Atrial Fibrillation | Indication Electric Countershock | Initiation Anticoagulation Therapy
Item
subjects with non-valvular atrial fibrillation indicated for cardioversion and initiation of anticoagulation in accordance with the approved local label.
boolean
C0004238 (UMLS CUI [1])
C3146298 (UMLS CUI [2,1])
C0013778 (UMLS CUI [2,2])
C1704686 (UMLS CUI [3,1])
C0003281 (UMLS CUI [3,2])
Age | Japan
Item
age ≥18 years (age ≥ 20 years for japan only).
boolean
C0001779 (UMLS CUI [1])
C0022341 (UMLS CUI [2])
Informed Consent | Informed Consent Patient Representative
Item
evidence of a personally signed and dated informed consent document indicating that the subject (or their legally-recognized representative) has been informed of all pertinent aspects of the study.
boolean
C0021430 (UMLS CUI [1])
C0021430 (UMLS CUI [2,1])
C0030701 (UMLS CUI [2,2])
Contact Person Alternate
Item
the subject is willing to provide contact details for at least one alternate person for study staff to contact regarding their whereabouts, should the subject be lost-to-follow-up over the course of the study. (subject to irb/iec approval)
boolean
C0332158 (UMLS CUI [1,1])
C0027361 (UMLS CUI [1,2])
C1523987 (UMLS CUI [1,3])
Childbearing Potential Sexually active Contraceptive methods
Item
female subjects of childbearing potential must agree to use a highly effective method of contraception throughout the study and for at least 28 days after the last dose of assigned treatment. a subject is of childbearing potential if, in the opinion of the investigator, she is biologically capable of having children and is sexually active.
boolean
C3831118 (UMLS CUI [1,1])
C0241028 (UMLS CUI [1,2])
C0700589 (UMLS CUI [1,3])
Protocol Compliance
Item
subjects who are willing and able to comply with scheduled visits, treatment plan, and other study procedures.
boolean
C0525058 (UMLS CUI [1])
Oral anticoagulants | Anticoagulants Parenteral
Item
subjects having taken more than 48 hours of an anticoagulant (oral and/or parenteral) immediately prior to randomization.
boolean
C0354604 (UMLS CUI [1])
C0003280 (UMLS CUI [2,1])
C1518896 (UMLS CUI [2,2])
Medical contraindication Apixaban | Medical contraindication Standard of Care | Medical contraindication Vitamin K antagonists
Item
contraindications to apixaban or usual care (eg, vka) in accordance with the approved local label.
boolean
C1301624 (UMLS CUI [1,1])
C1831808 (UMLS CUI [1,2])
C1301624 (UMLS CUI [2,1])
C2936643 (UMLS CUI [2,2])
C1301624 (UMLS CUI [3,1])
C3653316 (UMLS CUI [3,2])
Impairment Hemodynamic Severe | Requirement Emergency Electric Countershock
Item
severe haemodynamically compromised subjects requiring emergent cardioversion.
boolean
C0221099 (UMLS CUI [1,1])
C0019010 (UMLS CUI [1,2])
C0205082 (UMLS CUI [1,3])
C1514873 (UMLS CUI [2,1])
C0013956 (UMLS CUI [2,2])
C0013778 (UMLS CUI [2,3])
Mitral Stenosis Hemodynamic Significant | Prosthetic valve | Prosthetic valve biological | Valve Repair
Item
patients with hemodynamically significant mitral stenosis, mechanical or biological prosthetic valve or valve repair.
boolean
C0026269 (UMLS CUI [1,1])
C0019010 (UMLS CUI [1,2])
C0750502 (UMLS CUI [1,3])
C0336548 (UMLS CUI [2])
C0336548 (UMLS CUI [3,1])
C0205460 (UMLS CUI [3,2])
C1186983 (UMLS CUI [4,1])
C4319951 (UMLS CUI [4,2])
Condition Requirement Chronic anticoagulation | Exception Atrial Fibrillation | Heart Valve Prosthesis
Item
conditions other than atrial fibrillation that require chronic anticoagulation (eg, a prosthetic heart valve).
boolean
C0348080 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0694554 (UMLS CUI [1,3])
C1705847 (UMLS CUI [2,1])
C0004238 (UMLS CUI [2,2])
C0018825 (UMLS CUI [3])
Combined Modality Therapy | Aspirin | Thienopyridines | clopidogrel | Ticlopidine | prasugrel
Item
simultaneous treatment with both aspirin and a thienopyridine (eg, clopidogrel, ticlopidine, prasugrel)
boolean
C0009429 (UMLS CUI [1])
C0004057 (UMLS CUI [2])
C2936588 (UMLS CUI [3])
C0070166 (UMLS CUI [4])
C0040207 (UMLS CUI [5])
C1620287 (UMLS CUI [6])
Pregnancy | Breast Feeding | Childbearing Potential Contraceptive methods Unwilling | Childbearing Potential Contraceptive methods Unable
Item
pregnant females; breastfeeding females; females of childbearing potential who are unwilling or unable to use a highly effective method of contraception as outlined in this protocol for the duration of the study and for at least 28 days after last dose of investigational product.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C3831118 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
C0558080 (UMLS CUI [3,3])
C3831118 (UMLS CUI [4,1])
C0700589 (UMLS CUI [4,2])
C1299582 (UMLS CUI [4,3])
Study Subject Participation Status | Investigational New Drugs
Item
participation in other studies involving investigational drug(s) (phases 1-4) within 30 days before the current study begins and/or during study participation. note: subjects cannot be randomized into this study more than once.
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
Disease Study Subject Participation Status At risk | Disease Investigational New Drugs At risk | Disease Interferes with Interpretation Research results | Disease Study Subject Participation Status Inappropriate | Chronic disease Study Subject Participation Status At risk | Chronic disease Investigational New Drugs At risk | Chronic disease Interferes with Interpretation Research results | Chronic disease Study Subject Participation Status Inappropriate | Mental disorder Study Subject Participation Status At risk | Mental disorder Investigational New Drugs At risk | Mental disorder Interferes with Interpretation Research results | Mental disorder Study Subject Participation Status Inappropriate | Laboratory test result abnormal Study Subject Participation Status At risk | Laboratory test result abnormal Investigational New Drugs At risk | Laboratory test result abnormal Interferes with Interpretation Research results | Laboratory test result abnormal Study Subject Participation Status Inappropriate
Item
severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.
boolean
C0012634 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
C1444641 (UMLS CUI [1,3])
C0012634 (UMLS CUI [2,1])
C0013230 (UMLS CUI [2,2])
C1444641 (UMLS CUI [2,3])
C0012634 (UMLS CUI [3,1])
C0521102 (UMLS CUI [3,2])
C0459471 (UMLS CUI [3,3])
C0683954 (UMLS CUI [3,4])
C0012634 (UMLS CUI [4,1])
C2348568 (UMLS CUI [4,2])
C1548788 (UMLS CUI [4,3])
C0008679 (UMLS CUI [5,1])
C2348568 (UMLS CUI [5,2])
C1444641 (UMLS CUI [5,3])
C0008679 (UMLS CUI [6,1])
C0013230 (UMLS CUI [6,2])
C1444641 (UMLS CUI [6,3])
C0008679 (UMLS CUI [7,1])
C0521102 (UMLS CUI [7,2])
C0459471 (UMLS CUI [7,3])
C0683954 (UMLS CUI [7,4])
C0008679 (UMLS CUI [8,1])
C2348568 (UMLS CUI [8,2])
C1548788 (UMLS CUI [8,3])
C0004936 (UMLS CUI [9,1])
C2348568 (UMLS CUI [9,2])
C1444641 (UMLS CUI [9,3])
C0004936 (UMLS CUI [10,1])
C0013230 (UMLS CUI [10,2])
C1444641 (UMLS CUI [10,3])
C0004936 (UMLS CUI [11,1])
C0521102 (UMLS CUI [11,2])
C0459471 (UMLS CUI [11,3])
C0683954 (UMLS CUI [11,4])
C0004936 (UMLS CUI [12,1])
C2348568 (UMLS CUI [12,2])
C1548788 (UMLS CUI [12,3])
C0438215 (UMLS CUI [13,1])
C2348568 (UMLS CUI [13,2])
C1444641 (UMLS CUI [13,3])
C0438215 (UMLS CUI [14,1])
C0013230 (UMLS CUI [14,2])
C1444641 (UMLS CUI [14,3])
C0438215 (UMLS CUI [15,1])
C0521102 (UMLS CUI [15,2])
C0459471 (UMLS CUI [15,3])
C0683954 (UMLS CUI [15,4])
C0438215 (UMLS CUI [16,1])
C2348568 (UMLS CUI [16,2])
C1548788 (UMLS CUI [16,3])
Member Research Personnel | Involvement with Completion of clinical trial
Item
subjects who are investigational site staff members directly involved in the conduct of the trial and their family members, site staff members otherwise supervised by the investigator, or subjects who are bms/pfizer employees directly involved in the conduct of the trial.
boolean
C0680022 (UMLS CUI [1,1])
C0035173 (UMLS CUI [1,2])
C1314939 (UMLS CUI [2,1])
C2732579 (UMLS CUI [2,2])