Informatie:
Fout:
ID
35155
Beschrijving
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
Trefwoorden
Versies (1)
- 20-02-19 20-02-19 -
Houder van rechten
GlaxoSmithKline
Geüploaded op
20 februari 2019
DOI
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Licentie
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
Similar models
Screening
- StudyEvent: ODM
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
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)
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])
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])
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])
C0563454 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,3])
CL Item
Negative (1)
CL Item
Positive (2)
CL Item
Not available (3)
Patient date of birth
Item
Date of birth
date
C0421451 (UMLS CUI [1])
CL Item
Male (1)
CL Item
Female - Record child-bearing potential (2)
CL Item
Female - Post-menopausal (3)
CL Item
Female - Sterile (of child-bearing age) (4)
CL Item
Female - Potentially able to bear children (5)
CL Item
Hispanic or Latino (1)
CL Item
Not Hispanic or Latino (2)
CL Item
African American/African Heritage (1)
CL Item
American Indian or Alaskan Native (2)
CL Item
Asian - Central/South Asian Heritage (3)
CL Item
Asian - East Asian Heritage (4)
CL Item
Asian - Japanese Heritage (5)
CL Item
Asian - South East Asian Heritage (6)
CL Item
Native Hawaiian or Other Pacific Islander (7)
CL Item
White - Arabic/North African Heritage (8)
CL Item
White - White/Caucasian/European Heritage (9)
Chronic Obstructive Airway Disease, Duration
Item
Duration of COPD
text
C0024117 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
C0449238 (UMLS CUI [1,2])
Item Group
Date of Visit/Assessment
C1320303 (UMLS CUI-1)
C2985720 (UMLS CUI-2)
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])
C2985720 (UMLS CUI [1,2])
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])
C0011008 (UMLS CUI [1,2])
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)
Eligibility Determination
Item
Did the subject meet all the entry criteria?
boolean
C0013893 (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])
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])
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])
C0262926 (UMLS CUI [1,2])
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])
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])
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])
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])
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])
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])
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])
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])
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])
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])
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])
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])
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])
C0205145 (UMLS CUI [1,2])
C1510825 (UMLS CUI [1,3])
Item Group
Exacerbation History
C0740304 (UMLS CUI-1)
C0262926 (UMLS CUI-2)
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])
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])
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])
C0262926 (UMLS CUI [1,2])
C0019993 (UMLS CUI [1,3])
Item
COPD Type
text
C0024117 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
C0332307 (UMLS CUI [1,2])
CL Item
Chronic bronchitis (1)
CL Item
Emphysema (2)
Investigator Signature
Item
Is this casebook ready to sign?
boolean
C2346576 (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])
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])
C0870078 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,3])
CL Item
Current (1)
CL Item
Past (2)
CL Item
Not Assessed (3)
CL Item
No Medical Condition (4)
CL Item
Current (1)
CL Item
Past (2)
CL Item
Not Assessed (3)
CL Item
No Medical Condition (4)
CL Item
Current (1)
CL Item
Past (2)
CL Item
Not Assessed (3)
CL Item
No Medical Condition (4)
CL Item
Current (1)
CL Item
Past (2)
CL Item
Not Assessed (3)
CL Item
No Medical Condition (4)
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])
C1260953 (UMLS CUI [1,2])
CL Item
Current (1)
CL Item
Past (2)
CL Item
Not Assessed (3)
CL Item
No Medical Condition (4)
CL Item
Current (1)
CL Item
Past (2)
CL Item
Not Assessed (3)
CL Item
No Medical Condition (4)
CL Item
Current (1)
CL Item
Past (2)
CL Item
Not Assessed (3)
CL Item
No Medical Condition (4)
CL Item
Current (1)
CL Item
Past (2)
CL Item
Not Assessed (3)
CL Item
No Medical Condition (4)
CL Item
Current (1)
CL Item
Past (2)
CL Item
Not Assessed (3)
CL Item
No Medical Condition (4)
CL Item
Current (1)
CL Item
Past (2)
CL Item
Not Assessed (3)
CL Item
No Medical Condition (4)
CL Item
Current (1)
CL Item
Past (2)
CL Item
Not Assessed (3)
CL Item
No Medical Condition (4)
CL Item
Current (1)
CL Item
Past (2)
CL Item
Not Assessed (3)
CL Item
No Medical Condition (4)
CL Item
Current (1)
CL Item
Past (2)
CL Item
Not Assessed (3)
CL Item
No Medical Condition (4)
Plain chest X-ray, Date in time
Item
Date of x-ray
date
C0039985 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
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])
C0235896 (UMLS CUI [1,2])
C0238767 (UMLS CUI [1,3])
C0205092 (UMLS CUI [1,4])
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])
C0235896 (UMLS CUI [1,2])
C1880022 (UMLS CUI [1,3])
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])
C0235896 (UMLS CUI [1,2])
C1261074 (UMLS CUI [1,3])
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])
C0235896 (UMLS CUI [1,2])
C0225757 (UMLS CUI [1,3])
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])
C0235896 (UMLS CUI [1,2])
C1261075 (UMLS CUI [1,3])
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])
C0235896 (UMLS CUI [1,2])
C1261076 (UMLS CUI [1,3])
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])
C0235896 (UMLS CUI [1,2])
C0225740 (UMLS CUI [1,3])
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])
C0235896 (UMLS CUI [1,2])
C1261077 (UMLS CUI [1,3])
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])
C0032227 (UMLS CUI [1,2])
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])
C0032227 (UMLS CUI [1,2])
C0450429 (UMLS CUI [1,3])
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])
C0004144 (UMLS CUI [1,2])
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])
C0149726 (UMLS CUI [1,2])
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])
C0018800 (UMLS CUI [1,2])
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])
C0034063 (UMLS CUI [1,2])
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])
C0947611 (UMLS CUI [1,2])
Item Group
Previous Clinical Trial Participation
C2348568 (UMLS CUI-1)
Item
Did the subject participate in a previous Fluticasone Furoate/GW642444 clinical trial?
text
C2348568 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0013230 (UMLS CUI [1,2])
Code List
Did the subject participate in a previous Fluticasone Furoate/GW642444 clinical trial?
CL Item
No (1)
CL Item
Yes, complete the following: B2C111045 - Subject # HZC111348 - Subject # (2)
Item Group
Rescreening of Subject
C0220908 (UMLS CUI-1)
C0205341 (UMLS CUI-2)
C0205341 (UMLS CUI-2)
Screening Procedure, Repeat
Item
Was the subject rescreened?
boolean
C0220908 (UMLS CUI [1,1])
C0205341 (UMLS CUI [1,2])
C0205341 (UMLS CUI [1,2])
Item Group
Subject Status at Screening
C0220908 (UMLS CUI-1)
C0449438 (UMLS CUI-2)
C0449438 (UMLS CUI-2)
Screening procedure, Trial Screen Failure
Item
Was the subject a screen failure at the Screening visit?
boolean
C0220908 (UMLS CUI [1,1])
C1710476 (UMLS CUI [1,2])
C1710476 (UMLS CUI [1,2])
Clinical Trial Subject Unique Identifier
Item
Subject number
integer
C2348585 (UMLS CUI [1])
Item
What is the subject's history of smoking use?
text
C0841002 (UMLS CUI [1])
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])
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])
C0439234 (UMLS CUI [1,2])
C0449788 (UMLS CUI [1,3])
Pack years
Item
Number of pack years?
integer
C1277691 (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])