Table 3 Safety analyses
From: Valproic acid as adjuvant treatment for convulsive status epilepticus: a randomised clinical trial
Placebo (n = 118) | Valproic acid (n = 126) | P | |
|---|---|---|---|
Adverse events | |||
Patients with at least one AE | 52 (44%) | 45 (36%) | 0.19* |
Patients with multiple AEs | 27 (23%) | 19 (15%) | |
Number of AEs | 102 | 71 | 0.088† |
Serious adverse events | |||
Patients with at least one SAE | 27 (23%) | 33 (26%) | 0.56* |
Patients with multiple SAEs | 5 (4%) | 8 (6%) | |
Number of SAEs | 34 | 48 | 0.27† |
Severity criteria | |||
Death | 3 | 8 | |
Life-threatening event | 6 | 12 | |
Hospitalisation | 22 | 23 | |
Disability or incapacity | 0 | 1 | |
Other significant event | 3 | 4 | |
Related to the investigational drugs‡ | 3 | 0 | |
Serious adverse events | |||
Recurrence of seizure | 6 | 8 | |
Recurrence of status epilepticus | 4 | 6 | |
Death | 2 | 7 | |
Hepatic cytolysis | 3 | 4 | |
Myocardial ischaemia | 1 | 3 | |
Psychogenic non-epileptic seizure | 0 | 3 | |
Septicaemia | 0 | 3 | |
Stroke | 1 | 2 | |
Refractory status epilepticus | 1 | 2 | |
Pulmonary embolism | 1 | 1 | |
Shock | 1 | 1 | |
Fracture | 2 | 0 | |
Pneumonia | 2 | 0 | |
Cardiac arrest | 0 | 1 | |
Confusion | 0 | 1 | |
Hemiplegia | 0 | 1 | |
Hypoglycaemia | 0 | 1 | |
Hyponatremia | 0 | 1 | |
Acute urinary retention | 0 | 1 | |
Occlusive syndrome | 0 | 1 | |
Dysrhythmia | 0 | 1 | |
Diarrhoea | 1 | 0 | |
Encephalopathy | 1 | 0 | |
Pressure ulcer | 1 | 0 | |
Hyperglycaemia | 1 | 0 | |
Acute renal failure | 1 | 0 | |
Acute pulmonary oedema | 1 | 0 | |
Valproate overdosing | 1 | 0 | |
Thrombosis | 1 | 0 | |
Toxidermia | 1 | 0 | |
Causes of death | n = 3 | n = 8 | |
Withdrawal of care due to severity of brain insult | 2 | 5 | |
Brain tumour | 0 | 3 | |
Brain metastases | 1 | 0 | |
Brain tumour and stroke | 0 | 1 | |
Stroke | 0 | 1 | |
Dementia | 1 | 0 | |
Withdrawal of care due to poor general status | 0 | 1 | |
Multiple organ failure | 0 | 1 | |
Withdrawal of care, reason unspecified | 1 | 1 | |