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Table 4 Effect of tranexamic acid (TXA) on thromboembolic events, need for surgery and transfusion and level of dependency

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

  TXA Placebo Risk ratio (95 % CI) p value*
(n = 10,000) (n = 10,000)
Thromboembolic events     
 Any event NN (X %) NN (X %) X.XX (X.XX–X.XX) p = 0.XX
 Venous events (DVT, PE) NN (X %) NN (X %) X.XX (X.XX–X.XX) p = 0.XX
 DVT NN (X %) NN (X %) X.XX (X.XX–X.XX) p = 0.XX
 PE NN (X %) NN (X %) X.XX (X.XX–X.XX) p = 0.XX
 Arterial events (MI, stroke) NN (X %) NN (X %) X.XX (X.XX–X.XX) p = 0.XX
 MI NN (X %) NN (X %) X.XX (X.XX–X.XX) p = 0.XX
 Stroke NN (X %) NN (X %) X.XX (X.XX–X.XX) p = 0.XX
Surgical interventions     
 Hysterectomy NN (X %) NN (X %) X.XX (X.XX–X.XX) p = 0.XX
 Manual removal of placenta NN (X %) NN (X %) X.XX (X.XX–X.XX) p = 0.XX
 Intrauterine tamponade NN (X %) NN (X %) X.XX (X.XX–X.XX) p = 0.XX
 Embolisation NN (X %) NN (X %) X.XX (X.XX–X.XX) p = 0.XX
 Brace sutures of uterus NN (X %) NN (X %) X.XX (X.XX–X.XX) p = 0.XX
 Arterial ligation NN (X %) NN (X %) X.XX (X.XX–X.XX) p = 0.XX
 Laparotomy NN (X %) NN (X %) X.XX (X.XX–X.XX) p = 0.XX
 Any surgical or radiological intervention NN (X %) NN (X %) X.XX (X.XX–X.XX) p = 0.XX
Blood transfusion     
 Whole blood NN (X %) NN (X %) X.XX (X.XX–X.XX) p = 0.XX
 Packed red blood cells NN (X %) NN (X %) X.XX (X.XX–X.XX) p = 0.XX
 Frozen plasma NN (X %) NN (X %) X.XX (X.XX–X.XX) p = 0.XX
 Other blood products NN (X %) NN (X %) X.XX (X.XX–X.XX) p = 0.XX
 Any transfusion NN (X %) NN (X %) X.XX (X.XX–X.XX) p = 0.XX
Blood transfusion (units)     
 Whole blood mean (SD) mean (SD) Diff in means (X.X – X.X) p = 0.XX
 Packed red blood cells mean (SD) mean (SD) Diff in means (X.X – X.X) p = 0.XX
 Frozen plasma mean (SD) mean (SD) Diff in means (X.X – X.X) p = 0.XX
 Other blood products mean (SD) mean (SD) Diff in means (X.X – X.X) p = 0.XX
 Any transfusion mean (SD) mean (SD) Diff in means (X.X – X.X) p = 0.XX
EQ-5Da     
 Mobility NN (X %) NN (X %) X.XX (X.XX–X.XX) p = 0.XX
 Self-care NN (X %) NN (X %) X.XX (X.XX–X.XX) p = 0.XX
 Usual activities NN (X %) NN (X %) X.XX (X.XX–X.XX) p = 0.XX
 Pain/discomfort NN (X %) NN (X %) X.XX (X.XX–X.XX) p = 0.XX
 Anxiety/depression NN (X %) NN (X %) X.XX (X.XX–X.XX) p = 0.XX
 Visual analogue scale mean (SD) mean (SD) Diff in means (X.X – X.X) p = 0.XX
  1. DVT deep vein thrombosis, MI myocardial infarction, PE pulmonary embolism
  2. *p values from Pearson’s chi-squared test
  3. aProportion with severe problems