Study of Rivaroxaban Use and Potential Adverse Outcomes in Routine Clinical Pratice (Netherlands)

Age and sex distribution at index date 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 Renal disease based on in- and outpatient diagnoses Hospital admissions for bleeding Healthcare utilization (e.g. number of hospital admissions). Smoking status Body mass index (BMI)

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)

Cases of intracranial haemorrhage will be identified in patients admitted to the hospital 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 Potential cases will be identified by hospital discharge diagnoses

A patient will have to meet the following criteria to be considered a case of gastrointestinal bleeding:

The specific site of bleeding originating 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.

The lesion type being NOT related to cancer. Cases will be identified by hospital discharge diagnoses (ICD-9-CM).

A patient will have to be admitted to the hospital for urogenital bleeding, i.e. the specific site of bleeding originating in the urogenital tract.

Cases will be identified by hospital discharge diagnoses (ICD-9-CM).

A patient will have to meet the following criteria to be considered a case of "other bleeding":

Admitted to hospital with a bleeding event occurring before hospitalization (i.e. excluding inhospital bleeding events).

Cases will be identified by hospital discharge diagnoses (ICD-9-CM).

A patient will have to meet both of the following criteria to be considered a case of non-infective liver disease:

The patient having been admitted to hospital with acute liver injury. Free of cancer, other liver disease (including infectious hepatitis, chronic liver disease etc.), gallbladder or pancreatic disease and alcoholism.

A patient will have to meet the following criteria to be considered a case of DVT or PE:

The patient having been admitted to hospital with a diagnosis of DVT or PE or having a DVT or PE diagnosis documented in the general practitioner database.

A patient will have to meet the following criteria to be considered a case of ischaemic stroke: the patient having been admitted to hospital with a diagnosis of ischaemic stroke.

A patient will have to meet the following criteria to be considered a case of MI: the patient having been admitted to hospital with a diagnosis of MI.

Date of death as registered in the different databases (GP, pharmacy, hospital deaths) and confirmed through linkage with the Dutch central bureau of genealogy