Atrial Fibrillation | Indication Anticoagulation Therapy
Item
subjects diagnosed with non-valvular atrial fibrillation with an indication for the anticoagulation therapy,
boolean
C0004238 (UMLS CUI [1])
C3146298 (UMLS CUI [2,1])
C0003281 (UMLS CUI [2,2])
Renal Insufficiency Severe | Estimation of creatinine clearance by Cockcroft-Gault formula
Item
subjects with severe renal function impairment defined as creatinine clearance between 15 and 30 ml/min by cockcroft-gault formula,
boolean
C1565489 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C2711451 (UMLS CUI [2])
Age
Item
male and female patients, age =18 years at entry
boolean
C0001779 (UMLS CUI [1])
Medical contraindication Pradaxa | Hypersensitivity Serious Pradaxa | Hemorrhage | Mechanical heart valve prosthesis
Item
contraindications to pradaxa (history of a serious hypersensitivity reaction to pradaxa, active pathological bleeding, patients with mechanical prosthetic heart valve),
boolean
C1301624 (UMLS CUI [1,1])
C2940579 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0205404 (UMLS CUI [2,2])
C2940579 (UMLS CUI [2,3])
C0019080 (UMLS CUI [3])
C3873910 (UMLS CUI [4])
Creatinine clearance measurement | Kidney Failure, Chronic | Dialysis
Item
creatinine clearance <15ml/min or patients with end stage renal disease on dialysis,
boolean
C0373595 (UMLS CUI [1])
C0022661 (UMLS CUI [2])
C0011946 (UMLS CUI [3])
Creatinine clearance measurement
Item
creatinine clearance >30 ml/min,
boolean
C0373595 (UMLS CUI [1])
Premenopausal state | Breast Feeding | Pregnancy | Childbearing Potential Contraceptive methods Absent | Sexual Abstinence | Tubal Ligation | Transdermal patch as birth control method | Intrauterine Devices | Contraceptives, Oral | Contraceptive implant | Contraceptive injection | Barrier Contraception Double | Partner had vasectomy
Item
pre-menopausal women (last menstruation less than one year prior to informed consent) who are nursing or pregnant, or are of child bearing potential and are not practicing an acceptable method of birth control, or do not plan to continue using this method throughout the study. acceptable methods of birth control include abstinence, tubal ligation, transdermal patch, intra uterine devices/systems (iuds/iuss), oral, implantable or injectable contraceptives, double barrier method and vasectomised partner,
boolean
C0232969 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0032961 (UMLS CUI [3])
C3831118 (UMLS CUI [4,1])
C0700589 (UMLS CUI [4,2])
C0332197 (UMLS CUI [4,3])
C0036899 (UMLS CUI [5])
C0520483 (UMLS CUI [6])
C2135981 (UMLS CUI [7])
C0021900 (UMLS CUI [8])
C0009905 (UMLS CUI [9])
C1657106 (UMLS CUI [10])
C1656586 (UMLS CUI [11])
C0004764 (UMLS CUI [12,1])
C0205173 (UMLS CUI [12,2])
C0420842 (UMLS CUI [13])
Study Subject Participation Status | Investigational New Drugs
Item
patients who are participating in another drug study,
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
Study Subject Participation Status Previous | Investigational New Drugs
Item
patients who have participated in another drug study within 6 weeks,
boolean
C2348568 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
C0013230 (UMLS CUI [2])
Study Subject Participation Status | Protocol Compliance Unlikely
Item
patients considered unreliable by the investigator concerning the requirements for participating in the study, including a follow-up interview,
boolean
C2348568 (UMLS CUI [1])
C0525058 (UMLS CUI [2,1])
C0750558 (UMLS CUI [2,2])
Condition Study Subject Participation Status At risk
Item
any condition the investigator believes would not allow safe participation in the study,
boolean
C0348080 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
C1444641 (UMLS CUI [1,3])