Registered outcomes11

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

1 to 11 of 11

List	Outcome	Time frame	Description
Primary	Descriptive analysis of demographic and clinical characteristics of patients who are prescribed oral rivaroxaban for the first time in comparison with those who are prescribed standard of care for the first time	up to 8 years	Age and sex distribution Proportion of patients defined as naïve, non-naïve, recent switchers and distant switchers Type and estimated duration of other anticoagulant use among the non-naïve group and for all patients Number of pregnancies and pregnancy outcomes' Use of specific prescribed medications confirming ACS indication Use of other prescribed medications Comorbidity based on inpatient and outpatient diagnoses Renal disease based on in- and outpatient diagnoses Healthcare utilization (e.g. number of hospital admissions).
Primary	Characteristics of rivaroxaban use in comparison with standard of care	up to 8 years	Estimated dose of index drug at index date and estimated duration of treatment Where available, the diagnosis associated with the prescribing of the index drug (where not available, estimated dose and duration of index drug will be used as a proxy for the associated diagnosis among rivaroxaban users) Dispensed amount (can be used to estimate duration of treatment)
Primary	Safety: occurrence of intracranial haemorrhage leading to hospitalization among users of rivaroxaban in comparison with individuals receiving current standard of care	up to 8 years	Cases of intracranial haemorrhage will be identified in hospitalized patients with a discharge diagnosis of intracranial haemorrhage that meet the criteria for one of the three following categories: Incident cases of intracerebral haemorrhage Incident cases of subarachnoid haemorrhage Incident cases of epidural, dural, subdural and arachnoid haemorrhage
Primary	Safety: occurrence of gastrointestinal bleeding leading to hospitalization among users of rivaroxaban in comparison with individuals receiving current standard of care	up to 8 years	A patient will have to meet the following criteria to be considered a case of gastrointestinal bleeding: A hospital admission with a discharge diagnosis of gastrointestinal bleeding, i.e. a bleeding riginating in the upper or lower gastrointestinal tract or, more specifically, in the oesophagus, stomach, duodenum, jejunum, ileum, colon or rectum. For upper gastrointestinal bleeding: the lesion type being erosion, gastritis, duodenitis or peptic (gastric or duodenal) ulcer.
Primary	Safety: occurrence urogenital bleeding leading to hospitalization among users of rivaroxaban in comparison with individuals receiving current standard of care	up to 8 years	A patient will have to meet the following criteria to be considered a case of urogenital bleeding: A hospital admission with a discharge diagnosis of urogenital bleeding.
Secondary	Safety: occurrence of bleeding events leading to hospitalization not specified as primary safety outcomes ("other bleeding") in individuals receiving rivaroxaban, in comparison with those receiving current standard of care	up to 8 years	A patient will have to meet the following criteria to be considered a case of "other bleeding": A hospital admission with a discharge diagnosis of "other bleeding"
Secondary	Safety: occurrence of non-infective liver disease leading to hospitalization in individuals receiving rivaroxaban in comparison with those receiving current standard of care	up to 8 years	A patient will have to meet all of the following criteria to be considered a case of non-infective liver disease: A hospital admission with a discharge diagnosis of acute liver injury. No diagnosis of cancer, other liver disease (including infectious hepatitis, chronic liver disease etc.), gallbladder or pancreatic disease, or alcoholism
Secondary	Effectiveness: occurrence of deep vein thrombosis (DVT) or pulmonary embolism (PE) in individuals receiving rivaroxaban in comparison with those receiving current standard of care	up to 8 years	A patient will have to meet the following criteria to be considered a case of DVT or PE: A hospital admission with a discharge diagnosis of DVT or PE, or an ambulatory diagnosis of DVT with a dispensation of another antithrombotic agent
Secondary	Effectiveness: occurrence of Ischaemic stroke in individuals receiving rivaroxaban in comparison with those receiving current standard of care	up to 8 years	A patient will have to meet the following criteria to be considered a case of ischaemic stroke: A hospital admission with a main discharge diagnosis of ischaemic stroke.
Secondary	Effectiveness: occurrence acute myocardial infarction (MI) in individuals receiving rivaroxaban in comparison with those receiving current standard of care	up to 8 years	A patient will have to meet all of the following criteria to be considered a case of acute myocardial infarction: A hospital admission with a main discharge diagnosis of acute MI
Secondary	All-cause mortality as well as cause-specific mortality	up to 8 years	Deaths can be identified from core data and hospital data

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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