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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| All Patients |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients by Each Type of Study-target OAC Drug Prescribed for New Users of Anticoagulants With NVAF | Number of patients by each type of study-target OAC drug (dabigatran, warfarin, apixaban, rivaroxaban, or edoxaban) prescribed as the first Oral Anticoagulants (OAC) with Non-valvular atrial fibrillation (NVAF) | Day 1 |
| Number of Patients Prescribed OAC Drug Dabigatran by Dosage | Number of patients prescribed OAC drug dabigatran at the index date by dosage. If a patient had more than one prescriptions of an OAC at the day, the patient was multiple-counted. | Day 1 |
| Number of Patients Prescribed OAC Drug Warfarin by Dosage | Number of patients prescribed OAC drug Warfarin at the index date by dosage. If a patient had more than one prescriptions of an OAC at the day, the patient was multiple-counted. | Day 1 |
| Number of Patients Prescribed OAC Drug Rivaroxaban by Dosage | Number of patients prescribed OAC drug rivaroxaban at the index date by dosage. If a patient had more than one prescriptions of an OAC at the day, the patient was multiple-counted. | Day 1 |
| Number of Patients Prescribed OAC Drug Apixaban by Dosage | Number of patients prescribed OAC drug Apixaban at the index date by dosage. If a patient had more than one prescriptions of an OAC at the day, the patient was multiple-counted. | Day 1 |
| Number of Patients Prescribed OAC Drug Edoxaban by Dosage | Number of patients prescribed OAC drug edoxaban at the index date by dosage. If a patient had more than one prescriptions of an OAC at the day, the patient was multiple-counted. |
| Measure | Description | Time Frame |
|---|---|---|
| Baseline Characteristics: Age | Baseline characteristics of patients in each treatment group: age | 1 day |
| Baseline Characteristics: Gender | Baseline characteristics of patients in each treatment group: gender |
Not provided
Inclusion criteria:
Exclusion criteria:
Not provided
Not provided
Not provided
Medical Data Vision (MDV) clinical database
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Boehringer Ingelheim | Boehringer Ingelheim | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NISED Center | Tokyo, Shinagawa | 1416017 | Japan |
The Japanese patients diagnosed as Non-Valvular Atrial Fibrillation (NVAF) between April 2010 and June 2016, were prescribed dabigatran, warfarin, apixaban, edoxaban, or rivaroxaban as the first OACs.
DPC; Diagnosis Procedure Combination (DPC)
A retrospective, observational study using health insurance claims data.48696 patients were prescribed dabigatran, warfarin, apixaban, edoxaban, or rivaroxaban as the first OACs but 50 patients were removed as they took more than one these drugs. Thus only 48646 patients were prescribed the drugs of interest.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Dabigatran | Patients prescribed dabigatran as the first Oral Anticoagulants (OACs) with nonvalvular atrial fibrillation. |
| FG001 | Warfarin | Patients prescribed warfarin as the first Oral Anticoagulants (OACs) with nonvalvular atrial fibrillation. |
| FG002 | Apixaban | Patients prescribed Apixaban as the first Oral Anticoagulants (OACs) with nonvalvular atrial fibrillation. |
| FG003 | Rivaroxaban | Patients prescribed Rivaroxaban as the first Oral Anticoagulants (OACs) with nonvalvular atrial fibrillation. |
| FG004 | Edoxaban | Patients prescribed Edoxaban as the first Oral Anticoagulants (OACs) with nonvalvular atrial fibrillation. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Eligible patient who were prescribed dabigatran, warfarin, apixaban, or edoxaban as the first OACs
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Dabigatran | Patients prescribed dabigatran as the first Oral Anticoagulants (OACs) with nonvalvular atrial fibrillation. |
| BG001 | Warfarin | Patients prescribed warfarin as the first Oral Anticoagulants (OACs) with nonvalvular atrial fibrillation. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Patients by Each Type of Study-target OAC Drug Prescribed for New Users of Anticoagulants With NVAF | Number of patients by each type of study-target OAC drug (dabigatran, warfarin, apixaban, rivaroxaban, or edoxaban) prescribed as the first Oral Anticoagulants (OAC) with Non-valvular atrial fibrillation (NVAF) | Patients prescribed dabigatran, warfarin, apixaban, rivaroxaban, or edoxaban as the first OAC | Posted | Count of Participants | Participants | Day 1 |
|
Not provided
The outcomes of the study were the baseline characteristics (pre-treatment) and medication prescriptions. The study was not desinged to assess adverse event; therefore safety reporting was not applicable for this study.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Dabigatran | Patients prescribed dabigatran as the first Oral Anticoagulants (OACs) with nonvalvular atrial fibrillation. |
Not provided
Not provided
Generalizability of findings may be limited outside of population. The data in Medical Data Vision Co., Ltd. (MDV) database is collected from DPC hospitals that may contain out-patient data with greater disease severity.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim, Call Center | Boehringer Ingelheim | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
Not provided
| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
Not provided
Not provided
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| Day 1 |
| Day 1 |
| Baseline Characteristics: Year of Initiating Treatment | Baseline characteristics of patients in each treatment group: year of initiating treatment | Day 1 |
| Baseline Characteristics: Speciality of Prescribers of OAC | Baseline characteristics of patients in each treatment group: speciality of prescribers of OAC. int.= internal; Med.= Medicine | Day 1 |
| Baseline Characteristics: History of Disease | Baseline characteristics of patients in each treatment group: history of disease and hospitalization. | Day 1 |
| Baseline Characteristics: History of Hospitalization | Baseline characteristics: history of hospitalization | Day 1 |
| Baseline Characteristics: AF Risk Score | Baseline characteristics of patients in each treatment group: Atrial Fibrillation (AF) risk score CHADS2: Congestive heart failure, Hypertension, Age, Diabetes, Stroke(doubled). CHADS2 score range from 0-6, with higher scores indicating the higher risk CHA2DS2VASc: Cardiac failure or dysfunction, Hypertension, Age 75 (doubled), Diabetes, Stroke (doubled) Vascular disease, Age 65-74 and Sex category (female) score. CHA2DS2VASc score range from 1-9, with higher scores indicating the higher risk. HAS-BLED: Hypertension, Abnormal renal function, Abnormal hepatic function. HAS-BLED score range from 0-8, with higher scores indicating the higher risk. | Day 1 |
| Baseline Characteristics: Concomitant Medication | Baseline characteristics of patients in each treatment group: concomitant medication | Day 1 |
| BG002 | Apixaban | Patients prescribed Apixaban as the first Oral Anticoagulants (OACs) with nonvalvular atrial fibrillation. |
| BG003 | Rivaroxaban | Patients prescribed Rivaroxaban as the first Oral Anticoagulants (OACs) with nonvalvular atrial fibrillation. |
| BG004 | Edoxaban | Patients prescribed Edoxaban as the first Oral Anticoagulants (OACs) with nonvalvular atrial fibrillation. |
| BG005 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG002 | Apixaban | Patients prescribed Apixaban as the first Oral Anticoagulants (OACs) with nonvalvular atrial fibrillation. |
| OG003 | Rivaroxaban | Patients prescribed Rivaroxaban as the first Oral Anticoagulants (OACs) with nonvalvular atrial fibrillation. |
| OG004 | Edoxaban | Patients prescribed Edoxaban as the first Oral Anticoagulants (OACs) with nonvalvular atrial fibrillation. |
|
|
| Primary | Number of Patients Prescribed OAC Drug Dabigatran by Dosage | Number of patients prescribed OAC drug dabigatran at the index date by dosage. If a patient had more than one prescriptions of an OAC at the day, the patient was multiple-counted. | eligible patients prescribed dabigatran, warfarin, apixaban, rivaroxaban, or edoxaban as the first OAC | Posted | Count of Participants | Participants | Day 1 |
|
|
|
| Primary | Number of Patients Prescribed OAC Drug Warfarin by Dosage | Number of patients prescribed OAC drug Warfarin at the index date by dosage. If a patient had more than one prescriptions of an OAC at the day, the patient was multiple-counted. | eligible patients prescribed dabigatran, warfarin, apixaban, rivaroxaban, or edoxaban as the first OAC | Posted | Count of Participants | Participants | Day 1 |
|
|
|
| Primary | Number of Patients Prescribed OAC Drug Rivaroxaban by Dosage | Number of patients prescribed OAC drug rivaroxaban at the index date by dosage. If a patient had more than one prescriptions of an OAC at the day, the patient was multiple-counted. | eligible patients prescribed dabigatran, warfarin, apixaban, rivaroxaban, or edoxaban as the first OAC | Posted | Count of Participants | Participants | Day 1 |
|
|
|
| Primary | Number of Patients Prescribed OAC Drug Apixaban by Dosage | Number of patients prescribed OAC drug Apixaban at the index date by dosage. If a patient had more than one prescriptions of an OAC at the day, the patient was multiple-counted. | eligible patients prescribed dabigatran, warfarin, apixaban, rivaroxaban, or edoxaban as the first OAC | Posted | Count of Participants | Participants | Day 1 |
|
|
|
| Primary | Number of Patients Prescribed OAC Drug Edoxaban by Dosage | Number of patients prescribed OAC drug edoxaban at the index date by dosage. If a patient had more than one prescriptions of an OAC at the day, the patient was multiple-counted. | eligible patients prescribed dabigatran, warfarin, apixaban, rivaroxaban, or edoxaban as the first OAC | Posted | Count of Participants | Participants | Day 1 |
|
|
|
| Secondary | Baseline Characteristics: Age | Baseline characteristics of patients in each treatment group: age | eligible patients prescribed dabigatran, warfarin, apixaban, rivaroxaban, or edoxaban as the first OAC | Posted | Mean | Standard Deviation | Years | 1 day |
|
|
|
| Secondary | Baseline Characteristics: Gender | Baseline characteristics of patients in each treatment group: gender | eligible patients prescribed dabigatran, warfarin, apixaban, rivaroxaban, or edoxaban as the first OAC | Posted | Count of Participants | Participants | Day 1 |
|
|
|
| Secondary | Baseline Characteristics: Year of Initiating Treatment | Baseline characteristics of patients in each treatment group: year of initiating treatment | eligible patients prescribed dabigatran, warfarin, apixaban, rivaroxaban, or edoxaban as the first OAC | Posted | Count of Participants | Participants | Day 1 |
|
|
|
| Secondary | Baseline Characteristics: Speciality of Prescribers of OAC | Baseline characteristics of patients in each treatment group: speciality of prescribers of OAC. int.= internal; Med.= Medicine | eligible patients prescribed dabigatran, warfarin, apixaban, rivaroxaban, or edoxaban as the first OAC | Posted | Count of Participants | Participants | Day 1 |
|
|
|
| Secondary | Baseline Characteristics: History of Disease | Baseline characteristics of patients in each treatment group: history of disease and hospitalization. | eligible patients prescribed dabigatran, warfarin, apixaban, rivaroxaban, or edoxaban as the first OAC | Posted | Count of Participants | Participants | Day 1 |
|
|
|
| Secondary | Baseline Characteristics: History of Hospitalization | Baseline characteristics: history of hospitalization | eligible patients prescribed dabigatran, warfarin, apixaban, rivaroxaban, or edoxaban as the first OAC | Posted | Count of Participants | Participants | Day 1 |
|
|
|
| Secondary | Baseline Characteristics: AF Risk Score | Baseline characteristics of patients in each treatment group: Atrial Fibrillation (AF) risk score CHADS2: Congestive heart failure, Hypertension, Age, Diabetes, Stroke(doubled). CHADS2 score range from 0-6, with higher scores indicating the higher risk CHA2DS2VASc: Cardiac failure or dysfunction, Hypertension, Age 75 (doubled), Diabetes, Stroke (doubled) Vascular disease, Age 65-74 and Sex category (female) score. CHA2DS2VASc score range from 1-9, with higher scores indicating the higher risk. HAS-BLED: Hypertension, Abnormal renal function, Abnormal hepatic function. HAS-BLED score range from 0-8, with higher scores indicating the higher risk. | eligible patients prescribed dabigatran, warfarin, apixaban, rivaroxaban, or edoxaban as the first OAC. | Posted | Count of Participants | Participants | Day 1 |
|
|
|
| Secondary | Baseline Characteristics: Concomitant Medication | Baseline characteristics of patients in each treatment group: concomitant medication | eligible patients prescribed dabigatran, warfarin, apixaban, rivaroxaban, or edoxaban as the first OAC | Posted | Count of Participants | Participants | Day 1 |
|
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Warfarin | Patients prescribed warfarin as the first Oral Anticoagulants (OACs) with nonvalvular atrial fibrillation. | 0 | 0 | 0 | 0 |
| EG002 | Apixaban | Patients prescribed Apixaban as the first Oral Anticoagulants (OACs) with nonvalvular atrial fibrillation. | 0 | 0 | 0 | 0 |
| EG003 | Rivaroxaban | Patients prescribed Rivaroxaban as the first Oral Anticoagulants (OACs) with nonvalvular atrial fibrillation. | 0 | 0 | 0 | 0 |
| EG004 | Edoxaban | Patients prescribed Edoxaban as the first Oral Anticoagulants (OACs) with nonvalvular atrial fibrillation. | 0 | 0 | 0 | 0 |
Not provided
Not provided
Not provided
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| Title | Measurements |
|---|---|
|
| 220 mg |
|
| 225 mg |
|
| 300 mg |
|
| 440 mg |
|
| Title | Measurements |
|---|
|
| 0.2 mg |
|
| 0.25 mg |
|
| 0.3 mg |
|
| 0.374 mg |
|
| 0.5 mg |
|
| 0.6 mg |
|
| 0.625 mg |
|
| 0.65 mg |
|
| 0.7 mg |
|
| 0.75 mg |
|
| 0.8 mg |
|
| 0.875 mg |
|
| 0.9 mg |
|
| 1 mg |
|
| 1.2 mg |
|
| 1.25 mg |
|
| 1.3 mg |
|
| 1.5 mg |
|
| 1.55 mg |
|
| 1.7 mg |
|
| 1.75 mg |
|
| 1.8 mg |
|
| 1.9 mg |
|
| 2 mg |
|
| 2.2 mg |
|
| 2.25 mg |
|
| 2.3 mg |
|
| 2.4 mg |
|
| 2.5 mg |
|
| 2.7 mg |
|
| 2.75 mg |
|
| 3 mg |
|
| 3.2 mg |
|
| 3.25 mg |
|
| 3.3 mg |
|
| 3.5 mg |
|
| 3.7 mg |
|
| 3.75 mg |
|
| 4 mg |
|
| 4.25 mg |
|
| 4.5 mg |
|
| 4.6 mg |
|
| 4.75 mg |
|
| 5 mg |
|
| 5.5 mg |
|
| 6 mg |
|
| 6.5 mg |
|
| 7 mg |
|
| 7.75 mg |
|
| 8 mg |
|
| 9 mg |
|
| 10 mg |
|
| 17.5 mg |
|
| 20 mg |
|
| 30 mg |
|
| 40 mg |
|
| 50 mg |
|
| Title | Measurements |
|---|
|
| 9.99 mg |
|
| 10 mg |
|
| 10.005 mg |
|
| 10.05 mg |
|
| 10.5 mg |
|
| 15 mg |
|
| 20 mg |
|
| 22.5 mg |
|
| 30 mg |
|
| Title | Measurements |
|---|
|
| 5 mg |
|
| 7.5 mg |
|
| 10 mg |
|
| 15 mg |
|
| 20 mg |
|
| 25 mg |
|
| 35 mg |
|
| Title | Measurements |
|---|
|
| Male |
|
| 2012/3/1-2013/2/28 |
|
| 2013/3/1-2014/2/28 |
|
| 2014/3/1-2015/2/28 |
|
| 2015/3/1-2016/2/29 |
|
| 2016/3/1-2016/6/30 |
|
| Psychodiagnosis medical |
|
| Psychiatry |
|
| Neurology |
|
| Respiratory |
|
| Gastroenterology |
|
| Cardiology |
|
| Allergy |
|
| Rheumatology |
|
| Pediatrics |
|
| Surgery |
|
| Orthopedics |
|
| Plastic surgery |
|
| Cranial nerve surgery |
|
| Thoracic surgery |
|
| Cardiovascular surgery |
|
| Pediatric surgery |
|
| Obstetrics and gynecology |
|
| Ophthalmology |
|
| Otorhinolaryngology |
|
| Rehabilitation |
|
| Radiology |
|
| Neuropathic internal medicine |
|
| Gastrointestinal |
|
| Dermatology |
|
| Urology |
|
| Gynecology |
|
| Respiratory medicine |
|
| Cardiovascular internal medicine |
|
| Diabetes |
|
| Nephrology |
|
| Hemodialysis |
|
| Metabolism internal medicine |
|
| Endocrinology |
|
| Emergency medicine |
|
| Gastroenterological medicine |
|
| Digestive surgery |
|
| Hepato-biliarypancreatic surgery |
|
| Diabetes medicine |
|
| Large intestine and proctology |
|
| Connective tissue disease & iheumatic int. med. |
|
| Stroke |
|
| Oncotherapy |
|
| Comprehensive medical care |
|
| Breast and thyroid surgery |
|
| Pediatric cardiology |
|
| Palliative care |
|
| Hematology & medical Oncology |
|
| Psychiatry & neurology |
|
| Endocrinology & metabolism |
|
| Unknown |
|
| Hematology |
|
| Anesthesiology |
|
| Myocardial infarction |
|
| Coronary artery disease |
|
| Heart failure |
|
| Diabetes mellitus |
|
| Dyslipidemia |
|
| Arterial hypertension |
|
| Peripheral artery disease |
|
| Peptic ulcer disease |
|
| Dementia |
|
| Malignant lymphoma |
|
| Leukemia |
|
| Solid tumor cancer |
|
| Kidney impairment |
|
| Liver disease |
|
| Valvular disease |
|
| Bleeding (gastrointestinal, etc.) |
|
| 1 (CHADS2) |
|
| 2 (CHADS2) |
|
| 3 (CHADS2) |
|
| 4 (CHADS2) |
|
| 5 (CHADS2) |
|
| 6 (CHADS2) |
|
| 0 (CHA2DS2VASc) |
|
| 1 (CHA2DS2VASc) |
|
| 2 (CHA2DS2VASc) |
|
| 3 (CHA2DS2VASc) |
|
| 4 (CHA2DS2VASc) |
|
| 5 (CHA2DS2VASc) |
|
| 6 (CHA2DS2VASc) |
|
| 7 (CHA2DS2VASc) |
|
| 8 (CHA2DS2VASc) |
|
| 9 (CHA2DS2VASc) |
|
| 0 (HAS-BLED) |
|
| 1 (HAS-BLED) |
|
| 2 (HAS-BLED) |
|
| 3 (HAS-BLED) |
|
| 4 (HAS-BLED) |
|
| 5 (HAS-BLED) |
|
| 6 (HAS-BLED) |
|
| 7 (HAS-BLED) |
|
| 8 (HAS-BLED) |
|
| Ticlodipine |
|
| Cilostazole |
|
| Clopidogrel |
|
| ARB or ACE |
|
| Beta blocker |
|
| Amiodarone |
|
| Procainamide |
|
| Disopyramide |
|
| Flecainide |
|
| Pilsicainide |
|
| Calcium channel blockers (CCB) |
|
| Digoxin |
|
| Diuretics |
|
| Statins |
|
| Proton pump inhibitor |
|
| H2 receptor antagonist |
|