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Table 3 Summary of meta-analysis results for the individual MedDRA preferred term 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From: Reporting of harms outcomes: a comparison of journal publications with unpublished clinical study reports of orlistat trials

Adverse events (AEs)   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
 
  1. Footnote:
  2. aThese adverse events were mild and unrelated to treatment