Table 3.
All Grade Adverse Events Regardless of Attribution at Baseline and Post-Baseline (CTCAE version 5.0)
| Baseline Grade | Post-Baseline Grade | |||||||
|---|---|---|---|---|---|---|---|---|
| 1 (n) | 2 (n) | 1 (n) | 2 (n) | 3 (n) | 4 (n) | 5 (n) | ||
| Category | 1 | . | . | . | . | . | . | |
| Ear and labyrinth disorders | Tinnitus | |||||||
| Gastrointestinal disorders | Nausea | 3 | . | 1 | . | . | . | . |
| General disorders and administration site conditions | Death NOS | . | . | . | . | . | . | 7 |
| Disease progression | . | . | . | . | . | . | 1 | |
| Fatigue | 8 | 3 | 2 | . | . | . | . | |
| Gait disturbance | 1 | . | . | . | . | . | . | |
| General disorders and administration site conditions— Other, specify | 1 | 1 | . | . | . | . | . | |
| Infections and infestations | Infections and infestations—Other, specify | . | . | . | 1 | . | . | . |
| Metabolism and nutrition disorders | Anorexia | 2 | . | . | . | . | . | . |
| Musculoskeletal and connective tissue disorders | Arthralgia | 1 | . | . | . | . | . | . |
| Back pain | 2 | . | . | . | . | . | . | |
| Generalized muscle weakness | . | 2 | . | 1 | . | . | . | |
| Muscle weakness lower limb | . | . | 1 | . | . | . | . | |
| Muscle weakness upper limb | 1 | . | . | . | . | . | . | |
| Nervous system disorders | Ataxia | 1 | . | 1 | . | . | . | . |
| Cognitive disturbance | 1 | . | . | . | . | . | . | |
| Concentration impairment | 1 | . | . | . | . | . | . | |
| Dysarthria | 1 | 2 | . | . | . | . | . | |
| Dysphasia | 1 | . | . | . | . | . | . | |
| Edema cerebral | . | 2 | 1 | . | . | 1 | . | |
| Headache | 7 | . | . | . | 1 | . | . | |
| Hydrocephalus | . | . | . | . | . | 1 | . | |
| Memory impairment | 1 | . | . | . | . | . | . | |
| Muscle weakness right-sided | . | 2 | . | . | . | . | . | |
| Seizure | 6 | 3 | . | . | . | 1 | . | |
| Psychiatric disorders | Anxiety | 1 | . | . | . | . | . | . |
| Confusion | 1 | . | . | . | . | . | . | |
| Depression | 1 | . | . | . | . | . | . | |
| Maximum grade of any toxicity | 8 | 6 | 2 | 1 | 0 | 0 | 8 |