Table 4.
Safety outcomes during hospital admission
| 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) |
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