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Efient · 4.8 Undesirable effects · 1
Eintrag öffnenEfient · 4.8 · 7 Table 1: Incidence of Non-CABG related bleedinga (% Patients) Event All ACS UA/NSTEMI STEMI Prasugrelb Clopi
Eintrag öffnenEfient · 4.8 · 8 CABG-related bleeding In the phase 3 clinical trial, 437 patients underwent CABG during the course of the st
Eintrag öffnenEfient · 4.8 · 9 Tabulated summary of adverse reactions Table 2 summarises haemorrhagic and non-haemorrhagic adverse reaction
Eintrag öffnenEfient · 4.8 · Age Prasugrel 10 mg Clopidogrel 75 mg ≥ 75 years (N=1785)* 9.0% (1.0% fatal) 6.9% (0.1% fatal) < 75 years (N=1
Eintrag öffnenEfient · 4.8 · Bleeding Non-Coronary Artery Bypass Graft (CABG) related bleeding In TRITON, the frequency of patients experie
Eintrag öffnenEfient · 4.8 · Bleeding Risk Associated with Timing of Loading Dose in NSTEMI In a clinical study of NSTEMI patients (the ACC
Eintrag öffnenEfient · 4.8 · History of TIA or stroke Prasugrel Clopidogrel Yes (N=518) 6.5% (2.3% ICH*) 1.2% (0% ICH*) No (N=13090) 0.9% (
Eintrag öffnenEfient · 4.8 · In patients with or without a history of TIA or stroke, the incidence of stroke in the phase 3 clinical trial
Eintrag öffnenEfient · 4.8 · Patients < 60 kg Non-CABG-related TIMI major or minor bleeding rates:
Eintrag öffnenEfient · 4.8 · Patients ≥ 60 kg and age < 75 years In patients ≥ 60 kg and age < 75 years, non-CABG-related TIMI major or min
Eintrag öffnenEfient · 4.8 · Patients ≥ 75 years old Non-CABG-related TIMI major or minor bleeding rates:
Eintrag öffnenEfient · 4.8 · Prasugrel Prior to Prasugrel At Adverse Reaction Coronary time of PCIa Angiographya (N=2037) (N=1996) % %
Eintrag öffnenEfient · 4.8 · Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medi
Eintrag öffnenEfient · 4.8 · Summary of the safety profile Safety in patients with acute coronary syndrome undergoing PCI was evaluated in
Eintrag öffnenEfient · 4.8 · TIMI Major bleedingb 1.3 0.5 Life-threateningc 0.8 0.2 Fatal 0.1 0.0 Symptomatic ICHd 0.0 0.0 Requiring inotro
Eintrag öffnenEfient · 4.8 · Table 2: Haemorrhagic and Non-haemorrhagic adverse reactions System Organ Common Uncommon Rare Not Known Class
Eintrag öffnenEfient · 4.8 · Weight Prasugrel 10 mg Clopidogrel 75 mg < 60 kg (N=664)* 10.1% (0% fatal) 6.5% (0.3% fatal) ≥ 60 kg (N=12672)
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