Rule-based criteria listed in documents, for selecting adverse reactions to report in document from all adverse events collected during a clinical trial
| Drug | Document | No | Criteria listed* |
|---|---|---|---|
| Gabapentin | USA | 1 | All AEs except those too general to be informative OR not reasonably associated with the use of drug |
| Lamotrigine | USA | 1 | AEs from RCT except AEs that are too general to be informative or not reasonably attributed to the drug |
| USA | 2 | AEs from RCT that were >5% AND greater than placebo arm | |
| USA | 3 | AEs from RCT with frequency between 2–5% AND greater than placebo arm | |
| Oxcarbazepine | Europe | 1 | AEs that were clinically meaningful post marketing reports |
| USA | 1 | AEs from RCT that were ≥2% AND the incidence was greater than placebo | |
| Pregabablin | Europe | 1 | All AEs that occurred at an incidence greater than placebo and in more than one patient |
| USA | 1 | AEs from RCT that were ≥1% AND at least numerically more than in the placebo group | |
| USA | 2 | AEs from RCT that were ≥2% AND the AE in higher dose group that was ≥2% the rate in both the placebo and low dose groups | |
| Topiramate | USA | 1 | AEs from RCT that were ≥2% AND the incidence was greater than placebo |
| USA | 2 | AEs from RCT that were ≥1% AND the incidence was greater than placebo | |
| USA | 3 | All AEs except those too general to be informative OR those not reasonably associated with the use of drug | |
| Zonisamide | USA | 1 | All events included except those too general to be informative, trivial events or those not reasonably thought to be associated with drug |
| USA | 2 | AEs from RCT that were ≥2% AND the incidence was greater than placebo | |
| Clomipramine | USA | 1 | Commonly observed AEs associated with the drug and not seen at an equivalent incidence among placebo treated patients |
| USA | 2 | AEs leading to discontinuation | |
| Duloxetine | Europe | 1 | Most common AEs reported |
| USA | 1 | AEs from RCT that were ≥5% AND twice the placebo rate | |
| USA | 2 | AEs from RCT that were ≥2% in RCT | |
| USA | 3 | AEs from RCT that were ≥5% in RCT | |
| Fluoxetine | USA | 1 | AEs from RCT that were >5% AND at least 2 times greater than placebo |
| USA | 2 | AEs from RCT that were ≥2% AND the incidence was greater than placebo |
*Criteria are from 9/12 documents from the USA and 3/12 from Europe, the other documents did not report any criteria by which the harms were selected for reporting in the document.
AEs, adverse events; RCT, randomised controlled trial.