Very common (10% or more): Nausea (%)
Common (1% to 10%): Constipation, vomiting, diarrhea, abdominal pain upper, abdominal pain, dyspepsia, gastritis, gastroenteritis, toothache, gingival bleeding, rectal hemorrhage, dyspepsia, gastrointestinal hemorrhage (including hematemesis and melena),
Uncommon (% to 1%): Major gastrointestinal bleed, hematochezia, hemorrhoidal hemorrhage, hematemesis, melena, anal hemorrhage, occult blood positive, occult blood, intra-abdominal hemorrhage, mouth hemorrhage
Rare (less than %): Retroperitoneal hemorrhage [ Ref ]
n (per 100 pt-year) Warfarin
n (per 100 pt-year) Hazard Ratio
(95% CI) P-value Major† 327 () 462 () (, ) < Intracranial (ICH)‡ 52 () 125 () (, ) - Hemorrhagic stroke § 38 () 74 () (, ) - Other ICH 15 () 51 () (, ) - Gastrointestinal ( GI )& para ; 128 () 141 () (, ) - Fatal** 10 () 37 () (, ) - Intracranial 4 () 30 () (, ) - Non-intracranial 6 () 7 () (, ) - * Bleeding events within each subcategory were counted once per subject, but subjects may have contributed events to multiple endpoints. Bleeding events were counted during treatment or within 2 days of stopping study treatment (on-treatment period).
†Defined as clinically overt bleeding accompanied by one or more of the following: a decrease in hemoglobin of ≥ 2 g/dL, a transfusion of 2 or more units of packed red blood cells , bleeding at a critical site: intracranial, intraspinal, intraocular , pericardial , intra-articular, intramuscular with compartment syndrome , retroperitoneal or with fatal outcome.
‡Intracranial bleed includes intracerebral, intraventricular , subdural , and subarachnoid bleeding. Any type of hemorrhagic stroke was adjudicated and counted as an intracranial major bleed.
§On-treatment analysis based on the safety population, compared to ITT analysis presented in Section 14.
¶GI bleed includes upper GI, lower GI, and rectal bleeding.
** Fatal bleeding is an adjudicated death with the primary cause of death as intracranial bleeding or non-intracranial bleeding during the on-treatment period.
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