Event rate per 100 participant-years for first occurrence of stroke or SE events after index date in morbidly obese participants was reported. Stroke/SE were identified using hospital claims and occurred anytime during the period of drug use or within 30 days from the last day of treatment prescription. Index date was defined as date of first DOAC pharmacy claim date during the identification period (July 1, 2013-December 31, 2017). The first warfarin prescription date was designated as the index date for participants without any DOAC claim. Stroke events included the composite of any ischemic, any hemorrhagic and SE stroke events. Stroke/SE was equal to 1 if stroke event was >=1.

Event rate per 100 participant-years for first occurrence of net clinical benefit after index date in obese participants was reported. For participants with stroke/SE or MB event, net clinical benefit was assessed by evaluating the first hospital claim for a stroke/SE or MB event. The hospital claim occurred anytime during the period of drug use or within 30 days from the last day of supply of treatment prescription. Index date was defined as date of first DOAC pharmacy claim date during the identification period (July 1, 2013-December 31, 2017). The first warfarin prescription date was designated as the index date for participants without any DOAC claim.

Event rate per 100 participant-years for first occurrence of net clinical benefit after index date in morbidly obese participants was reported. For participants with stroke/SE or MB event, net clinical benefit was assessed by evaluating the first hospital claim for a stroke/SE or MB event. The hospital claim occurred anytime during the period of drug use or within 30 days from the last day of supply of treatment prescription. Index date was defined as date of first DOAC pharmacy claim date during the identification period (July 1, 2013-December 31, 2017). The first warfarin prescription date was designated as the index date for participants without any DOAC claim.

CCI based on various comorbid conditions such as myocardial infarction, CHF, peripheral vascular disease, cerebrovascular disease, dementia, chronic obstructive pulmonary disease, rheumatologic disease, peptic ulcer disease, mild liver disease, diabetes (mild to moderate), diabetes + complications, hemiplegia or paraplegia, renal disease, any malignancy (lymphoma and leukemia), moderate/severe liver disease, metastatic solid tumor, and acquired immune deficiency syndrome (AIDS) were reported. CCI score range was from 0 to 14, where "0"= low comorbid condition and "14"= high comorbid condition, higher scores indicated more comorbidity.

Participants diagnosed with NVAF, who initiated dabigatran on the index date, were included in this cohort and their data from July 2013 to December 2017, available in VA and CMS database observed retrospectively. Index date was defined as the date of the first DOAC pharmacy claim date during the identification period (July 1, 2013-December 31, 2017).

Participants diagnosed with NVAF, who initiated rivaroxaban on the index date, were included in this cohort and their data from July 2013 to December 2017, available in VA and CMS database observed retrospectively. Index date was defined as the date of the first DOAC pharmacy claim date during the identification period (July 1, 2013-December 31, 2017).

Total of all reporting groups

In this baseline measure, number of participants from different regions of the United States were reported. The United States was divided into 5 regions: northeast, midwest, south, west, and other/unknown.

In this baseline measure, number of participants were classified according to the index year in which they received OAC. Index year was defined as the year (2013-2017) in which the treatment was initiated for the participants.

In this baseline measure, number of participants received a standard dose (apixaban - 5 milligram [mg], dabigatran - 150 mg, and rivaroxaban - 20 mg); a lower dose (apixaban - 2.5 mg, dabigatran - 75 mg, and rivaroxaban - 15 mg/10 mg); and other dose (rivaroxaban - 10 mg, dabigatran - 110 mg) based on initial prescription of DOAC were reported.

No participant for reporting arm 'warfarin' had dose of DOAC at index date, hence, for this reporting group no data was collected and reported.

In this baseline measure, number of participants with body weight in kilogram (Kg) were reported within +/- 6 months from the index date.

In this baseline measure, number of participants with BMI in kilogram per square meters (kg/m^2) ranged from less than (<) 18.5 kg/m^2 to greater than (>) 40 kg/m^2 were reported within +/- 6 months from index date.

In this baseline measure, number of participants with or without INR were reported.

In this baseline measure, CHADS2 score was assessed by combining score of 5 risk factors (congestive heart failure [CHF] history, hypertension history, age >=75 years, diabetes mellitus history and stroke symptoms previously). Score ranged from 0-6, where "0" indicates low risk and "6" indicates high risk, where higher scores indicated more risk.

In this baseline measure, CHA2DS2-VASc score was assessed by combining score of 8 risk factors (CHF, hypertension, age >=75 years, diabetes mellitus, stroke [non-hemorrhagic only and transient ischemic attack {TIA}], vascular disease [myocardial infarction, peripheral arterial disease, aortic plaque], age 65 to 74 years, and sex category). Score ranged from 0-9, where "0" indicates low risk and "9" indicates high risk, where higher scores indicated more risk.

In this baseline measure, HAS-BLED score was assessed by combining score of 8 risk factors (hypertension, abnormal kidney or/liver function, age >=75 years, stroke, bleeding, labile INR, age >65 years, and alcohol/drug therapy). Score ranged from 0-9, where "0" indicates low risk and "9" indicates high risk, where higher scores indicated more risk.

In this baseline measure, number of participants on medications prescribed at baseline were reported. Prescribed medications were angiotensin-converting enzyme (ACE) inhibitors/ angiotensin-receptor blockers (ARB), beta blockers, H2 receptor-antagonist, proton pump inhibitor, statins, anti-platelets, and non-steroidal anti inflammatory drugs (NSAIDS).

In this baseline measure, number of participants with bariatric surgery at baseline were reported.

In this baseline measure, number of participants with various comorbid conditions such as bleeding history, CHF, diabetes mellitus, hypertension, renal disease, liver disease, myocardial infarction, dyspepsia or stomach discomfort, non-stroke/systemic embolism (SE) peripheral vascular disease, stroke/SE, TIA, anemia and coagulation defects, alcoholism, peripheral artery disease, and coronary artery disease were reported.

Event rate per 100 participant-years for first occurrence of MB event after index date in morbidly obese participants was reported. MB after index date was identified using hospital claims and occurred anytime during the follow-up period of drug use or within 30 days from the last day of treatment prescription. Index date was defined as date of first DOAC pharmacy claim date during the identification period (July 1, 2013-December 31, 2017). The first warfarin prescription date was designated as the index date for participants without any DOAC claim. MB events included the composite of GI, ICH, and other sites. MB was equal to 1 if bleeding event was >=1.

Morbidly obese participants with or without DOAC treatment diagnosed with NVAF were included in the outcome measure. Analysis performed using IPTW method to balance participant characteristics among reporting groups.

Event rate per 100 participant-years for first occurrence of stroke or SE events after index date in obese participants was reported. Stroke/SE were identified using hospital claims and occurred anytime during the period of drug use or within 30 days from the last day of treatment prescription. Index date was defined as date of first DOAC pharmacy claim date during the identification period (July 1, 2013-December 31, 2017). The first warfarin prescription date was designated as the index date for participants without any DOAC claim. Stroke events included the composite of any ischemic, any hemorrhagic and SE stroke events. Stroke/SE was equal to 1 if stroke event was >=1.

Obese participants with or without DOAC treatment diagnosed with NVAF were included in this outcome measure. Analysis performed using IPTW method to balance participant characteristics among reporting groups.

Event rate per 100 participant-years for first occurrence of stroke or SE events after index date in morbidly obese participants was reported. Stroke/SE were identified using hospital claims and occurred anytime during the period of drug use or within 30 days from the last day of treatment prescription. Index date was defined as date of first DOAC pharmacy claim date during the identification period (July 1, 2013-December 31, 2017). The first warfarin prescription date was designated as the index date for participants without any DOAC claim. Stroke events included the composite of any ischemic, any hemorrhagic and SE stroke events. Stroke/SE was equal to 1 if stroke event was >=1.

Morbidly obese participants with or without DOAC treatment diagnosed with NVAF were included in this outcome measure. Analysis performed using IPTW method to balance participant characteristics among reporting groups.

Event rate per 100 participant-years for first occurrence of net clinical benefit after index date in obese participants was reported. For participants with stroke/SE or MB event, net clinical benefit was assessed by evaluating the first hospital claim for a stroke/SE or MB event. The hospital claim occurred anytime during the period of drug use or within 30 days from the last day of supply of treatment prescription. Index date was defined as date of first DOAC pharmacy claim date during the identification period (July 1, 2013-December 31, 2017). The first warfarin prescription date was designated as the index date for participants without any DOAC claim.

Obese participants with or without DOAC treatment diagnosed with NVAF were included in this outcome measure. Analysis performed using IPTW method to balance participant characteristics among reporting groups.

Event rate per 100 participant-years for first occurrence of net clinical benefit after index date in morbidly obese participants was reported. For participants with stroke/SE or MB event, net clinical benefit was assessed by evaluating the first hospital claim for a stroke/SE or MB event. The hospital claim occurred anytime during the period of drug use or within 30 days from the last day of supply of treatment prescription. Index date was defined as date of first DOAC pharmacy claim date during the identification period (July 1, 2013-December 31, 2017). The first warfarin prescription date was designated as the index date for participants without any DOAC claim.

Morbidly obese participants with or without DOAC treatment diagnosed with NVAF were included in this outcome measure. Analysis performed using IPTW method to balance participant characteristics among reporting groups.

CCI based on various comorbid conditions such as myocardial infarction, CHF, peripheral vascular disease, cerebrovascular disease, dementia, chronic obstructive pulmonary disease, rheumatologic disease, peptic ulcer disease, mild liver disease, diabetes (mild to moderate), diabetes + complications, hemiplegia or paraplegia, renal disease, any malignancy (lymphoma and leukemia), moderate/severe liver disease, metastatic solid tumor, and acquired immune deficiency syndrome (AIDS) were reported. CCI score range was from 0 to 14, where "0"= low comorbid condition and "14"= high comorbid condition, higher scores indicated more comorbidity.

Analysis population included obese or morbidly obese AF participants in the CMS and VA databases with newly prescribed OACs or DOACs between January 1, 2013 and December 31, 2017.

TTR was computed using INR values among warfarin participants during the follow-up. TTR was calculated based on the percentage of time a participant remained in therapeutic range evaluated during the entire follow-up period. TTR >=65 percent (%) was observed as good and TTR less than (<) 65% was observed as poor.

TTR was calculated only for the warfarin arm, therefore data was not collected/observed for DOACs cohorts - apixaban, dabigatran, rivaroxaban.

Participants diagnosed with NVAF, who initiated apixaban on the index date, were included in this cohort and their data from July 2013 to December 2017, available in VA and CMS database observed retrospectively. Index date was defined as the date of the first DOAC pharmacy claim date during the identification period (July 1, 2013-December 31, 2017).

Participants diagnosed with NVAF, who initiated dabigatran on the index date, were included in this cohort and their data from July 2013 to December 2017, available in VA and CMS database observed retrospectively. Index date was defined as the date of the first DOAC pharmacy claim date during the identification period (July 1, 2013-December 31, 2017).

Participants diagnosed with NVAF, who initiated rivaroxaban on the index date, were included in this cohort and their data from July 2013 to December 2017, available in VA and CMS database observed retrospectively. Index date was defined as the date of the first DOAC pharmacy claim date during the identification period (July 1, 2013-December 31, 2017).