Table 3 Summary of meta-analysis results for the individual MedDRA preferred term adverse events pooled across all five trials
Adverse events (AEs) | Â | Breakdown of adverse events reporting | ||
|---|---|---|---|---|
Meta-analysis characteristic | Total | Once in the clinical study report (CSR) and journal publication | CSR | Journal publication |
Number of AE terms reported (% of total) | 61 | 30 (49 %) | 31 (51 %) | 0 (0) |
Direction of pooled risk effect in meta-analysis |  | For all 30 AEs there is agreement in direction of the pooled risk effect between the pairing of documents | • 23 (74 %) showed an increased pooled risk of AE on orlistat • four (13 %) showed no difference • four (13 %) showed increased pooled risk of AE on placebo |  |
AE listings for when there is a change in effect including statistical significance |  | • Pooled risk effect was greater in journal publication for four AEs; increased defecation, oily spotting, oily evacuation, faecal incontinence • Pooled risk effect was greater in the CSR for two AEs; soft stools, faecal urgency | • two (6 %) of the 23 AEs were statistically significant; faeces discolouration, dry skin a • one (3 %) of the four AEs with increased risk on placebo was statistically significant; haemorrhoids a |  |