| Primary | Type of Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) and Current NOAC Dose According to Sex | Number of patients receiving dabigatran (Current NOAC: Dabigatran), rivaroxaban (Current NOAC: Rivaroxaban), apixaban (Current NOAC: Apixaban), edoxaban (Current NOAC: Edoxaban), dabigatran 110 mg (twice daily) BID, dabigatran 150 mg BID, rivaroxaban 15 mg once daily (QD), rivaroxaban 20 mg QD, apixaban 2.5 mg BID, apixaban 5 mg BID, edoxaban 30 mg QD and edoxaban 60 mg QD at the time of study visit according to sex is reported. | Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria. | Posted | | Count of Participants | | Participants | | At the single study visit (Day 1). | | | | ID | Title | Description |
|---|
| OG000 | Sex: Male | This arm included all male patients who participated in the study and were receiving any Non-vitamin K antagonist oral anticoagulant (NOAC) (either dabigatran, rivaroxaban, apixaban or edoxaban) for their nonvalvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC). | | OG001 | Sex: Female | This arm included all female patients who participated in the study and were receiving any Non-vitamin K antagonist oral anticoagulant (NOAC) (either dabigatran, rivaroxaban, apixaban or edoxaban) for their nonvalvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC). |
| | | Title | Denominators | Categories |
|---|
| Current NOAC: Dabigatran (110 mg BID and 150 mg BID patients) | - ParticipantsOG000250
- ParticipantsOG001250
| |
| |
| Primary | Number of Years Since First Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Initiation to Study Visit According to Sex | Number of years since first Non-vitamin K antagonist oral anticoagulant (NOAC) initiation to study visit according to sex is reported. | Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria. | Posted | | Mean | Standard Deviation | Years | | At the single study visit (Day 1). | | | | ID | Title | Description |
|---|
| OG000 | Sex: Male | This arm included all male patients who participated in the study and were receiving any Non-vitamin K antagonist oral anticoagulant (NOAC) (either dabigatran, rivaroxaban, apixaban or edoxaban) for their nonvalvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC). | | OG001 | Sex: Female | This arm included all female patients who participated in the study and were receiving any Non-vitamin K antagonist oral anticoagulant (NOAC) (either dabigatran, rivaroxaban, apixaban or edoxaban) for their nonvalvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC). |
| |
| Primary | Type of Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) and NOAC Dose According to Age (Categorical) | Number of patients receiving dabigatran (Current NOAC: Dabigatran), rivaroxaban (Current NOAC: Rivaroxaban), apixaban (Current NOAC: Apixaban), edoxaban (Current NOAC: Edoxaban), dabigatran 110 mg (twice daily) BID, dabigatran 150 mg BID, rivaroxaban 15 mg once daily (QD), rivaroxaban 20 mg QD, apixaban 2.5 mg BID, apixaban 5 mg BID, edoxaban 30 mg QD and edoxaban 60 mg QD at the time of study visit according to patients' age is reported. | Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria. | Posted | | Count of Participants | | Participants | | At the single study visit (Day 1). | | | | ID | Title | Description |
|---|
| OG000 | Age: 75-79 Years | This arm included all patients aged between 75-79 years who participated in the study and were receiving any Non-vitamin K antagonist oral anticoagulant (NOAC) (either dabigatran, rivaroxaban, apixaban or edoxaban) for their nonvalvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC). | | OG001 | Age: 80-84 Years | This arm included all patients aged between 80-84 years who participated in the study and were receiving any Non-vitamin K antagonist oral anticoagulant (NOAC) (either dabigatran, rivaroxaban, apixaban or edoxaban) for their nonvalvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC). |
|
| Primary | Number of Years Since First Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Initiation to Study Visit According to Patient's Age (Categorical) | Number of years since first Non-vitamin K antagonist oral anticoagulant (NOAC) initiation to study visit according to patient's age (categorical) is reported. | Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria. | Posted | | Mean | Standard Deviation | Years | | At the single study visit (Day 1). | | | | ID | Title | Description |
|---|
| OG000 | Age: 75-79 Years | This arm included all patients aged between 75-79 years who participated in the study and were receiving any Non-vitamin K antagonist oral anticoagulant (NOAC) (either dabigatran, rivaroxaban, apixaban or edoxaban) for their nonvalvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC). | | OG001 | Age: 80-84 Years | This arm included all patients aged between 80-84 years who participated in the study and were receiving any Non-vitamin K antagonist oral anticoagulant (NOAC) (either dabigatran, rivaroxaban, apixaban or edoxaban) for their nonvalvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC). | | OG002 | Age: ≥85 Years |
|
| Primary | Type of Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) and NOAC Dose According to a Prior Diagnosis of Heart Failure | Number of patients receiving dabigatran (Current NOAC: Dabigatran), rivaroxaban (Current NOAC: Rivaroxaban), apixaban (Current NOAC: Apixaban), edoxaban (Current NOAC: Edoxaban), dabigatran 110 mg (twice daily) BID, dabigatran 150 mg BID, rivaroxaban 15 mg once daily (QD), rivaroxaban 20 mg QD, apixaban 2.5 mg BID, apixaban 5 mg BID, edoxaban 30 mg QD and edoxaban 60 mg QD at the time of study visit according to a prior diagnosis of heart failure is reported. | Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria. | Posted | | Count of Participants | | Participants | | At the single study visit (Day 1). | | | | ID | Title | Description |
|---|
| OG000 | Heart Failure: No | This arm included patients who participated in the study and had no prior diagnosis of heart failure and were receiving any Non-vitamin K antagonist oral anticoagulant (NOAC) (either dabigatran, rivaroxaban, apixaban or edoxaban) for their nonvalvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC). | | OG001 | Heart Failure: Yes | This arm included patients who participated in the study and had prior diagnosis of heart failure and were receiving any Non-vitamin K antagonist oral anticoagulant (NOAC) (either dabigatran, rivaroxaban, apixaban or edoxaban) for their nonvalvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC). |
|
| Primary | Number of Years Since First Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Initiation to Study Visit According to a Prior Diagnosis of Heart Failure | Number of years since first Non-vitamin K antagonist oral anticoagulant (NOAC) initiation to study visit according to a prior diagnosis of heart failure is reported. | Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria. | Posted | | Mean | Standard Deviation | Years | | At the single study visit (Day 1). | | | | ID | Title | Description |
|---|
| OG000 | Heart Failure: No | This arm included patients who participated in the study and had no prior diagnosis of heart failure and were receiving any Non-vitamin K antagonist oral anticoagulant (NOAC) (either dabigatran, rivaroxaban, apixaban or edoxaban) for their nonvalvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC). | | OG001 | Heart Failure: Yes | This arm included patients who participated in the study and had prior diagnosis of heart failure and were receiving any Non-vitamin K antagonist oral anticoagulant (NOAC) (either dabigatran, rivaroxaban, apixaban or edoxaban) for their nonvalvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC). |
| |
| Primary | Type of Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) and NOAC Dose According to Coronary Artery Disease | Number of patients receiving dabigatran (Current NOAC: Dabigatran), rivaroxaban (Current NOAC: Rivaroxaban), apixaban (Current NOAC: Apixaban), edoxaban (Current NOAC: Edoxaban), dabigatran 110 mg (twice daily) BID, dabigatran 150 mg BID, rivaroxaban 15 mg once daily (QD), rivaroxaban 20 mg QD, apixaban 2.5 mg BID, apixaban 5 mg BID, edoxaban 30 mg QD and edoxaban 60 mg QD at the study visit according to patients' coronary artery disease is reported. | Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria. Only participants with non-missing outcomes were included in the analysis. | Posted | | Count of Participants | | Participants | | At the single study visit (Day 1). | | | | ID | Title | Description |
|---|
| OG000 | Coronary Artery Disease: No | This arm included patients who participated in the study and had no coronary artery disease and were receiving any Non-vitamin K antagonist oral anticoagulant (NOAC) (either dabigatran, rivaroxaban, apixaban or edoxaban) for their nonvalvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC). | | OG001 | Coronary Artery Disease: Yes | This arm included patients who participated in the study and had coronary artery disease and were receiving any Non-vitamin K antagonist oral anticoagulant (NOAC) (either dabigatran, rivaroxaban, apixaban or edoxaban) for their nonvalvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC). |
|
| Primary | Number of Years Since First Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Initiation to Study Visit According to Coronary Artery Disease | Number of years since first Non-vitamin K antagonist oral anticoagulant (NOAC) initiation to study visit according to patients' coronary artery disease is reported. | Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria. Only participants with non-missing outcomes were included in the analysis. | Posted | | Mean | Standard Deviation | Years | | At the single study visit (Day 1). | | | | ID | Title | Description |
|---|
| OG000 | Coronary Artery Disease: No | This arm included patients who participated in the study and had no coronary artery disease and were receiving any Non-vitamin K antagonist oral anticoagulant (NOAC) (either dabigatran, rivaroxaban, apixaban or edoxaban) for their nonvalvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC). | | OG001 | Coronary Artery Disease: Yes | This arm included patients who participated in the study and had coronary artery disease and were receiving any Non-vitamin K antagonist oral anticoagulant (NOAC) (either dabigatran, rivaroxaban, apixaban or edoxaban) for their nonvalvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC). |
|
| Primary | Type of Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) and NOAC Dose According to Diabetes | Number of patients receiving dabigatran (Current NOAC: Dabigatran), rivaroxaban (Current NOAC: Rivaroxaban), apixaban (Current NOAC: Apixaban), edoxaban (Current NOAC: Edoxaban), dabigatran 110 mg (twice daily) BID, dabigatran 150 mg BID, rivaroxaban 15 mg once daily (QD), rivaroxaban 20 mg QD, apixaban 2.5 mg BID, apixaban 5 mg BID, edoxaban 30 mg QD and edoxaban 60 mg QD at the time of study visit according to patients' diabetes is reported. | Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria. | Posted | | Count of Participants | | Participants | | At the single study visit (Day 1). | | | | ID | Title | Description |
|---|
| OG000 | Diabetes: No | This arm included patients who participated in the study and had no diabetes were receiving any Non-vitamin K antagonist oral anticoagulant (NOAC) (either dabigatran, rivaroxaban, apixaban or edoxaban) for their nonvalvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC). | | OG001 | Diabetes: Yes | This arm included patients who participated in the study and had diabetes and were receiving any Non-vitamin K antagonist oral anticoagulant (NOAC) (either dabigatran, rivaroxaban, apixaban or edoxaban) for their nonvalvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC). |
|
| Primary | Number of Years Since First Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Initiation to Study Visit According to Diabetes | Number of years since first Non-vitamin K antagonist oral anticoagulant (NOAC) initiation to study visit according to patients' diabetes is reported. | Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria. | Posted | | Mean | Standard Deviation | Years | | At the single study visit (Day 1). | | | | ID | Title | Description |
|---|
| OG000 | Diabetes: No | This arm included patients who participated in the study and had no diabetes were receiving any Non-vitamin K antagonist oral anticoagulant (NOAC) (either dabigatran, rivaroxaban, apixaban or edoxaban) for their nonvalvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC). | | OG001 | Diabetes: Yes | This arm included patients who participated in the study and had diabetes and were receiving any Non-vitamin K antagonist oral anticoagulant (NOAC) (either dabigatran, rivaroxaban, apixaban or edoxaban) for their nonvalvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC). |
| |
| Primary | Type of Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) and NOAC Dose According to Chronic Kidney Disease | Number of patients receiving dabigatran (Current NOAC: Dabigatran), rivaroxaban (Current NOAC: Rivaroxaban), apixaban (Current NOAC: Apixaban), edoxaban (Current NOAC: Edoxaban), dabigatran 110 mg (twice daily) BID, dabigatran 150 mg BID, rivaroxaban 15 mg once daily (QD), rivaroxaban 20 mg QD, apixaban 2.5 mg BID, apixaban 5 mg BID, edoxaban 30 mg QD and edoxaban 60 mg QD at the time of study visit according to patients' chronic kidney disease is reported. | Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria. | Posted | | Count of Participants | | Participants | | At the single study visit (Day 1). | | | | ID | Title | Description |
|---|
| OG000 | Chronic Kidney Disease: No | This arm included patients who participated in the study and had no chronic kidney disease were receiving any Non-vitamin K antagonist oral anticoagulant (NOAC) (either dabigatran, rivaroxaban, apixaban or edoxaban) for their nonvalvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC). | | OG001 | Chronic Kidney Disease: Yes | This arm included patients who participated in the study and had chronic kidney disease and were receiving any Non-vitamin K antagonist oral anticoagulant (NOAC) (either dabigatran, rivaroxaban, apixaban or edoxaban) for their nonvalvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC). |
|
| Primary | Number of Years Since First Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Initiation to Study Visit According to Chronic Kidney Disease | Number of years since first Non-vitamin K antagonist oral anticoagulant (NOAC) initiation to study visit according to patients' chronic kidney disease is reported. | Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria. | Posted | | Mean | Standard Deviation | Years | | At the single study visit (Day 1). | | | | ID | Title | Description |
|---|
| OG000 | Chronic Kidney Disease: No | This arm included patients who participated in the study and had no chronic kidney disease were receiving any Non-vitamin K antagonist oral anticoagulant (NOAC) (either dabigatran, rivaroxaban, apixaban or edoxaban) for their nonvalvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC). | | OG001 | Chronic Kidney Disease: Yes | This arm included patients who participated in the study and had chronic kidney disease and were receiving any Non-vitamin K antagonist oral anticoagulant (NOAC) (either dabigatran, rivaroxaban, apixaban or edoxaban) for their nonvalvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC). |
| |
| Secondary | Serum Creatinine Concentration From the Last Available Blood Sample According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type | Serum creatinine concentration from the last available blood sample analysis was retrieved from patients' medical records. Serum creatinine concentration from the last available blood sample analysis according to current NOAC type is reported. | Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria. Only participants with non-missing outcomes were included in the analysis. | Posted | | Mean | Standard Deviation | milligram/deciliter (mg/dl) | | At the single study visit (Day 1). | | | | ID | Title | Description |
|---|
| OG000 | Dabigatran | Patients in this arm were on treatment with dabigatran (either were receiving 110 milligram (mg) dabigatran twice daily (BID) or 150 mg dabigatran BID) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit. | | OG001 | Rivaroxaban | Patients in this arm were on treatment with rivaroxaban (either were receiving 15 milligram (mg) rivaroxaban once daily (QD) or 20 mg rivaroxaban QD) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit. |
|
| Secondary | Creatinine Clearance From the Last Available Blood Sample According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type | Results from the last available blood sample analysis from patients' medical records were used to retrieve the creatinine clearance (CrCl). These results were directly collected in the Electronic Case Report Form (eCRF). In cases where CrCl was not available in patients's medical record but serum creatinine was available, CrCl was estimated using Cockcroft-Gault formula: CrCl = (140 - Age(years)) x Weight (kilogram) x [0.85 if female] / 72 x [Serum Creatinine (milligram/deciliterL)] Reported are Crcl values which are calculated according to:
- Cockcroft-Gault formula and CrCl values directly collected in the eCRF
- Cockcroft-Gault formula only
- Directly collected in the eCRF
| Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria. Only participants with non-missing outcomes were included in the analysis. | Posted | | Mean | Standard Deviation | milliliter/minute (ml/min) | | At the single study visit (Day 1). | | | | ID | Title | Description |
|---|
| OG000 | Dabigatran | Patients in this arm were on treatment with dabigatran (either were receiving 110 milligram (mg) dabigatran twice daily (BID) or 150 mg dabigatran BID) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit. | |
|
| Secondary | Number of Participants in Each Category of Creatinine Clearance Range From the Last Available Blood Sample According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type | Results from the last available blood sample analysis from patients' medical records were used to retrieve the creatinine clearance (CrCl). These results were directly collected in the Electronic Case Report Form (eCRF). In cases where CrCl was not available in patients' medical record but serum creatinine was available, CrCl was estimated using Cockcroft-Gault formula: CrCl = (140 - Age(years)) x Weight (kilogram) x [0.85 if female] / 72 x [Serum Creatinine (milligram/deciliterL)] The number of participants for each of the following creatinine clearance (CrCl) ranges is reported:
- CrCl ≥90: Kidney damage with normal or increased glomerular filtration rate (GFR)
- CrCl 60-89: Kidney damage with mild decreased GFR
- CrCl 30-59: Moderate decrease in GFR
- CrCl 15-29: Severe decrease in GFR
- CrCl <15: Kidney failure
| Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria. Only participants with non-missing outcomes were included in the analysis. | Posted | | Count of Participants | | Participants | | At the single study visit (Day 1). | | | | ID | Title | Description |
|---|
| OG000 | Dabigatran | Patients in this arm were on treatment with dabigatran (either were receiving 110 milligram (mg) dabigatran twice daily (BID) or 150 mg dabigatran BID) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit. |
|
| Secondary | Aspartate Aminotransferase (AST) Concentration From the Last Available Blood Sample According to Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type | Results from the last available blood sample analysis from patients' medical records were used to retrieve AST concentration. AST concentration from the last available blood sample according to non-vitamin K antagonist oral anticoagulant (NOAC) type is reported. | Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria. Only participants with non-missing outcomes were included in the analysis. | Posted | | Mean | Standard Deviation | international units per liter (IU/L) | | At the single study visit (Day 1). | | | | ID | Title | Description |
|---|
| OG000 | Dabigatran | Patients in this arm were on treatment with dabigatran (either were receiving 110 milligram (mg) dabigatran twice daily (BID) or 150 mg dabigatran BID) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit. | | OG001 | Rivaroxaban | Patients in this arm were on treatment with rivaroxaban (either were receiving 15 milligram (mg) rivaroxaban once daily (QD) or 20 mg rivaroxaban QD) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit. |
|
| Secondary | Alanine Aminotransferase (ALT) From the Last Available Blood Sample According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type | Results from the last available blood sample analysis from patients's medical records were used to retrieve ALT concentration. ALT concentration from the last available blood sample according to NOAC type is reported. | Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria. Only participants with non-missing outcomes were included in the analysis. | Posted | | Mean | Standard Deviation | units per liter (UI/L) | | At the single study visit (Day 1). | | | | ID | Title | Description |
|---|
| OG000 | Dabigatran | Patients in this arm were on treatment with dabigatran (either were receiving 110 milligram (mg) dabigatran twice daily (BID) or 150 mg dabigatran BID) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit. | | OG001 | Rivaroxaban | Patients in this arm were on treatment with rivaroxaban (either were receiving 15 milligram (mg) rivaroxaban once daily (QD) or 20 mg rivaroxaban QD) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit. |
|
| Secondary | Bilirubin Concentration From the Last Available Blood Sample According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type | Results from the last available blood sample analysis from patients's medical records were used to retrieve bilirubin concentration. Bilirubin concentration from the last available blood sample according to NOAC type is reported.Results from the last available blood sample analysis from patients' medical records were used to retrieve bilirubin concentration. Bilirubin concentration from the last available blood sample according to NOAC type is reported. | Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria. Only participants with non-missing outcomes were included in the analysis. | Posted | | Mean | Standard Deviation | milligram/deciliter (mg/dl) | | At the single study visit (Day 1). | | | | ID | Title | Description |
|---|
| OG000 | Dabigatran | Patients in this arm were on treatment with dabigatran (either were receiving 110 milligram (mg) dabigatran twice daily (BID) or 150 mg dabigatran BID) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit. | | OG001 | Rivaroxaban | Patients in this arm were on treatment with rivaroxaban (either were receiving 15 milligram (mg) rivaroxaban once daily (QD) or 20 mg rivaroxaban QD) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit. |
|
| Secondary | Haemoglobin Concentration From the Last Available Blood Sample According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type | Results from the last available blood sample analysis from patients' medical records were used to retrieve haemoglobin concentration. Haemoglobin concentration from the last available blood sample according to NOAC type is reported. | Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria. Only participants with non-missing outcomes were included in the analysis. | Posted | | Mean | Standard Deviation | gram/deciliter (g/dl) | | At the single study visit (Day 1). | | | | ID | Title | Description |
|---|
| OG000 | Dabigatran | Patients in this arm were on treatment with dabigatran (either were receiving 110 milligram (mg) dabigatran twice daily (BID) or 150 mg dabigatran BID) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit. | | OG001 | Rivaroxaban | Patients in this arm were on treatment with rivaroxaban (either were receiving 15 milligram (mg) rivaroxaban once daily (QD) or 20 mg rivaroxaban QD) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit. |
|
| Secondary | Platelet Levels From the Last Available Blood Sample According to Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type | Results from the last available blood sample analysis from patients's medical records were used to retrieve platelet levels. Platelet levels from the last available blood sample according to NOAC type is reported. | Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria. Only participants with non-missing outcomes were included in the analysis. | Posted | | Mean | Standard Deviation | x 10^3/microliter (μL) | | At the single study visit (Day 1). | | | | ID | Title | Description |
|---|
| OG000 | Dabigatran | Patients in this arm were on treatment with dabigatran (either were receiving 110 milligram (mg) dabigatran twice daily (BID) or 150 mg dabigatran BID) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit. | | OG001 | Rivaroxaban | Patients in this arm were on treatment with rivaroxaban (either were receiving 15 milligram (mg) rivaroxaban once daily (QD) or 20 mg rivaroxaban QD) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit. |
|
| Secondary | Number of Patients in Each Category of Serum Creatinine, Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Bilirubin, Hemoglobin and Platelet Levels According to Current Non-vitamin K Antagonist Oral (NOAC) Type | Results from the last available blood sample analysis from patients' medical records were used to retrieve serum creatinine, ALT, AST, bilirubin, hemoglobin concentration and platelet levels. For each reported laboratory parameter the values were categorized in two categories: Serum creatinine:
- Normal value : 0.6-1.2 mg/dl in males and 0.5-1.1 mg/dl in females
- High/low value
ALT:
- Normal values: 7-55 units per liter (UI/L)
- High/low values
AST:
- Normal values: 8-48 UI/L
- High/low values
Bilirubin:
- Normal values: 0.2-1.2 milligram per deciliter (mg/dl)
- High/low values
Haemoglobin:
- Normal values: 12-18 gram/deciliter (g/dL)
- High/low values
Platelets:
- Normal values: 150-450 x10^3/µL
- High/low values
| Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria. Only participants with non-missing outcomes were included in the analysis. | Posted | | Count of Participants | | Participants | | At the single study visit (Day 1). | | | | ID | Title | Description |
|---|
| OG000 | Dabigatran | Patients in this arm were on treatment with dabigatran (either were receiving 110 milligram (mg) dabigatran twice daily (BID) or 150 mg dabigatran BID) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit. |
|
| Secondary | Non-valvular Atrial Fibrillation (NVAF) Characteristics: Number of Years Since NVAF Diagnosis According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type | The number of years since NVAF diagnosis was obtained from number of years between date of NVAF diagnosis and date of study visit. The date of NVAF diagnosis was retrieved from patient's medical records. The number of years since NVAF diagnosis and date of study visit is reported for:
- All patients;
- Patients treated previously with vitamin K antagonists (VKA);
- Patients treated with NOAC as first anticoagulant .
| Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria. Only participants with non-missing outcomes were included in the analysis. | Posted | | Mean | Standard Deviation | Years | | At the single study visit (day 1). | | | | ID | Title | Description |
|---|
| OG000 | Dabigatran | Patients in this arm were on treatment with dabigatran (either were receiving 110 milligram (mg) dabigatran twice daily (BID) or 150 mg dabigatran BID) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit. | | OG001 | Rivaroxaban | Patients in this arm were on treatment with rivaroxaban (either were receiving 15 milligram (mg) rivaroxaban once daily (QD) or 20 mg rivaroxaban QD) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit. |
|
| Secondary | Non-valvular Atrial Fibrillation (NVAF) Characteristics: Number of Patients in Each Category of NVAF Type According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type | NVAF was categorized in four categories:
- Persistent;
- Long standing persistent;
- Permanent;
- Paroxysmal.
| Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria. Only participants with non-missing outcomes were included in the analysis. | Posted | | Count of Participants | | Participants | | At the single study visit (day 1). | | | | ID | Title | Description |
|---|
| OG000 | Dabigatran | Patients in this arm were on treatment with dabigatran (either were receiving 110 milligram (mg) dabigatran twice daily (BID) or 150 mg dabigatran BID) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit. | | OG001 | Rivaroxaban | Patients in this arm were on treatment with rivaroxaban (either were receiving 15 milligram (mg) rivaroxaban once daily (QD) or 20 mg rivaroxaban QD) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit. |
|
| Secondary | Non-valvular Atrial Fibrillation (NVAF) Characteristics: Number of Patients in Each Category of EHRA Scale for Atrial Fibrillation (AF) Related Symptoms According to Current NOAC Type | The European Heart Rhythm Association (EHRA) score of atrial fibrillation is a classification system for the extent of atrial fibrillation. It places patients in one of five categories based on how much they are limited during physical activity; the limitations/symptoms are in regard to normal breathing and varying degrees in shortness of breath and/or angina. The EHRA categories are the following: 1-no symptoms 2a-mild symptoms; normal daily activity not affected. 2b-moderate symptoms; normal daily activity not affected. 3-severe symptoms; normal daily activity affected. 4-disabling; normal daily activity discontinued. | Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria. Only participants with non-missing outcomes were included in the analysis. | Posted | | Count of Participants | | Participants | | At the single study visit (day 1). | | | | ID | Title | Description |
|---|
| OG000 | Dabigatran | Patients in this arm were on treatment with dabigatran (either were receiving 110 milligram (mg) dabigatran twice daily (BID) or 150 mg dabigatran BID) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit. | | OG001 |
|
| Secondary | Number of Patients in Each Category of Cardioversion, Ablation, Coronary Interventions and Pacemaker Carrier According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type | Number of patients with (category Yes) and without (category No) cardioversion, ablation, coronary interventions and pacemaker carrier according to current NOAC type is reported. | Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria. Only participants with non-missing outcomes were included in the analysis. | Posted | | Count of Participants | | Participants | | At the single study visit (Day 1). | | | | ID | Title | Description |
|---|
| OG000 | Dabigatran | Patients in this arm were on treatment with dabigatran (either were receiving 110 milligram (mg) dabigatran twice daily (BID) or 150 mg dabigatran BID) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit. | | OG001 | Rivaroxaban | Patients in this arm were on treatment with rivaroxaban (either were receiving 15 milligram (mg) rivaroxaban once daily (QD) or 20 mg rivaroxaban QD) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit. |
|
| Secondary | Number of Patients in Each Category of Coronary Interventions According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type | Number of patients in each category of coronary interventions according to current non-vitamin K antagonist oral anticoagulant (NOAC) type is reported. Coronary interventions were categorized in:
- Percutaneous coronary intervention and
- Coronary artery bypass grafting.
| Participants of FAS who underwent coronary interventions. | Posted | | Count of Participants | | Participants | | At the single study visit (Day 1). | | | | ID | Title | Description |
|---|
| OG000 | Dabigatran | Patients in this arm were on treatment with dabigatran (either were receiving 110 milligram (mg) dabigatran twice daily (BID) or 150 mg dabigatran BID) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit. | | OG001 | Rivaroxaban | Patients in this arm were on treatment with rivaroxaban (either were receiving 15 milligram (mg) rivaroxaban once daily (QD) or 20 mg rivaroxaban QD) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit. |
|
| Secondary | Clinical Risk Factors: Number of Patients in Each Category of Heart Failure, Coronary Artery Disease, Sleep Apnoea-hypopnoea Syndrome, Hypertension and Hyperlipidaemia According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type | Number of patients in each category of heart failure, coronary artery disease, sleep apnoea-hypopnoea syndrome, hypertension and hyperlipidaemia according to current non-vitamin K antagonist oral anticoagulant (NOAC) type is reported. Heart failure, coronary artery disease, sleep apnoea-hypopnoea syndrome, hypertension and hyperlipidaemia were categorized in the following two categories: | Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria. Only participants with non-missing outcomes were included in the analysis. | Posted | | Count of Participants | | Participants | | At the single study visit (Day 1). | | | | ID | Title | Description |
|---|
| OG000 | Dabigatran | Patients in this arm were on treatment with dabigatran (either were receiving 110 milligram (mg) dabigatran twice daily (BID) or 150 mg dabigatran BID) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit. | | OG001 | Rivaroxaban | Patients in this arm were on treatment with rivaroxaban (either were receiving 15 milligram (mg) rivaroxaban once daily (QD) or 20 mg rivaroxaban QD) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit. |
|
| Secondary | Clinical Risk Factors: Number of Heart Failure Patients in Each Category of New York Heart Association (NYHA) Classification According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type | The NYHA provides a simple way of classifying the extent of heart failure and it has 4 categories:
- A - No objective evidence of cardiovascular disease
- B - Objective evidence of minimal cardiovascular disease
- C - Objective evidence of moderately severe cardiovascular disease
- D - Objective evidence of severe cardiovascular disease Number of heart failure patients in each category of New York Heart Association (NYHA) classification according to current NOAC type is reported.
| Participants of FAS with heart failure. NYHA classification for heart failure patients is missing. | Posted | | Count of Participants | | Participants | | At the single study visit (Day 1). | | | | ID | Title | Description |
|---|
| OG000 | Dabigatran | Patients in this arm were on treatment with dabigatran (either were receiving 110 milligram (mg) dabigatran twice daily (BID) or 150 mg dabigatran BID) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit. | | OG001 | Rivaroxaban | Patients in this arm were on treatment with rivaroxaban (either were receiving 15 milligram (mg) rivaroxaban once daily (QD) or 20 mg rivaroxaban QD) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit. |
|
| Secondary | Clinical Risk Factors: Left Ventricular Ejection Fraction According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type | Left ventricular ejection fraction (LVEF) according to current non-vitamin K antagonist oral anticoagulant (NOAC) type is reported. LVEF was obtained from the patients' medical records. | Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria. Only participants with non-missing outcomes were included in the analysis. | Posted | | Mean | Standard Deviation | percent ejection fraction (%) | | At the single study visit (Day 1). | | | | ID | Title | Description |
|---|
| OG000 | Dabigatran | Patients in this arm were on treatment with dabigatran (either were receiving 110 milligram (mg) dabigatran twice daily (BID) or 150 mg dabigatran BID) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit. | | OG001 | Rivaroxaban | Patients in this arm were on treatment with rivaroxaban (either were receiving 15 milligram (mg) rivaroxaban once daily (QD) or 20 mg rivaroxaban QD) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit. |
|
| Secondary | Age-adjusted Charlson Comorbidity Index Score According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type | The Charlson Comorbidity Index is a method of categorizing comorbidities of patients based on the International Classification of Diseases (ICD) diagnosis. Each comorbidity category has an associated weight (from 1 to 6), based on the adjusted risk of mortality or resource use, and the sum of all the weights results in a single comorbidity score for a patient. A score of zero indicates that no comorbidities were found. The higher the score, the more likely the predicted outcome will result in mortality or higher resource use. Up to 12 comorbidities with various weightings can result in a maximum score of 24. The minimum score is zero. | Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria. Only participants with non-missing outcomes were included in the analysis. | Posted | | Mean | Standard Deviation | Score on a scale | | At the single study visit (Day 1). | | | | ID | Title | Description |
|---|
| OG000 | Dabigatran | Patients in this arm were on treatment with dabigatran (either were receiving 110 milligram (mg) dabigatran twice daily (BID) or 150 mg dabigatran BID) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit. | | OG001 | Rivaroxaban |
|
| Secondary | Number of Patients With and Without the Comorbidities Included in the Charlson Comorbidity Index According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type | Number of patients with (Yes) and without (No) the comorbidities which were included in the Charlson Comorbidity Index according to current NOAC type is reported. The comorbidities which were included in the Charlson Comorbidity Index were the following:
- Myocardial infarction
- Congestive heart failure
- Peripheral vascular disease
- Cerebrovascular disease
- Dementia
- Chronic Obstructive Pulmonary Disease (COPD)
- Connective tissue disease
- Peptic ulcer disease
- Liver disease (No/Mild/Moderate to severe)
- Diabetes mellitus (No/Uncomplicated/End-organ damage)
- Hemiplegia
- Moderate to severe renal disease
- Solid Tumor (No/Localized/Metastatic)
- Leukaemia
- Lymphoma
- Acquired Immune Deficiency Syndrome (AIDS).
| Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria. Only participants with non-missing outcomes were included in the analysis. | Posted | | Count of Participants | | Participants | | At the single study visit (Day 1). | | | | ID | Title | Description |
|---|
| OG000 | Dabigatran | Patients in this arm were on treatment with dabigatran (either were receiving 110 milligram (mg) dabigatran twice daily (BID) or 150 mg dabigatran BID) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit. |
|
| Secondary | Number of Patients With and Without Any History of Thromboembolic Events, Number of Patients in Each Category of Different Types of Thromboembolic Events According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type | Reported is the number of patients in each category of:
- Any history of thromboembolic events
- Transient Ischemic Attack (TIA)
- Ischemic stroke
- Haemorrhagic stroke
- Embolism systemic
- Deep vein thrombosis
- Pulmonary embolism.
Any history of thromboembolic events, Transient Ischemic Attack (TIA), ischemic stroke, haemorrhagic stroke, embolism systemic, deep vein thrombosis and pulmonary embolism were categorized in the following two categories: | Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria. Only participants with non-missing outcomes were included in the analysis. | Posted | | Count of Participants | | Participants | | At the single study visit (Day 1). | | | | ID | Title | Description |
|---|
| OG000 | Dabigatran | Patients in this arm were on treatment with dabigatran (either were receiving 110 milligram (mg) dabigatran twice daily (BID) or 150 mg dabigatran BID) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit. | | OG001 | Rivaroxaban | |
|
| Secondary | Number of Patients in Each Category of Stable Angina, Unstable Angina, Myocardial Infarction With ST Segment Elevation and Myocardial Infarction Without ST Segment Elevation According to Current NOAC Type | Number of patients in each category of stable angina, unstable angina, myocardial infarction with ST segment elevation and myocardial infarction without ST segment elevation according to current non-vitamin K antagonist oral anticoagulant (NOAC) type is reported. Stable angina, unstable angina, myocardial infarction with ST segment elevation myocardial infarction without ST segment elevation were categorized in the following 2 categories: | Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria. Only participants with non-missing outcomes were included in the analysis. | Posted | | Count of Participants | | Participants | | At the single study visit (Day 1). | | | | ID | Title | Description |
|---|
| OG000 | Dabigatran | Patients in this arm were on treatment with dabigatran (either were receiving 110 milligram (mg) dabigatran twice daily (BID) or 150 mg dabigatran BID) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit. | | OG001 | Rivaroxaban | |
|
| Secondary | Total Number of Thromboembolic Events, Number of Each Type of Thromboembolic Events, Number of Stable and Unstable Anginas, and Number of ST and Non-ST Myocardial Infarction According to Current NOAC Type | Total number of thromboembolic events, number of each type of thromboembolic events, number of stable and unstable anginas, and number of ST and non-ST myocardial infarction according to current non-vitamin K antagonist oral anticoagulant (NOAC) type is reported. | Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria. Only participants with non-missing outcomes were included in the analysis. | Posted | | Mean | Standard Deviation | events | | At the single study visit (Day 1). | | | | ID | Title | Description |
|---|
| OG000 | Dabigatran | Patients in this arm were on treatment with dabigatran (either were receiving 110 milligram (mg) dabigatran twice daily (BID) or 150 mg dabigatran BID) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit. | | OG001 | Rivaroxaban | Patients in this arm were on treatment with rivaroxaban (either were receiving 15 milligram (mg) rivaroxaban once daily (QD) or 20 mg rivaroxaban QD) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit. |
|
| Secondary | Number of Patients With and Without Any History of Bleeding Events and Number of Patients in Each Category of Bleeding Type According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type | Number of patients with (category Yes) and without (category No) any history of bleeding events and number of patients in each category of the following bleeding types is reported:
- Intracranial
- Digestive
- Genitourinary
- Gingival
- Nasal
- Pulmonary
- Articular-muscular
- Conjunctival.
Intracranial, digestive, genitourinary, gingival, nasal, pulmonary, articular-muscular, conjunctival were categorized in two categories: | Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria. Only participants with non-missing outcomes were included in the analysis. | Posted | | Count of Participants | | Participants | | At the single study visit (Day 1). | | | | ID | Title | Description |
|---|
| OG000 | Dabigatran | Patients in this arm were on treatment with dabigatran (either were receiving 110 milligram (mg) dabigatran twice daily (BID) or 150 mg dabigatran BID) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit. | | OG001 | Rivaroxaban | Patients in this arm were on treatment with rivaroxaban (either were receiving 15 milligram (mg) rivaroxaban once daily (QD) or 20 mg rivaroxaban QD) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit. |
|
| Secondary | Total Number of Bleeding Events and Number of Each Type of Bleeding Events According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type | Total number of bleeding events and number of bleeding events for the following bleeding types is reported:
- Intracranial
- Digestive
- Genitourinary
- Gingival
- Nasal
- Pulmonary
- Articular-muscular
- Conjunctival.
| Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria. Only participants with non-missing outcomes were included in the analysis. | Posted | | Mean | Standard Deviation | events | | At the single study visit (Day 1). | | | | ID | Title | Description |
|---|
| OG000 | Dabigatran | Patients in this arm were on treatment with dabigatran (either were receiving 110 milligram (mg) dabigatran twice daily (BID) or 150 mg dabigatran BID) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit. | | OG001 | Rivaroxaban | Patients in this arm were on treatment with rivaroxaban (either were receiving 15 milligram (mg) rivaroxaban once daily (QD) or 20 mg rivaroxaban QD) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit. |
|
| Secondary | CHA2DS2-VASc Total Score According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type | The Congestive heart failure, Hypertension, Age (> 75), Diabetes mellitus, Stroke/TIA, Vascular disease, Age 65-74, Sex Category (CHA2DS2-VASc) score is a clinical prediction rule to estimate the risk of stroke in patients with Atrial Fibrillation (AF); it is frequently used to determine the need for an anticoagulation therapy, relating the high scores to a great risk of stroke and a low score corresponds to a lower risk of stroke. CHA2DS2-VASc stroke risk score may range from 0 to 9 with 0 being the best outcome. | Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria. | Posted | | Mean | Standard Deviation | score on a scale | | At the single study visit (Day 1). | | | | ID | Title | Description |
|---|
| OG000 | Dabigatran | Patients in this arm were on treatment with dabigatran (either were receiving 110 milligram (mg) dabigatran twice daily (BID) or 150 mg dabigatran BID) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit. | | OG001 | Rivaroxaban | Patients in this arm were on treatment with rivaroxaban (either were receiving 15 milligram (mg) rivaroxaban once daily (QD) or 20 mg rivaroxaban QD) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit. |
|
| Secondary | Number of Patients on Each Category of CHA2DS2-VASc Score According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type | The Congestive heart failure, Hypertension, Age (> 75), Diabetes mellitus, Stroke/TIA, Vascular disease, Age 65-74, Sex Category (CHA2DS2-VASc) total score was categorized in three categories, according to the risk of stroke:
- Low risk (score 0 in male; score 1 in female)
- Moderate risk (score 1 in male; score 2 in female)
- High risk (score ≥2 in male; score ≥3 in female)
| Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria. | Posted | | Count of Participants | | Participants | | At the single study visit (Day 1). | | | | ID | Title | Description |
|---|
| OG000 | Dabigatran | Patients in this arm were on treatment with dabigatran (either were receiving 110 milligram (mg) dabigatran twice daily (BID) or 150 mg dabigatran BID) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit. | | OG001 | Rivaroxaban | Patients in this arm were on treatment with rivaroxaban (either were receiving 15 milligram (mg) rivaroxaban once daily (QD) or 20 mg rivaroxaban QD) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit. |
|
| Secondary | HAS-BLED Total Score According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type | Hypertension, Abnormal renal and liver function, Stroke (1 point), Bleeding history or predisposition, Labile International Normalized Ratio (INR), Elderly (>65 years), Drugs and Alcohol (HAS-BLED) score may range from 0 to 9 with 0 being the best outcome. The high scores indicate a greater risk of bleeding and a low score corresponds to a lower risk of bleeding. | Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria. | Posted | | Mean | Standard Deviation | score on a scale | | At the single study visit (Day 1). | | | | ID | Title | Description |
|---|
| OG000 | Dabigatran | Patients in this arm were on treatment with dabigatran (either were receiving 110 milligram (mg) dabigatran twice daily (BID) or 150 mg dabigatran BID) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit. | | OG001 | Rivaroxaban | Patients in this arm were on treatment with rivaroxaban (either were receiving 15 milligram (mg) rivaroxaban once daily (QD) or 20 mg rivaroxaban QD) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit. |
|
| Secondary | Number of Patients in Each Category of HAS-BLED Score According to Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type | The Hypertension, Abnormal renal and liver function, Stroke (1 point), Bleeding history or predisposition, Labile INR, Elderly (>65 years), Drugs and Alcohol (HAS-BLED) total score was categorized in three categories according to the bleeding risk:
- Low risk (score 0)
- Intermediate risk (score 1-2)
- High risk (score ≥3)
| Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria. | Posted | | Count of Participants | | Participants | | At the single study visit (Day 1). | | | | ID | Title | Description |
|---|
| OG000 | Dabigatran | Patients in this arm were on treatment with dabigatran (either were receiving 110 milligram (mg) dabigatran twice daily (BID) or 150 mg dabigatran BID) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit. | | OG001 | Rivaroxaban | Patients in this arm were on treatment with rivaroxaban (either were receiving 15 milligram (mg) rivaroxaban once daily (QD) or 20 mg rivaroxaban QD) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit. |
|
| Secondary | Number of Patients With Any Concomitant Treatments to Non-vitamin K Antagonist Oral Anticoagulant (NOAC) and Number of Patients for Each Concomitant Treatment to NOAC at Study Visit According to Current NOAC Type | Number of patients in each category (No;Yes) of any concomitant treatments to NOAC and number of patients in each category (No; Yes) for each concomitant treatment to NOAC at study visit according to current NOAC type is reported. The concomitant treatment to non-vitamin K antagonist oral anticoagulant (NOAC) were the following:
- Angiotensin-Receptor Blockers (ARB) or Angiotensin Converting Enzyme inhibitors (ACE) inhibitor
- Beta-blocker
- Calcium channel blockers
- Diuretics
- Amiodarone
- Statin
- Proton pump inhibitor
- H2-receptor antagonist
- Digoxin
- NSAIDs (Nonsteroidal Anti-Inflammatory Drugs)
- Dronedarone
- Ketoconazole
- Cyclosporine
- Itraconazole
- Other antiarrhythmics
| Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria. | Posted | | Count of Participants | | Participants | | At the single study visit (Day 1). | | | | ID | Title | Description |
|---|
| OG000 | Dabigatran | Patients in this arm were on treatment with dabigatran (either were receiving 110 milligram (mg) dabigatran twice daily (BID) or 150 mg dabigatran BID) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit. | | OG001 |
|
| Secondary | Number of Patients in Each Category of Previous Vitamin K Antagonists (VKA) Treatment According to Duration Since the First Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Initiation | Number of patients in each category of previous Vitamin K Antagonists (VKA) treatment according to duration since the first non-vitamin K antagonist oral anticoagulant (NOAC) initiation is reported. Previous VKA treatment was categorized in 2 categories: | Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria. Only participants with non-missing outcomes were included in the analysis. | Posted | | Count of Participants | | Participants | | At the single study visit (Day 1). | | | | ID | Title | Description |
|---|
| OG000 | ≤4 Months | All patients who were on non-vitamin K antagonist oral anticoagulant (NOAC) ≤4 months. | | OG001 | >4 Months | All patients who were on non-vitamin K antagonist oral anticoagulant (NOAC)>4 months. |
| |
| Secondary | Number of Patients Treated Previously With the VKA Acenocoumarol and Number of Patients Treated Previously With the VKA Warfarin According to Duration Since the First NOAC Initiation | Number of patients treated previously (before they were treated with non-vitamin K antagonist oral anticoagulant (NOAC)) with the Vitamin K Antagonists (VKA) acenocoumarol and number of patients treated previously with the VKA warfarin according to duration since the first NOAC initiation is reported. | Participants of FAS who previously received VKA treatment. One patient received acenocoumarol and warfarin during the study, so the total percentage is not 100%. | Posted | | Count of Participants | | Participants | | At the single study visit (Day 1). | | | | ID | Title | Description |
|---|
| OG000 | ≤4 Months | All patients who were on non-vitamin K antagonist oral anticoagulant (NOAC) ≤4 months. | | OG001 | >4 Months | All patients who were on non-vitamin K antagonist oral anticoagulant (NOAC) >4 months. |
| |
| Secondary | Duration of Previous Vitamin K Antagonists (VKA) Treatment According to Duration Since the First Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Initiation | Duration of treatment (in years) is reported for:
- All patients treated previously with Vitamin K Antagonists (VKA) (row:All patients treated previously with VKA)
- Patients treated only with the VKA warfarin (row: Warfarin patients)
- Patients treated only with the VKA acenocoumarol (row: Acenocoumarol patients)
| Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria. Only participants with non-missing outcomes were included in the analysis. | Posted | | Mean | Standard Deviation | Years | | At the single study visit (Day 1). | | | | ID | Title | Description |
|---|
| OG000 | ≤4 Months | All patients who were on non-vitamin K antagonist oral anticoagulant (NOAC) ≤4 months. | | OG001 | >4 Months | All patients who were on non-vitamin K antagonist oral anticoagulant (NOAC) >4 months. |
| |
| Secondary | Duration Since Non-valvular Atrial Fibrillation (NVAF) Diagnosis Until First Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Initiation According to Duration Since the First NOAC Initiation | Duration (in years) since non-valvular atrial fibrillation (NVAF) diagnosis until first NOAC initiation according to duration since the first NOAC initiation is reported for:
- All patients
- Patients treated previously with VKA
- Patients treated only with NOAC as anticoagulant (AC)
| Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria. Only participants with non-missing outcomes were included in the analysis. | Posted | | Mean | Standard Deviation | Years | | At the single study visit (Day 1). | | | | ID | Title | Description |
|---|
| OG000 | ≤4 Months | All patients who were on non-vitamin K antagonist oral anticoagulant (NOAC) ≤4 months. | | OG001 | >4 Months | All patients who were on non-vitamin K antagonist oral anticoagulant (NOAC) >4 months. |
| |
| Secondary | First Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Received and First NOAC Dose According to Duration Since the First NOAC Initiation | Number of patients who received dabigatran, rivaroxaban, apixaban, edoxaban as first NOAC and number of patients who received dabigatran 110 mg BID (twice daily), dabigatran 150 mg BID, rivaroxaban 15 mg once daily (QD), rivaroxaban 20 mg QD, apixaban 2.5 mg BID, apixaban 5 mg BID, edoxaban 30 mg QD and edoxaban 60 mg QD as first NOAC according to duration since the first NOAC initiation is reported. | Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria. | Posted | | Count of Participants | | Participants | | At the single study visit (Day 1). | | | | ID | Title | Description |
|---|
| OG000 | ≤4 Months | All patients who were on non-vitamin K antagonist oral anticoagulant (NOAC) ≤4 months. | | OG001 | >4 Months | All patients who were on non-vitamin K antagonist oral anticoagulant (NOAC) >4 months. |
| |
| Secondary | Number of Patients Who Changed (Increased and Decreased) and Did Not Change the First Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Dose According to Duration Since the First NOAC Initiation | Number of patients who changed (increased and decreased) and did not change the first non-vitamin K antagonist oral anticoagulant (NOAC) dose according to duration since the first NOAC initiation is reported. | Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria. | Posted | | Count of Participants | | Participants | | At the single study visit (Day 1). | | | | ID | Title | Description |
|---|
| OG000 | ≤4 Months | All patients who were on non-vitamin K antagonist oral anticoagulant (NOAC) ≤4 months. | | OG001 | >4 Months | All patients who were on non-vitamin K antagonist oral anticoagulant (NOAC) ≤4 months. |
| |
| Secondary | First Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Treatment Duration (in Years) According to Duration Since the First NOAC Initiation | Treatment duration (in years) is reported for:
- Patients who stopped first NOAC treatment;
- Patients who did not stop the first NOAC treatment.
| Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria. | Posted | | Mean | Standard Deviation | Years | | At the single study visit (Day 1). | | | | ID | Title | Description |
|---|
| OG000 | ≤4 Months | All patients who were on non-vitamin K antagonist oral anticoagulant (NOAC) ≤4 months. | | OG001 | >4 Months | All patients who were on non-vitamin K antagonist oral anticoagulant (NOAC) >4 months. |
| |
| Secondary | Number of Patients in Each Category of Reason for First Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Treatment Discontinuation According to Duration Since the First NOAC Initiation | Reason for first NOAC treatment discontinuation was categorized in four categories:
- Lack of effectiveness
- Investigator's decision
- Patient's decision
- Adverse event
| Only patients who stopped first NOAC treatment. | Posted | | Count of Participants | | Participants | | At the single study visit (Day 1). | | | | ID | Title | Description |
|---|
| OG000 | ≤4 Months | All patients who were on non-vitamin K antagonist oral anticoagulant (NOAC) ≤4 months. | | OG001 | >4 Months | All patients who were on non-vitamin K antagonist oral anticoagulant (NOAC) >4 months. |
| |
| Secondary | Number of Patients in Each Category of Reason for First Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Treatment Change Dose According to Duration Since the First NOAC Initiation | Reason for first NOAC treatment change was categorized in four categories:
- Lack of effectiveness
- Investigator's decision
- Patient's decision
- Adverse event
| Only patients who changed dose in first NOAC treatment. | Posted | | Count of Participants | | Participants | | At the single study visit (Day 1). | | | | ID | Title | Description |
|---|
| OG000 | ≤4 Months | All patients who were on non-vitamin K antagonist oral anticoagulant (NOAC) ≤4 months. | | OG001 | >4 Months | All patients who were on non-vitamin K antagonist oral anticoagulant (NOAC) >4 months. |
| |
| Secondary | Number of Switches to a New Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Per Patient According to Duration Since the First NOAC Initiation | Number of switches to a new non-vitamin K antagonist oral anticoagulant (NOAC) per patient according to duration since the first NOAC initiation is reported. | Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria. | Posted | | Mean | Standard Deviation | switches per patient | | At the single study visit (Day 1). | | | | ID | Title | Description |
|---|
| OG000 | ≤4 Months | All patients who were on non-vitamin K antagonist oral anticoagulant (NOAC) ≤4 months. | | OG001 | >4 Months | All patients who were on non-vitamin K antagonist oral anticoagulant (NOAC) >4 months. |
| |
| Secondary | Number of Patients in Each Category of Number of Switches to a New Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Per Patient According to Duration Since the First NOAC Initiation | Number of patients based on the number of switches to a new NOAC per patient according to duration since the first NOAC initiation is reported. Number of switches to a new NOAC was categorized in 3 categories:
- 0 switches
- 1 switch
- 2 switches.
| Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria. | Posted | | Count of Participants | | Participants | | At the single study visit (Day 1). | | | | ID | Title | Description |
|---|
| OG000 | ≤4 Months | All patients who were on non-vitamin K antagonist oral anticoagulant (NOAC) ≤4 months. | | OG001 | >4 Months | All patients who were on non-vitamin K antagonist oral anticoagulant (NOAC) >4 months. |
| |
| Secondary | Total Number of Switches According to Duration Since the First Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Initiation | Total number of switches according to duration since the first NOAC initiation is reported. | Participants of FAS who switched to a new NOAC. | Posted | | Number | | Switches to a new NOAC | | At the single study visit (Day 1). | | | | ID | Title | Description |
|---|
| OG000 | ≤4 Months | All patients who were on non-vitamin K antagonist oral anticoagulant (NOAC) ≤4 months. | | OG001 | >4 Months | All patients who were on non-vitamin K antagonist oral anticoagulant (NOAC) >4 months. |
| |
| Secondary | Number of Switches in Each Category of Reason for Switch According to Duration Since the First Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Initiation | Reason for switch was categorized in four categories:
- Lack of effectiveness
- Investigator's decision
- Patient's decision
- Adverse event
| Participants of FAS who switched to a new NOAC. | Posted | | Number | | Switches to another NOAC | | At the single study visit (Day 1). | | | | ID | Title | Description |
|---|
| OG000 | ≤4 Months | All patients who were on non-vitamin K antagonist oral anticoagulant (NOAC) ≤4 months. | | OG001 | >4 Months | All patients who were on non-vitamin K antagonist oral anticoagulant (NOAC) >4 months. |
| |
| Secondary | Second Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Received and Second NOAC Dose According to Duration Since the First NOAC Initiation | Number of patients who received dabigatran, rivaroxaban, apixaban, edoxaban as second NOAC and number of patients who received dabigatran 110 mg BID (twice daily), dabigatran 150 mg BID, rivaroxaban 15 mg once daily (QD), rivaroxaban 20 mg QD, apixaban 2.5 mg BID, apixaban 5 mg BID, edoxaban 30 mg QD and edoxaban 60 mg QD as second NOAC according to duration since the first NOAC initiation is reported. | Number of patients who stopped the first NOAC treatment and switched to a second NOAC treatment. | Posted | | Count of Participants | | Participants | | At the single study visit (Day 1). | | | | ID | Title | Description |
|---|
| OG000 | ≤4 Months | All patients who were on non-vitamin K antagonist oral anticoagulant (NOAC) ≤4 months. | | OG001 | >4 Months | All patients who were on non-vitamin K antagonist oral anticoagulant (NOAC) >4 months. |
| |
| Secondary | Number of Patients Who Changed (Increased or Decreased) and Did Not Change the Second Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Dose According to Duration Since the First NOAC Initiation | Number of patients who changed (increased or decreased) and did not change the second non-vitamin K antagonist oral anticoagulant (NOAC) dose according to duration since the first NOAC initiation is reported. | Participants of FAS who stopped the first NOAC treatment and switched to a second NOAC treatment. | Posted | | Count of Participants | | Participants | | At the single study visit (Day 1). | | | | ID | Title | Description |
|---|
| OG000 | ≤4 Months | All patients who were on non-vitamin K antagonist oral anticoagulant (NOAC) ≤4 months. | | OG001 | >4 Months | All patients who were on non-vitamin K antagonist oral anticoagulant (NOAC) >4 months. |
| |
| Secondary | Second Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Treatment Duration (in Years) According to Duration Since the First NOAC Initiation | Second NOAC treatment duration (in years) according to duration since the first NOAC initiation is reported. | Participants of FAS who stopped second NOAC treatment. | Posted | | Mean | Standard Deviation | Years | | At the single study visit (Day 1). | | | | ID | Title | Description |
|---|
| OG000 | ≤4 Months | All patients who were on non-vitamin K antagonist oral anticoagulant (NOAC) ≤4 months. | | OG001 | >4 Months | All patients who were on non-vitamin K antagonist oral anticoagulant (NOAC) >4 months.. |
| |
| Secondary | Number of Patients in Each Category of Reason for Second Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Treatment Discontinuation According to Duration Since the First NOAC Initiation | Reason for second non-vitamin K antagonist oral anticoagulant (NOAC) treatment discontinuation was categorized in four categories:
- Lack of effectiveness
- Investigator's decision
- Patient's decision
- Adverse event
| Participants of FAS who stopped second NOAC treatment. | Posted | | Count of Participants | | Participants | | At the single study visit (Day 1). | | | | ID | Title | Description |
|---|
| OG000 | ≤4 Months | All patients who were on non-vitamin K antagonist oral anticoagulant (NOAC) ≤4 months. | | OG001 | >4 Months | All patients who were on non-vitamin K antagonist oral anticoagulant (NOAC) >4 months. |
| |
| Secondary | Number of Patients in Each Category of Reason for Second Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Treatment Change Dose According to Duration Since the First NOAC Initiation | Reason for second NOAC treatment change was categorized in four categories:
- Lack of effectiveness
- Investigator's decision
- Patient's decision
- Adverse event
| Participants of FAS who changed dose in second NOAC treatment. | Posted | | Count of Participants | | Participants | | At the single study visit (Day 1). | | | | ID | Title | Description |
|---|
| OG000 | ≤4 Months | All patients who were on non-vitamin K antagonist oral anticoagulant (NOAC) ≤4 months. | | OG001 | >4 Months | All patients who were on non-vitamin K antagonist oral anticoagulant (NOAC) >4 months. |
| |
| Secondary | Third Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Received and Third NOAC Dose According to Duration Since the First NOAC Initiation | Number of patients who received dabigatran, rivaroxaban, apixaban, edoxaban as third NOAC and number of patients who received dabigatran 110 mg BID (twice daily), dabigatran 150 mg BID, rivaroxaban 15 mg once daily (QD), rivaroxaban 20 mg QD, apixaban 2.5 mg BID, apixaban 5 mg BID, edoxaban 30 mg QD and edoxaban 60 mg QD as third NOAC according to duration since the first NOAC initiation is reported. | Participants of FAS who stopped second NOAC treatment. | Posted | | Count of Participants | | Participants | | At the single study visit (Day 1). | | | | ID | Title | Description |
|---|
| OG000 | ≤4 Months | All patients who were on non-vitamin K antagonist oral anticoagulant (NOAC) ≤4 months. | | OG001 | >4 Months | All patients who were on non-vitamin K antagonist oral anticoagulant (NOAC) >4 months. |
| |
| Secondary | Number of Patients Who Changed (Increased and Decreased) and Did Not Change the Third Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Dose According to Duration Since the First NOAC Initiation | Number of patients who changed (increased and decreased) and did not change the third non-vitamin K antagonist oral anticoagulant (NOAC) dose according to duration since the first NOAC initiation is reported. | Participants of FAS who started third NOAC treatment. | Posted | | Count of Participants | | Participants | | At the single study visit (Day 1). | | | | ID | Title | Description |
|---|
| OG000 | ≤4 Months | All patients who were on non-vitamin K antagonist oral anticoagulant (NOAC) ≤4 months. | | OG001 | >4 Months | All patients who were on non-vitamin K antagonist oral anticoagulant (NOAC) >4 months. |
| |
| Secondary | Third Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Treatment Duration (in Years) According to Duration Since the First NOAC Initiation | Duration of third NOAC treatment for patients who stopped NOAC treatment. | Participants of FAS who stopped third NOAC treatment. No patient stopped the third NOAC treatment. | Posted | | | | | | At the single study visit (Day 1). | | | | ID | Title | Description |
|---|
| OG000 | ≤4 Months | All patients who were on non-vitamin K antagonist oral anticoagulant (NOAC) ≤4 months. | | OG001 | >4 Months | All patients who were on non-vitamin K antagonist oral anticoagulant (NOAC) >4 months. |
| |
| Secondary | Number of Patients in Each Category of Reason for Third Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Treatment Discontinuation According to Duration Since the First NOAC Initiation | Reason for Third NOAC treatment discontinuation was categorized in four categories:
- Lack of effectiveness
- Investigator's decision
- Patient's decision
- Adverse event
| Participants of FAS who stopped third NOAC treatment. No patient stopped the third NOAC treatment. | Posted | | | | | | At the single study visit (Day 1). | | | | ID | Title | Description |
|---|
| OG000 | ≤4 Months | All patients who were on non-vitamin K antagonist oral anticoagulant (NOAC) ≤4 months. | | OG001 | >4 Months | All patients who were on non-vitamin K antagonist oral anticoagulant (NOAC) >4 months. |
| |
| Secondary | Number of Patients in Each Category of Reason for Third Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Treatment Change Dose According to Duration Since the First NOAC Initiation | Reason for Third NOAC treatment change was categorized in four categories:
- Lack of effectiveness
- Investigator's decision
- Patient's decision
- Adverse event
| Participants of FAS who changed dose in third NOAC treatment. No patients stopped the third NOAC treatment. | Posted | | | | | | At the single study visit (Day 1). | | | | ID | Title | Description |
|---|
| OG000 | ≤4 Months | All patients who were on non-vitamin K antagonist oral anticoagulant (NOAC) ≤4 months. | | OG001 | >4 Months | All patients who were on non-vitamin K antagonist oral anticoagulant (NOAC) >4 months. |
| |
| Secondary | Duration (in Years) in Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Treatment According to Duration Since the First NOAC Initiation | Duration (in years) in NOAC treatment is reported for:
- All patients (patients who received or did not receive VKA)
- Patients treated previously with Vitamin K Antagonists (VKA)
- Patients treated with NOAC as first anticoagulant
| Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria. | Posted | | Mean | Standard Deviation | Years | | At the single study visit (Day 1). | | | | ID | Title | Description |
|---|
| OG000 | ≤4 Months | All patients who were on non-vitamin K antagonist oral anticoagulant (NOAC) ≤4 months. | | OG001 | >4 Months | All patients who were on non-vitamin K antagonist oral anticoagulant (NOAC) >4 months. |
| |
| Secondary | Number of Patients in Each Category of Total Time in Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Treatment According to Duration Since the First NOAC Initiation | Number of patients in each category of total time in non-vitamin K antagonist oral anticoagulant (NOAC) treatment according to duration since the first NOAC initiation is reported. Total time in NOAC treatment was categorized in 4 categories:
- <1 year;
- 1-2 years;
- 2-3 years;
- >3 years.
| Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria. | Posted | | Count of Participants | | Participants | | At the single study visit (Day 1). | | | | ID | Title | Description |
|---|
| OG000 | ≤4 Months | All patients who were on non-vitamin K antagonist oral anticoagulant (NOAC) ≤4 months. | | OG001 | >4 Months | All patients who were on non-vitamin K antagonist oral anticoagulant (NOAC) >4 months. |
| |
| Secondary | Number of Patients for Each Type of Antiplatelet Treatment According to Duration Since the First Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Initiation | Number of patients for each type of following antiplatelet treatment that the patients ever received is reported:
- None (reports the patients who did not receive any antiplatelet treatment)
- Acetyl salicylic acid
- Clopidogrel
- Prasugrel
- Ticlopidine
- Ticagrelor
- Cilostazol
- Triflusal
- Dipyridamole
- Others (other antiplatelet treatment than above mentioned).
| Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria. | Posted | | Count of Participants | | Participants | | At the single study visit (Day 1). | | | | ID | Title | Description |
|---|
| OG000 | ≤4 Months | All patients who were on non-vitamin K antagonist oral anticoagulant (NOAC) ≤4 months. | | OG001 | >4 Months | All patients who were on non-vitamin K antagonist oral anticoagulant (NOAC) >4 months. |
| |
| Secondary | Number of Patients for Each Type of Antiplatelet Treatment at the Time of Study Visit According to Duration Since the First NOAC Initiation | Number of patients for each of the following antiplatelet treatment types at the time of study visit according to duration since the first NOAC initiation is reported:
- None (reports the patients who did not receive any antiplatelet treatment)
- Acetyl salicylic acid
- Clopidogrel
- Prasugrel
- Ticlopidine
- Ticagrelor
- Cilostazol
- Triflusal
- Dipyridamole
- Others (other antiplatelet treatment than above mentioned).
| Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria. | Posted | | Count of Participants | | Participants | | At the single study visit (Day 1). | | | | ID | Title | Description |
|---|
| OG000 | ≤4 Months | All patients who were on non-vitamin K antagonist oral anticoagulant (NOAC) ≤4 months. | | OG001 | >4 Months | All patients who were on non-vitamin K antagonist oral anticoagulant (NOAC) >4 months. |
| |
| Secondary | Time in Treatment With Antiplatelet Agents (in Years) According to Duration Since the First Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Initiation | Time in treatment with antiplatelet agents (in years) according to duration since the first NOAC initiation is reported. | Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria. | Posted | | Mean | Standard Deviation | Years | | At the single study visit (Day 1). | | | | ID | Title | Description |
|---|
| OG000 | ≤4 Months | All patients who were on non-vitamin K antagonist oral anticoagulant (NOAC) ≤4 months. | | OG001 | >4 Months | All patients who were on non-vitamin K antagonist oral anticoagulant (NOAC) >4 months. |
| |
| Secondary | Number of Patients in Each Score of Clinical Frailty Scale Grading at the Time of the Study Visit According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type | Clinical Frailty Scale (CFS) is used commonly to assess frailty. It is a 9-point scale from 1 to 9 (1=very fit; 2=well; 3=Managing well; 4=Vulnerable; 5=Mildly frail; 6=Moderately frail; 7=Severely frail; 8=very severely frail; 9=terminally ill) that summarizes the overall level of fitness or frailty of an older adult after they had been evaluated by a health care professional. Applying the CFS to patients is quick and requires data collection by watching the patient (mobilize), inquiring about their habitual physical activity and ability. A person with a score >4 was considered frail. | Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria. | Posted | | Count of Participants | | Participants | | At the single study visit (Day 1). | | | | ID | Title | Description |
|---|
| OG000 | Dabigatran | Patients in this arm were on treatment with dabigatran (either were receiving 110 milligram (mg) dabigatran twice daily (BID) or 150 mg dabigatran BID) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit. | | OG001 | Rivaroxaban | |
|
| Secondary | Number of Patients in Each Category Clinical Frailty Scale at the Time of the Study Visit According to Current Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Type | Clinical Frailty Scale (CFS) is used commonly to assess frailty. It is a 9-point scale from 1 to 9 (1=very fit; 2=well; 3=Managing well; 4=Vulnerable; 5=Mildly frail; 6=Moderately frail; 7=Severely frail; 8=very severely frail; 9=terminally ill) that summarizes the overall level of fitness or frailty of an older adult after they had been evaluated by a health care professional. Applying the CFS to patients is quick and requires data collection by watching the patient (mobilize), inquiring about their habitual physical activity and ability. CFS was categorized in two categories, according to this ranges:
- Frailty patients - CFS scoring >4
- Non-frailty patients - CFS scoring ≤4
| Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria. | Posted | | Count of Participants | | Participants | | At the single study visit (Day 1). | | | | ID | Title | Description |
|---|
| OG000 | Dabigatran | Patients in this arm were on treatment with dabigatran (either were receiving 110 milligram (mg) dabigatran twice daily (BID) or 150 mg dabigatran BID) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit. | | OG001 |
|
| Secondary | Number of Patients in Each Category of Reason for First Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Usage at the Time of First NOAC Initiation According to Current NOAC Type | Reason for First NOAC usage was categorized in the following two categories:
- Primary prevention;
- Secondary prevention.
| Full Analysis Set (FAS): All enrolled subjects who provided informed consent for this study and fulfilled all selection criteria. Only participants with non-missing outcomes were included in the analysis. | Posted | | Count of Participants | | Participants | | At the single study visit (Day 1). | | | | ID | Title | Description |
|---|
| OG000 | Dabigatran | Patients in this arm were on treatment with dabigatran (either were receiving 110 milligram (mg) dabigatran twice daily (BID) or 150 mg dabigatran BID) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit. | | OG001 | Rivaroxaban | Patients in this arm were on treatment with rivaroxaban (either were receiving 15 milligram (mg) rivaroxaban once daily (QD) or 20 mg rivaroxaban QD) at the time of study visit for their non-valvular atrial fibrillation (NVAF), according to the indication approved in their Summary of Product Characteristics (SmPC), and had initiated treatment with non-vitamin K antagonist oral anticoagulant (NOAC) at least 3 months before the study visit. |
|