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Table 4 Summary of meta-analysis results for the individual MedDRA preferred term serious adverse events pooled across all five trials

From: Reporting of harms outcomes: a comparison of journal publications with unpublished clinical study reports of orlistat trials

Serious Adverse Events (SAEs)   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    Two (13 %) of the 16 SAEs were statistically significant; carotid artery stenosis, varicose veins a One SAE; encephalomyelitis was statistically non-significant
  1. Footnote:
  2. aThese serious adverse events were mild and unrelated to treatment