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35206

Description

Study ID: 102970 Clinical Study ID: 102970 Study Title: A 52-week Efficacy and Safety Study to Compare the Effect of Three Dosage Strengths of Fluticasone Furoate/GW642444 Inhalation Powder With GW642444 on the Annual Rate of Exacerbations in Subjects With Chronic Obstructive Pulmonary Disease (COPD) Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01017952 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: GW642444 Inhalation Powder; FF/GW642444 Inhalation Powder Trade Name: Fluticasone Furoate;Fluticasone Propionate;Fluticasone Propionate/Salmeterol;Salmeterol;Vilanterol Study Indication: Pulmonary Disease, Chronic Obstructive

Keywords

Versions (1)
  1. 2/24/19 2/24/19 -
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GlaxoSmithKline

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February 24, 2019

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Creative Commons BY-NC 3.0
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    Effect of Fluticasone Furoate/GW642444 Inhalation Powder With GW642444 on Annual Rate of Exacerbations in Subjects with COPD; 102970

    English

    Rescreening

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

    Administrative Data

    Site
    Description

    Study Site

    Data type

    text

    Alias
    UMLS CUI [1]
    C2825164
    Subject
    Description

    Clinical trial participant

    Data type

    text

    Alias
    UMLS CUI [1]
    C1997894
    Subject No.
    Description

    Clinical Trial Subject Unique Identifier

    Data type

    integer

    Alias
    UMLS CUI [1]
    C2348585
    Oropharyngeal Candidiasis Examination
    Description

    Oropharyngeal Candidiasis Examination

    Alias
    UMLS CUI-1
    C0919659
    UMLS CUI-2
    C0582103
    Does the subject have clinical evidence of oropharyngeal candidiasis?
    Description

    Oropharyngeal Candidiasis, Evidence

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0919659
    UMLS CUI [1,2]
    C3887511
    Was a culture swab taken?
    Description

    Oropharyngeal Candidiasis, Taking of swab

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0919659
    UMLS CUI [1,2]
    C0563454
    Result of culture swab
    Description

    Oropharyngeal Candidiasis, Taking of swab, Result

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0919659
    UMLS CUI [1,2]
    C0563454
    UMLS CUI [1,3]
    C1274040
    Disease Duration
    Description

    Disease Duration

    Alias
    UMLS CUI-1
    C0872146
    Duration of COPD
    Description

    Select appropriate category

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0024117
    UMLS CUI [1,2]
    C0449238
    Date of Visit/Assessment
    Description

    Date of Visit/Assessment

    Alias
    UMLS CUI-1
    C1320303
    UMLS CUI-2
    C2985720
    Date of visit/assessment
    Description

    Date of visit, Assessment Date

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C1320303
    UMLS CUI [1,2]
    C2985720
    Screen Failure
    Description

    Screen Failure

    Alias
    UMLS CUI-1
    C1710476
    Was this subject a screen failure?
    Description

    Trial Screen Failure

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1710476
    Screen failure date
    Description

    Trial Screen Failure, Date in time

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C1710476
    UMLS CUI [1,2]
    C0011008
    Reason
    Description

    Trial Screen Failure, Reason

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C1710476
    UMLS CUI [1,2]
    C0566251
    Eligibility Question
    Description

    Eligibility Question

    Alias
    UMLS CUI-1
    C0013893
    Did the subject meet all the entry criteria?
    Description

    Eligibility Determination

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0013893
    Inclusion Criteria
    Description

    Inclusion Criteria

    Alias
    UMLS CUI-1
    C1512693
    Type of Subject: outpatient
    Description

    Outpatients

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0029921
    Informed consent: Subjects must give their signed and dated written informed consent to participate.
    Description

    Informed Consent

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0021430
    Gender: Male or female subjects
    Description

    A female is eligible to enter and participate in the study if she is of: Non-child bearing potential (i.e. physiologically incapable of becoming pregnant, including any female who is post- menopausal or surgically sterile). Surgically sterile females are defined as those with a documented hysterectomy and/or bilateral oophorectomy or tubal ligation. Post-menopausal females are defined as being amenorrhoeic for greater than 1 year with an appropriate clinical profile, e.g. age appropriate, >45 years, in the absence of hormone replacement therapy. However in questionable cases, a blood sample with FSH > 40 MIU/ml and estradiol < 40pg/ml (<140pmol/L) is confirmatory. OR Child bearing potential, has a negative pregnancy test at screening, and agrees to one of the following acceptable contraceptive methods used consistently and correctly (i.e. in accordance with the approved product label and the instructions of the physician for the duration of the study-- screening to follow-up contact): - Complete abstinence from intercourse from screening until the follow-up contact; or - Male partner is sterile (vasectomy with documentation of azoospermia) prior to female subject entry into the study, and this male partner is the sole partner for that subject; or - Implants of levonorgestral inserted for at least 1 month prior to the study medication administration but not beyond the third successive year following insertion; or - Injectable progestogen administered for at least 1 month prior to study medication administration; or - Oral contraceptive (combined or progestogen only) administered for at least one monthly cycle prior to study medication administration; or - Double barrier method: condom or occlusive cap (diaphragm or cervical/vault caps) plus spermicidal agent (foam/gel/film/cream/suppository); or - An intrauterine device (IUD), inserted by a qualified physician, with published data showing that the highest expected failure rate is less than 1% per year; or - Estrogenic vaginal ring; or - Percutaneous contraceptive patches

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0079399
    Age: >=40 years of age at Screening (Visit 1)
    Description

    Age

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0001779
    COPD diagnosis: Subjects with a clinical history of COPD in accordance with the following definition by the American Thoracic Society/European Respiratory Society [Celli, 2004]: COPD is a preventable and treatable disease characterized by airflow limitation that is not fully reversible. The airflow limitation is usually progressive and is associated with an abnormal inflammatory response of the lungs to noxious particles or gases, primarily caused by cigarette smoking. Although COPD affects the lungs, it also produces significant systemic consequences.
    Description

    Chronic Obstructive Airway Disease, Diagnosis

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0024117
    UMLS CUI [1,2]
    C0011900
    Tobacco use: Subjects with a current or prior history of >=10 pack-years of cigarette smoking at screening (Visit 1). Former smokers are defined as those who have stopped smoking for at least 6 months prior to Visit 1. Number of pack years = (number of cigarettes per day /20) x number of years smoked
    Description

    Tobacco Use

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0543414
    Severity of Disease: Subject with a measured post-albuterol/salbutamol FEV1/FVC ratio of <=0.70 at Screening (Visit 1) Subjects with a measured post-albuterol/salbutamol FEV1 <=70% of predicted normal values calculated using NHANES III reference equations [Hankinson, 1999] at Screening (Visit 1) Post-bronchodilator spirometry will be performed approximately 10-15 minutes after the subject has self- administered 4 inhalations (i.e., total 400mcg) of albuterol/salbutamol via an MDI with a valved-holding chamber. The FEV1/FVC ratio and FEV1 percent predicted values will be calculated.
    Description

    Chronic Obstructive Airway Disease, Severity of illness

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0024117
    UMLS CUI [1,2]
    C0521117
    History of Exacerbations: A documented history (e.g., medical record verification) of at least one COPD exacerbation in the 12 months prior to Visit 1 that required either oral corticosteroids, antibiotics and/or hospitalization. Prior use of antibiotics alone does not qualify as an exacerbation history unless the use was associated with treatment of worsening symptoms of COPD, such as increased dyspnea, sputum volume, or sputum purulence (color). Subject verbal reports are not acceptable.
    Description

    COPD exacerbation, Medical History

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0740304
    UMLS CUI [1,2]
    C0262926
    Exclusion Criteria
    Description

    Exclusion Criteria

    Alias
    UMLS CUI-1
    C0680251
    Pregnancy: Women who are pregnant or lactating or are planning on becoming pregnant during the study.
    Description

    Pregnancy, Breast Feeding, Pregnancy, Planned

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0032961
    UMLS CUI [1,2]
    C0006147
    UMLS CUI [1,3]
    C0032992
    Asthma: Subjects with a current diagnosis of asthma. (Subjects with a prior history of asthma are eligible if they have a current diagnosis of COPD)
    Description

    Asthma

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0004096
    α1-antitrypsin deficiency: Subjects with α-1 antitrypsin deficiency as the underlying cause of COPD
    Description

    alpha 1-Antitrypsin Deficiency

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0221757
    Other respiratory disorders: Subjects with active tuberculosis, lung cancer, bronchiectasis, sarcoidosis, lung fibrosis, pulmonary hypertension, interstitial lung diseases or other active pulmonary diseases
    Description

    Respiration Disorders, Other

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0035204
    UMLS CUI [1,2]
    C0205394
    Lung resection: Subjects with lung volume reduction surgery within the 12 months prior to Screening
    Description

    Lung excision

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0396565
    Chest X-ray: Chest X-ray (posteroanterior with lateral) reveals evidence of pneumonia or a clinically significant abnormality not believed to be due to the presence of COPD or another condition that would hinder the ability to detect an infiltrate on CXR (e.g. cardiomegaly, pleural effusion or scarring etc). All subjects will have a chest x- ray at Screening Visit 1 (or historical radiograph obtained within 2 weeks prior to screening) that will be over-read by a central vendor.
    Description

    Standard chest X-ray abnormal

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0436503
    Risk Factors for Pneumonia: immune suppression (HIV, Lupus, etc) or other risk for pneumonia (e.g. neurological disorders affecting control of the upper airway, such as Parkinson's, Myaesthenia Gravis, etc).
    Description

    Pneumonia, Risk factors

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0032285
    UMLS CUI [1,2]
    C0035648
    A moderate and severe COPD exacerbation that has not resolved at least 14 days prior to Visit 1 and at least 30 days following the last dose of oral corticosteroids (if applicable).
    Description

    COPD exacerbation, Unresolved

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0740304
    UMLS CUI [1,2]
    C0443342
    Pneumonia and/or moderate and severe COPD exacerbation at Visit 1 Note: Subjects who experience a pneumonia and/or exacerbation at Screening (Visit 1) must be not continue in the study, but may be re-screened at a later time provided the pneumonia and/or COPD exacerbation has resolved prior to the re-screening visit. At the Re-screening Visit, the chest x-ray should confirm resolution of pneumonia. The Re-screening Visit must be conducted at least >= 14 days following the resolution date of the exacerbation and/or pneumonia and at least 30 days following the last dose of oral corticosteroids (if applicable).
    Description

    Pneumonia, COPD exacerbation, Current

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0032285
    UMLS CUI [1,2]
    C0740304
    UMLS CUI [1,3]
    C0521116
    Other diseases/abnormalities: Subjects with historical or current evidence of clinically significant cardiovascular (i.e. pacemaker), neurological, psychiatric, renal, hepatic, immunological, endocrine (including uncontrolled diabetes or thyroid disease) or haematological abnormalities that are uncontrolled. Significant is defined as any disease that, in the opinion of the investigator, would put the safety of the subject at risk through participation, or which would affect the efficacy or safety analysis if the disease/condition exacerbated during the study.
    Description

    Disease, Other; Abnormality, Other

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0012634
    UMLS CUI [1,2]
    C0205394
    UMLS CUI [2,1]
    C1704258
    UMLS CUI [2,2]
    C0205394
    Peptic Ulcer disease: Subjects with clinically significant peptic ulcer disease that is uncontrolled.
    Description

    Peptic Ulcer

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0030920
    Hypertension: Subjects with clinically significant hypertension that is uncontrolled
    Description

    Uncontrolled hypertension

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1868885
    Cancer: Subjects with carcinoma that has not been in complete remission for at least 5 years. Carcinoma in situ of the cervix, squamous cell carcinoma and basal cell carcinoma of the skin would not be excluded if the subject has been considered cured within 5 years since diagnosis.
    Description

    Malignant Neoplasms

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0006826
    Drug/food allergy: Subjects with a history of hypersensitivity to any of the study medications (e.g. beta- agonists, corticosteroid) or components of the inhalation powder (e.g. lactose, magnesium stearate). In addition, patients with a history of severe milk protein allergy that, in the opinion of the study physician, contraindicates the subject's participation will also be excluded.
    Description

    Experimental drug, Hypersensitivity

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0304229
    UMLS CUI [1,2]
    C0020517
    Drug/alcohol abuse: Subjects with a known or suspected history of alcohol or drug abuse within the last 2 years
    Description

    Substance Use Disorders; Alcohol abuse

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0038586
    UMLS CUI [2]
    C0085762
    Medication prior to spirometry: Subjects who are medically unable to withhold their albuterol/salbutamol or their ipratropium for the 4-hour period required prior to spirometry testing at each study visit.
    Description

    Pharmaceutical Preparations, Unable, Spirometry

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0013227
    UMLS CUI [1,2]
    C1299582
    UMLS CUI [1,3]
    C0037981
    Additional medication: Use of the following medications within the following time intervals prior to Visit 1 or during the study: Inhaled short-acting beta2- agonists: 4 hours (albuterol/salbutamol will be supplied for rescue during the study) Ipratropium/salbutamol combination product: 4 hours (note: stable doses of ipratropium alone or study- supplied salbutamol alone is allowed during the study but must be withheld 4 hours prior to each study visit) Inhaled Long acting beta- agonists (LABA): 48 hours Theophylline preparations: 48 hours Cromolyn and Nedocromil inhaler: 48 hours Zafirlukast, montelukast, zileuton: 48 hours ICS/LABA combination products: 48 hours Inhaled corticosteroids:48 hours Antibiotics: 48 hours (except for the short term treatment of an exacerbation or for short term treatment of other acute infections) Tiotropium: 1 week Systemic, Oral, parenteral, intra-articular corticosteroids: 30 days (oral corticosteroids may be used to treat COPD exacerbations during the study) Cytochrome P450 3A4 strong inhibitors including but not limited to antiretrovirals (protease inhibitors) (e.g.Indinavir, Nelfinavir, Ritonavir, Saquinavir); Imidazole and Triazole anti-fungals (e.g. Ketaconazole, Itraconazole); Clarithromycin, Telithromycin, Amiodarone, Nefazodone: 6 weeks Grapefruit is allowed up to Visit 1, then limited to no more than one glass of grapefruit juice (250 mL/8 ounces) or one grapefruit per day Any other investigational drug: 30 days or 5 half lives whichever is longer
    Description

    Pharmaceutical Preparations, Other

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0013227
    UMLS CUI [1,2]
    C0205394
    Oxygen therapy: Subjects receiving treatment with long- term oxygen therapy (LTOT) or nocturnal oxygen therapy required for greater than 12 hours a day. Oxygen prn use (i.e. <=12 hours per day) is not exclusionary.
    Description

    Oxygen Therapy Care

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0184633
    Sleep apnea: Subjects with clinically significant sleep apnea who require the use of continuous positive airway pressure (CPAP) device or non-invasive positive pressure ventilation (NIPPV) device.
    Description

    Sleep Apnea Syndromes

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0037315
    Pulmonary rehabilitation: Subjects who have participated in the acute phase of a Pulmonary Rehabilitation Program within 4 weeks prior to Screening or who will enter the acute phase of a Pulmonary Rehabilitation Program during the study. Subjects who are in the maintenance phase of a Pulmonary Rehabilitation Program are not excluded.
    Description

    Pulmonary Rehabilitation

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0199529
    Non-compliance: Subjects at risk of non-compliance, or unable to comply with the study procedures. Any infirmity, disability, or geographic location that would limit compliance for scheduled visits.
    Description

    Non-compliance

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0457432
    Questionable validity of consent: Subjects with a history of psychiatric disease, intellectual deficiency, poor motivation or other conditions that will limit the validity of informed consent to participate in the study
    Description

    Informed Consent, Validity, Equivocal

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0021430
    UMLS CUI [1,2]
    C2349101
    UMLS CUI [1,3]
    C0332241
    Prior use of study medication/other investigational drugs: Subjects who have previously been randomized in the Phase IIa (HZC111348) study or Phase III (i.e. HZC112206, HZC112207, HZC102871, HZC110946) studies. Subjects who have received an investigational drug within 30 days of entry into this study (Screening), or within 5 drug half-lives of the investigational drug, whichever is longer
    Description

    Experimental drug, Previous; Investigational New Drugs, Previous

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0304229
    UMLS CUI [1,2]
    C0205156
    UMLS CUI [2,1]
    C0013230
    UMLS CUI [2,2]
    C0205156
    Affiliation with investigator site: Study investigators, sub- investigators, study coordinators, employees of a participating investigator or immediate family members of the aforementioned are excluded from participating in this study
    Description

    Clinical Investigators, Site, Affiliate

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0008961
    UMLS CUI [1,2]
    C0205145
    UMLS CUI [1,3]
    C1510825
    Exacerbation History
    Description

    Exacerbation History

    Alias
    UMLS CUI-1
    C0740304
    UMLS CUI-2
    C0262926
    Number of exacerbations in the last 12 months that were managed without oral/systemic corticosteroids and/or antibiotics (not involving hospitalisation)
    Description

    COPD exacerbation, Medical History, Antibiotics and corticosteroids, No

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0740304
    UMLS CUI [1,2]
    C0262926
    UMLS CUI [1,3]
    C3653724
    UMLS CUI [1,4]
    C1298908
    Number of exacerbations in the last 12 months that required oral/systemic corticosteroids and/or antibiotics (not involving hospitalisation)
    Description

    COPD exacerbation, Medical History, Antibiotics and corticosteroids

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0740304
    UMLS CUI [1,2]
    C0262926
    UMLS CUI [1,3]
    C3653724
    Number of exacerbations in the last 12 months that required hospitalisation
    Description

    COPD exacerbation, Medical History, Hospitalization

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0740304
    UMLS CUI [1,2]
    C0262926
    UMLS CUI [1,3]
    C0019993
    COPD Type
    Description

    Check both if applicable.

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0024117
    UMLS CUI [1,2]
    C0332307
    Investigator Signature
    Description

    Investigator Signature

    Alias
    UMLS CUI-1
    C2346576
    Is this casebook ready to sign?
    Description

    Investigator Signature

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C2346576
    Electronically Transferred Lab Data
    Description

    Electronically Transferred Lab Data

    Alias
    UMLS CUI-1
    C0022885
    Date sample taken
    Description

    Laboratory Procedures, Sampling, Date in time

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0022885
    UMLS CUI [1,2]
    C0870078
    UMLS CUI [1,3]
    C0011008
    Not done
    Description

    Laboratory Procedures, Sampling, Not done

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0022885
    UMLS CUI [1,2]
    C0870078
    UMLS CUI [1,3]
    C1272696
    Medical Conditions
    Description

    Medical Conditions

    Alias
    UMLS CUI-1
    C0012634
    Coronary Artery Disease
    Description

    Coronary Artery Disease

    Data type

    text

    Alias
    UMLS CUI [1]
    C1956346
    Myocardial Infarction
    Description

    Myocardial Infarction

    Data type

    text

    Alias
    UMLS CUI [1]
    C0027051
    Arrhythmia
    Description

    Cardiac Arrhythmia

    Data type

    text

    Alias
    UMLS CUI [1]
    C0003811
    Congestive Heart Failure
    Description

    Congestive Heart Failure

    Data type

    text

    Alias
    UMLS CUI [1]
    C0018802
    Cushing's Syndrome
    Description

    Cushing Syndrome

    Data type

    text

    Alias
    UMLS CUI [1]
    C0010481
    Adrenal Suppression
    Description

    Adrenal Glands, Suppressed

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0001625
    UMLS CUI [1,2]
    C1260953
    Cataract
    Description

    Cataract

    Data type

    text

    Alias
    UMLS CUI [1]
    C0086543
    Glaucoma
    Description

    Glaucoma

    Data type

    text

    Alias
    UMLS CUI [1]
    C0017601
    Hypertension
    Description

    Hypertensive disease

    Data type

    text

    Alias
    UMLS CUI [1]
    C0020538
    Cerebrovascular accident
    Description

    Cerebrovascular accident

    Data type

    text

    Alias
    UMLS CUI [1]
    C0038454
    Hypercholesterolemia
    Description

    Hypercholesterolemia

    Data type

    text

    Alias
    UMLS CUI [1]
    C0020443
    Diabetes Mellitus
    Description

    Diabetes Mellitus

    Data type

    text

    Alias
    UMLS CUI [1]
    C0011849
    Osteoporosis
    Description

    Osteoporosis

    Data type

    text

    Alias
    UMLS CUI [1]
    C0029456
    Pneumonia
    Description

    Pneumonia

    Data type

    text

    Alias
    UMLS CUI [1]
    C0032285
    Chest X-Ray
    Description

    Chest X-Ray

    Alias
    UMLS CUI-1
    C0039985
    Date of x-ray
    Description

    Plain chest X-ray, Date in time

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0039985
    UMLS CUI [1,2]
    C0011008
    Was an infiltrate present?
    Description

    x-ray of chest: pulmonary infiltrate

    Data type

    text

    Alias
    UMLS CUI [1]
    C2073654
    Infiltrate unilateral or bilateral
    Description

    Plain chest X-ray, Pulmonary infiltrate, Bilateral, Unilateral

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0039985
    UMLS CUI [1,2]
    C0235896
    UMLS CUI [1,3]
    C0238767
    UMLS CUI [1,4]
    C0205092
    Characterization of infiltrate
    Description

    Plain chest X-ray, Pulmonary infiltrate, Characterization

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0039985
    UMLS CUI [1,2]
    C0235896
    UMLS CUI [1,3]
    C1880022
    Right upper lobe involved with infiltrate
    Description

    Plain chest X-ray, Pulmonary infiltrate, Structure of right upper lobe of lung

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0039985
    UMLS CUI [1,2]
    C0235896
    UMLS CUI [1,3]
    C1261074
    Right middle lobe involved with infiltrate
    Description

    Plain chest X-ray, Pulmonary infiltrate, Structure of middle lobe of lung

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0039985
    UMLS CUI [1,2]
    C0235896
    UMLS CUI [1,3]
    C0225757
    Right lower lobe involved with infiltrate
    Description

    Plain chest X-ray, Pulmonary infiltrate, Structure of right lower lobe of lung

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0039985
    UMLS CUI [1,2]
    C0235896
    UMLS CUI [1,3]
    C1261075
    Left upper lobe involved with infiltrate
    Description

    Plain chest X-ray, Pulmonary infiltrate, Structure of left upper lobe of lung

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0039985
    UMLS CUI [1,2]
    C0235896
    UMLS CUI [1,3]
    C1261076
    Lingula involved with infiltrate
    Description

    Plain chest X-ray, Pulmonary infiltrate, Lingula of left lung

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0039985
    UMLS CUI [1,2]
    C0235896
    UMLS CUI [1,3]
    C0225740
    Left lower lobe involved with infiltrate
    Description

    Plain chest X-ray, Pulmonary infiltrate, Structure of left lower lobe of lung

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0039985
    UMLS CUI [1,2]
    C0235896
    UMLS CUI [1,3]
    C1261077
    Was a pleural effusion identified?
    Description

    Plain chest X-ray, Pleural effusion disorder

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0039985
    UMLS CUI [1,2]
    C0032227
    Present, specify Location
    Description

    Plain chest X-ray, Pleural effusion disorder, Location

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0039985
    UMLS CUI [1,2]
    C0032227
    UMLS CUI [1,3]
    C0450429
    Lung findings atelectasis
    Description

    Plain chest X-ray, Atelectasis

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0039985
    UMLS CUI [1,2]
    C0004144
    Lung findings mass?
    Description

    Plain chest X-ray, Lung mass

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0039985
    UMLS CUI [1,2]
    C0149726
    Lung findings cardiomegaly?
    Description

    Plain chest X-ray, Cardiomegaly

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0039985
    UMLS CUI [1,2]
    C0018800
    Was pulmonary edema identified?
    Description

    Plain chest X-ray, Pulmonary Edema

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0039985
    UMLS CUI [1,2]
    C0034063
    Comment
    Description

    Plain chest X-ray, Comment

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0039985
    UMLS CUI [1,2]
    C0947611
    History of Tobacco Use
    Description

    History of Tobacco Use

    Alias
    UMLS CUI-1
    C0841002
    What is the subject's history of smoking use?
    Description

    History of tobacco use

    Data type

    text

    Alias
    UMLS CUI [1]
    C0841002
    Former smoker, when did the subject last smoke?
    Description

    Tobacco use, Last, Date in time

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0543414
    UMLS CUI [1,2]
    C1517741
    UMLS CUI [1,3]
    C0011008
    Average number of cigarettes smoked per day?
    Description

    number of cigarettes per day

    Data type

    integer

    Measurement units
    • cigarettes per day
    Alias
    UMLS CUI [1]
    C3694146
    cigarettes per day
    Number of years during which the subject has smoked tobacco?
    Description

    Smoking, year, Count of entities

    Data type

    integer

    Measurement units
    • years
    Alias
    UMLS CUI [1,1]
    C0037369
    UMLS CUI [1,2]
    C0439234
    UMLS CUI [1,3]
    C0449788
    years
    Number of pack years?
    Description

    Pack years

    Data type

    integer

    Alias
    UMLS CUI [1]
    C1277691
    Vital Signs
    Description

    Vital Signs

    Alias
    UMLS CUI-1
    C0518766
    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]
    C0005910
    kg
    Blood pressure (systolic)
    Description

    Systolic Pressure

    Data type

    integer

    Measurement units
    • mmHg
    Alias
    UMLS CUI [1]
    C0871470
    mmHg
    Blood pressure (diastolic)
    Description

    Diastolic blood pressure

    Data type

    integer

    Measurement units
    • mmHg
    Alias
    UMLS CUI [1]
    C0428883
    mmHg
    Heart rate
    Description

    Heart rate

    Data type

    integer

    Measurement units
    • bpm
    Alias
    UMLS CUI [1]
    C0018810
    bpm
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    Similar models

    Rescreening

    1 forms
    1. StudyEvent: ODM
      1. Rescreening
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Administrative Data
    Study Site
    Item
    Site
    text
    C2825164 (UMLS CUI [1])
    Clinical trial participant
    Item
    Subject
    text
    C1997894 (UMLS CUI [1])
    Clinical Trial Subject Unique Identifier
    Item
    Subject No.
    integer
    C2348585 (UMLS CUI [1])
    Item Group
    Oropharyngeal Candidiasis Examination
    C0919659 (UMLS CUI-1)
    C0582103 (UMLS CUI-2)
    Oropharyngeal Candidiasis, Evidence
    Item
    Does the subject have clinical evidence of oropharyngeal candidiasis?
    boolean
    C0919659 (UMLS CUI [1,1])
    C3887511 (UMLS CUI [1,2])
    Oropharyngeal Candidiasis, Taking of swab
    Item
    Was a culture swab taken?
    boolean
    C0919659 (UMLS CUI [1,1])
    C0563454 (UMLS CUI [1,2])
    Item
    Result of culture swab
    text
    C0919659 (UMLS CUI [1,1])
    C0563454 (UMLS CUI [1,2])
    C1274040 (UMLS CUI [1,3])
    Oropharyngeal Candidiasis, Taking of swab, Result
    Code List
    Result of culture swab
    CL Item
    Negative (1)
    CL Item
    Positive (2)
    CL Item
    Not available (3)
    Item Group
    Disease Duration
    C0872146 (UMLS CUI-1)
    Chronic Obstructive Airway Disease, Duration
    Item
    Duration of COPD
    text
    C0024117 (UMLS CUI [1,1])
    C0449238 (UMLS CUI [1,2])
    Item Group
    Date of Visit/Assessment
    C1320303 (UMLS CUI-1)
    C2985720 (UMLS CUI-2)
    Date of visit, Assessment Date
    Item
    Date of visit/assessment
    date
    C1320303 (UMLS CUI [1,1])
    C2985720 (UMLS CUI [1,2])
    Item Group
    Screen Failure
    C1710476 (UMLS CUI-1)
    Trial Screen Failure
    Item
    Was this subject a screen failure?
    boolean
    C1710476 (UMLS CUI [1])
    Trial Screen Failure, Date in time
    Item
    Screen failure date
    date
    C1710476 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Item
    Reason
    text
    C1710476 (UMLS CUI [1,1])
    C0566251 (UMLS CUI [1,2])
    Trial Screen Failure, Reason
    Code List
    Reason
    CL Item
    Did not meet inclusion/exclusion criteria  (1)
    CL Item
    Adverse Event (unspecified) (2)
    CL Item
    Investigator discretion, specify  (3)
    CL Item
    Withdrew consent, specify (4)
    Item Group
    Eligibility Question
    C0013893 (UMLS CUI-1)
    Eligibility Determination
    Item
    Did the subject meet all the entry criteria?
    boolean
    C0013893 (UMLS CUI [1])
    Item Group
    Inclusion Criteria
    C1512693 (UMLS CUI-1)
    Outpatients
    Item
    Type of Subject: outpatient
    boolean
    C0029921 (UMLS CUI [1])
    Informed Consent
    Item
    Informed consent: Subjects must give their signed and dated written informed consent to participate.
    boolean
    C0021430 (UMLS CUI [1])
    Gender
    Item
    Gender: Male or female subjects
    boolean
    C0079399 (UMLS CUI [1])
    Age
    Item
    Age: >=40 years of age at Screening (Visit 1)
    boolean
    C0001779 (UMLS CUI [1])
    Chronic Obstructive Airway Disease, Diagnosis
    Item
    COPD diagnosis: Subjects with a clinical history of COPD in accordance with the following definition by the American Thoracic Society/European Respiratory Society [Celli, 2004]: COPD is a preventable and treatable disease characterized by airflow limitation that is not fully reversible. The airflow limitation is usually progressive and is associated with an abnormal inflammatory response of the lungs to noxious particles or gases, primarily caused by cigarette smoking. Although COPD affects the lungs, it also produces significant systemic consequences.
    boolean
    C0024117 (UMLS CUI [1,1])
    C0011900 (UMLS CUI [1,2])
    Tobacco Use
    Item
    Tobacco use: Subjects with a current or prior history of >=10 pack-years of cigarette smoking at screening (Visit 1). Former smokers are defined as those who have stopped smoking for at least 6 months prior to Visit 1. Number of pack years = (number of cigarettes per day /20) x number of years smoked
    boolean
    C0543414 (UMLS CUI [1])
    Chronic Obstructive Airway Disease, Severity of illness
    Item
    Severity of Disease: Subject with a measured post-albuterol/salbutamol FEV1/FVC ratio of <=0.70 at Screening (Visit 1) Subjects with a measured post-albuterol/salbutamol FEV1 <=70% of predicted normal values calculated using NHANES III reference equations [Hankinson, 1999] at Screening (Visit 1) Post-bronchodilator spirometry will be performed approximately 10-15 minutes after the subject has self- administered 4 inhalations (i.e., total 400mcg) of albuterol/salbutamol via an MDI with a valved-holding chamber. The FEV1/FVC ratio and FEV1 percent predicted values will be calculated.
    boolean
    C0024117 (UMLS CUI [1,1])
    C0521117 (UMLS CUI [1,2])
    COPD exacerbation, Medical History
    Item
    History of Exacerbations: A documented history (e.g., medical record verification) of at least one COPD exacerbation in the 12 months prior to Visit 1 that required either oral corticosteroids, antibiotics and/or hospitalization. Prior use of antibiotics alone does not qualify as an exacerbation history unless the use was associated with treatment of worsening symptoms of COPD, such as increased dyspnea, sputum volume, or sputum purulence (color). Subject verbal reports are not acceptable.
    boolean
    C0740304 (UMLS CUI [1,1])
    C0262926 (UMLS CUI [1,2])
    Item Group
    Exclusion Criteria
    C0680251 (UMLS CUI-1)
    Pregnancy, Breast Feeding, Pregnancy, Planned
    Item
    Pregnancy: Women who are pregnant or lactating or are planning on becoming pregnant during the study.
    boolean
    C0032961 (UMLS CUI [1,1])
    C0006147 (UMLS CUI [1,2])
    C0032992 (UMLS CUI [1,3])
    Asthma
    Item
    Asthma: Subjects with a current diagnosis of asthma. (Subjects with a prior history of asthma are eligible if they have a current diagnosis of COPD)
    boolean
    C0004096 (UMLS CUI [1])
    alpha 1-Antitrypsin Deficiency
    Item
    α1-antitrypsin deficiency: Subjects with α-1 antitrypsin deficiency as the underlying cause of COPD
    boolean
    C0221757 (UMLS CUI [1])
    Respiration Disorders, Other
    Item
    Other respiratory disorders: Subjects with active tuberculosis, lung cancer, bronchiectasis, sarcoidosis, lung fibrosis, pulmonary hypertension, interstitial lung diseases or other active pulmonary diseases
    boolean
    C0035204 (UMLS CUI [1,1])
    C0205394 (UMLS CUI [1,2])
    Lung excision
    Item
    Lung resection: Subjects with lung volume reduction surgery within the 12 months prior to Screening
    boolean
    C0396565 (UMLS CUI [1])
    Standard chest X-ray abnormal
    Item
    Chest X-ray: Chest X-ray (posteroanterior with lateral) reveals evidence of pneumonia or a clinically significant abnormality not believed to be due to the presence of COPD or another condition that would hinder the ability to detect an infiltrate on CXR (e.g. cardiomegaly, pleural effusion or scarring etc). All subjects will have a chest x- ray at Screening Visit 1 (or historical radiograph obtained within 2 weeks prior to screening) that will be over-read by a central vendor.
    boolean
    C0436503 (UMLS CUI [1])
    Pneumonia, Risk factors
    Item
    Risk Factors for Pneumonia: immune suppression (HIV, Lupus, etc) or other risk for pneumonia (e.g. neurological disorders affecting control of the upper airway, such as Parkinson's, Myaesthenia Gravis, etc).
    boolean
    C0032285 (UMLS CUI [1,1])
    C0035648 (UMLS CUI [1,2])
    COPD exacerbation, Unresolved
    Item
    A moderate and severe COPD exacerbation that has not resolved at least 14 days prior to Visit 1 and at least 30 days following the last dose of oral corticosteroids (if applicable).
    boolean
    C0740304 (UMLS CUI [1,1])
    C0443342 (UMLS CUI [1,2])
    Pneumonia, COPD exacerbation, Current
    Item
    Pneumonia and/or moderate and severe COPD exacerbation at Visit 1 Note: Subjects who experience a pneumonia and/or exacerbation at Screening (Visit 1) must be not continue in the study, but may be re-screened at a later time provided the pneumonia and/or COPD exacerbation has resolved prior to the re-screening visit. At the Re-screening Visit, the chest x-ray should confirm resolution of pneumonia. The Re-screening Visit must be conducted at least >= 14 days following the resolution date of the exacerbation and/or pneumonia and at least 30 days following the last dose of oral corticosteroids (if applicable).
    boolean
    C0032285 (UMLS CUI [1,1])
    C0740304 (UMLS CUI [1,2])
    C0521116 (UMLS CUI [1,3])
    Disease, Other; Abnormality, Other
    Item
    Other diseases/abnormalities: Subjects with historical or current evidence of clinically significant cardiovascular (i.e. pacemaker), neurological, psychiatric, renal, hepatic, immunological, endocrine (including uncontrolled diabetes or thyroid disease) or haematological abnormalities that are uncontrolled. Significant is defined as any disease that, in the opinion of the investigator, would put the safety of the subject at risk through participation, or which would affect the efficacy or safety analysis if the disease/condition exacerbated during the study.
    boolean
    C0012634 (UMLS CUI [1,1])
    C0205394 (UMLS CUI [1,2])
    C1704258 (UMLS CUI [2,1])
    C0205394 (UMLS CUI [2,2])
    Peptic Ulcer
    Item
    Peptic Ulcer disease: Subjects with clinically significant peptic ulcer disease that is uncontrolled.
    boolean
    C0030920 (UMLS CUI [1])
    Uncontrolled hypertension
    Item
    Hypertension: Subjects with clinically significant hypertension that is uncontrolled
    boolean
    C1868885 (UMLS CUI [1])
    Malignant Neoplasms
    Item
    Cancer: Subjects with carcinoma that has not been in complete remission for at least 5 years. Carcinoma in situ of the cervix, squamous cell carcinoma and basal cell carcinoma of the skin would not be excluded if the subject has been considered cured within 5 years since diagnosis.
    boolean
    C0006826 (UMLS CUI [1])
    Experimental drug, Hypersensitivity
    Item
    Drug/food allergy: Subjects with a history of hypersensitivity to any of the study medications (e.g. beta- agonists, corticosteroid) or components of the inhalation powder (e.g. lactose, magnesium stearate). In addition, patients with a history of severe milk protein allergy that, in the opinion of the study physician, contraindicates the subject's participation will also be excluded.
    boolean
    C0304229 (UMLS CUI [1,1])
    C0020517 (UMLS CUI [1,2])
    Substance Use Disorders; Alcohol abuse
    Item
    Drug/alcohol abuse: Subjects with a known or suspected history of alcohol or drug abuse within the last 2 years
    boolean
    C0038586 (UMLS CUI [1])
    C0085762 (UMLS CUI [2])
    Pharmaceutical Preparations, Unable, Spirometry
    Item
    Medication prior to spirometry: Subjects who are medically unable to withhold their albuterol/salbutamol or their ipratropium for the 4-hour period required prior to spirometry testing at each study visit.
    boolean
    C0013227 (UMLS CUI [1,1])
    C1299582 (UMLS CUI [1,2])
    C0037981 (UMLS CUI [1,3])
    Pharmaceutical Preparations, Other
    Item
    Additional medication: Use of the following medications within the following time intervals prior to Visit 1 or during the study: Inhaled short-acting beta2- agonists: 4 hours (albuterol/salbutamol will be supplied for rescue during the study) Ipratropium/salbutamol combination product: 4 hours (note: stable doses of ipratropium alone or study- supplied salbutamol alone is allowed during the study but must be withheld 4 hours prior to each study visit) Inhaled Long acting beta- agonists (LABA): 48 hours Theophylline preparations: 48 hours Cromolyn and Nedocromil inhaler: 48 hours Zafirlukast, montelukast, zileuton: 48 hours ICS/LABA combination products: 48 hours Inhaled corticosteroids:48 hours Antibiotics: 48 hours (except for the short term treatment of an exacerbation or for short term treatment of other acute infections) Tiotropium: 1 week Systemic, Oral, parenteral, intra-articular corticosteroids: 30 days (oral corticosteroids may be used to treat COPD exacerbations during the study) Cytochrome P450 3A4 strong inhibitors including but not limited to antiretrovirals (protease inhibitors) (e.g.Indinavir, Nelfinavir, Ritonavir, Saquinavir); Imidazole and Triazole anti-fungals (e.g. Ketaconazole, Itraconazole); Clarithromycin, Telithromycin, Amiodarone, Nefazodone: 6 weeks Grapefruit is allowed up to Visit 1, then limited to no more than one glass of grapefruit juice (250 mL/8 ounces) or one grapefruit per day Any other investigational drug: 30 days or 5 half lives whichever is longer
    boolean
    C0013227 (UMLS CUI [1,1])
    C0205394 (UMLS CUI [1,2])
    Oxygen Therapy Care
    Item
    Oxygen therapy: Subjects receiving treatment with long- term oxygen therapy (LTOT) or nocturnal oxygen therapy required for greater than 12 hours a day. Oxygen prn use (i.e. <=12 hours per day) is not exclusionary.
    boolean
    C0184633 (UMLS CUI [1])
    Sleep Apnea Syndromes
    Item
    Sleep apnea: Subjects with clinically significant sleep apnea who require the use of continuous positive airway pressure (CPAP) device or non-invasive positive pressure ventilation (NIPPV) device.
    boolean
    C0037315 (UMLS CUI [1])
    Pulmonary Rehabilitation
    Item
    Pulmonary rehabilitation: Subjects who have participated in the acute phase of a Pulmonary Rehabilitation Program within 4 weeks prior to Screening or who will enter the acute phase of a Pulmonary Rehabilitation Program during the study. Subjects who are in the maintenance phase of a Pulmonary Rehabilitation Program are not excluded.
    boolean
    C0199529 (UMLS CUI [1])
    Non-compliance
    Item
    Non-compliance: Subjects at risk of non-compliance, or unable to comply with the study procedures. Any infirmity, disability, or geographic location that would limit compliance for scheduled visits.
    boolean
    C0457432 (UMLS CUI [1])
    Informed Consent, Validity, Equivocal
    Item
    Questionable validity of consent: Subjects with a history of psychiatric disease, intellectual deficiency, poor motivation or other conditions that will limit the validity of informed consent to participate in the study
    boolean
    C0021430 (UMLS CUI [1,1])
    C2349101 (UMLS CUI [1,2])
    C0332241 (UMLS CUI [1,3])
    Experimental drug, Previous; Investigational New Drugs, Previous
    Item
    Prior use of study medication/other investigational drugs: Subjects who have previously been randomized in the Phase IIa (HZC111348) study or Phase III (i.e. HZC112206, HZC112207, HZC102871, HZC110946) studies. Subjects who have received an investigational drug within 30 days of entry into this study (Screening), or within 5 drug half-lives of the investigational drug, whichever is longer
    boolean
    C0304229 (UMLS CUI [1,1])
    C0205156 (UMLS CUI [1,2])
    C0013230 (UMLS CUI [2,1])
    C0205156 (UMLS CUI [2,2])
    Clinical Investigators, Site, Affiliate
    Item
    Affiliation with investigator site: Study investigators, sub- investigators, study coordinators, employees of a participating investigator or immediate family members of the aforementioned are excluded from participating in this study
    boolean
    C0008961 (UMLS CUI [1,1])
    C0205145 (UMLS CUI [1,2])
    C1510825 (UMLS CUI [1,3])
    Item Group
    Exacerbation History
    C0740304 (UMLS CUI-1)
    C0262926 (UMLS CUI-2)
    COPD exacerbation, Medical History, Antibiotics and corticosteroids, No
    Item
    Number of exacerbations in the last 12 months that were managed without oral/systemic corticosteroids and/or antibiotics (not involving hospitalisation)
    integer
    C0740304 (UMLS CUI [1,1])
    C0262926 (UMLS CUI [1,2])
    C3653724 (UMLS CUI [1,3])
    C1298908 (UMLS CUI [1,4])
    COPD exacerbation, Medical History, Antibiotics and corticosteroids
    Item
    Number of exacerbations in the last 12 months that required oral/systemic corticosteroids and/or antibiotics (not involving hospitalisation)
    integer
    C0740304 (UMLS CUI [1,1])
    C0262926 (UMLS CUI [1,2])
    C3653724 (UMLS CUI [1,3])
    COPD exacerbation, Medical History, Hospitalization
    Item
    Number of exacerbations in the last 12 months that required hospitalisation
    integer
    C0740304 (UMLS CUI [1,1])
    C0262926 (UMLS CUI [1,2])
    C0019993 (UMLS CUI [1,3])
    Item
    COPD Type
    text
    C0024117 (UMLS CUI [1,1])
    C0332307 (UMLS CUI [1,2])
    Chronic Obstructive Airway Disease, Type
    Code List
    COPD Type
    CL Item
    Chronic bronchitis (1)
    CL Item
    Emphysema (2)
    Item Group
    Investigator Signature
    C2346576 (UMLS CUI-1)
    Investigator Signature
    Item
    Is this casebook ready to sign?
    boolean
    C2346576 (UMLS CUI [1])
    Item Group
    Electronically Transferred Lab Data
    C0022885 (UMLS CUI-1)
    Laboratory Procedures, Sampling, Date in time
    Item
    Date sample taken
    date
    C0022885 (UMLS CUI [1,1])
    C0870078 (UMLS CUI [1,2])
    C0011008 (UMLS CUI [1,3])
    Laboratory Procedures, Sampling, Not done
    Item
    Not done
    boolean
    C0022885 (UMLS CUI [1,1])
    C0870078 (UMLS CUI [1,2])
    C1272696 (UMLS CUI [1,3])
    Item Group
    Medical Conditions
    C0012634 (UMLS CUI-1)
    Item
    Coronary Artery Disease
    text
    C1956346 (UMLS CUI [1])
    Coronary Artery Disease
    Code List
    Coronary Artery Disease
    CL Item
    Current (1)
    CL Item
    Past (2)
    CL Item
    Not Assessed (3)
    CL Item
    No Medical Condition (4)
    Item
    Myocardial Infarction
    text
    C0027051 (UMLS CUI [1])
    Coronary Artery Disease
    Code List
    Myocardial Infarction
    CL Item
    Current (1)
    CL Item
    Past (2)
    CL Item
    Not Assessed (3)
    CL Item
    No Medical Condition (4)
    Item
    Arrhythmia
    text
    C0003811 (UMLS CUI [1])
    Coronary Artery Disease
    Code List
    Arrhythmia
    CL Item
    Current (1)
    CL Item
    Past (2)
    CL Item
    Not Assessed (3)
    CL Item
    No Medical Condition (4)
    Item
    Congestive Heart Failure
    text
    C0018802 (UMLS CUI [1])
    Coronary Artery Disease
    Code List
    Congestive Heart Failure
    CL Item
    Current (1)
    CL Item
    Past (2)
    CL Item
    Not Assessed (3)
    CL Item
    No Medical Condition (4)
    Item
    Cushing's Syndrome
    text
    C0010481 (UMLS CUI [1])
    Coronary Artery Disease
    Code List
    Cushing's Syndrome
    CL Item
    Current (1)
    CL Item
    Past (2)
    CL Item
    Not Assessed (3)
    CL Item
    No Medical Condition (4)
    Item
    Adrenal Suppression
    text
    C0001625 (UMLS CUI [1,1])
    C1260953 (UMLS CUI [1,2])
    Coronary Artery Disease
    Code List
    Adrenal Suppression
    CL Item
    Current (1)
    CL Item
    Past (2)
    CL Item
    Not Assessed (3)
    CL Item
    No Medical Condition (4)
    Item
    Cataract
    text
    C0086543 (UMLS CUI [1])
    Coronary Artery Disease
    Code List
    Cataract
    CL Item
    Current (1)
    CL Item
    Past (2)
    CL Item
    Not Assessed (3)
    CL Item
    No Medical Condition (4)
    Item
    Glaucoma
    text
    C0017601 (UMLS CUI [1])
    Coronary Artery Disease
    Code List
    Glaucoma
    CL Item
    Current (1)
    CL Item
    Past (2)
    CL Item
    Not Assessed (3)
    CL Item
    No Medical Condition (4)
    Item
    Hypertension
    text
    C0020538 (UMLS CUI [1])
    Coronary Artery Disease
    Code List
    Hypertension
    CL Item
    Current (1)
    CL Item
    Past (2)
    CL Item
    Not Assessed (3)
    CL Item
    No Medical Condition (4)
    Item
    Cerebrovascular accident
    text
    C0038454 (UMLS CUI [1])
    Coronary Artery Disease
    Code List
    Cerebrovascular accident
    CL Item
    Current (1)
    CL Item
    Past (2)
    CL Item
    Not Assessed (3)
    CL Item
    No Medical Condition (4)
    Item
    Hypercholesterolemia
    text
    C0020443 (UMLS CUI [1])
    Coronary Artery Disease
    Code List
    Hypercholesterolemia
    CL Item
    Current (1)
    CL Item
    Past (2)
    CL Item
    Not Assessed (3)
    CL Item
    No Medical Condition (4)
    Item
    Diabetes Mellitus
    text
    C0011849 (UMLS CUI [1])
    Coronary Artery Disease
    Code List
    Diabetes Mellitus
    CL Item
    Current (1)
    CL Item
    Past (2)
    CL Item
    Not Assessed (3)
    CL Item
    No Medical Condition (4)
    Item
    Osteoporosis
    text
    C0029456 (UMLS CUI [1])
    Coronary Artery Disease
    Code List
    Osteoporosis
    CL Item
    Current (1)
    CL Item
    Past (2)
    CL Item
    Not Assessed (3)
    CL Item
    No Medical Condition (4)
    Item
    Pneumonia
    text
    C0032285 (UMLS CUI [1])
    Coronary Artery Disease
    Code List
    Pneumonia
    CL Item
    Current (1)
    CL Item
    Past (2)
    CL Item
    Not Assessed (3)
    CL Item
    No Medical Condition (4)
    Item Group
    Chest X-Ray
    C0039985 (UMLS CUI-1)
    Plain chest X-ray, Date in time
    Item
    Date of x-ray
    date
    C0039985 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Item
    Was an infiltrate present?
    text
    C2073654 (UMLS CUI [1])
    x-ray of chest: pulmonary infiltrate
    Code List
    Was an infiltrate present?
    CL Item
    No  (1)
    CL Item
    Unknown (2)
    CL Item
    Yes (3)
    Item
    Infiltrate unilateral or bilateral
    text
    C0039985 (UMLS CUI [1,1])
    C0235896 (UMLS CUI [1,2])
    C0238767 (UMLS CUI [1,3])
    C0205092 (UMLS CUI [1,4])
    x-ray of chest: pulmonary infiltrate
    Code List
    Infiltrate unilateral or bilateral
    CL Item
    Unilateral (1)
    CL Item
    Bilateral (2)
    Item
    Characterization of infiltrate
    text
    C0039985 (UMLS CUI [1,1])
    C0235896 (UMLS CUI [1,2])
    C1880022 (UMLS CUI [1,3])
    x-ray of chest: pulmonary infiltrate
    Code List
    Characterization of infiltrate
    CL Item
    Reticular (patchy)  (1)
    CL Item
    Reticulonodular (2)
    CL Item
    Acinar (consolidated) (3)
    CL Item
    Acinar with Air Bronchograms  (4)
    CL Item
    Not applicable (5)
    Item
    Right upper lobe involved with infiltrate
    text
    C0039985 (UMLS CUI [1,1])
    C0235896 (UMLS CUI [1,2])
    C1261074 (UMLS CUI [1,3])
    x-ray of chest: pulmonary infiltrate
    Code List
    Right upper lobe involved with infiltrate
    CL Item
    Yes (1)
    CL Item
    No (2)
    CL Item
    Not applicable (3)
    Item
    Right middle lobe involved with infiltrate
    text
    C0039985 (UMLS CUI [1,1])
    C0235896 (UMLS CUI [1,2])
    C0225757 (UMLS CUI [1,3])
    x-ray of chest: pulmonary infiltrate
    Code List
    Right middle lobe involved with infiltrate
    CL Item
    Yes (1)
    CL Item
    No (2)
    CL Item
    Not applicable (3)
    Item
    Right lower lobe involved with infiltrate
    text
    C0039985 (UMLS CUI [1,1])
    C0235896 (UMLS CUI [1,2])
    C1261075 (UMLS CUI [1,3])
    x-ray of chest: pulmonary infiltrate
    Code List
    Right lower lobe involved with infiltrate
    CL Item
    Yes (1)
    CL Item
    No (2)
    CL Item
    Not applicable (3)
    Item
    Left upper lobe involved with infiltrate
    text
    C0039985 (UMLS CUI [1,1])
    C0235896 (UMLS CUI [1,2])
    C1261076 (UMLS CUI [1,3])
    x-ray of chest: pulmonary infiltrate
    Code List
    Left upper lobe involved with infiltrate
    CL Item
    Yes (1)
    CL Item
    No (2)
    CL Item
    Not applicable (3)
    Item
    Lingula involved with infiltrate
    text
    C0039985 (UMLS CUI [1,1])
    C0235896 (UMLS CUI [1,2])
    C0225740 (UMLS CUI [1,3])
    x-ray of chest: pulmonary infiltrate
    Code List
    Lingula involved with infiltrate
    CL Item
    Yes (1)
    CL Item
    No (2)
    CL Item
    Not applicable (3)
    Item
    Left lower lobe involved with infiltrate
    text
    C0039985 (UMLS CUI [1,1])
    C0235896 (UMLS CUI [1,2])
    C1261077 (UMLS CUI [1,3])
    x-ray of chest: pulmonary infiltrate
    Code List
    Left lower lobe involved with infiltrate
    CL Item
    Yes (1)
    CL Item
    No (2)
    CL Item
    Not applicable (3)
    Item
    Was a pleural effusion identified?
    text
    C0039985 (UMLS CUI [1,1])
    C0032227 (UMLS CUI [1,2])
    x-ray of chest: pulmonary infiltrate
    Code List
    Was a pleural effusion identified?
    CL Item
    Absent  (1)
    CL Item
    Unknown (2)
    CL Item
    Present (3)
    Item
    Present, specify Location
    text
    C0039985 (UMLS CUI [1,1])
    C0032227 (UMLS CUI [1,2])
    C0450429 (UMLS CUI [1,3])
    x-ray of chest: pulmonary infiltrate
    Code List
    Present, specify Location
    CL Item
    Right chest (1)
    CL Item
    Left chest  (2)
    CL Item
    Bilateral (3)
    Item
    Lung findings atelectasis
    text
    C0039985 (UMLS CUI [1,1])
    C0004144 (UMLS CUI [1,2])
    x-ray of chest: pulmonary infiltrate
    Code List
    Lung findings atelectasis
    CL Item
    Yes (1)
    CL Item
    No (2)
    CL Item
    Unknown (3)
    Item
    Lung findings mass?
    text
    C0039985 (UMLS CUI [1,1])
    C0149726 (UMLS CUI [1,2])
    x-ray of chest: pulmonary infiltrate
    Code List
    Lung findings mass?
    CL Item
    Yes (1)
    CL Item
    No (2)
    CL Item
    Unknown (3)
    Item
    Lung findings cardiomegaly?
    text
    C0039985 (UMLS CUI [1,1])
    C0018800 (UMLS CUI [1,2])
    x-ray of chest: pulmonary infiltrate
    Code List
    Lung findings cardiomegaly?
    CL Item
    Yes (1)
    CL Item
    No (2)
    CL Item
    Unknown (3)
    Item
    Was pulmonary edema identified?
    text
    C0039985 (UMLS CUI [1,1])
    C0034063 (UMLS CUI [1,2])
    Plain chest X-ray, Pulmonary Edema
    Code List
    Was pulmonary edema identified?
    CL Item
    Yes (1)
    CL Item
    No (2)
    CL Item
    Unknown (3)
    Plain chest X-ray, Comment
    Item
    Comment
    text
    C0039985 (UMLS CUI [1,1])
    C0947611 (UMLS CUI [1,2])
    Item Group
    History of Tobacco Use
    C0841002 (UMLS CUI-1)
    Item
    What is the subject's history of smoking use?
    text
    C0841002 (UMLS CUI [1])
    History of tobacco use
    Code List
    What is the subject's history of smoking use?
    CL Item
    Current smoker (1)
    CL Item
    Former smoker (2)
    Tobacco use, Last, Date in time
    Item
    Former smoker, when did the subject last smoke?
    date
    C0543414 (UMLS CUI [1,1])
    C1517741 (UMLS CUI [1,2])
    C0011008 (UMLS CUI [1,3])
    number of cigarettes per day
    Item
    Average number of cigarettes smoked per day?
    integer
    C3694146 (UMLS CUI [1])
    Smoking, year, Count of entities
    Item
    Number of years during which the subject has smoked tobacco?
    integer
    C0037369 (UMLS CUI [1,1])
    C0439234 (UMLS CUI [1,2])
    C0449788 (UMLS CUI [1,3])
    Pack years
    Item
    Number of pack years?
    integer
    C1277691 (UMLS CUI [1])
    Item Group
    Vital Signs
    C0518766 (UMLS CUI-1)
    Body Height
    Item
    Height
    integer
    C0005890 (UMLS CUI [1])
    Body Weight
    Item
    Weight
    float
    C0005910 (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])
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