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Among all 14 studies, 67 events (accounting for an overall 1.40% incidence) of major bleeding were reported, with no significant differences observed between the two treatment arms (1.48% dabigatran vs 1.35% warfarin; RR=1.07, 95% CI 0.51 to 2.26; p=0.86).
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Vaginal bleeding was reported with low frequency, but was more common in lasofoxifene-treated patients compared to placebo.
One case of gastrointestinal bleeding was reported with ibuprofen 400 mg, otherwise no adverse effects were described as serious for any intervention.
In the PEARL study, vaginal bleeding was reported with low frequency, but was more common in lasofoxifene-treated patients compared to placebo.
Two cases (1.5%) in the PT group were reported with postoperative bleeding from the tracheostomy site that did not required intervention.
In a US study that was published in 2011, the frequency of warfarin-induced bleeding was reported to be 15%to20%0% per year, with life-threatening or fatal bleeding rates as high as 1% to 3% per year [ 8].
Unscheduled bleeding was reported by 14/22 of all women and among these, 9 suffered migraine during such bleeding.
No new gastrointestinal bleeding was reported.
Bleeding was reported in three studies [ 20, 23, 24], including intracranial hemorrhage and gastrointestinal bleeding.
Prolonged bleeding was reported in two cases (0.4%).
No gastrointestinal bleeding was reported during the study.
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Justyna Jupowicz-Kozak
CEO of Professional Science Editing for Scientists @ prosciediting.com