Table 3:
Secondary efficacy outcomes and safety analysis by age group
Children (aged <18 years) | Adults (aged 18–65 years) | Older adults (aged >65 years) | |||||||
---|---|---|---|---|---|---|---|---|---|
Levetiracetam | Fosphenytoin | Valproate | Levetiracetam | Fosphenytoin | Valproate | Levetiracetam | Fosphenytoin | Valproate | |
ITT population | 85 | 71 | 69 | 71 | 54 | 61 | 19 | 17 | 15 |
Admission to ICU | 53 (62%) | 45 (63%) | 43 (62%) | 38 (54%) | 26 (48%) | 34 (56%) | 15 (79%) | 13 (76%) | 8 (53%) |
Length of ICU stay, days | 1 (0–2) | 1 (0–2) | 1 (0–2) | 1 (0–3) | 0 (0–3) | 1 (0–3) | 3 (1–6) | 2 (1–7) | 2 (0–6) |
Length of hospital stay, days | 2 (1–3) | 2 (1–3) | 2 (1–4) | 3 (1–6) | 3 (1–7) | 2 (1–6) | 7 (5–12) | 5 (3–16) | 5 (3–16) |
Safety population | 86 | 73 | 70 | 74 | 58 | 64 | 20 | 18 | 15 |
Life-threatening hypotension within 60 min of start of study drug infusion | 0 | 2 (3%) | 3 (4%) | 0 | 2 (3%) | 0 | 1 (5%) | 1 (6%) | 0 |
Life-threatening cardiac arrhythmia within 60 min of start of study drug infusion | 0 | 0 | 0 | 1 (1%) | 0 | 0 | 0 | 0 | 0 |
Acute respiratory depression | 5 (6%) | 13 (18%) | 7 (10%) | 10 (14%) | 6 (10%) | 5 (8%) | 0 | 2 (11%) | 0 |
Endotracheal intubation within 60 min of start of study drug infusion | 7 (8%) | 24 (33%) | 8 (11%) | 19 (26%) | 13 (22%) | 14 (22%) | 7 (35%) | 5 (28%) | 2 (13%) |
Acute seizure recurrence 60 min-12 h after start of study drug infusion | 8 (9%) | 11 (15%) | 6 (9%) | 5 (7%) | 3 (5%) | 5 (8%) | 4 (20%) | 4 (22%) | 3 (20%) |
Death | 1 (1%) | 0 | 1 (1%) | 2 (3%) | 2 (3%) | 1 (2%) | 4 (20%) | 1 (6%) | 0 |
Data are n, n (%), or median (IQR). No patients had anaphylaxis or purple glove syndrome. ITT=intention-to-treat. ICU=intensive care unit.