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Table 4 Safety outcomes during hospital admission

From: Update of the ULtra-early TRranexamic Acid after Subarachnoid Hemorrhage (ULTRA) trial: statistical analysis plan

 

ITT

TXA group (n = xx)

Standard care group (n = xx)

OR (95% CI)

Any SAE, n (%)

NN (X)

NN (X)

X.XX (X.XX–X.XX)

Recurrent bleeding

NN (X)

NN (X)

X.XX (X.XX–X.XX)

Hydrocephalus

NN (X)

NN (X)

X.XX (X.XX–X.XX)

Delayed cerebral ischemia

NN (X)

NN (X)

X.XX (X.XX–X.XX)

Thromboembolic complications during treatment

Coiling, n (%)

NN (X)

NN (X)

X.XX (X.XX–X.XX)

Infarct related to procedure

Clipping, n (%)

NN (X)

NN (X)

X.XX (X.XX–X.XX)

Procedural rupture

Coiling, n (%)

Clipping, n (%)

NN (X)

NN (X)

X.XX (X.XX–X.XX)

Extracranial thrombosis

NN (X)

NN (X)

X.XX (X.XX–X.XX)

 - DVT

NN (X)

NN (X)

X.XX (X.XX–X.XX)

 - PE

NN (X)

NN (X)

X.XX (X.XX–X.XX)

Hemorrhagic complication

NN (X)

NN (X)

X.XX (X.XX–X.XX)

Severe hyponatremia

NN (X)

NN (X)

X.XX (X.XX–X.XX)

Pneumonia

NN (X)

NN (X)

X.XX (X.XX–X.XX)

Meningitis

NN (X)

NN (X)

X.XX (X.XX–X.XX)

Urinary tract infection

NN (X)

NN (X)

X.XX (X.XX–X.XX)

Epilepsy

NN (X)

NN (X)

X.XX (X.XX–X.XX)

Delirium

NN (X)

NN (X)

X.XX (X.XX–X.XX)

Terson’s syndrome

NN (X)

NN (X)

X.XX (X.XX–X.XX)

SUSARs

NN (X)

NN (X)

X.XX (X.XX–X.XX)

Other

NN (X)

NN (X)

X.XX (X.XX–X.XX)

  1. CI confidence interval, DVT deep venous thrombosis, ITT intention to treat, OR odds ratio, PE pulmonary embolism, SAE serious adverse event, SUSARs suspected unexpected serious adverse reactions, TXA tranexamic acid