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Table 6 Adverse events

From: The effect of tranexamic acid on the risk of death and hysterectomy in women with post-partum haemorrhage: statistical analysis plan for the WOMAN trial

Type of adverse eventa Tranexamic acid Placebo Risk ratio (95 % CI) p value*
(n = 10,000) (n = 10,000)
MedDRA code groups N (X %) N (X %) X.XX (X.XX–X.XX) p = 0.XX
  1. Notes
  2. *p values from Pearson’s chi-squared test (or Fisher’s exact test)
  3. aAE’s, SAE, and SUSAR grouped by MedDRA® codes