Wirkstoffe & Arzneimittelsicherheit

Nebenwirkungen · Brilique

Brilique 90 mg orodispersible tablets · Abschnitt 4.8 · PDF-Seite 57–58

HOS-123675 · Präparat HOS-095701

57  (1.95, 5.83) 15.2 2.71 6.2 <0.0001 PLATO Major or Minor (2.40, 3.08) Bleeding category definitions: TIMI Major: Fatal bleeding, OR any intracranial bleeding, OR clinically overt signs of haemorrhage associated with a drop in haemoglobin (Hgb) of ≥50 g/L, or when Hgb is not available, a fall in haematocrit (Hct) of 15%. Fatal: A bleeding event that directly led to death within 7 days. ICH: Intracranial haemorrhage. Other TIMI Major: Non-fatal non-ICH TIMI Major bleeding. TIMI Minor: Clinically apparent with 30-50 g/L decrease in haemoglobin. TIMI Requiring medical attention: Requiring intervention, OR leading to hospitalisation, OR prompting evaluation. PLATO Major Fatal/life-threatening: Fatal bleeding, OR any intracranial bleeding, OR intrapericardial with cardiac tamponade, OR with hypovolaemic shock or severe hypotension requiring pressors/inotropes or surgery OR clinically apparent with >50 g/L decrease in haemoglobin or ≥4 red cell units transfused. PLATO Major Other: Significantly disabling, OR clinically apparent with 30-50 g/L decrease in haemoglobin, OR 2-3 red cell units transfused. PLATO Minor: Requires medical intervention to stop or treat bleeding.

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