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Hemopericardium
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Vascular disorders
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Haematoma
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Respiratory, thoracic and mediastinal disorders
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Haemoptysis, epistaxis
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Pulmonary (alveolar) haemorrhage
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Gastrointestinal disorders
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Nausea
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Oral haemorrhage gingival haemorrhage
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GI haemorrhage, haematemesis
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Retroperitoneal bleeding
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Skin and subcutaneous tissue disorders
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Ecchymosis
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Renal and urinary disorders
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Haematuria
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General disorders and administration site conditions
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Fever
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Injury, poisoning and procedural complications
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Post-operative haemorrhage*
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Vessel puncture site haemorrhage
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Investigations
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Occult blood in stool or urine
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Decreases in haematocrit and haemoglobin, platelet counts <90,000/mm3
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Platelet counts <50,000/mm3
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Both, with the Aggrastat 0.4 microgram/kg/min infusion regimen and the 25 microgram/kg dose bolus regimen, rates of major bleeding complications are low and not significantly increased.
In the PRISM-PLUS study, using the Aggrastat 0.4 microgram/kg/min infusion regimen, the incidence of TIMI major bleeding was 1.4% for Aggrastat in combination with heparin and 0.8% for heparin alone. The incidence of TIMI minor bleeding was 10.5% for Aggrastat in combination with heparin and 8.0% for heparin alone. The percentage of patients who received a transfusion was 4.0% for Aggrastat in combination with heparin and 2.8% for heparin alone.
With the Aggrastat 25 microgram/kg dose bolus regimen, data from the ADVANCE study suggest that the number of bleeding events is low and does not seem to be significantly increased compared to placebo. There were no TIMI major bleedings and no transfusions in either group. TIMI minor bleeding with the Aggrastat 25 microgram/kg dose bolus regimen was 4% as compared with 1% in the placebo arm p=0.19).
In the On-TIME 2 study, there were no significant differences in the incidence of TIMI major bleeding (3.4% vs. 2.9% p =0.58) and TIMI minor bleeding (5.9% vs. 4.4%; p=0.206) between the Aggrastat 25 microgram/kg dose bolus regimen and the control arm.
The rates of TIMI major (2.4% vs. 1.6%; p=0.44)
