9) | 0 |
|
| ||||
| Vomiting | 28 (14) | 0 | 12 (6) | 1 (1) |
|
| ||||
| Headache | 27 (14) | 2 (1) | 11 (6) | 0 |
|
| ||||
| Petechiae | 27 (14) | 0 | 2 (1) | 0 |
|
| ||||
| Muscle spasm | 25 (13) | 0 | 16 (8) | 0 |
|
| ||||
| Dyspnea | 23 (12) | 4 (2) | 20 (10) | 1 (1) |
|
| ||||
| Peripheral edema | 22 (11) | 0 | 15 (8) | 0 |
|
| ||||
| Back pain | 22 (11) | 2 (1) | 12 (6) | 1 (1) |
|
| ||||
| Sinusitis | 21 (11) | 1 (1) | 12 (6) | 0 |
|
| ||||
| Dizziness | 22 (11) | 0 | 10 (5) | 0 |
|
| ||||
| Contusion | 21 (11) | 0 | 6 (3) | 0 |
|
| ||||
| Stomatitis | 21 (11) | 1 (1) | 4 (2) | 1 (1) |
|
| ||||
| Pain in limb | 20 (10) | 1 (1) | 8 (4) | 0 |
|
| ||||
| Pneumonia | 19 (10) | 13 (7) | 13 (7) | 9 (5) |
|
| ||||
| Urinary tract infection | 19 (10) | 7 (4) | 10 (5) | 1 (1) |
|
| ||||
| Myalgia | 19 (10) | 1 (1) | 7 (4) | 0 |
|
| ||||
| Blurred vision | 19 (10) | 0 | 6 (3) | 0 |
|
| ||||
| Night sweats | 10 (5) | 1 (1) | 24 (13) | 0 |
|
| ||||
| Peripheral sensory neuropathy | 8 (4) | 0 | 24 (13) | 0 |
|
| ||||
| Infusion-related reaction | 0 | 0 | 53 (28) | 6 (3) |
*
Listed are all adverse events that occurred in at least 10% of the patients in either group. Five patients in the ofatumumab group did not receive a study drug. All serious adverse events are listed in Tables S3 and S4 in the Supplementary Appendix.