0 Ratings
ID

42623

Description

Study ID: 102146 Clinical Study ID: SUM102146 Study Title: An open-label, randomized, three-period crossover study to demonstrate the bioequivalence of sumatriptan 4 mg STATdose to IMITREX™ 6 mg STATdose after dose-normalization, and to assess the relative bioavailability of 4 mg sumatriptan injected using the STATdose device compared to 4 mg sumatriptan injected manually 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 Study Indication: Migraine Disorders

Keywords

Versions (2)
  1. 6/23/19 6/23/19 -
  2. 9/17/21 9/17/21 -
Copyright Holder

GlaxoSmithKline

Uploaded on

September 17, 2021

DOI

To request one please log in.

License

Creative Commons BY-NC 3.0
Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Back to model comments
Itemgroup comments for :

Item comments for :

  • Newest
  • Oldest
  • Popular
  • Newest
    • Newest
    • Oldest
    • Popular

    No comments

    In order to download data models you must be logged in. Please log in or register for free.

    Bioequivalence of Sumatriptan 4 mg STATdose to IMITREX™ 6 mg STATdose; 102146

    English

    Screen

    1 forms  
    1. StudyEvent: ODM
      1. Screen
    Administrative Data
    Description

    Administrative Data

    Alias
    UMLS CUI-1
    C1320722
    Subject number
    Description

    Clinical Trial Subject Unique Identifier

    Data type

    integer

    Alias
    UMLS CUI [1]
    C2348585
    Inclusion Criteria
    Description

    Inclusion Criteria

    Alias
    UMLS CUI-1
    C1512693
    Is the subject a healthy adult male or female between 18 and 55 years of age, inclusive?
    Description

    Health Status; Age; Gender

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0018759
    UMLS CUI [2]
    C0079399
    UMLS CUI [3]
    C0001779
    Is the subject male, or an eligible female?
    Description

    Female subjects are eligible for participation in the study if they are of: Yes No DD DD 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, and 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 12.5 hours); 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 1% per year (not all IUDs meet this criteria); or, • Double barrier method (2 physical barriers or 1 physical barrier plus spermicidal); or • Any other method with published data showing that the lowest expected failure rate is less than 1% per year.

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0079399
    UMLS CUI [2]
    C3831118
    UMLS CUI [3]
    C0700589
    Is the subject male, a female of non-childbearing potential, or a female taking oral contraceptives or HRT and has been on a stable regimen for at least 2 months prior to screening?
    Description

    Gender; Childbearing Potential; Contraceptive methods

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0079399
    UMLS CUI [2]
    C3831118
    UMLS CUI [3]
    C0700589
    Is the subject's BMI 20-30 kg/m2, inclusive?
    Description

    Body mass index

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1305855
    Has a signed and dated written informed consent been obtained from the subject?
    Description

    Informed Consent

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0021430
    Exclusion Criteria
    Description

    Exclusion Criteria

    Alias
    UMLS CUI-1
    C0680251
    Does the subject have any clinically relevant abnormality identified on the screening history and physical or laboratory examination?
    Description

    Abnormality, Clinically Significant Indicator

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C1704258
    UMLS CUI [1,2]
    C2985739
    Does the subject have a history of impaired hepatic or renal function?
    Description

    Liver Dysfunction, Medical History; Renal Insufficiency, Medical History

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0086565
    UMLS CUI [1,2]
    C0262926
    UMLS CUI [2,1]
    C1565489
    UMLS CUI [2,2]
    C0262926
    Does the subject suffer from migraine attacks?
    Description

    Migraine Disorders

    Data type

    text

    Alias
    UMLS CUI [1]
    C0149931
    Does the subject have 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?
    Description

    Myocardial Ischemia; Angina pectoris

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0151744
    UMLS CUI [2]
    C0002962
    Does the subject have cardiac arrhythmias requiring medication or a history of a clinically significant electrocardiogram abnormality that, in the investigator’s opinion, contraindicates participation in this study?
    Description

    Cardiac Arrhythmia; Electrocardiography, Abnormality, Relevance, Clinical

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0003811
    UMLS CUI [2,1]
    C1623258
    UMLS CUI [2,2]
    C1704258
    UMLS CUI [2,3]
    C2347946
    UMLS CUI [2,4]
    C0205210
    Does the subject have a history of congenital heart disease?
    Description

    Congenital heart disease, Medical History

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0152021
    UMLS CUI [1,2]
    C0262926
    Does the subject have a history of cerebrovascular pathology including stroke?
    Description

    Cerebrovascular Disorders, Medical History

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0007820
    UMLS CUI [1,2]
    C0262926
    Is the subject, in the investigator’s opinion, likely to have unrecognized cardiovascular or cerebrovascular disease?
    Description

    Cardiovascular Diseases; Cerebrovascular Disorders

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0007222
    UMLS CUI [2]
    C0007820
    Does the subject have evidence or history of ischemic abdominal syndromes, peripheral vascular disease or Raynaud Syndrome?
    Description

    Ischemic, Abdomen; Peripheral Vascular Disease; Raynaud Syndrome

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0022116
    UMLS CUI [1,2]
    C0000726
    UMLS CUI [2]
    C0085096
    UMLS CUI [3]
    C0034734
    Does the subject have uncontrolled hypertension at screening (sitting systolic pressure >140mm/Hg, diastolic pressure >90mm/Hg)?
    Description

    Uncontrolled hypertension

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1868885
    Has the subject had treatment with an investigational drug within 30 days preceding the first dose of study medication?
    Description

    Experimental drug, Previous

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0304229
    UMLS CUI [1,2]
    C0205156
    Has the subject used other prescription or non-prescription drugs, vitamins, herbal and dietary supplements, within 7 days prior to the first dose of study medication? NOTE: Excluded from this list are: acetaminophen at doses of <2 grams/day and contraceptives as detailed in Section 8.1 of the protocol).
    Description

    Pharmaceutical Preparations; Vitamins, Herbal supplements; Dietary Supplements

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0013227
    UMLS CUI [2]
    C0042890
    UMLS CUI [3]
    C1504473
    UMLS CUI [4]
    C0242295
    Does the subject have a positive serum beta-human chorionic gonadotropin (β-hCG) test (females) at screening or check-in?
    Description

    Pregnancy test positive

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0240802
    Is the subject a pregnant or nursing female?
    Description

    Pregnancy; Breast Feeding

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0032961
    UMLS CUI [1,2]
    C0006147
    Does the subject have a history of drug or alcohol abuse?
    Description

    Drug Abuse; Alcohol Abuse

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0013146
    UMLS CUI [2]
    C0085762
    Does the subject have a 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?
    Description

    Alcohol consumption, Regular

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0001948
    UMLS CUI [1,2]
    C0205272
    Does the subject have a positive urine drug screen (UDS) including alcohol at screening or check-in?
    Description

    Urine drug screen positive

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0743300
    Has the subject donated blood in excess of 500 mL within 56 days prior to first dose of study medication?
    Description

    Blood Donation

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0005794
    Does the subject have a history of allergic, anaphylactic, hypersensitivity or idiosyncratic reaction(s) to sumatriptan or drugs of a similar type, including sulphonamides?
    Description

    Sumatriptan, Hypersensitivity

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0075632
    UMLS CUI [1,2]
    C0020517
    Does the subject smoke more than 10 cigarettes per day?
    Description

    Tobacco use

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0543414
    Does the subject have a history of sensitivity to heparin, heparin-induced thrombocytopenia or sensitivity to any of the study medications or components thereof?
    Description

    Heparin, Hypersensitivity; Heparin-induced Thrombocytopenia; Experimental drug, Hypersensitivity

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0020517
    UMLS CUI [1,2]
    C0019134
    UMLS CUI [2]
    C0272285
    UMLS CUI [3,1]
    C0304229
    UMLS CUI [3,2]
    C0020517
    Demography
    Description

    Demography

    Alias
    UMLS CUI-1
    C0011298
    Date of assessment
    Description

    Demography, Assessment date

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0011298
    UMLS CUI [1,2]
    C2985720
    Date of birth
    Description

    Patient date of birth

    Data type

    date

    Alias
    UMLS CUI [1]
    C0421451
    Sex
    Description

    Gender

    Data type

    text

    Alias
    UMLS CUI [1]
    C0079399
    Race
    Description

    Racial group

    Data type

    text

    Alias
    UMLS CUI [1]
    C0034510
    Height
    Description

    Body Height

    Data type

    integer

    Measurement units
    • cm
    Alias
    UMLS CUI [1]
    C0005890
    cm
    Weight
    Description

    Body Weight

    Data type

    float

    Measurement units
    • kg
    Alias
    UMLS CUI [1]
    C0005890
    kg
    Body mass index
    Description

    Body mass index

    Data type

    float

    Measurement units
    • kg/m2
    Alias
    UMLS CUI [1]
    C1305855
    kg/m2
    Vital Signs
    Description

    Vital Signs

    Alias
    UMLS CUI-1
    C0518766
    Date
    Description

    Vital Signs Date

    Data type

    date

    Alias
    UMLS CUI [1]
    C2826644
    Blood pressure systolic
    Description

    Systolic Pressure

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0871470
    Blood pressure diastolic
    Description

    Diastolic blood pressure

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0428883
    Heart rate
    Description

    Heart rate

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0018810
    Demography for Females
    Description

    Demography for Females

    Alias
    UMLS CUI-1
    C0011298
    UMLS CUI-2
    C0086287
    Childbearing potential
    Description

    Childbearing Potential

    Data type

    text

    Alias
    UMLS CUI [1]
    C3831118
    Pregnancy test result
    Description

    Pregnancy test finding

    Data type

    text

    Alias
    UMLS CUI [1]
    C0427777
    Medical history
    Description

    Medical history

    Alias
    UMLS CUI-1
    C0262926
    Organ
    Description

    Medical History, body system or organ function

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0262926
    UMLS CUI [1,2]
    C0678852
    Medical Condition
    Description

    Mediacal History, Disease

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0262926
    UMLS CUI [1,2]
    C0012634
    Description
    Description

    Mediacal History, Description

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0262926
    UMLS CUI [1,2]
    C0678257
    Current Medical Conditions
    Description

    Current Medical Conditions

    Alias
    UMLS CUI-1
    C0012634
    UMLS CUI-2
    C0521116
    Organ
    Description

    Disease, Current, body system or organ function

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0012634
    UMLS CUI [1,2]
    C0521116
    UMLS CUI [1,3]
    C0678852
    Medical Condition?
    Description

    Disease, Current

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0012634
    UMLS CUI [1,2]
    C0521116
    Description
    Description

    Disease, Current, Description

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0012634
    UMLS CUI [1,2]
    C0521116
    UMLS CUI [1,3]
    C0678257
    Medication History
    Description

    Medication History

    Alias
    UMLS CUI-1
    C0013227
    UMLS CUI-2
    C0262926
    Were any medications taken by the subject within 30 days prior to screening?
    Description

    Pharmaceutical Preparations, Medical History

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0013227
    UMLS CUI [1,2]
    C0262926
    Drug (Trade name preferred)
    Description

    Pharmaceutical Preparations, Medical History, Medication name

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0013227
    UMLS CUI [1,2]
    C0262926
    UMLS CUI [1,3]
    C2360065
    Date started
    Description

    Pharmaceutical Preparations, Medical History, Start Date

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0013227
    UMLS CUI [1,2]
    C0262926
    UMLS CUI [1,3]
    C0808070
    Check if started Pre-study
    Description

    Pharmaceutical Preparations, Medical History, Start Date, Pre-study

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0013227
    UMLS CUI [1,2]
    C0262926
    UMLS CUI [1,3]
    C0808070
    Date stopped
    Description

    Pharmaceutical Preparations, Medical History, End Date

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0013227
    UMLS CUI [1,2]
    C0262926
    UMLS CUI [1,3]
    C0806020
    if continued Post-study
    Description

    Pharmaceutical Preparations, Medical History, Continuous

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0013227
    UMLS CUI [1,2]
    C0262926
    UMLS CUI [1,3]
    C0549178
    Physical Examination
    Description

    Physical Examination

    Alias
    UMLS CUI-1
    C0031809
    Date of assessment
    Description

    Physical Examination Date

    Data type

    date

    Alias
    UMLS CUI [1]
    C2826643
    Organ
    Description

    Physical Examination, body function or organ system

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0031809
    UMLS CUI [1,2]
    C0678852
    Not Done
    Description

    Physical Examination, Not Done

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0031809
    UMLS CUI [1,2]
    C1272696
    Normal or abnormal?
    Description

    Physical Examination, Abnormality

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0031809
    UMLS CUI [1,2]
    C1704258
    Description
    Description

    Physical Examination, Description

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0031809
    UMLS CUI [1,2]
    C0678257
    Electrocardiogram
    Description

    Electrocardiogram

    Alias
    UMLS CUI-1
    C1623258
    Date of ECG
    Description

    Electrocardiogram Date

    Data type

    date

    Alias
    UMLS CUI [1]
    C2826640
    Time
    Description

    Electrocardiogram, Time

    Data type

    time

    Alias
    UMLS CUI [1,1]
    C0013798
    UMLS CUI [1,2]
    C0040223
    Ventricular rate/heart rate
    Description

    Electrocardiography, Heart rate

    Data type

    integer

    Measurement units
    • bpm
    Alias
    UMLS CUI [1,1]
    C1623258
    UMLS CUI [1,2]
    C0018810
    bpm
    PR interval
    Description

    Electrocardiogram: P-R interval

    Data type

    integer

    Measurement units
    • msec
    Alias
    UMLS CUI [1]
    C0429087
    msec
    QRS duration
    Description

    Electrocardiography, QRS complex duration

    Data type

    integer

    Measurement units
    • msec
    Alias
    UMLS CUI [1,1]
    C1623258
    UMLS CUI [1,2]
    C0429025
    msec
    QT interval
    Description

    Electrocardiography, QT interval - finding

    Data type

    integer

    Measurement units
    • msec
    Alias
    UMLS CUI [1,1]
    C1623258
    UMLS CUI [1,2]
    C1287082
    msec
    QTc interval
    Description

    Electrocardiography, QTc interval

    Data type

    integer

    Measurement units
    • msec
    Alias
    UMLS CUI [1,1]
    C1623258
    UMLS CUI [1,2]
    C0489625
    msec
    Abnormalities?
    Description

    Electrocardiography, Abnormality

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C1623258
    UMLS CUI [1,2]
    C1704258
    Were any of the abnormalities clinically significant?
    Description

    Electrocardiography, Abnormality, Clinical Significance

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C1623258
    UMLS CUI [1,2]
    C1704258
    UMLS CUI [1,3]
    C2826293
    Rhythm
    Description

    Electrocardiography, Abnormality, Rhythm

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C1623258
    UMLS CUI [1,2]
    C1704258
    UMLS CUI [1,3]
    C0199556
    P-Wave Morphology
    Description

    Electrocardiography, Abnormality, P-Wave shifting Morphology

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C1623258
    UMLS CUI [1,2]
    C1704258
    UMLS CUI [1,3]
    C2216025
    Conduction
    Description

    Electrocardiography, Abnormality, Cardiac Conduction

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C1623258
    UMLS CUI [1,2]
    C1704258
    UMLS CUI [1,3]
    C0232217
    Depolarization/Repolarization (QRS-T)
    Description

    Electrocardiography, Abnormality, Depolarization, Repolarization

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C1623258
    UMLS CUI [1,2]
    C1704258
    UMLS CUI [1,3]
    C1331539
    UMLS CUI [1,4]
    C3279217
    Other
    Description

    Electrocardiography, Abnormality, Other

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C1623258
    UMLS CUI [1,2]
    C1704258
    UMLS CUI [1,3]
    C0205394
    Comment
    Description

    Electrocardiography, Abnormality, Comment

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C1623258
    UMLS CUI [1,2]
    C1704258
    UMLS CUI [1,3]
    C0947611
    Laboratory Data Abnormalities - Hematology Abnormalities
    Description

    Laboratory Data Abnormalities - Hematology Abnormalities

    Alias
    UMLS CUI-1
    C0022885
    UMLS CUI-2
    C1704258
    UMLS CUI-3
    C0474523
    Lab code
    Description

    Laboratory, Code

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0022877
    UMLS CUI [1,2]
    C0805701
    Date hematology sample taken
    Description

    Laboratory Procedures, Hematology finding, Sampling, Date in time

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0022885
    UMLS CUI [1,2]
    C0474523
    UMLS CUI [1,3]
    C0870078
    UMLS CUI [1,4]
    C0011008
    Time of sample
    Description

    Laboratory Procedures, Hematology finding, Sampling, Time

    Data type

    time

    Alias
    UMLS CUI [1,1]
    C0022885
    UMLS CUI [1,2]
    C0474523
    UMLS CUI [1,3]
    C0870078
    UMLS CUI [1,4]
    C0040223
    Were there any clinically significant hematology abnormalities?
    Description

    Laboratory Procedures, Hematology finding, Abnormality, Clinical Significance

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0022885
    UMLS CUI [1,2]
    C0474523
    UMLS CUI [1,3]
    C1704258
    UMLS CUI [1,4]
    C2826293
    Laboratory Data Abnormalities - Clinical Chemistry Abnormalities
    Description

    Laboratory Data Abnormalities - Clinical Chemistry Abnormalities

    Alias
    UMLS CUI-1
    C0022885
    UMLS CUI-2
    C0008000
    UMLS CUI-3
    C1704258
    Lab code
    Description

    Laboratory, Code

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0022877
    UMLS CUI [1,2]
    C0805701
    Date clinical chemistry sample taken
    Description

    Laboratory Procedures, Chemistry, Clinical, Sampling, Date in time

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0022885
    UMLS CUI [1,2]
    C0008000
    UMLS CUI [1,3]
    C0870078
    UMLS CUI [1,4]
    C0011008
    Time of sample
    Description

    Laboratory Procedures, Chemistry, Clinical, Sampling, Time

    Data type

    time

    Alias
    UMLS CUI [1,1]
    C0022885
    UMLS CUI [1,2]
    C0008000
    UMLS CUI [1,3]
    C0870078
    UMLS CUI [1,4]
    C0040223
    Were there any clinically significant clinical chemistry abnormalities?
    Description

    Laboratory Procedures, Chemistry, Clinical, Abnormality, Clinical Significance

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0022885
    UMLS CUI [1,2]
    C0008000
    UMLS CUI [1,3]
    C1704258
    UMLS CUI [1,4]
    C2826293
    Laboratory Data Abnormalities - Urinalysis Abnormalities
    Description

    Laboratory Data Abnormalities - Urinalysis Abnormalities

    Alias
    UMLS CUI-1
    C0022885
    UMLS CUI-2
    C0042014
    UMLS CUI-3
    C1704258
    Lab code
    Description

    Laboratory, Code

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0022877
    UMLS CUI [1,2]
    C0805701
    Date sample taken
    Description

    Laboratory Procedures, Urinalysis , Sampling, Date in time

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0022885
    UMLS CUI [1,2]
    C0042014
    UMLS CUI [1,3]
    C0870078
    UMLS CUI [1,4]
    C0011008
    Time of sample
    Description

    Laboratory Procedures, Urinalysis , Sampling, Time

    Data type

    time

    Alias
    UMLS CUI [1,1]
    C0022885
    UMLS CUI [1,2]
    C0042014
    UMLS CUI [1,3]
    C0870078
    UMLS CUI [1,4]
    C0040223
    Were there any clinically significant urinalysis abnormalities?
    Description

    Laboratory Procedures, Urinalysis, Abnormality, Clinical Significance

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0022885
    UMLS CUI [1,2]
    C0042014
    UMLS CUI [1,3]
    C1704258
    UMLS CUI [1,4]
    C2826293
    Drugs of Abuse
    Description

    Drugs of Abuse

    Alias
    UMLS CUI-1
    C0013146
    Date sample taken
    Description

    Drug screen, Sampling, Date in time

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0373483
    UMLS CUI [1,2]
    C0870078
    UMLS CUI [1,3]
    C0011008
    Drug
    Description

    Drug screen, Illicit Drugs

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0373483
    UMLS CUI [1,2]
    C0086190
    Result
    Description

    Drug screen, Result

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0373483
    UMLS CUI [1,2]
    C1274040
    Serology / HIV Screen
    Description

    Serology / HIV Screen

    Alias
    UMLS CUI-1
    C0036743
    UMLS CUI-2
    C0459958
    Date sample taken
    Description

    Serologic tests, HIV Screen, Sampling, Date in time

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0036743
    UMLS CUI [1,2]
    C0459958
    UMLS CUI [1,3]
    C0870078
    UMLS CUI [1,4]
    C0011008
    Hepatitis B surface antigen
    Description

    Serologic tests, Hepatitis B surface antigen

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0036743
    UMLS CUI [1,2]
    C0019168
    Hepatitis C antibody
    Description

    Serologic tests, Hepatitis C antibody measurement

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0036743
    UMLS CUI [1,2]
    C0201487
    HIV antibody
    Description

    HIV screen, HIV antibodies

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0459958
    UMLS CUI [1,2]
    C0019683
    Treatment Assignment
    Description

    Treatment Assignment

    Alias
    UMLS CUI-1
    C0087111
    UMLS CUI-2
    C1516050
    Check the appropriate box to indicate the study cohort to which the subject is assigned:
    Description

    Therapeutic procedure, Assignment

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0087111
    UMLS CUI [1,2]
    C1516050
    Back to the top of the page

    Similar models

    Screen

    1 forms
    1. StudyEvent: ODM
      1. Screen
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Administrative Data
    C1320722 (UMLS CUI-1)
    Clinical Trial Subject Unique Identifier
    Item
    Subject number
    integer
    C2348585 (UMLS CUI [1])
    Item Group
    Inclusion Criteria
    C1512693 (UMLS CUI-1)
    Health Status; Age; Gender
    Item
    Is the subject a healthy adult male or female between 18 and 55 years of age, inclusive?
    boolean
    C0018759 (UMLS CUI [1])
    C0079399 (UMLS CUI [2])
    C0001779 (UMLS CUI [3])
    Gender; Childbearing Potential; Contraceptive methods
    Item
    Is the subject male, or an eligible female?
    boolean
    C0079399 (UMLS CUI [1])
    C3831118 (UMLS CUI [2])
    C0700589 (UMLS CUI [3])
    Gender; Childbearing Potential; Contraceptive methods
    Item
    Is the subject male, a female of non-childbearing potential, or a female taking oral contraceptives or HRT and has been on a stable regimen for at least 2 months prior to screening?
    boolean
    C0079399 (UMLS CUI [1])
    C3831118 (UMLS CUI [2])
    C0700589 (UMLS CUI [3])
    Body mass index
    Item
    Is the subject's BMI 20-30 kg/m2, inclusive?
    boolean
    C1305855 (UMLS CUI [1])
    Informed Consent
    Item
    Has a signed and dated written informed consent been obtained from the subject?
    boolean
    C0021430 (UMLS CUI [1])
    Item Group
    Exclusion Criteria
    C0680251 (UMLS CUI-1)
    Abnormality, Clinically Significant Indicator
    Item
    Does the subject have any clinically relevant abnormality identified on the screening history and physical or laboratory examination?
    boolean
    C1704258 (UMLS CUI [1,1])
    C2985739 (UMLS CUI [1,2])
    Liver Dysfunction, Medical History; Renal Insufficiency, Medical History
    Item
    Does the subject have a history of impaired hepatic or renal function?
    boolean
    C0086565 (UMLS CUI [1,1])
    C0262926 (UMLS CUI [1,2])
    C1565489 (UMLS CUI [2,1])
    C0262926 (UMLS CUI [2,2])
    Migraine Disorders
    Item
    Does the subject suffer from migraine attacks?
    text
    C0149931 (UMLS CUI [1])
    Myocardial Ischemia; Angina pectoris
    Item
    Does the subject have 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])
    Cardiac Arrhythmia; Electrocardiography, Abnormality, Relevance, Clinical
    Item
    Does the subject have cardiac arrhythmias requiring medication or a history of a clinically significant electrocardiogram abnormality that, in the investigator’s opinion, contraindicates participation in this study?
    boolean
    C0003811 (UMLS CUI [1])
    C1623258 (UMLS CUI [2,1])
    C1704258 (UMLS CUI [2,2])
    C2347946 (UMLS CUI [2,3])
    C0205210 (UMLS CUI [2,4])
    Congenital heart disease, Medical History
    Item
    Does the subject have a history of congenital heart disease?
    boolean
    C0152021 (UMLS CUI [1,1])
    C0262926 (UMLS CUI [1,2])
    Cerebrovascular Disorders, Medical History
    Item
    Does the subject have a history of cerebrovascular pathology including stroke?
    boolean
    C0007820 (UMLS CUI [1,1])
    C0262926 (UMLS CUI [1,2])
    Cardiovascular Diseases; Cerebrovascular Disorders
    Item
    Is the subject, in the investigator’s opinion, likely to have unrecognized cardiovascular or cerebrovascular disease?
    boolean
    C0007222 (UMLS CUI [1])
    C0007820 (UMLS CUI [2])
    Ischemic, Abdomen; Peripheral Vascular Disease; Raynaud Syndrome
    Item
    Does the subject have evidence or history of ischemic abdominal syndromes, peripheral vascular disease or Raynaud Syndrome?
    boolean
    C0022116 (UMLS CUI [1,1])
    C0000726 (UMLS CUI [1,2])
    C0085096 (UMLS CUI [2])
    C0034734 (UMLS CUI [3])
    Uncontrolled hypertension
    Item
    Does the subject have uncontrolled hypertension at screening (sitting systolic pressure >140mm/Hg, diastolic pressure >90mm/Hg)?
    boolean
    C1868885 (UMLS CUI [1])
    Experimental drug, Previous
    Item
    Has the subject had treatment with an investigational drug within 30 days preceding the first dose of study medication?
    boolean
    C0304229 (UMLS CUI [1,1])
    C0205156 (UMLS CUI [1,2])
    Pharmaceutical Preparations; Vitamins, Herbal supplements; Dietary Supplements
    Item
    Has the subject used other prescription or non-prescription drugs, vitamins, herbal and dietary supplements, within 7 days prior to the first dose of study medication? NOTE: Excluded from this list are: acetaminophen at doses of <2 grams/day and contraceptives as detailed in Section 8.1 of the protocol).
    boolean
    C0013227 (UMLS CUI [1])
    C0042890 (UMLS CUI [2])
    C1504473 (UMLS CUI [3])
    C0242295 (UMLS CUI [4])
    Pregnancy test positive
    Item
    Does the subject have a positive serum beta-human chorionic gonadotropin (β-hCG) test (females) at screening or check-in?
    boolean
    C0240802 (UMLS CUI [1])
    Pregnancy; Breast Feeding
    Item
    Is the subject a pregnant or nursing female?
    boolean
    C0032961 (UMLS CUI [1,1])
    C0006147 (UMLS CUI [1,2])
    Drug Abuse; Alcohol Abuse
    Item
    Does the subject have a history of drug or alcohol abuse?
    boolean
    C0013146 (UMLS CUI [1])
    C0085762 (UMLS CUI [2])
    Alcohol consumption, Regular
    Item
    Does the subject have a 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])
    Urine drug screen positive
    Item
    Does the subject have a positive urine drug screen (UDS) including alcohol at screening or check-in?
    boolean
    C0743300 (UMLS CUI [1])
    Blood Donation
    Item
    Has the subject donated blood in excess of 500 mL within 56 days prior to first dose of study medication?
    boolean
    C0005794 (UMLS CUI [1])
    Sumatriptan, Hypersensitivity
    Item
    Does the subject have a history of allergic, anaphylactic, hypersensitivity or idiosyncratic reaction(s) to sumatriptan or drugs of a similar type, including sulphonamides?
    boolean
    C0075632 (UMLS CUI [1,1])
    C0020517 (UMLS CUI [1,2])
    Tobacco use
    Item
    Does the subject smoke more than 10 cigarettes per day?
    boolean
    C0543414 (UMLS CUI [1])
    Heparin, Hypersensitivity; Heparin-induced Thrombocytopenia; Experimental drug, Hypersensitivity
    Item
    Does the subject have a history of sensitivity to heparin, heparin-induced thrombocytopenia or sensitivity to any of the study medications or components thereof?
    text
    C0020517 (UMLS CUI [1,1])
    C0019134 (UMLS CUI [1,2])
    C0272285 (UMLS CUI [2])
    C0304229 (UMLS CUI [3,1])
    C0020517 (UMLS CUI [3,2])
    Item Group
    Demography
    C0011298 (UMLS CUI-1)
    Demography, Assessment date
    Item
    Date of assessment
    date
    C0011298 (UMLS CUI [1,1])
    C2985720 (UMLS CUI [1,2])
    Patient date of birth
    Item
    Date of birth
    date
    C0421451 (UMLS CUI [1])
    Item
    Sex
    text
    C0079399 (UMLS CUI [1])
    Gender
    Code List
    Sex
    CL Item
    Male (1)
    CL Item
    Female (2)
    Item
    Race
    text
    C0034510 (UMLS CUI [1])
    Racial group
    Code List
    Race
    CL Item
    White (1)
    CL Item
    Black (2)
    CL Item
    Asian (3)
    CL Item
    American Hispanic (4)
    CL Item
    Other (5)
    Body Height
    Item
    Height
    integer
    C0005890 (UMLS CUI [1])
    Body Weight
    Item
    Weight
    float
    C0005890 (UMLS CUI [1])
    Body mass index
    Item
    Body mass index
    float
    C1305855 (UMLS CUI [1])
    Item Group
    Vital Signs
    C0518766 (UMLS CUI-1)
    Vital Signs Date
    Item
    Date
    date
    C2826644 (UMLS CUI [1])
    Systolic Pressure
    Item
    Blood pressure systolic
    integer
    C0871470 (UMLS CUI [1])
    Diastolic blood pressure
    Item
    Blood pressure diastolic
    integer
    C0428883 (UMLS CUI [1])
    Heart rate
    Item
    Heart rate
    integer
    C0018810 (UMLS CUI [1])
    Item Group
    Demography for Females
    C0011298 (UMLS CUI-1)
    C0086287 (UMLS CUI-2)
    Item
    Childbearing potential
    text
    C3831118 (UMLS CUI [1])
    Childbearing Potential
    Code List
    Childbearing potential
    CL Item
    Premenarcheal  (1)
    CL Item
    Sterile (of childbearing age)  (2)
    CL Item
    Postmenopausal (3)
    CL Item
    Potentially able to conceive children (4)
    Item
    Pregnancy test result
    text
    C0427777 (UMLS CUI [1])
    Pregnancy test finding
    Code List
    Pregnancy test result
    CL Item
    Positive  (1)
    CL Item
    Negative  (2)
    CL Item
    Not applicable (3)
    Item Group
    Medical history
    C0262926 (UMLS CUI-1)
    Item
    Organ
    text
    C0262926 (UMLS CUI [1,1])
    C0678852 (UMLS CUI [1,2])
    Medical History, body system or organ function
    Code List
    Organ
    CL Item
    Ear, Nose and Throat (1)
    CL Item
    Eyes (2)
    CL Item
    Respiratory (3)
    CL Item
    Cardiovascular (4)
    CL Item
    Gastrointestinal (5)
    CL Item
    Hepatobiliary and pancreas (6)
    CL Item
    Urology (7)
    CL Item
    Reproduction (8)
    CL Item
    Neurology (9)
    CL Item
    Blood and lymphatic (10)
    CL Item
    Endocrine and metabolic (11)
    CL Item
    Muskuloskeletal (12)
    CL Item
    Skin (13)
    CL Item
    Psychiatry (14)
    CL Item
    Allergies (15)
    Mediacal History, Disease
    Item
    Medical Condition
    boolean
    C0262926 (UMLS CUI [1,1])
    C0012634 (UMLS CUI [1,2])
    Mediacal History, Description
    Item
    Description
    text
    C0262926 (UMLS CUI [1,1])
    C0678257 (UMLS CUI [1,2])
    Item Group
    Current Medical Conditions
    C0012634 (UMLS CUI-1)
    C0521116 (UMLS CUI-2)
    Item
    Organ
    text
    C0012634 (UMLS CUI [1,1])
    C0521116 (UMLS CUI [1,2])
    C0678852 (UMLS CUI [1,3])
    Disease, Current, body system or organ function
    Code List
    Organ
    CL Item
    Ear, Nose and Throat (1)
    CL Item
    Eyes (2)
    CL Item
    Respiratory (3)
    CL Item
    Cardiovascular (4)
    CL Item
    Gastrointestinal (5)
    CL Item
    Hepatobiliary and pancreas (6)
    CL Item
    Urology (7)
    CL Item
    Reproduction (8)
    CL Item
    Neurology (9)
    CL Item
    Blood and lymphatic (10)
    CL Item
    Endocrine and metabolic (11)
    CL Item
    Muskuloskeletal (12)
    CL Item
    Skin (13)
    CL Item
    Psychiatry (14)
    CL Item
    Allergies (15)
    Disease, Current
    Item
    Medical Condition?
    boolean
    C0012634 (UMLS CUI [1,1])
    C0521116 (UMLS CUI [1,2])
    Disease, Current, Description
    Item
    Description
    text
    C0012634 (UMLS CUI [1,1])
    C0521116 (UMLS CUI [1,2])
    C0678257 (UMLS CUI [1,3])
    Item Group
    Medication History
    C0013227 (UMLS CUI-1)
    C0262926 (UMLS CUI-2)
    Pharmaceutical Preparations, Medical History
    Item
    Were any medications taken by the subject within 30 days prior to screening?
    boolean
    C0013227 (UMLS CUI [1,1])
    C0262926 (UMLS CUI [1,2])
    Pharmaceutical Preparations, Medical History, Medication name
    Item
    Drug (Trade name preferred)
    text
    C0013227 (UMLS CUI [1,1])
    C0262926 (UMLS CUI [1,2])
    C2360065 (UMLS CUI [1,3])
    Pharmaceutical Preparations, Medical History, Start Date
    Item
    Date started
    date
    C0013227 (UMLS CUI [1,1])
    C0262926 (UMLS CUI [1,2])
    C0808070 (UMLS CUI [1,3])
    Pharmaceutical Preparations, Medical History, Start Date, Pre-study
    Item
    Check if started Pre-study
    boolean
    C0013227 (UMLS CUI [1,1])
    C0262926 (UMLS CUI [1,2])
    C0808070 (UMLS CUI [1,3])
    Pharmaceutical Preparations, Medical History, End Date
    Item
    Date stopped
    date
    C0013227 (UMLS CUI [1,1])
    C0262926 (UMLS CUI [1,2])
    C0806020 (UMLS CUI [1,3])
    Pharmaceutical Preparations, Medical History, Continuous
    Item
    if continued Post-study
    boolean
    C0013227 (UMLS CUI [1,1])
    C0262926 (UMLS CUI [1,2])
    C0549178 (UMLS CUI [1,3])
    Item Group
    Physical Examination
    C0031809 (UMLS CUI-1)
    Physical Examination Date
    Item
    Date of assessment
    date
    C2826643 (UMLS CUI [1])
    Item
    Organ
    text
    C0031809 (UMLS CUI [1,1])
    C0678852 (UMLS CUI [1,2])
    Physical Examination, body function or organ system
    Code List
    Organ
    CL Item
    Hair and Skin (1)
    CL Item
    Lymph nodes (2)
    CL Item
    Eyes (3)
    CL Item
    Ears, Nose and Throat (4)
    CL Item
    Breasts (5)
    CL Item
    Respiratory (6)
    CL Item
    Cardiovascular (7)
    CL Item
    Abdomen (8)
    CL Item
    Urogenital (9)
    CL Item
    Pelvic (10)
    CL Item
    Rectal (11)
    CL Item
    Musculoskeletal (12)
    CL Item
    Neurological (13)
    CL Item
    Mental Status (14)
    Physical Examination, Not Done
    Item
    Not Done
    boolean
    C0031809 (UMLS CUI [1,1])
    C1272696 (UMLS CUI [1,2])
    Item
    Normal or abnormal?
    text
    C0031809 (UMLS CUI [1,1])
    C1704258 (UMLS CUI [1,2])
    Physical Examination, Abnormality
    Code List
    Normal or abnormal?
    CL Item
    Normal  (1)
    CL Item
    Abnormal (2)
    Physical Examination, Description
    Item
    Description
    text
    C0031809 (UMLS CUI [1,1])
    C0678257 (UMLS CUI [1,2])
    Item Group
    Electrocardiogram
    C1623258 (UMLS CUI-1)
    Electrocardiogram Date
    Item
    Date of ECG
    date
    C2826640 (UMLS CUI [1])
    Electrocardiogram, Time
    Item
    Time
    time
    C0013798 (UMLS CUI [1,1])
    C0040223 (UMLS CUI [1,2])
    Electrocardiography, Heart rate
    Item
    Ventricular rate/heart rate
    integer
    C1623258 (UMLS CUI [1,1])
    C0018810 (UMLS CUI [1,2])
    Electrocardiogram: P-R interval
    Item
    PR interval
    integer
    C0429087 (UMLS CUI [1])
    Electrocardiography, QRS complex duration
    Item
    QRS duration
    integer
    C1623258 (UMLS CUI [1,1])
    C0429025 (UMLS CUI [1,2])
    Electrocardiography, QT interval - finding
    Item
    QT interval
    integer
    C1623258 (UMLS CUI [1,1])
    C1287082 (UMLS CUI [1,2])
    Electrocardiography, QTc interval
    Item
    QTc interval
    integer
    C1623258 (UMLS CUI [1,1])
    C0489625 (UMLS CUI [1,2])
    Item
    Abnormalities?
    text
    C1623258 (UMLS CUI [1,1])
    C1704258 (UMLS CUI [1,2])
    Electrocardiography, Abnormality
    Code List
    Abnormalities?
    CL Item
    Normal (1)
    CL Item
    Abnormalities present (2)
    Electrocardiography, Abnormality, Clinical Significance
    Item
    Were any of the abnormalities clinically significant?
    boolean
    C1623258 (UMLS CUI [1,1])
    C1704258 (UMLS CUI [1,2])
    C2826293 (UMLS CUI [1,3])
    Item
    Rhythm
    text
    C1623258 (UMLS CUI [1,1])
    C1704258 (UMLS CUI [1,2])
    C0199556 (UMLS CUI [1,3])
    Electrocardiography, Abnormality, Rhythm
    Code List
    Rhythm
    CL Item
    Sinus bradycardia (1)
    CL Item
    Sinus tachycardia  (2)
    CL Item
    Sinus pause  (3)
    CL Item
    Ectopic supraventricular beats  (4)
    CL Item
    Junctional rhythm (≤100/min)  (5)
    CL Item
    Supraventricular tachycardia (>100/min)  (6)
    CL Item
    Atrial flutter  (7)
    CL Item
    Atrial fibrillation  (8)
    CL Item
    Ectopic ventricular beats  (9)
    CL Item
    Ventricular rhythm, comment below  (10)
    CL Item
    Pacemaker (11)
    Item
    P-Wave Morphology
    text
    C1623258 (UMLS CUI [1,1])
    C1704258 (UMLS CUI [1,2])
    C2216025 (UMLS CUI [1,3])
    Electrocardiography, Abnormality, Rhythm
    Code List
    P-Wave Morphology
    CL Item
    Left atrial abnormality (P mitrale) (1)
    CL Item
    Right atrial abnormality (P pulmonale) (2)
    Item
    Conduction
    text
    C1623258 (UMLS CUI [1,1])
    C1704258 (UMLS CUI [1,2])
    C0232217 (UMLS CUI [1,3])
    Electrocardiography, Abnormality, Rhythm
    Code List
    Conduction
    CL Item
    First degree AV block (PR interval >0.20sec)  (1)
    CL Item
    Second degree AV block (Mobitz type 1) (2)
    CL Item
    Second degree AV block (Mobitz type 2) (3)
    CL Item
    Third degree AV block (4)
    CL Item
    Left axis deviation (QRS axis more negative than - 30 degrees) (5)
    CL Item
    Right axis deviation (QRS axis more positive than + 110 degrees) (6)
    CL Item
    Incomplete right bundle branch block (7)
    CL Item
    Right bundle branch block (8)
    CL Item
    Left bundle branch block (9)
    CL Item
    Nonspecific intraventricular conduction delay (QRS ≥0.12sec) (10)
    CL Item
    Accessory pathway (Wolff-Parkinson-White, Lown-Ganong-Levine) (12)
    CL Item
    QT/QTc prolongation (13)
    Item
    Depolarization/Repolarization (QRS-T)
    text
    C1623258 (UMLS CUI [1,1])
    C1704258 (UMLS CUI [1,2])
    C1331539 (UMLS CUI [1,3])
    C3279217 (UMLS CUI [1,4])
    Electrocardiography, Abnormality, Rhythm
    Code List
    Depolarization/Repolarization (QRS-T)
    CL Item
    Myocardial infarction, old  (1)
    CL Item
    Myocardial infarction, other (2)
    CL Item
    Non-specific ST-T changes  (3)
    CL Item
    Low QRS voltage (4)
    Electrocardiography, Abnormality, Other
    Item
    Other
    boolean
    C1623258 (UMLS CUI [1,1])
    C1704258 (UMLS CUI [1,2])
    C0205394 (UMLS CUI [1,3])
    Electrocardiography, Abnormality, Comment
    Item
    Comment
    text
    C1623258 (UMLS CUI [1,1])
    C1704258 (UMLS CUI [1,2])
    C0947611 (UMLS CUI [1,3])
    Item Group
    Laboratory Data Abnormalities - Hematology Abnormalities
    C0022885 (UMLS CUI-1)
    C1704258 (UMLS CUI-2)
    C0474523 (UMLS CUI-3)
    Laboratory, Code
    Item
    Lab code
    text
    C0022877 (UMLS CUI [1,1])
    C0805701 (UMLS CUI [1,2])
    Laboratory Procedures, Hematology finding, Sampling, Date in time
    Item
    Date hematology sample taken
    date
    C0022885 (UMLS CUI [1,1])
    C0474523 (UMLS CUI [1,2])
    C0870078 (UMLS CUI [1,3])
    C0011008 (UMLS CUI [1,4])
    Laboratory Procedures, Hematology finding, Sampling, Time
    Item
    Time of sample
    time
    C0022885 (UMLS CUI [1,1])
    C0474523 (UMLS CUI [1,2])
    C0870078 (UMLS CUI [1,3])
    C0040223 (UMLS CUI [1,4])
    Laboratory Procedures, Hematology finding, Abnormality, Clinical Significance
    Item
    Were there any clinically significant hematology abnormalities?
    boolean
    C0022885 (UMLS CUI [1,1])
    C0474523 (UMLS CUI [1,2])
    C1704258 (UMLS CUI [1,3])
    C2826293 (UMLS CUI [1,4])
    Item Group
    Laboratory Data Abnormalities - Clinical Chemistry Abnormalities
    C0022885 (UMLS CUI-1)
    C0008000 (UMLS CUI-2)
    C1704258 (UMLS CUI-3)
    Laboratory, Code
    Item
    Lab code
    text
    C0022877 (UMLS CUI [1,1])
    C0805701 (UMLS CUI [1,2])
    Laboratory Procedures, Chemistry, Clinical, Sampling, Date in time
    Item
    Date clinical chemistry sample taken
    date
    C0022885 (UMLS CUI [1,1])
    C0008000 (UMLS CUI [1,2])
    C0870078 (UMLS CUI [1,3])
    C0011008 (UMLS CUI [1,4])
    Laboratory Procedures, Chemistry, Clinical, Sampling, Time
    Item
    Time of sample
    time
    C0022885 (UMLS CUI [1,1])
    C0008000 (UMLS CUI [1,2])
    C0870078 (UMLS CUI [1,3])
    C0040223 (UMLS CUI [1,4])
    Laboratory Procedures, Chemistry, Clinical, Abnormality, Clinical Significance
    Item
    Were there any clinically significant clinical chemistry abnormalities?
    boolean
    C0022885 (UMLS CUI [1,1])
    C0008000 (UMLS CUI [1,2])
    C1704258 (UMLS CUI [1,3])
    C2826293 (UMLS CUI [1,4])
    Item Group
    Laboratory Data Abnormalities - Urinalysis Abnormalities
    C0022885 (UMLS CUI-1)
    C0042014 (UMLS CUI-2)
    C1704258 (UMLS CUI-3)
    Laboratory, Code
    Item
    Lab code
    text
    C0022877 (UMLS CUI [1,1])
    C0805701 (UMLS CUI [1,2])
    Laboratory Procedures, Urinalysis , Sampling, Date in time
    Item
    Date sample taken
    date
    C0022885 (UMLS CUI [1,1])
    C0042014 (UMLS CUI [1,2])
    C0870078 (UMLS CUI [1,3])
    C0011008 (UMLS CUI [1,4])
    Laboratory Procedures, Urinalysis , Sampling, Time
    Item
    Time of sample
    time
    C0022885 (UMLS CUI [1,1])
    C0042014 (UMLS CUI [1,2])
    C0870078 (UMLS CUI [1,3])
    C0040223 (UMLS CUI [1,4])
    Laboratory Procedures, Urinalysis, Abnormality, Clinical Significance
    Item
    Were there any clinically significant urinalysis abnormalities?
    boolean
    C0022885 (UMLS CUI [1,1])
    C0042014 (UMLS CUI [1,2])
    C1704258 (UMLS CUI [1,3])
    C2826293 (UMLS CUI [1,4])
    Item Group
    Drugs of Abuse
    C0013146 (UMLS CUI-1)
    Drug screen, Sampling, Date in time
    Item
    Date sample taken
    date
    C0373483 (UMLS CUI [1,1])
    C0870078 (UMLS CUI [1,2])
    C0011008 (UMLS CUI [1,3])
    Item
    Drug
    text
    C0373483 (UMLS CUI [1,1])
    C0086190 (UMLS CUI [1,2])
    Drug screen, Illicit Drugs
    Code List
    Drug
    CL Item
    Opiates (1)
    CL Item
    Benzoylecgonine (cocaine metabolite) (2)
    CL Item
    Barbiturates  (3)
    CL Item
    Amphetamines  (4)
    CL Item
    Benzodiazepines  (5)
    CL Item
    Cannabinoids (6)
    CL Item
    Alcohol (7)
    Item
    Result
    text
    C0373483 (UMLS CUI [1,1])
    C1274040 (UMLS CUI [1,2])
    Drug screen, Illicit Drugs
    Code List
    Result
    CL Item
    Positive (1)
    CL Item
    Negative (2)
    Item Group
    Serology / HIV Screen
    C0036743 (UMLS CUI-1)
    C0459958 (UMLS CUI-2)
    Serologic tests, HIV Screen, Sampling, Date in time
    Item
    Date sample taken
    date
    C0036743 (UMLS CUI [1,1])
    C0459958 (UMLS CUI [1,2])
    C0870078 (UMLS CUI [1,3])
    C0011008 (UMLS CUI [1,4])
    Item
    Hepatitis B surface antigen
    text
    C0036743 (UMLS CUI [1,1])
    C0019168 (UMLS CUI [1,2])
    Serologic tests, Hepatitis B surface antigen
    Code List
    Hepatitis B surface antigen
    CL Item
    Positive (1)
    CL Item
    Negative (2)
    Item
    Hepatitis C antibody
    text
    C0036743 (UMLS CUI [1,1])
    C0201487 (UMLS CUI [1,2])
    Serologic tests, Hepatitis B surface antigen
    Code List
    Hepatitis C antibody
    CL Item
    Positive (1)
    CL Item
    Negative (2)
    Item
    HIV antibody
    text
    C0459958 (UMLS CUI [1,1])
    C0019683 (UMLS CUI [1,2])
    HIV screen, HIV antibodies
    Code List
    HIV antibody
    CL Item
    Positive (1)
    CL Item
    Negative (2)
    Item Group
    Treatment Assignment
    C0087111 (UMLS CUI-1)
    C1516050 (UMLS CUI-2)
    Item
    Check the appropriate box to indicate the study cohort to which the subject is assigned:
    text
    C0087111 (UMLS CUI [1,1])
    C1516050 (UMLS CUI [1,2])
    Therapeutic procedure, Assignment
    Code List
    Check the appropriate box to indicate the study cohort to which the subject is assigned:
    CL Item
    Regimen A  (1)
    CL Item
    Regimen B (2)
    CL Item
    Regimen C (3)
    Back to the top of the page 

    Help

    Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

    Watch Tutorial