16. Adverse events ‐ number of participants and number of events.
Drug | Number of participants randomised | Number of participants reporting adverse eventsa,b | Number of events reporteda,b |
CBZ | 5134 | 3023 | 9769 |
PHB | 754 | 271 | 181 |
PHT | 1384 | 614 | 1513 |
VPS | 2303 | 1294 | 3599 |
LTG | 3107 | 1608 | 6296 |
OXC | 978 | 623 | 1000 |
TPM | 1898 | 920 | 6316 |
GBP | 1209 | 506 | 2580 |
LEV | 948 | 1441 | 4258 |
ZNS | 282 | 182 | 606 |
Total | 18,045 | 10,482 | 36,118 |
CBZ: carbamazepine; GBP: gabapentin; LEV: levetiracetam; LTG: lamotrigine; OXC: oxcarbazepine; PHB: phenobarbitone; PHT: phenytoin; TPM: topiramate; VPS: sodium valproate; ZNS: zonisamide
aAdverse event data were provided as detailed individual participant data for 23 trials and we extracted summary adverse event information from 36 trial publications. No adverse event data were reported in 18 trial publications. bSome trial publications reported only on the “most common” adverse events, the totals and frequencies are likely to be an underestimation of the true number of events and number of individuals experiencing events. Furthermore, detailed information was provided in the more recent trial publications and individual participant data requests of more recent trials, often involving newer antiepileptic drugs, such as LTG, LEV and TPM; which may indicate that these newer drugs are associated with more adverse events than older drugs such as PHB and PHT, for which less detailed information was available.