Safety and Effectiveness of Oral Anticoagulants in Patients With Non-valvular Atrial Fibrillation

Event rate per 100 participant-years for first occurrence of any bleeding event after index date was reported. Any bleeding was defined using ICD-10 diagnosis codes and participants were considered to have any bleeding if pre-defined bleeding-associated ICD-10 diagnosis codes appeared in the records. Index date was defined as the date of the first prescription of any of OACs (warfarin, apixaban, dabigatran, rivaroxaban or edoxaban) during the observation period of approximately 7 years (2011-2017). Pseudo datasets refers to number derived using IPTW method and are different from the actual participants included in the reporting arm.

Time frame: During the observation period of approximately 7 years

Population: OACs treatment-naive participants diagnosed with NVAF, initiating any OACs treatment were included in study. Analysis performed using IPTW method to balance participant characteristics among reporting groups. IPTW method created weighted pseudo-datasets which were used in analysis of outcome measure and are reported in the units analyzed field.

Event rate per 100 participant-years for first occurrence of major bleeding event after index date was reported. Major bleeding after index date was identified using hospital claims which had a bleeding diagnosis code as the first listed in International Statistical Classification of Diseases and Related Health Problems (ICD)-10 diagnosis code. An event occurrence of major bleeding was defined as that appears as 21: Disease name behind hospitalization in database. Index date was defined as the date of the first prescription of any of OACs (warfarin, apixaban, dabigatran, rivaroxaban or edoxaban) during the observation period of approximately 7 years (2011-2017). Pseudo datasets refers to number derived using IPTW method and are different from the actual participants included in the reporting arm.

Time frame: During the observation period of approximately 7 years

Population: OACs treatment-naive participants diagnosed with NVAF, initiating any OACs treatment were included in study. Analysis performed using IPTW method to balance participant characteristics among reporting groups. IPTW method created weighted pseudo-datasets which were used in analysis of outcome measure and are reported in the units analyzed field.

Event rate per 100 participant-years for first occurrence of stroke and systemic embolism events after index date was reported. Stroke events included the composite of any ischemic and any hemorrhagic stroke events (non-traumatic extradural hemorrhage). Systemic embolism events were defined as any of the following: abdominal aortic embolism, aortic embolism, acute arterial occlusive disease of arteries of upper extremities, femoral arterial occlusion and acute arterial occlusive disease of arteries of lower extremities, iliac artery embolism, hepatic artery embolism, thromboembolism, embolic infarction, aortic embolism, subclavian artery stenosis. Index date was defined as date of first prescription of any OACs (warfarin, apixaban, dabigatran, rivaroxaban or edoxaban) during the observation period of approximately 7 years (2011-2017). Pseudo datasets refers to number derived using IPTW method and are different from the actual participants included in the reporting arm.

Time frame: During the observation period of approximately 7 years

Population: OACs treatment-naive participants diagnosed with NVAF, initiating any OACs treatment were included in study. Analysis performed using IPTW method to balance participant characteristics among reporting groups. IPTW method created weighted pseudo-datasets which were used in analysis of outcome measure and are reported in the units analyzed field.

Event rate per 100 participant-years for first occurrence of any gastrointestinal bleeding event after index date was reported. Any gastrointestinal bleeding was defined by ICD-10 diagnosis codes. If participants had ICD-10 diagnosis codes which suggest bleeding from the gastrointestinal tract, they were considered to have any gastrointestinal bleeding. Index date was defined as the date of the first prescription of any of OACs (warfarin, apixaban, dabigatran, rivaroxaban or edoxaban) during the observation period of approximately 7 years (2011-2017). Pseudo datasets refers to number derived using IPTW method and are different from the actual participants included in the reporting arm.

Time frame: During the observation period of approximately 7 years

Population: OACs treatment-naive participants diagnosed with NVAF, initiating any OACs treatment were included in study. Analysis performed using IPTW method to balance participant characteristics among reporting groups. IPTW method created weighted pseudo-datasets which were used in analysis of outcome measure and are reported in the units analyzed field.

Event rate per 100 participant-years for first occurrence of any intracranial hemorrhage event after index date was reported. Any intracranial hemorrhage was defined by ICD-10 diagnosis codes and participants were considered to have any intracranial hemorrhagic event if pre-defined any intracranial hemorrhagic-associated ICD-10 diagnosis codes appeared in the records. Index date was defined as the date of the first prescription of any of OACs (warfarin, apixaban, dabigatran, rivaroxaban or edoxaban) during the observation period of approximately 7 years (2011-2017). Pseudo datasets refers to number derived using IPTW method and are different from the actual participants included in the reporting arm.

Time frame: During the observation period of approximately 7 years

Population: OACs treatment-naive participants diagnosed with NVAF, initiating any OACs treatment were included in study. Analysis performed using IPTW method to balance participant characteristics among reporting groups. IPTW method created weighted pseudo-datasets which were used in analysis of outcome measure and are reported in the units analyzed field.

Event rate per 100 participant-years for first occurrence of hemorrhagic stroke after index date was reported. Index date was defined as the date of the first prescription of any of OACs (warfarin, apixaban, dabigatran, rivaroxaban or edoxaban) during the observation period of approximately 7 years (2011-2017). Pseudo datasets refers to number derived using IPTW method and are different from the actual participants included in the reporting arm.

Time frame: During the observation period of approximately 7 years

Population: OACs treatment-naive participants diagnosed with NVAF, initiating any OACs treatment were included in study. Analysis performed using IPTW method to balance participant characteristics among reporting groups. IPTW method created weighted pseudo-datasets which were used in analysis of outcome measure and are reported in the units analyzed field.

Event rate per 100 participant-years for first occurrence of ischemic stroke after index date was reported. Index date was defined as the date of the first prescription of any of OACs (warfarin, apixaban, dabigatran, rivaroxaban or edoxaban) during the observation period of approximately 7 years (2011-2017). Pseudo datasets refers to number derived using IPTW method and are different from the actual participants included in the reporting arm.

Time frame: During the observation period of approximately 7 years

Population: OACs treatment-naive participants diagnosed with NVAF, initiating any OACs treatment were included in study. Analysis performed using IPTW method to balance participant characteristics among reporting groups. IPTW method created weighted pseudo-datasets which were used in analysis of outcome measure and are reported in the units analyzed field.

Event rate per 100 participant-years for first occurrence of major gastrointestinal bleeding events after index date was reported. Major gastrointestinal bleeding after index date was identified using hospital claims which had a gastrointestinal bleeding diagnosis code as the first listed ICD-10 diagnosis code. An event occurrence of major bleeding was defined as that appears as 21: Disease name behind hospitalization in database. Index date was defined as the date of the first prescription of any of OACs (warfarin, apixaban, dabigatran, rivaroxaban or edoxaban) during the observation period of approximately 7 years (2011-2017). Pseudo datasets refers to number derived using IPTW method and are different from the actual participants included in the reporting arm.

Time frame: During the observation period of approximately 7 years

Population: OACs treatment-naive participants diagnosed with NVAF, initiating any OACs treatment were included in study. Analysis performed using IPTW method to balance participant characteristics among reporting groups. IPTW method created weighted pseudo-datasets which were used in analysis of outcome measure and are reported in the units analyzed field.

Event rate per 100 participant-years for first occurrence of major intracranial hemorrhage events after index date was reported. Major intracranial hemorrhage was defined by ICD-10 diagnosis codes and participants were considered to have major intracranial hemorrhage if pre-defined major intracranial hemorrhagic-associated ICD-10 diagnosis codes appeared in the records. Index date was defined as the date of the first prescription of any of OACs (warfarin, apixaban, dabigatran, rivaroxaban or edoxaban) during the observation period of approximately 7 years (2011-2017). Pseudo datasets refers to number derived using IPTW method and are different from the actual participants included in the reporting arm.

Time frame: During the observation period of approximately 7 years

Population: OACs treatment-naive participants diagnosed with NVAF, initiating any OACs treatment were included in study. Analysis performed using IPTW method to balance participant characteristics among reporting groups. IPTW method created weighted pseudo-datasets which were used in analysis of outcome measure and are reported in the units analyzed field.

Event rate per 100 participant-years for first occurrence of systemic embolism events after index date was reported. Systemic embolism events included any of the following: abdominal aortic embolism, aortic embolism, acute arterial occlusive disease of arteries of upper extremities, femoral arterial occlusion and acute arterial occlusive disease of arteries of lower extremities, iliac artery embolism, hepatic artery embolism, thromboembolism, embolic infarction, aortic embolism, subclavian artery stenosis. Index date was defined as the date of the first prescription of any of OACs (warfarin, apixaban, dabigatran, rivaroxaban or edoxaban) during the observation period of approximately 7 years (2011-2017). Pseudo datasets refers to number derived using IPTW method and are different from the actual participants included in the reporting arm.

Time frame: During the observation period of approximately 7 years

Population: OACs treatment-naive participants diagnosed with NVAF, initiating any OACs treatment were included in study. Analysis performed using IPTW method to balance participant characteristics among reporting groups. IPTW method created weighted pseudo-datasets which were used in analysis of outcome measure and are reported in the units analyzed field.