Skip to main content
. Author manuscript; available in PMC: 2021 Apr 11.
Published in final edited form as: Lancet. 2020 Mar 20;395(10231):1217–1224. doi: 10.1016/S0140-6736(20)30611-5

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.