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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