Table 4 Summary of meta-analysis results for the individual MedDRA preferred term serious adverse events pooled across all five trials
Serious Adverse Events (SAEs) | Â | Breakdown of serious adverse events reporting | ||
|---|---|---|---|---|
Meta-analysis characteristic | Total | Once in the clinical study report (CSR) and journal publication | CSR | Journal publication |
Number of SAE terms reported (% of total) | 326 | 14 (4 %) | 311 (95 %) | 1 (<1 %) |
Direction of the pooled risk effect in the meta-analysis |  | For all 14 SAEs, there is agreement in direction of the pooled risk effect between the pairing of documents | • 16 (5 %) showed increased pooled risk of SAE on orlistat • 281 (90 %) showed no difference • 14 (5 %) showed an increased pooled risk of SAE on placebo | The one SAE showed increased pooled risk on placebo |
SAE listings for when there is a change in effect including statistical significance | Â | Â | Two (13 %) of the 16 SAEs were statistically significant; carotid artery stenosis, varicose veins a | One SAE; encephalomyelitis was statistically non-significant |