Table 3.
Highest-grade adverse event by specific event term definitely, probably, or possibly related to protocol therapy
| Group III (n = 53) |
|||||
|---|---|---|---|---|---|
| n and (%) of patients by grade | |||||
| Category and Term | 1 | 2 | 3 | 4 | 5 |
| Constitutional symptoms | 13 (21.7) | 10 (16.7) | 1 (1.7) | 0 (0.0) | 0 (0.0) |
| Fatigue | 13 (21.7) | 10 (16.7) | 1 (1.7) | 0 (0.0) | 0 (0.0) |
| Gastrointestinal | 9 (15.0) | 1 (1.7) | 1 (1.7) | 0 (0.0) | 0 (0.0) |
| Dysphagia | 0 (0.0) | 0 (0.0) | 1 (1.7) | 0 (0.0) | 0 (0.0) |
| Musculoskeletal, soft tissue | 0 (0.0) | 1 (1.7) | 2 (3.3) | 0 (0.0) | 0 (0.0) |
| Extraocular muscle paresis | 0 (0.0) | 0 (0.0) | 1 (1.7) | 0 (0.0) | 0 (0.0) |
| Gait abnormal | 0 (0.0) | 1 (1.7) | 1 (1.7) | 0 (0.0) | 0 (0.0) |
| Neurology | 8 (13.3) | 12 (20.0) | 4 (6.7) | 0 (0.0) | 1 (1.7) |
| Central nervous system necrosis | 0 (0.0) | 2 (3.3) | 0 (0.0) | 0 (0.0) | 1 (1.7) |
| Cognitive disturbance | 2 (3.3) | 2 (3.3) | 1 (1.7) | 0 (0.0) | 0 (0.0) |
| Confusion | 0 (0.0) | 0 (0.0) | 1 (1.7) | 0 (0.0) | 0 (0.0) |
| Memory impairment | 3 (5.0) | 5 (8.3) | 1 (1.7) | 0 (0.0) | 0 (0.0) |
| Mini mental status examination abnormal | 0 (0.0) | 0 (0.0) | 1 (1.7) | 0 (0.0) | 0 (0.0) |
| Peripheral sensory neuropathy | 2 (3.3) | 0 (0.0) | 1 (1.7) | 0 (0.0) | 0 (0.0) |
| Seizure | 0 (0.0) | 5 (8.3) | 1 (1.7) | 0 (0.0) | 0 (0.0) |
| Speech disorder | 0 (0.0) | 2 (3.3) | 2 (3.3) | 0 (0.0) | 0 (0.0) |
| Tremor | 0 (0.0) | 0 (0.0) | 1 (1.7) | 0 (0.0) | 0 (0.0) |
| Pain | 13 (21.7) | 6 (10.0) | 1 (1.7) | 0 (0.0) | 0 (0.0) |
| Headache | 9 (15.0) | 5 (8.3) | 1 (1.7) | 0 (0.0) | 0 (0.0) |
Adverse events were graded with Common Terminology Criteria for Adverse Events version 3.0. including only categories and terms with at least one grade 3, 4, or 5.