Table 3.

Safety analyses

	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

Type and rates of declared adverse events occurring during hospital stay

* Fisher’s exact test

^† Robust Poisson model

^‡ Assessed by the investigator

In one patient, five recurrences of seizures were each declared an adverse event (AE)

SAE Serious adverse event