Table 2.
Adverse Events.*
| Adverse Event | Grade 1–2 | Grade 3–4 | Total† |
|---|---|---|---|
| number of patients (percent) | |||
| Diarrhea | 40 (47) | 2 (2) | 42 (49) |
|
| |||
| Upper respiratory tract infection | 28 (33) | 0 | 28 (33) |
|
| |||
| Fatigue | 24 (28) | 3 (4) | 27 (32) |
|
| |||
| Cough | 26 (31) | 0 | 26 (31) |
|
| |||
| Arthralgia | 23 (27) | 0 | 23 (27) |
|
| |||
| Rash | 23 (27) | 0 | 23 (27) |
|
| |||
| Pyrexia | 19 (22) | 4 (5) | 23 (27) |
|
| |||
| Edema, peripheral | 18 (21) | 0 | 18 (21) |
|
| |||
| Muscle spasms | 16 (19) | 1 (1) | 17 (20) |
|
| |||
| Constipation | 14 (16) | 1 (1) | 15 (18) |
|
| |||
| Dizziness | 14 (16) | 1 (1) | 15 (18) |
|
| |||
| Headache | 14 (16) | 1 (1) | 15 (18) |
|
| |||
| Hypertension | 11 (13) | 4 (5) | 15 (18) |
|
| |||
| Nausea | 14 (16) | 1 (1) | 15 (18) |
|
| |||
| Sinusitis | 11 (13) | 4 (5) | 15 (18) |
|
| |||
| Contusion | 14 (16) | 0 | 14 (16) |
|
| |||
| Vomiting | 13 (15) | 1 (1) | 14 (16) |
|
| |||
| Neutropenia‡ | 0 | 13 (15) | 13 (15) |
|
| |||
| Oropharyngeal pain | 13 (15) | 0 | 13 (15) |
*
Listed are adverse events that were reported in 13 or more of the 85 patients (≥15%), regardless of the cause.
†
Seven grade 5 adverse events were reported: pneumonia, influenza-like pneumonia, cryptococcal pneumonia, chronic lymphocytic leukemia, Richter's syndrome, sarcoma, and the systemic inflammatory response syndrome. (The event terms are those deemed most appropriate by the investigator.)
‡
Neutropenia did not lead to treatment discontinuation and was managed with the administration of growth factors in 5 of 13 patients.