Table 3.
Number of patients (%) who attributable to BCNU implants according to Common Terminology Criteria for Adverse Events (CTC AE) grade
| System organ class/event name | Cases (%) (n = 24) | |
|---|---|---|
| All grades | Grade 3 or higher | |
| All adverse reactions | 13 (54.2) | 5 (20.8) |
| Gastrointestinal disorders | ||
| Nausea | 2 (8.3) | – |
| Abdominal discomfort | 1 (4.2) | – |
| Vomiting | 2 (8.3) | – |
| General disorders and administration site conditions | ||
| Hypothermia | 1 (4.2) | – |
| Fever | 3 (12.5) | – |
| Edema | 1 (4.2) | – |
| Nervous system disorders | ||
| Hyperesthesia | 1 (4.2) | – |
| Memory disorder | 1 (4.2) | – |
| Aphasia | 1 (4.2) | – |
| Heterotropia | 1 (4.2) | – |
| Headache | 2 (8.3) | – |
| Homonymous hemianopsia | 1 (4.2) | – |
| Urinary incontinence | 1 (4.2) | – |
| Brain edema | 6 (25.0) | 2 (8.3) |
| Monoparesis | 1 (4.2) | – |
| Hemiparesis | 2 (8.3) | 2 (8.3) |
| Hemiplegia | 1 (4.2) | – |
| Reproductive system and breast disorders | ||
| Irregular menstruation | 1 (4.2) | – |
| Metabolism and nutrition disorders | ||
| Anorexia | 2 (8.3) | – |
| Investigations | ||
| C-reactive protein increased | 1 (4.2) | |
| Alanine aminotransferase increasd | 2 (8.3) | 1 (4.2) |
| Lymphocyte decreased | 3 (12.5) | – |
| Platelet decreased | 1 (4.2) | – |
| Blood creatine phosphokinase increased | 1 (4.2) | 1 (4.2) |
| Leukocyte increased | 1 (4.2) | – |
MedDRA/J Version 14.0. Event name: the same event name seen in the same patient was counted as one case.