Table 3.
Summary of toxicities
| Toxicity category | Number of patients | Total (%)† | |
|---|---|---|---|
| Grade <3* | Grade ≥3* | ||
| Allergy/immunology | 1 | 0 | 1 (0.8) |
| Auditory/ear | 1 | 0 | 1 (0.8) |
| Blood/bone marrow | 16 | 75 | 91 (71.7) |
| Cardiac arrhythmia | 3 | 2 | 5 (3.9) |
| Cardiac general | 12 | 4 | 16 (12.6) |
| Coagulation | 2 | 2 | 4 (3.1) |
| Constitutional symptoms | 63 | 36 | 99 (80.0) |
| Death | 0 | 1 | 1 (0.8) |
| Dermatology/skin | 12 | 2 | 14 (11.0) |
| Gastrointestinal | 80 | 24 | 104 (81.9) |
| Haemorrhage/bleeding | 17 | 8 | 25 (19.7) |
| Infection | 8 | 12 | 20 (15.7) |
| Lymphatic | 6 | 0 | 6 (4.7) |
| Metabolic/laboratory | 48 | 9 | 57 (44.9) |
| Musculoskeletal/soft tissue | 8 | 3 | 11 (8.7) |
| Neurology | 56 | 20 | 76 (59.8) |
| Ocular/visual | 6 | 0 | 6 (4.7) |
| Pain | 28 | 9 | 37 (29.1) |
| Pulmonary | 1 | 0 | 1 (0.8) |
| Pulmonary/upper respiratory | 25 | 3 | 28 (22.0) |
| Renal/genitourinary | 8 | 1 | 9 (7.1) |
| Sexual/reproductive function | 1 | 0 | 1 (0.8) |
| Vascular | 1 | 0 | 1 (0.8) |
*
Defined by National Cancer Institute Common Terminology Criteria for Adverse Events grade.
†
Percentage was calculated using total number of patients with toxicities determined to be attributable to the study drug, which is 127.
For each patient, the toxicities with highest grade are summarized in this table.