ID

34785

Description

Therapeutic Equivalence Between Branded and Generic Warfarin Tablets in Brazil; ODM derived from: https://clinicaltrials.gov/show/NCT02017197

Link

https://clinicaltrials.gov/show/NCT02017197

Keywords

Versions (1)
  1. 1/28/19 1/28/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

January 28, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Atrial Fibrillation NCT02017197

English

Eligibility Atrial Fibrillation NCT02017197

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
diagnosis of nonvalvular atrial fibrillation by electrocardiogram and echocardiography;
Description

Atrial Fibrillation Electrocardiogram | Atrial Fibrillation Echocardiography | Involvement with Heart Valve Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C0004238
UMLS CUI [1,2]
C0013798
UMLS CUI [2,1]
C0004238
UMLS CUI [2,2]
C0013516
UMLS CUI [3,1]
C1314939
UMLS CUI [3,2]
C0018826
UMLS CUI [3,3]
C0332197
cha2ds2vasc score equal to or greater than 1;
Description

CHA2DS2-VASc score

Data type

boolean

Alias
UMLS CUI [1]
C4049268
already in use of warfarin;
Description

Warfarin therapy

Data type

boolean

Alias
UMLS CUI [1]
C4303340
signing of informed consent form.
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients with contraindications to the use of anticoagulants (patients either taking other anticoagulants, or with active bleeding, or hypersensitive to warfarin or with ulcers);
Description

Medical contraindication Anticoagulants | Use of Anticoagulants Other | Hemorrhage | Warfarin allergy | Ulcer

Data type

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0003280
UMLS CUI [2,1]
C1524063
UMLS CUI [2,2]
C0003280
UMLS CUI [2,3]
C0205394
UMLS CUI [3]
C0019080
UMLS CUI [4]
C0571785
UMLS CUI [5]
C0041582
women of childbearing age, pregnant or breastfeeding;
Description

Childbearing Potential | Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C3831118
UMLS CUI [2]
C0032961
UMLS CUI [3]
C0006147
patients with thrombocytopenia;
Description

Thrombocytopenia

Data type

boolean

Alias
UMLS CUI [1]
C0040034
patients with hepatic or renal impairment;
Description

Hepatic impairment | Renal Insufficiency

Data type

boolean

Alias
UMLS CUI [1]
C0948807
UMLS CUI [2]
C1565489
patients with a history of bleeding episodes due to congenital deficiency of coagulation factors;
Description

Bleeding episodes Due to Coagulation factor deficiency

Data type

boolean

Alias
UMLS CUI [1,1]
C1970394
UMLS CUI [1,2]
C0678226
UMLS CUI [1,3]
C0272315
patients enrolled in another trial;
Description

Study Subject Participation Status

Data type

boolean

Alias
UMLS CUI [1]
C2348568
patients not achieving at least 70% ttr in the run-in period
Description

Time Range INR Percentage failed

Data type

boolean

Alias
UMLS CUI [1,1]
C1554109
UMLS CUI [1,2]
C0525032
UMLS CUI [1,3]
C0439165
UMLS CUI [1,4]
C0231175
patients initiating treatment with drugs with either moderate or major interactions or which are contraindicated when used concomitantly with warfarin, according to our list (annex i).
Description

Pharmacotherapy Drug Interactions Moderate | Pharmacotherapy Drug Interactions Major | Medical contraindication Pharmacotherapy | Relationship Warfarin

Data type

boolean

Alias
UMLS CUI [1,1]
C0013216
UMLS CUI [1,2]
C0687133
UMLS CUI [1,3]
C0205081
UMLS CUI [2,1]
C0013216
UMLS CUI [2,2]
C0687133
UMLS CUI [2,3]
C0205164
UMLS CUI [3,1]
C1301624
UMLS CUI [3,2]
C0013216
UMLS CUI [4,1]
C0439849
UMLS CUI [4,2]
C0043031
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Similar models

Eligibility Atrial Fibrillation NCT02017197

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Atrial Fibrillation Electrocardiogram | Atrial Fibrillation Echocardiography | Involvement with Heart Valve Absent
Item
diagnosis of nonvalvular atrial fibrillation by electrocardiogram and echocardiography;
boolean
C0004238 (UMLS CUI [1,1])
C0013798 (UMLS CUI [1,2])
C0004238 (UMLS CUI [2,1])
C0013516 (UMLS CUI [2,2])
C1314939 (UMLS CUI [3,1])
C0018826 (UMLS CUI [3,2])
C0332197 (UMLS CUI [3,3])
CHA2DS2-VASc score
Item
cha2ds2vasc score equal to or greater than 1;
boolean
C4049268 (UMLS CUI [1])
Warfarin therapy
Item
already in use of warfarin;
boolean
C4303340 (UMLS CUI [1])
Informed Consent
Item
signing of informed consent form.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Medical contraindication Anticoagulants | Use of Anticoagulants Other | Hemorrhage | Warfarin allergy | Ulcer
Item
patients with contraindications to the use of anticoagulants (patients either taking other anticoagulants, or with active bleeding, or hypersensitive to warfarin or with ulcers);
boolean
C1301624 (UMLS CUI [1,1])
C0003280 (UMLS CUI [1,2])
C1524063 (UMLS CUI [2,1])
C0003280 (UMLS CUI [2,2])
C0205394 (UMLS CUI [2,3])
C0019080 (UMLS CUI [3])
C0571785 (UMLS CUI [4])
C0041582 (UMLS CUI [5])
Childbearing Potential | Pregnancy | Breast Feeding
Item
women of childbearing age, pregnant or breastfeeding;
boolean
C3831118 (UMLS CUI [1])
C0032961 (UMLS CUI [2])
C0006147 (UMLS CUI [3])
Thrombocytopenia
Item
patients with thrombocytopenia;
boolean
C0040034 (UMLS CUI [1])
Hepatic impairment | Renal Insufficiency
Item
patients with hepatic or renal impairment;
boolean
C0948807 (UMLS CUI [1])
C1565489 (UMLS CUI [2])
Bleeding episodes Due to Coagulation factor deficiency
Item
patients with a history of bleeding episodes due to congenital deficiency of coagulation factors;
boolean
C1970394 (UMLS CUI [1,1])
C0678226 (UMLS CUI [1,2])
C0272315 (UMLS CUI [1,3])
Study Subject Participation Status
Item
patients enrolled in another trial;
boolean
C2348568 (UMLS CUI [1])
Time Range INR Percentage failed
Item
patients not achieving at least 70% ttr in the run-in period
boolean
C1554109 (UMLS CUI [1,1])
C0525032 (UMLS CUI [1,2])
C0439165 (UMLS CUI [1,3])
C0231175 (UMLS CUI [1,4])
Pharmacotherapy Drug Interactions Moderate | Pharmacotherapy Drug Interactions Major | Medical contraindication Pharmacotherapy | Relationship Warfarin
Item
patients initiating treatment with drugs with either moderate or major interactions or which are contraindicated when used concomitantly with warfarin, according to our list (annex i).
boolean
C0013216 (UMLS CUI [1,1])
C0687133 (UMLS CUI [1,2])
C0205081 (UMLS CUI [1,3])
C0013216 (UMLS CUI [2,1])
C0687133 (UMLS CUI [2,2])
C0205164 (UMLS CUI [2,3])
C1301624 (UMLS CUI [3,1])
C0013216 (UMLS CUI [3,2])
C0439849 (UMLS CUI [4,1])
C0043031 (UMLS CUI [4,2])
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