Table 5 Post hoc adverse events in LVT group with admission serum Cr < 0.9 vs. ≥0.9 μg/mL
From: A clinical trial of enteral Levetiracetam for acute seizures in pediatric cerebral malaria
LVT Rx, Cr < 0.9 (n = 25) | LVT Rx Cr ≥ 0.9 (n = 5) | p -value | PB Rx, Cr ≥ 0.9 (n = 6) | |
|---|---|---|---|---|
Abnl electrolytes | 13 (52) | 3 (60) | p = 0.57 | 1 (17) |
Abnormal LFTs | 11 (44) | 3 (60) | p = 0.28 | 3 (50) |
Abnl Hematologic | 4 (16) | 3 (60) | p = 0.07 | 1 (17) |
Abnl other | 3 (12) | 2 (40) | p = 0.18 | 3 (50) |
Number of AEs | By category | |||
0 | 4 (16) | 0 | 1 (17) | |
1 | 10 (40) | 1 (20) | 2 (34) | |
2 | 6 (24) | 1 (20) | p = 0.17 | 1 (17) |
3 | 4 (16) | 2 (40) | 1 (17) | |
4 | 1 (4) | 0 | 0 | |
5 | 0 | 0 | 1 (17) | |
6 | 0 | 1 (20) | 0 | |
10 | 0 | 0 | 0 | |
Number of AEs | Mean 1.56 (SD 1.04) | Mean 3.80 (SD3.56) | p = 0.06 | Mean 2.0 (SD 1.8) |
AE severity (max) | By category | |||
0 | 3 (12) | 0 | 1 (17) | |
1 | 10 (40) | 0 | 0 | |
2 | 6 (24) | 0 | p = 0.001 | 0 |
3 | 3 (12) | 0 | 1 (17) | |
4 | 2 (8) | 4 (80) | 1 (17) | |
5 | 1 (4) | 1 (20) | 2 (34) | |
Severity of AEs# | Mean 1.8 (SD 1.3) | Mean 4.2 (SD 0.45) | p = 0.0008 | Mean 3.7 (SD 2.0) |
Efficacy failure | 3 (12) | 0 | p = 0.57 | 2 (34) |