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Engage af timi 483/5/2023 ![]() Bleeding In Patients With DVT And/Or PE In The Hokusai VTE Study In the overall population, major bleeding was lower in the SAVAYSA group compared to the warfarin group [HR 0.80 (0.70, 0.91), p 6 months for 2557 (62.1%) of patients and 12 months for 1661 (40.3%) of patients.īleeding was the most common reason for treatment discontinuation and occurred in 1.4% and 1.4% of patients in the SAVAYSA and warfarin arms, respectively. Bleeding led to treatment discontinuation in 3.9% and 4.1% of patients in the SAVAYSA 60 mg and warfarin treatment groups, respectively. In the ENGAGE AF-TIMI 48 study, the median study drug exposure for the SAVAYSA and warfarin treatment groups was 2.5 years.īleeding was the most common reason for treatment discontinuation. ![]() The safety of SAVAYSA was evaluated in the ENGAGE AF-TIMI 48, Hokusai VTE, and Hokusai VTE Cancer studies including 11,530 patients exposed to SAVAYSA 60 mg and 7124 patients exposed to SAVAYSA 30 mg once daily. Spinal/Epidural Anesthesia or Puncture īecause clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.Increased Risk of Stroke with Discontinuation of SAVAYSA in Patients with Nonvalvular Atrial Fibrillation.The following clinically significant adverse reactions are discussed in greater detail in other sections of the prescribing information. SLIDESHOW Heart Disease: Causes of a Heart Attack See Slideshow You may report side effects to FDA at 1-80. Call your doctor for medical advice about side effects. This is not a complete list of side effects and others may occur. low red blood cells (anemia)-pale skin, unusual tiredness, feeling light-headed or short of breath, cold hands and feet.bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds.urine that looks red, pink, or brown or.headaches, dizziness, weakness, feeling like you might pass out.bleeding from wounds or needle injections, any bleeding that will not stop. ![]()
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