ID

44037

Descrizione

This ODM-file contains the 'Eligibility Criteria' of the study. To be assessed at screening. Study ID: 106396 Clinical Study ID: TRX106396 Study Title: An open-label, randomized, single-dose, 2-period crossover study to evaluate sumatriptan pharmacokinetics for a TREXIMA™(sumatriptan 85mg and naproxen sodium 500mg)*, Tablet compared with an IMITREX® (sumatriptan) 100mg Tablet Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: sumatriptan Trade Name: Imitrex ,Imiject ,Imigran; Imitrex,Imiject,Imigran Study Indication: Migraine Disorders Sponsor: GlaxoSmithKline

Keywords

versioni (2)
  1. 26/09/18 26/09/18 -
  2. 20/09/21 20/09/21 -
Titolare del copyright

GlaxoSmithKline

Caricato su

20 settembre 2021

DOI

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Licenza

Creative Commons BY-NC-ND 3.0
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Sumatriptan pharmacokinetics TREXIMA and IMITREX tablet ID 106396

Inglese

Eligibility Criteria

1 moduli  
  1. StudyEvent: ODM
    1. Eligibility Criteria
Administrative Data
Descrizione

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject Identifier
Descrizione

Subject Identifier

Tipo di dati

text

Alias
UMLS CUI [1]
C2348585
Visit Date
Descrizione

Visit Date

Tipo di dati

date

Alias
UMLS CUI [1]
C1320303
Eligibility Question
Descrizione

Eligibility Question

Alias
UMLS CUI-1
C1516637
Did the subject meet all the entry criteria?
Descrizione

Eligibility

Tipo di dati

boolean

Alias
UMLS CUI [1]
C1516637
Inclusion Criteria
Descrizione

Inclusion Criteria

Alias
UMLS CUI-1
C1512693
Healthy, non-smoking (within 30 days of screening) adult males and females between 18 and 55 years of age, inclusive.
Descrizione

Note: Healthy subjects are defined as individuals who are free from clinically significant illness or disease as determined by their screening medical history, physical examination, clinical laboratory studies, ECG and other tests.

Tipo di dati

boolean

Alias
UMLS CUI [1]
C3898900
UMLS CUI [2]
C1519386
UMLS CUI [3]
C0079399
UMLS CUI [4]
C0001779
Female subjects are eligible for participation in the study if they are of: a) Non-childbearing potential (i.e., physiologically incapable of becoming pregnant); or, b) Childbearing potential, have a negative pregnancy test (urine or serum) at screening, one of the following applies: • Agree to complete abstinence from intercourse for at least 14 days prior to first dose of study medication, throughout the study, and for a time interval after completion of the study or premature discontinuation from the study to account for elimination of the investigational drug (a minimum of 3 days); or, • Female sterilization; or, • Sterilization of male partner; or, • Implants of levonorgestrel; or, • Injectable progestogen; or, • Oral contraceptive (combined or progestogen only); or • Any intrauterine device (IUD) with published data showing that the lowest expected failure rate is less than 1PERCENT per year (not all IUDs meet this criteria); or, • Double barrier method (2 physical barriers or 1 physical barrier plus spermicide); or • Any other method with published data showing that the lowest expected failure rate is less than 1PERCENT per year.
Descrizione

Pregnancy and contraceptive methods

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0427780
UMLS CUI [1,2]
C3831118
UMLS CUI [2,1]
C0700589
UMLS CUI [2,2]
C3831118
Any subject taking oral contraceptives or hormone replacement therapy (HRT) has been on a stable regimen for at least 2 months prior to screening.
Descrizione

Stable regimen of hormone treatment

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0279025
UMLS CUI [1,2]
C0205360
BMI: 20-30 kg/m2, inclusive.
Descrizione

BMI

Tipo di dati

boolean

Alias
UMLS CUI [1]
C1305855
Subject is willing and able to provide written informed consent.
Descrizione

Informed consent

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Descrizione

Exclusion Criteria

Alias
UMLS CUI-1
C0680251
History of impaired hepatic or renal function.
Descrizione

History of impaired hepatic or renal function

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0086565
UMLS CUI [2]
C1565489
Subjects with a current migraine diagnosis.
Descrizione

Current migraine diagnosis

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0149931
Subject has confirmed or suspected ischemic heart disease (e.g., angina pectoris, history of myocardial infarction, documented silent ischemia), Prinzmetal’s angina or signs/symptoms consistent with any of the above.
Descrizione

Confirmed or suspected Ischemic heart disease such as angina pectoris, Prinzmetal’s angina

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0151744
UMLS CUI [2]
C0002962
UMLS CUI [3]
C0002963
Subject has cardiac arrhythmias requiring medication or a history of clinically significant electrocardiogram abnormality that, in the investigator’s opinion, contraindicates participation in this study.
Descrizione

Cardiac arrhythmias requiring medication or a history of clinically significant electrocardiogram abnormality contraindicating the study participation

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0003811
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C0013227
UMLS CUI [2,1]
C0522055
UMLS CUI [2,2]
C2985739
UMLS CUI [2,3]
C1301624
UMLS CUI [2,4]
C2348568
Subject has a history of congenital heart disease.
Descrizione

Congenital heart disease

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0152021
Subject has a history of cerebrovascular pathology including stroke
Descrizione

History of cerebrovascular pathology including stroke

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0007820
UMLS CUI [2]
C0559159
The subject, in the investigator’s opinion, is likely to have unrecognized cardiovascular or cerebrovascular disease.
Descrizione

Likely to have unrecognized cardiovascular or cerebrovascular disease

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0007222
UMLS CUI [1,2]
C4288068
UMLS CUI [2,1]
C0007820
UMLS CUI [2,2]
C4288068
Subject has a positive hepatitis B surface antigen or hepatitis C antibody or HIV test within 84 days of the start of the study.
Descrizione

Infection status of hepatitis B, hepatitis C and HIV

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0149709
UMLS CUI [2]
C0281863
UMLS CUI [3]
C0019699
Subject has evidence or history of ischemic abdominal syndromes, peripheral vascular disease or Raynaud’s Syndrome.
Descrizione

Ischemic abdominal syndromes, peripheral vascular disease or Raynaud’s Syndrome

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0034734
UMLS CUI [2]
C0085096
UMLS CUI [3,1]
C0022116
UMLS CUI [3,2]
C0000726
Subject has uncontrolled hypertension at screening (sitting systolic pressure >= 140mm/Hg, diastolic pressure >= 90mm/Hg).
Descrizione

Uncontrolled hypertension

Tipo di dati

boolean

Alias
UMLS CUI [1]
C1868885
UMLS CUI [2]
C0871470
UMLS CUI [3]
C0428883
Treatment with an investigational drug within 30 days preceding the first dose of study medication.
Descrizione

Recent treatment with an investigational drug

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0332185
Subject is currently taking a monoamine oxidase inhibitor (MAOI) or has taken a MAOI within the 2 weeks prior to screening.
Descrizione

Current or recent treatment with a monoamine oxidase inhibitor (MAOI)

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0026457
UMLS CUI [1,2]
C2827774
UMLS CUI [2,1]
C0026457
UMLS CUI [2,2]
C0332185
Use of other prescription or non-prescription drugs, vitamins, herbal and dietary supplements, within 7 days (14 days for St John's wort) prior to the first dose of study medication.
Descrizione

Excluded from this list are: acetaminophen at doses of =< 2 grams/day, low-dose aspirin =< 325mg/day for cardioprotective reasons and contraceptives as detailed in Inclusion Criteria 2 and 3 above.

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0013231
UMLS CUI [2]
C0304227
UMLS CUI [3]
C0042890
UMLS CUI [4]
C1504473
UMLS CUI [5]
C0242295
Positive serum beta-human chorionic gonadotropin (beta-hCG) test (females).
Descrizione

Positive serum beta-hCG test

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C1255526
UMLS CUI [1,2]
C1446409
Pregnant or nursing females.
Descrizione

Pregnant or nursing females

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
Subjects with a history of drug or alcohol abuse.
Descrizione

History of drug or alcohol abuse

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0038586
History of regular alcohol consumption exceeding 7 drinks/week for females or 14 drinks/week for men (1 drink = 5 ounces of wine or 12 ounces of beer or 1.5 ounces of hard liquor) within 6 months of screening.
Descrizione

Regular Alcohol consumption as measured by alcohol units/week

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0001948
UMLS CUI [1,2]
C0205272
UMLS CUI [1,3]
C0560579
Positive urine drug screen (UDS) including alcohol at screening.
Descrizione

Positive urine drug screening including alcohol

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0743300
UMLS CUI [1,2]
C0332257
UMLS CUI [1,3]
C1112219
Donation of blood in excess of 500 mL within 56 days prior to first dose of study medication.
Descrizione

Donation of blood

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0005794
History of hypersensitivity, intolerance or contraindication to the use of sumatriptan or naproxen sodium or any of their components or aspirin or any other 5-HT1 receptor agonist.
Descrizione

History of hypersensitivity, intolerance or contraindication to the use of sumatriptan or naproxen sodium or any of their components or aspirin or any other 5-HT1 receptor agonist.

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0075632
UMLS CUI [2,1]
C0277585
UMLS CUI [2,2]
C0075632
UMLS CUI [3,1]
C1301624
UMLS CUI [3,2]
C0075632
UMLS CUI [4,1]
C0020517
UMLS CUI [4,2]
C0027396
UMLS CUI [5,1]
C0277585
UMLS CUI [5,2]
C0027396
UMLS CUI [6,1]
C0020517
UMLS CUI [6,2]
C0027396
UMLS CUI [7,1]
C1301624
UMLS CUI [7,2]
C0027396
UMLS CUI [8,1]
C0020517
UMLS CUI [8,2]
C0004057
UMLS CUI [9,1]
C0277585
UMLS CUI [9,2]
C0004057
UMLS CUI [10,1]
C1301624
UMLS CUI [10,2]
C0004057
UMLS CUI [11,1]
C0020517
UMLS CUI [11,2]
C0162754
UMLS CUI [12,1]
C0277585
UMLS CUI [12,2]
C0162754
UMLS CUI [13,1]
C1301624
UMLS CUI [13,2]
C0162754
History of allergic reactions to naproxen preparations, including subject in whom aspirin or other NSAID drugs induce the symdrome of asthma, rhinitis and nasal polyps.
Descrizione

Hypersensitivity to naproxen and/or aspiring or other nsaid drugs

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0003211
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0004057
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C0003211
History of gastrointestinal surgery that specifically indicates a past history of bleeding, ulceration or perforation.
Descrizione

Gastrointestinal surgery due to bleeding, ulceration or perforation

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C1963975
UMLS CUI [1,2]
C0543467
UMLS CUI [2,1]
C0017181
UMLS CUI [2,2]
C0543467
UMLS CUI [3,1]
C0151664
UMLS CUI [3,2]
C0543467
History of gastric bypass or stapling surgery.
Descrizione

History of gastric bypass or stapling surgery

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0149701
UMLS CUI [2]
C0017125
History of GI ulceration or gastrointestinal bleeding.
Descrizione

History of GI ulceration or gastrointestinal bleeding

Tipo di dati

boolean

Alias
UMLS CUI [1]
C1963975
UMLS CUI [2]
C0017181
History of any bleeding disorder.
Descrizione

History of bleeding disorder

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0005779
History of inflammatory bowel disease.
Descrizione

History of inflammatory bowel disease

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0021390
Taking anti-platlet agents (except low-dose aspirin < 325mg/day for cardioprotective reasons).
Descrizione

Treatment with anti-platelet agent (except low-dose aspirin)

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0085826
UMLS CUI [1,2]
C0332300
UMLS CUI [1,3]
C2608320
Taking angiotensin-converting enzyme (ACE) inhibitors or angiotensin receptor blockers.
Descrizione

Taking angiotensin-converting enzyme (ACE) inhibitors or angiotensin receptor blockers

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0003015
UMLS CUI [2]
C0521942
History of sensitivity to heparin, heparin-induced thrombocytopenia or sensitivity to any of the study medications or components thereof.
Descrizione

History of sensitivity to heparin, heparin-induced thrombocytopenia or sensitivity the study medications or components

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0019134
UMLS CUI [2,1]
C0262926
UMLS CUI [2,2]
C0272285
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C1521826
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Similar models

Eligibility Criteria

1 moduli
  1. StudyEvent: ODM
    1. Eligibility Criteria
Name
genere
Description | Question | Decode (Coded Value)
Tipo di dati
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Subject Identifier
Item
Subject Identifier
text
C2348585 (UMLS CUI [1])
Visit Date
Item
Visit Date
date
C1320303 (UMLS CUI [1])
Item Group
Eligibility Question
C1516637 (UMLS CUI-1)
Eligibility
Item
Did the subject meet all the entry criteria?
boolean
C1516637 (UMLS CUI [1])
Item Group
Inclusion Criteria
C1512693 (UMLS CUI-1)
Healthy, non-smoking adult males and females between 18 and 55 years of age
Item
Healthy, non-smoking (within 30 days of screening) adult males and females between 18 and 55 years of age, inclusive.
boolean
C3898900 (UMLS CUI [1])
C1519386 (UMLS CUI [2])
C0079399 (UMLS CUI [3])
C0001779 (UMLS CUI [4])
Pregnancy and contraceptive methods
Item
Female subjects are eligible for participation in the study if they are of: a) Non-childbearing potential (i.e., physiologically incapable of becoming pregnant); or, b) Childbearing potential, have a negative pregnancy test (urine or serum) at screening, one of the following applies: • Agree to complete abstinence from intercourse for at least 14 days prior to first dose of study medication, throughout the study, and for a time interval after completion of the study or premature discontinuation from the study to account for elimination of the investigational drug (a minimum of 3 days); or, • Female sterilization; or, • Sterilization of male partner; or, • Implants of levonorgestrel; or, • Injectable progestogen; or, • Oral contraceptive (combined or progestogen only); or • Any intrauterine device (IUD) with published data showing that the lowest expected failure rate is less than 1PERCENT per year (not all IUDs meet this criteria); or, • Double barrier method (2 physical barriers or 1 physical barrier plus spermicide); or • Any other method with published data showing that the lowest expected failure rate is less than 1PERCENT per year.
boolean
C0427780 (UMLS CUI [1,1])
C3831118 (UMLS CUI [1,2])
C0700589 (UMLS CUI [2,1])
C3831118 (UMLS CUI [2,2])
Stable regimen of hormone treatment
Item
Any subject taking oral contraceptives or hormone replacement therapy (HRT) has been on a stable regimen for at least 2 months prior to screening.
boolean
C0279025 (UMLS CUI [1,1])
C0205360 (UMLS CUI [1,2])
BMI
Item
BMI: 20-30 kg/m2, inclusive.
boolean
C1305855 (UMLS CUI [1])
Informed consent
Item
Subject is willing and able to provide written informed consent.
boolean
C0021430 (UMLS CUI [1])
Item Group
Exclusion Criteria
C0680251 (UMLS CUI-1)
History of impaired hepatic or renal function
Item
History of impaired hepatic or renal function.
boolean
C0086565 (UMLS CUI [1])
C1565489 (UMLS CUI [2])
Current migraine diagnosis
Item
Subjects with a current migraine diagnosis.
boolean
C0149931 (UMLS CUI [1])
Confirmed or suspected Ischemic heart disease such as angina pectoris, Prinzmetal’s angina
Item
Subject has confirmed or suspected ischemic heart disease (e.g., angina pectoris, history of myocardial infarction, documented silent ischemia), Prinzmetal’s angina or signs/symptoms consistent with any of the above.
boolean
C0151744 (UMLS CUI [1])
C0002962 (UMLS CUI [2])
C0002963 (UMLS CUI [3])
Cardiac arrhythmias requiring medication or a history of clinically significant electrocardiogram abnormality contraindicating the study participation
Item
Subject has cardiac arrhythmias requiring medication or a history of clinically significant electrocardiogram abnormality that, in the investigator’s opinion, contraindicates participation in this study.
boolean
C0003811 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,3])
C0522055 (UMLS CUI [2,1])
C2985739 (UMLS CUI [2,2])
C1301624 (UMLS CUI [2,3])
C2348568 (UMLS CUI [2,4])
Congenital heart disease
Item
Subject has a history of congenital heart disease.
boolean
C0152021 (UMLS CUI [1])
History of cerebrovascular pathology including stroke
Item
Subject has a history of cerebrovascular pathology including stroke
boolean
C0007820 (UMLS CUI [1])
C0559159 (UMLS CUI [2])
Likely to have unrecognized cardiovascular or cerebrovascular disease
Item
The subject, in the investigator’s opinion, is likely to have unrecognized cardiovascular or cerebrovascular disease.
boolean
C0007222 (UMLS CUI [1,1])
C4288068 (UMLS CUI [1,2])
C0007820 (UMLS CUI [2,1])
C4288068 (UMLS CUI [2,2])
Infection status of hepatitis B, hepatitis C and HIV
Item
Subject has a positive hepatitis B surface antigen or hepatitis C antibody or HIV test within 84 days of the start of the study.
boolean
C0149709 (UMLS CUI [1])
C0281863 (UMLS CUI [2])
C0019699 (UMLS CUI [3])
Ischemic abdominal syndromes, peripheral vascular disease or Raynaud’s Syndrome
Item
Subject has evidence or history of ischemic abdominal syndromes, peripheral vascular disease or Raynaud’s Syndrome.
boolean
C0034734 (UMLS CUI [1])
C0085096 (UMLS CUI [2])
C0022116 (UMLS CUI [3,1])
C0000726 (UMLS CUI [3,2])
Uncontrolled hypertension
Item
Subject has uncontrolled hypertension at screening (sitting systolic pressure >= 140mm/Hg, diastolic pressure >= 90mm/Hg).
boolean
C1868885 (UMLS CUI [1])
C0871470 (UMLS CUI [2])
C0428883 (UMLS CUI [3])
Recent treatment with an investigational drug
Item
Treatment with an investigational drug within 30 days preceding the first dose of study medication.
boolean
C0304229 (UMLS CUI [1,1])
C0332185 (UMLS CUI [1,2])
Current or recent treatment with a monoamine oxidase inhibitor (MAOI)
Item
Subject is currently taking a monoamine oxidase inhibitor (MAOI) or has taken a MAOI within the 2 weeks prior to screening.
boolean
C0026457 (UMLS CUI [1,1])
C2827774 (UMLS CUI [1,2])
C0026457 (UMLS CUI [2,1])
C0332185 (UMLS CUI [2,2])
Use of other prescription or non-prescription drugs, vitamins, herbal and dietary supplements
Item
Use of other prescription or non-prescription drugs, vitamins, herbal and dietary supplements, within 7 days (14 days for St John's wort) prior to the first dose of study medication.
boolean
C0013231 (UMLS CUI [1])
C0304227 (UMLS CUI [2])
C0042890 (UMLS CUI [3])
C1504473 (UMLS CUI [4])
C0242295 (UMLS CUI [5])
Positive serum beta-hCG test
Item
Positive serum beta-human chorionic gonadotropin (beta-hCG) test (females).
boolean
C1255526 (UMLS CUI [1,1])
C1446409 (UMLS CUI [1,2])
Pregnant or nursing females
Item
Pregnant or nursing females.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
History of drug or alcohol abuse
Item
Subjects with a history of drug or alcohol abuse.
boolean
C0262926 (UMLS CUI [1,1])
C0038586 (UMLS CUI [1,2])
Regular Alcohol consumption as measured by alcohol units/week
Item
History of regular alcohol consumption exceeding 7 drinks/week for females or 14 drinks/week for men (1 drink = 5 ounces of wine or 12 ounces of beer or 1.5 ounces of hard liquor) within 6 months of screening.
boolean
C0001948 (UMLS CUI [1,1])
C0205272 (UMLS CUI [1,2])
C0560579 (UMLS CUI [1,3])
Positive urine drug screening including alcohol
Item
Positive urine drug screen (UDS) including alcohol at screening.
boolean
C0743300 (UMLS CUI [1,1])
C0332257 (UMLS CUI [1,2])
C1112219 (UMLS CUI [1,3])
Donation of blood
Item
Donation of blood in excess of 500 mL within 56 days prior to first dose of study medication.
boolean
C0005794 (UMLS CUI [1])
History of hypersensitivity, intolerance or contraindication to the use of sumatriptan or naproxen sodium or any of their components or aspirin or any other 5-HT1 receptor agonist.
Item
History of hypersensitivity, intolerance or contraindication to the use of sumatriptan or naproxen sodium or any of their components or aspirin or any other 5-HT1 receptor agonist.
boolean
C0020517 (UMLS CUI [1,1])
C0075632 (UMLS CUI [1,2])
C0277585 (UMLS CUI [2,1])
C0075632 (UMLS CUI [2,2])
C1301624 (UMLS CUI [3,1])
C0075632 (UMLS CUI [3,2])
C0020517 (UMLS CUI [4,1])
C0027396 (UMLS CUI [4,2])
C0277585 (UMLS CUI [5,1])
C0027396 (UMLS CUI [5,2])
C0020517 (UMLS CUI [6,1])
C0027396 (UMLS CUI [6,2])
C1301624 (UMLS CUI [7,1])
C0027396 (UMLS CUI [7,2])
C0020517 (UMLS CUI [8,1])
C0004057 (UMLS CUI [8,2])
C0277585 (UMLS CUI [9,1])
C0004057 (UMLS CUI [9,2])
C1301624 (UMLS CUI [10,1])
C0004057 (UMLS CUI [10,2])
C0020517 (UMLS CUI [11,1])
C0162754 (UMLS CUI [11,2])
C0277585 (UMLS CUI [12,1])
C0162754 (UMLS CUI [12,2])
C1301624 (UMLS CUI [13,1])
C0162754 (UMLS CUI [13,2])
Hypersensitivity to naproxen and/or aspiring or other nsaid drugs
Item
History of allergic reactions to naproxen preparations, including subject in whom aspirin or other NSAID drugs induce the symdrome of asthma, rhinitis and nasal polyps.
boolean
C0020517 (UMLS CUI [1,1])
C0003211 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0004057 (UMLS CUI [2,2])
C0020517 (UMLS CUI [3,1])
C0003211 (UMLS CUI [3,2])
Gastrointestinal surgery due to bleeding, ulceration or perforation
Item
History of gastrointestinal surgery that specifically indicates a past history of bleeding, ulceration or perforation.
boolean
C1963975 (UMLS CUI [1,1])
C0543467 (UMLS CUI [1,2])
C0017181 (UMLS CUI [2,1])
C0543467 (UMLS CUI [2,2])
C0151664 (UMLS CUI [3,1])
C0543467 (UMLS CUI [3,2])
History of gastric bypass or stapling surgery
Item
History of gastric bypass or stapling surgery.
boolean
C0149701 (UMLS CUI [1])
C0017125 (UMLS CUI [2])
History of GI ulceration or gastrointestinal bleeding
Item
History of GI ulceration or gastrointestinal bleeding.
boolean
C1963975 (UMLS CUI [1])
C0017181 (UMLS CUI [2])
History of bleeding disorder
Item
History of any bleeding disorder.
boolean
C0005779 (UMLS CUI [1])
History of inflammatory bowel disease
Item
History of inflammatory bowel disease.
boolean
C0021390 (UMLS CUI [1])
Treatment with anti-platelet agent (except low-dose aspirin)
Item
Taking anti-platlet agents (except low-dose aspirin < 325mg/day for cardioprotective reasons).
boolean
C0085826 (UMLS CUI [1,1])
C0332300 (UMLS CUI [1,2])
C2608320 (UMLS CUI [1,3])
Taking angiotensin-converting enzyme (ACE) inhibitors or angiotensin receptor blockers
Item
Taking angiotensin-converting enzyme (ACE) inhibitors or angiotensin receptor blockers.
boolean
C0003015 (UMLS CUI [1])
C0521942 (UMLS CUI [2])
History of sensitivity to heparin, heparin-induced thrombocytopenia or sensitivity the study medications or components
Item
History of sensitivity to heparin, heparin-induced thrombocytopenia or sensitivity to any of the study medications or components thereof.
boolean
C0020517 (UMLS CUI [1,1])
C0019134 (UMLS CUI [1,2])
C0262926 (UMLS CUI [2,1])
C0272285 (UMLS CUI [2,2])
C0020517 (UMLS CUI [3,1])
C1521826 (UMLS CUI [3,2])
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