Table 2.
Adverse reactions by the MedRA system organ classification
| Valproate events | Levetiracetam events | Valproate patients (n=257) | Levetiracetam patients (n=258) | |
|---|---|---|---|---|
| Psychiatric disorders | 54 | 109 | 36 (14%) | 66 (26%) |
| Nervous system disorders | 58 | 46 | 42 (16%) | 37 (14%) |
| Gastrointestinal disorders | 24 | 20 | 19 (7%) | 15 (6%) |
| Investigations | 31 | 11 | 29 (11%) | 11 (4%) |
| General disorders and administration site conditions | 20 | 17 | 16 (6%) | 15 (6%) |
| Metabolism and nutrition disorders | 19 | 8 | 19 (7%) | 8 (3%) |
| Skin and subcutaneous tissue disorders | 11 | 6 | 11 (4%) | 5 (2%) |
| Blood and lymphatic system disorders | 1 | 1 | 1 (<1%) | 1 (<1%) |
| Eye disorders | 1 | 1 | 1 (<1%) | 1 (<1%) |
| Respiratory, thoracic, and mediastinal disorders | 0 | 2 | 0 | 2 (1%) |
| Congenital, familial, and genetic disorders | 0 | 1 | 0 | 1 (<1%) |
| Immune system disorders | 1 | 0 | 1 (<1%) | 0 |
| Injury, poisoning, and procedural complications | 0 | 1 | 0 | 1 (<1%) |