Informations:
Erreur:
ID
43676
Description
Randomised, open label, two period, crossover study to compare the steroid systemic exposure of Fluticasone Propionate (FP) from FP/Salmeterol (SALM) (500/50) DISKUS and Budesonide (BUD) from BUD/formoterol (FOR).(200/6) Turbuhaler in patients with severe Chronic Obstructive Pulmonary Disease. Primary objective:To compare the exposure of the inhaled steroid fluticasone propionate (FP) and budesonide following repeat dosing with SERETIDE DISKUS (500/50) one inhalation twice daily (b.i.d.) when compared with Symbicort Turbuhaler (200/6) two inhalations b.i.d. in a severe chronic pulmonary obstructive disease (COPD) population. Secondary objectives:To compare the pharmacokinetics of FP and budesonide following repeat dosing with SERETIDE DISKUS (500/50) one inhalation b.i.d. when compared with Symbicort Turbuhaler (200/6) two inhalations b.i.d. in a severe COPD population and to explore further the pharmacokinetics of FP and budesonide.
Mots-clés
Versions (2)
- 27/09/2017 27/09/2017 -
- 20/09/2021 20/09/2021 -
Détendeur de droits
Glaxo Smith Kline
Téléchargé le
20 septembre 2021
DOI
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Licence
Creative Commons BY-NC 3.0
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GSK Study ID 100807 Fluticasone Propionate from SERETIDE™ (500/50) DISKUS™ and Budesonide from Symbicort (200/6) Turbuhaler in patients with severe Chronic Obstructive Pulmonary Disease.- Screening Visit
Similar models
Screening Visit
- StudyEvent: ODM
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
COPD Diagnosis Stage III to Stage IV according to GOLD criteria
Item
Is the subject a COPD patient, defined as either Stage III to Stage IV COPD diagnosis according to GOLD criteria
boolean
C0024117 (UMLS CUI [1,1])
C0205563 (UMLS CUI [1,2])
C0162793 (UMLS CUI [1,3])
C0205563 (UMLS CUI [1,2])
C0162793 (UMLS CUI [1,3])
Age
Item
Is the subject aged 40-75 years inclusive?
boolean
C0001779 (UMLS CUI [1])
Gender
Item
Is the subject male or an eligible female?
boolean
C0079399 (UMLS CUI [1])
Body mass index
Item
Does the subject have a body mass index within the range 19-32kg/m2 inclusive?
boolean
C1305855 (UMLS CUI [1])
post-bronchodilator FEV1
Item
Does the subject have a post-bronchodilator FEV1 <= 50 percent predicted?
boolean
C0748133 (UMLS CUI [1,1])
C2599594 (UMLS CUI [1,2])
C2599594 (UMLS CUI [1,2])
post-bronchodilator FEV1/FVC ratio
Item
Does the subject have a post-bronchodilator FEV1/FVC ratio < 70 percent?
boolean
C2599594 (UMLS CUI [1,1])
C0429745 (UMLS CUI [1,2])
C0429745 (UMLS CUI [1,2])
Post-Bronchodilator FEV1
Item
Does the subject have an increase of less than 15 percent from baseline FEV1 or an absolute change of <200ml, 30 minutes after inhalation of 400mcg of salbutamol by MDI and spacer or 2.5mg by nebuliser?
boolean
C2021518 (UMLS CUI [1])
Informed consent and compliance behavior
Item
Is the subject capable of giving informed consent, which includes compliance with the requirements and restrictions listed in the consent form?
boolean
C0021430 (UMLS CUI [1,1])
C0085732 (UMLS CUI [1,2])
C1321605 (UMLS CUI [2,1])
C0085732 (UMLS CUI [2,2])
C0085732 (UMLS CUI [1,2])
C1321605 (UMLS CUI [2,1])
C0085732 (UMLS CUI [2,2])
Compliance behavior
Item
Is the subject able to use inhaler device adequately after training?
boolean
C1321605 (UMLS CUI [1,1])
C0085732 (UMLS CUI [1,2])
C0085732 (UMLS CUI [1,2])
Smoking history
Item
Is the subject an ex smoker for at least the past 6 months with a pack history > 10 pack years?
boolean
C1519384 (UMLS CUI [1,1])
C1277691 (UMLS CUI [1,2])
C1277691 (UMLS CUI [1,2])
Compliance behavior
Item
Is the subject available to complete the study?
boolean
C1321605 (UMLS CUI [1])
Comorbidities
Item
Has the subject any clinically relevant abnormality identified on the screening medical assessment, physical examination, laboratory examination (including clinical chemistry and haematology), or ECG?
boolean
C0009488 (UMLS CUI [1])
Lung disease, circulatory system disorder
Item
Does the subject have a respiratory disorder in addition to COPD (e.g. bronchiectasis, fibrosis) or significant co-morbidity that might affect lung function (e.g. poorly controlled heart failure, atrial fibrillation or ischaemic heart disease.)?
boolean
C0024115 (UMLS CUI [1,1])
C0728936 (UMLS CUI [1,2])
C0728936 (UMLS CUI [1,2])
Concomitant therapy
Item
Does the subject have regular oxygen or nebulised bronchodilator therapy?
boolean
C1707479 (UMLS CUI [1])
Study subject participation status
Item
Has the subject participated in a study with a new molecular entity during the previous 4 months or any other clinical trial during the previous 3 months?
boolean
C2348568 (UMLS CUI [1])
Substance use disorder
Item
Does the subject abuse alcohol defined as an average weekly intake of greater than 28 units (21 for females) or an average daily intake of greater than 4 units (3 unit for females)?
boolean
C0038586 (UMLS CUI [1])
Concomitant medication
Item
Has the subject used prescription or non-prescription drugs, vitamins, herbal and dietary supplements, within seven days or 5 half-lives (whichever is longer) prior to the first dose of study medication, which in the opinion of the Principal Investigator, may interfere with study outcome. (Specifically, calcium and vitamin D supplements and bisphosphonates)?
boolean
C2347852 (UMLS CUI [1])
Concomitant medication systemic steroids
Item
Has the subject used oral/injectable/depot corticosteroid for any indication within 8 weeks of study start? (Nasal and inhaled steroids will be permitted provided they do not contain either FP or BUD)
boolean
C2347852 (UMLS CUI [1,1])
C2825233 (UMLS CUI [1,2])
C2825233 (UMLS CUI [1,2])
Respiratory infection
Item
Has the subject a history of a respiratory infection (including sinusitis) within 4 weeks prior to first study visit?
boolean
C0035243 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
C0262926 (UMLS CUI [1,2])
Inclusion/exclusion criteria
Item
Did the subject meet all entry criteria?
boolean
C1704756 (UMLS CUI [1])
Item
Inclusion Criteria: check all boxes that represent a violation of the inclusion/exclusion criteria
integer
C1512693 (UMLS CUI [1,1])
C1516637 (UMLS CUI [1,2])
C1516637 (UMLS CUI [1,2])
Code List
Inclusion Criteria: check all boxes that represent a violation of the inclusion/exclusion criteria
CL Item
1 (1)
CL Item
2 (2)
CL Item
3 (3)
CL Item
4 (4)
CL Item
5 (5)
CL Item
6 (6)
CL Item
7 (7)
CL Item
8 (8)
CL Item
9 (9)
CL Item
10 (10)
CL Item
11 (11)
Item
Exclusion Criteria: check all boxes that represent a violation of the inclusion/exclusion criteria
integer
C0680251 (UMLS CUI [1])
Code List
Exclusion Criteria: check all boxes that represent a violation of the inclusion/exclusion criteria
CL Item
1 (1)
CL Item
2 (2)
CL Item
3 (3)
CL Item
4 (4)
CL Item
5 (5)
CL Item
6 (6)
CL Item
7 (7)
CL Item
8 (8)
Item Group
Compliance Restrictions Worksheet
C1321605 (UMLS CUI-1)
Compliance Restrictions Worksheet
Item
The Physician Responsible must be informed as soon as possible about any medication taken from the time of screening until the end of the clinical phase of the study (post-study screen). Subjects should refrain from alcohol for 24h before each study visit. No more than 4 standard drinks of alcohol per day should be taken from the first study visit until the end of the clinical phase of the study. Subjects should refrain from all caffeine or xanthine containing drinks and food for 12h before each study visit until discharged from the Unit. Subjects should remain on their usual anti-inflammatory bronchodilator (not Seretide or Symbicort or any of their components) therapy over the course of the study, as prescribed by their treating physician and advised by the Pl. Subjects should not exceed their normal pre-study levels of physical exercise for the duration of the study and during the period between the end of dosing and the final follow-up visit. Subjects must not take any recreational drugs throughout the study (from screening until post-study visit). Urine tests will be performed at each study visit to check for drugs of abuse. A positive result may lead to exclusion from the remainder of this study and all future studies.
text
C1321605 (UMLS CUI [1])
Compliance behavior
Item
Did the subject comply with the Requirements and Restrictions as listed in the protocol as appropriate thus far?
boolean
C1321605 (UMLS CUI [1])
Compliance behavior limited
Item
Is the subject aware of any forthcoming requirements?
boolean
C1321605 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0439801 (UMLS CUI [1,2])
Date of Assessment
Item
Date of Assessment
date
C2985720 (UMLS CUI [1])
Comments
Item
Comments
text
C0947611 (UMLS CUI [1])
Date of assessment
Item
Date of assessment
date
C2985720 (UMLS CUI [1])
Date of Birth
Item
Date of Birth
date
C0421451 (UMLS CUI [1])
CL Item
Male (M)
CL Item
Female (F)
CL Item
White (Origins in the original peoples of Europe, the Middle East, Western Russia,Afghanistan, or the white racial groups of Africa.) (W)
(Comment:en)
CL Item
Black (Origins in any of the black racial groups of Africa.) (B)
(Comment:en)
CL Item
Asian (Origins in the original peoples of the Indian subcontinent, the Far East,Southeast Asia, or the Pacific islands.) (A)
(Comment:en)
CL Item
Other (People whose racial group is not represented above, or whose predominant origin cannot be determined.) (X)
(Comment:en)
Height
Item
Height
integer
C0005890 (UMLS CUI [1])
Weight
Item
Weight
float
C0005910 (UMLS CUI [1])
BMI
Item
Body Mass Index
float
C1305855 (UMLS CUI [1])
Item Group
Demography for Females
C0011298 (UMLS CUI-1)
C0086287 (UMLS CUI-2)
C0086287 (UMLS CUI-2)
CL Item
Premenarcheal (1)
CL Item
Sterile (of childbearing age) (2)
CL Item
Postmenopausal (3)
CL Item
Potentially able to conceive children (4)
Item
If potentially able to conceive children check all type(s) of contraception used below
integer
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0700589 (UMLS CUI [1,2])
Code List
If potentially able to conceive children check all type(s) of contraception used below
CL Item
Oral contraceptive (1)
CL Item
Intrauterine contraceptive device (2)
CL Item
Depot contraceptive (implants, injectables) (3)
CL Item
Physical barrier (condom, diaphragm) (4)
CL Item
Abstinence (5)
CL Item
Sterilization of male partner (6)
CL Item
Other,specify (7)
Contraceptive methods
Item
Contraceptive methods, please specify other
text
C0700589 (UMLS CUI [1,1])
C3845569 (UMLS CUI [1,2])
C3845569 (UMLS CUI [1,2])
CL Item
Positive (1)
CL Item
Negative (2)
CL Item
Not applicable (Not of childbearing potential) (3)
Medical History
Item
Indicate significant past medical conditions (including intermittent disease e.g. migraine, seasonal rhinitis). Check the appropriate box(es) and if PRESENT, describe concisely: [different conditions should be separated by either a (;) or a (/ )].
text
C0262926 (UMLS CUI [1])
Ear, Nose and Throat Disorder
Item
Ear, Nose and Throat:
boolean
C0395797 (UMLS CUI [1])
Ear, Nose and Throat Disorder Specification
Item
If YES, specify condition(s):
text
C0395797 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,2])
Eye Disorders
Item
Eyes:
boolean
C0015397 (UMLS CUI [1])
Eye disorders
Item
If Yes, please specify Eye disorders
text
C0262926 (UMLS CUI [1,1])
C0015397 (UMLS CUI [1,2])
C0015397 (UMLS CUI [1,2])
Respiratory System Disorder
Item
Respiratory
boolean
C0035204 (UMLS CUI [1])
Respiratory System Disorder
Item
Respiratory: If yes, please specify
text
C0035204 (UMLS CUI [1])
Cardiovascular Diseases
Item
Cardiovascular
boolean
C0007222 (UMLS CUI [1])
Cardiovascular Diseases
Item
Cardiovascular: If yes, please specify
text
C0007222 (UMLS CUI [1])
Gastrointestinal Diseases
Item
Gastrointestinal
boolean
C0017178 (UMLS CUI [1])
Gastrointestinal Diseases
Item
Gastrointestinal: If Yes, please specify
text
C0017178 (UMLS CUI [1])
Hepatobiliary and pancreas Diseases
Item
Hepatobiliary and pancreas
boolean
C0267792 (UMLS CUI [1])
C0030286 (UMLS CUI [2])
C0030286 (UMLS CUI [2])
Hepatobiliary and pancreas Diseases
Item
Hepatobiliary and pancreas: If Yes, please specify
text
C0267792 (UMLS CUI [1])
C0030286 (UMLS CUI [2])
C0030286 (UMLS CUI [2])
Urologic diseases
Item
Urology
boolean
C0042075 (UMLS CUI [1])
Urologic diseases
Item
Urology: If yes, please specify
text
C0042075 (UMLS CUI [1])
Reproductive System Disorders
Item
Reproduction
boolean
C0178829 (UMLS CUI [1])
Reproductive System Disorders
Item
Reproduction: If Yes, please specify
text
C0178829 (UMLS CUI [1])
Neurology
Item
Neurology
boolean
C0027765 (UMLS CUI [1])
Neurology
Item
Neurology:If yes, please specify
text
C0027765 (UMLS CUI [1])
Blood and lymphatic system disorders
Item
Blood and lymphatic
boolean
C0851353 (UMLS CUI [1])
Blood and lymphatic system disorders
Item
Blood and lymphatic: If yes, please specify
text
C0851353 (UMLS CUI [1])
Endocrine and metabolic system disorder
Item
Endocrine and metabolic
boolean
C0025517 (UMLS CUI [1])
C0014130 (UMLS CUI [2])
C0014130 (UMLS CUI [2])
Endocrine and Metabolic System Disorders
Item
Endocrine and Metabolic: If Yes, please specify
text
C0025517 (UMLS CUI [1])
C0014130 (UMLS CUI [2])
C0014130 (UMLS CUI [2])
Musculoskeletal Diseases
Item
Musculoskeletal
boolean
C0026857 (UMLS CUI [1])
Musculoskeletal Diseases
Item
Musculoskeletal: If Yes, please specify
text
C0026857 (UMLS CUI [1])
Skin Diseases
Item
Skin
boolean
C0037274 (UMLS CUI [1])
Skin Diseases
Item
Skin: If Yes, please specify
text
C0037274 (UMLS CUI [1])
Psychiatric disorders
Item
Psychiatry
boolean
C0004936 (UMLS CUI [1])
Psychiatric disorders
Item
Psychiatry: If Yes, please specify
text
C0004936 (UMLS CUI [1])
Allergies
Item
Allergies
boolean
C0020517 (UMLS CUI [1])
Allergies
Item
Allergies:If Yes, please specify
text
C0020517 (UMLS CUI [1])
Physical Examination
Item
Indicate current physical findings by checking the appropriate box(es) below and if ABNORMAL, describe concisely: [different findings should be separated by either a (;) or a (/)].
text
C0031809 (UMLS CUI [1])
CL Item
Normal (1)
CL Item
Abnormal (2)
Hair and Skin
Item
Hair and Skin: If Abnormal, please specify
text
C0018494 (UMLS CUI [1,1])
C0558035 (UMLS CUI [1,2])
C0558035 (UMLS CUI [1,2])
CL Item
Normal (1)
CL Item
Abnormal (2)
Lymph nodes
Item
Lymph nodes: If Abnormal, please specify
text
C0031809 (UMLS CUI [1,1])
C0024204 (UMLS CUI [1,2])
C0024204 (UMLS CUI [1,2])
CL Item
Normal (1)
CL Item
Abnormal (2)
Eyes
Item
Eyes: If Abnormal, please specify
text
C0031809 (UMLS CUI [1,1])
C0200149 (UMLS CUI [1,2])
C0200149 (UMLS CUI [1,2])
Item
Ears, Nose and Throat
integer
C0031809 (UMLS CUI [1,1])
C0278350 (UMLS CUI [1,2])
C0278350 (UMLS CUI [1,2])
CL Item
Normal (1)
CL Item
Abnormal (2)
Ears, Nose and Throat
Item
Ears, Nose and Throat: If Abnormal, please specify
text
C0031809 (UMLS CUI [1,1])
C0278350 (UMLS CUI [1,2])
C0278350 (UMLS CUI [1,2])
CL Item
Normal (1)
CL Item
Abnormal (2)
CL Item
Not Done (3)
Breasts
Item
Breasts: If Abnormal or not done, please specify
text
C0031809 (UMLS CUI [1,1])
C0199850 (UMLS CUI [1,2])
C0199850 (UMLS CUI [1,2])
CL Item
Normal (1)
CL Item
Abnormal (2)
Respiratory
Item
Respiratory: If Abnormal, please specify
text
C0031809 (UMLS CUI [1,1])
C0436121 (UMLS CUI [1,2])
C0436121 (UMLS CUI [1,2])
CL Item
Normal (1)
CL Item
Abnormal (2)
Cardiovascular
Item
Cardiovascular: If Abnormal, please specify
text
C3854344 (UMLS CUI [1])
CL Item
normal (1)
CL Item
abnormal (2)
Abdomen
Item
Abdomen: If Abnormal, please specify
text
C0031809 (UMLS CUI [1,1])
C0000726 (UMLS CUI [1,2])
C0000726 (UMLS CUI [1,2])
CL Item
Normal (1)
CL Item
Abnormal (2)
CL Item
Not Done (3)
Urogenital
Item
Urogenital: If abnormal or not done, please specify
text
C1828035 (UMLS CUI [1])
CL Item
Normal (1)
CL Item
Abnormal (2)
CL Item
Not Done (3)
Pelvic
Item
Pelvic: If Abnormal or not done, please specify
text
C0200045 (UMLS CUI [1])
CL Item
Normal (1)
CL Item
Abnormal (2)
CL Item
Not Done (3)
Rectal
Item
Rectal: If abnormal or not done, please specify
text
C0199900 (UMLS CUI [1])
CL Item
Normal (1)
CL Item
Abnormal (2)
Musculoskeletal
Item
Musculoskeletal: If Abnormal, please specify
text
C0475091 (UMLS CUI [1])
CL Item
Normal (1)
CL Item
Abnormal (2)
Neurological
Item
Neurological: If Abnormal, please specify
text
C0027853 (UMLS CUI [1])
CL Item
Normal (0)
CL Item
Abnormal (1)
Mental Status
Item
Mental Status: If Abnormal, please specify
text
C3260990 (UMLS CUI [1])
Monitor Data Validation Checks Vital Signs
Item
Check that dates and times are in chronological order; Check that if times go past midnight, dates change accordingly; Check that blood pressure values are within reasonable limits and systolic blood pressure is greater than diastolic blood pressure; Check that heart rate values are within reasonable limits for beats per minute.
text
C1519941 (UMLS CUI [1,1])
C0518766 (UMLS CUI [1,2])
C0518766 (UMLS CUI [1,2])
CL Item
1 (1)
CL Item
2 (2)
CL Item
3 (3)
Assessment Date
Item
Date
date
C0518766 (UMLS CUI [1,1])
C2985720 (UMLS CUI [1,2])
C2985720 (UMLS CUI [1,2])
CL Item
Screening (1)
CL Item
Unscheduled (2)
Visit Time
Item
Actual Time
time
C1320304 (UMLS CUI [1])
Systolic Blood Pressure
Item
Systolic Blood Pressure
integer
C0871470 (UMLS CUI [1])
Diastolic blood pressure
Item
Diastolic blood pressure
integer
C0428883 (UMLS CUI [1])
Heart rate
Item
Heart rate
integer
C0018810 (UMLS CUI [1])
Monitor Data Validation Checks Electrocardiogram
Item
- Check that the ECG date on the Case Report Form page matches the ECG date on the source document - Check that the time of the ECG is entered in the Case Report Form page. - Check that ECG intervals (PR interval, QT interval, QRS duration, QTc interval) are entered in the Case Report Form page. - Check that ventricular rate/heart rate in beats/min has been entered on the Case Report Form page. - Check that either NORMAL or ABNORMALITIES PRESENT is checked. - If NORMAL is checked, check that no abnormality details are present. - If ABNORMALITIES PRESENT is checked, check that YES or NO is checked to indicate whether they are clinically significant. - If NO is checked, check that none of the listed abnormalities is checked. - If YES is checked, check that at least one of the listed abnormalities is checked. - If VENTRICULAR RHYTHM or MYOCARDIAL INFARCTION is checked, check that details are noted in the comment section. - If OTHER is checked, check that details are specified in the comment section. - Check that either YES or NO is checked to indicate whether there was a clinically significant change [from baseline or the previous ECG]. If YES is checked ensure details are specified.
text
C1519941 (UMLS CUI [1,1])
C1623258 (UMLS CUI [1,2])
C1623258 (UMLS CUI [1,2])
Date of ECG
Item
Date of ECG
date
C2826640 (UMLS CUI [1])
Time of ECG
Item
Time of ECG
time
C0040223 (UMLS CUI [1,1])
C0013798 (UMLS CUI [1,2])
C0013798 (UMLS CUI [1,2])
Ventricular rate
Item
Ventricular rate/heart rate
integer
C2189285 (UMLS CUI [1])
PR Interval
Item
PR Interval
integer
C0429087 (UMLS CUI [1])
QRS Duration
Item
QRS Duration
integer
C0429025 (UMLS CUI [1])
QT Interval
Item
QT Interval
integer
C0577807 (UMLS CUI [1])
QTc Interval
Item
QTc Interval
integer
C0855331 (UMLS CUI [1])
CL Item
Normal (N)
CL Item
Abnormalities present (A)
Item
Were any of the abnormalities clinically significant?
text
C1623258 (UMLS CUI [1,1])
C0456984 (UMLS CUI [1,2])
C0456984 (UMLS CUI [1,2])
CL Item
Yes (Y)
CL Item
No (N)
ECG Abnormalities
Item
ECG Abnormalities:If YES, check all that apply
text
C0522055 (UMLS CUI [1])
Sinus bradycardia
Item
Sinus bradycardia
boolean
C0085610 (UMLS CUI [1])
Sinus tachycardia
Item
Sinus tachycardia
boolean
C0039239 (UMLS CUI [1])
Sinus pause
Item
Sinus pause
boolean
C1955864 (UMLS CUI [1])
Ectopic supraventricular beats
Item
Ectopic supraventricular beats
boolean
C0033036 (UMLS CUI [1])
Junctional rhythm
Item
Junctional rhythm (<= 100/min)
boolean
C0232208 (UMLS CUI [1])
Supraventricular tachycardia
Item
Supraventricular tachycardia (>100/min)
boolean
C0039240 (UMLS CUI [1])
Atrial flutter
Item
Atrial flutter
boolean
C0004239 (UMLS CUI [1])
Atrial Fibrillation
Item
Atrial Fibrillation
boolean
C0004238 (UMLS CUI [1])
Ectopic ventricular beats
Item
Ectopic ventricular beats
boolean
C0151636 (UMLS CUI [1])
Ventricular rhythm
Item
Ventricular rhythm, comment below
boolean
C0232216 (UMLS CUI [1])
Pacemaker
Item
Pacemaker
boolean
C0030163 (UMLS CUI [1,1])
C2981711 (UMLS CUI [1,2])
C2981711 (UMLS CUI [1,2])
Left atrial abnormality (P mitrale)
Item
Left atrial abnormality (P mitrale)
boolean
C0344711 (UMLS CUI [1,1])
C0232310 (UMLS CUI [1,2])
C0232310 (UMLS CUI [1,2])
Right atrial abnormality (P pulmonale)
Item
Right atrial abnormality (P pulmonale)
boolean
C0344696 (UMLS CUI [1,1])
C0232308 (UMLS CUI [1,2])
C0232308 (UMLS CUI [1,2])
First degree AV block
Item
First degree AV block (PR interval> 0.20 sec)
boolean
C0085614 (UMLS CUI [1])
Second degree AV block (Mobitz type 1)
Item
Second degree AV block (Mobitz type 1)
boolean
C0264907 (UMLS CUI [1])
Second degree AV block (Mobitz type 2)
Item
Second degree AV block (Mobitz type 2)
boolean
C0155700 (UMLS CUI [1])
Third degree AV block
Item
Third degree AV block
boolean
C0151517 (UMLS CUI [1])
Left axis deviation (QRS axis more negative than - 30 degrees)
Item
Left axis deviation (QRS axis more negative than - 30 degrees)
boolean
C0232297 (UMLS CUI [1])
Right axis deviation
Item
Right axis deviation (ORS axis more positive than + 110 degrees)
boolean
C0232296 (UMLS CUI [1])
Incomplete right bundle branch block
Item
Incomplete right bundle branch block
boolean
C0262525 (UMLS CUI [1])
Right bundle branch block
Item
Right bundle branch block
boolean
C0085615 (UMLS CUI [1])
Left bundle branch block
Item
Left bundle branch block
boolean
C0023211 (UMLS CUI [1])
Nonspecific intraventricular conduction delay
Item
Nonspecific intraventricular conduction delay (QRS greater than 0,12sec)
boolean
C1882112 (UMLS CUI [1])
Accessory pathway (Wolff-Parkinson White, Lown-Ganong-Levine)
Item
Accessory pathway (Wolff-Parkinson White, Lown-Ganong-Levine)
boolean
C0264897 (UMLS CUI [1,1])
C0043202 (UMLS CUI [1,2])
C0043202 (UMLS CUI [1,2])
QT/QTc prolongation
Item
QT/QTc prolongation
boolean
C0855333 (UMLS CUI [1])
Myocardial infarction, old
Item
Myocardial infarction, old
boolean
C0155668 (UMLS CUI [1])
Myocardial infarction, other
Item
Myocardial infarction, other
boolean
C0027051 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,2])
Non-specific ST-T changes
Item
Non-specific ST-T changes
boolean
C1112720 (UMLS CUI [1])
Low QRS voltage
Item
Low QRS voltage
boolean
C2349945 (UMLS CUI [1])
Other
Item
Other, specify in comments
boolean
C0205394 (UMLS CUI [1])
ECG Abnormalities
Item
Comment
text
C0522055 (UMLS CUI [1,1])
C3845569 (UMLS CUI [1,2])
C3845569 (UMLS CUI [1,2])
Assessment Date
Item
Date
date
C2985720 (UMLS CUI [1])
Lung Function Tests
Item
Lung function tests mus/ be performed with the subject in a STANDING position .
text
C0024119 (UMLS CUI [1])
Item
Planned time Test type
integer
C2348792 (UMLS CUI [1,1])
C0449570 (UMLS CUI [1,2])
C0449570 (UMLS CUI [1,2])
CL Item
Pre-bronchodilator FEV1 (L) (1)
CL Item
Post-bronchodilator FEV1 (L) (2)
CL Item
Post-bronchodilator FVC (L) (3)
Time of pulmonary function test
Item
Actual time of first reading
time
C0040223 (UMLS CUI [1,1])
C0024119 (UMLS CUI [1,2])
C0024119 (UMLS CUI [1,2])
Test Result pulmonary function test
Item
Reading 1
float
C0456984 (UMLS CUI [1,1])
C0024119 (UMLS CUI [1,2])
C0024119 (UMLS CUI [1,2])
Test Result pulmonary function test
Item
Reading 2
float
C0456984 (UMLS CUI [1,1])
C0024119 (UMLS CUI [1,2])
C0024119 (UMLS CUI [1,2])
Test Result pulmonary function test
Item
Reading 3
float
C0456984 (UMLS CUI [1,1])
C0024119 (UMLS CUI [1,2])
C0024119 (UMLS CUI [1,2])
Test Result pulmonary function test
Item
Highest Reading
float
C0456984 (UMLS CUI [1,1])
C0024119 (UMLS CUI [1,2])
C0024119 (UMLS CUI [1,2])
Predicted Normal
Item
Predicted Normal
float
C0024119 (UMLS CUI [1,1])
C0086715 (UMLS CUI [1,2])
C0086715 (UMLS CUI [1,2])
Percent Predicted Normal
Item
Percent Predicted Normal
float
C0024119 (UMLS CUI [1,1])
C0086715 (UMLS CUI [1,2])
C0086715 (UMLS CUI [1,2])
Post-bronchodilator FEV1/FVC ratio
Item
Postbronchodilator FEV1/FVC ratio
float
C2599594 (UMLS CUI [1,1])
C0429745 (UMLS CUI [1,2])
C0429745 (UMLS CUI [1,2])
Reversibility
Item
Reversibility
float
C3548479 (UMLS CUI [1,1])
C0024119 (UMLS CUI [1,2])
C0024119 (UMLS CUI [1,2])
Laboratory code
Item
Lab code
integer
C0022885 (UMLS CUI [1,1])
C0805701 (UMLS CUI [1,2])
C0805701 (UMLS CUI [1,2])
Investigator Instructions
Item
If some results are abnormal, but none are clinically significant, answer NO to the abnormality question.
text
C0008961 (UMLS CUI [1,1])
C1442085 (UMLS CUI [1,2])
C1442085 (UMLS CUI [1,2])
Monitor Data Validation Checks Hematology
Item
- Check that the sample taken date on this page matches the sample taken date on the lab source document - Check that the sample time is recorded in 24-hour-clock format (00:00 - 23:59). - Check that the sample time on this page matches the sample time on the lab source document. - Check that the abnormality leading questions are marked. - If an abnormality question is answered NO, check that no reasons for abnormalities are present. - If an abnormality question is answered YES, check that at least one analyte contains an abnormality code. - Check that no box contains more than one abnormality code. - If the abnormality code is X (other), check that a concise text entry is present within the space - If there are any lab abnormalities of clinical significance, check that they are recorded on the appropriate ADVERSE EVENTS page(s).
text
C1519941 (UMLS CUI [1,1])
C0200627 (UMLS CUI [1,2])
C0200627 (UMLS CUI [1,2])
Date hematology sample taken
Item
Date hematology sample taken
date
C0011008 (UMLS CUI [1,1])
C0200345 (UMLS CUI [1,2])
C0018941 (UMLS CUI [1,3])
C0200345 (UMLS CUI [1,2])
C0018941 (UMLS CUI [1,3])
Time of blood sample
Item
Time of sample
time
C0200345 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
C0018941 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,2])
C0018941 (UMLS CUI [1,3])
Hematology abnormality
Item
Were there any clinically significant hematology abnormalities?
boolean
C0850715 (UMLS CUI [1,1])
C2985739 (UMLS CUI [1,2])
C2985739 (UMLS CUI [1,2])
Hemoglobin
Item
Hemoglobin
float
C0518015 (UMLS CUI [1,1])
C0587081 (UMLS CUI [1,2])
C0587081 (UMLS CUI [1,2])
Item
Hemoglobin if abnormal: Primary reason for clinically significant abnormality
text
C0518015 (UMLS CUI [1,1])
C2985739 (UMLS CUI [1,2])
C2985739 (UMLS CUI [1,2])
CL Item
Due to disease under study, (D)
CL Item
Due to other concurrent disease, (C)
CL Item
Reasonable possibility due to investigational product, (T)
CL Item
Reasonable possibility due to other concomitant medication, (M)
CL Item
Other, specify text in the box (X)
Other clinically significant abnormalities
Item
Other clinically significant abnormalities
text
C0497168 (UMLS CUI [1,1])
C2985739 (UMLS CUI [1,2])
C2985739 (UMLS CUI [1,2])
Hematocrit
Item
Hematocrit (PCV)
float
C0518014 (UMLS CUI [1,1])
C0587081 (UMLS CUI [1,2])
C0587081 (UMLS CUI [1,2])
Item
Hematocrit (PCV) Primary reason for clinically significant abnormality
text
C0518014 (UMLS CUI [1,1])
C2985739 (UMLS CUI [1,2])
C2985739 (UMLS CUI [1,2])
CL Item
Due to disease under study, (D)
CL Item
Due to other concurrent disease, (C)
CL Item
Reasonable possibility due to investigational product, (T)
CL Item
Reasonable possibility due to other concomitant medication, (M)
CL Item
Other, specify text in the box (X)
Other clinically significant abnormalities
Item
Other clinically significant abnormalities
text
C0497168 (UMLS CUI [1,1])
C2985739 (UMLS CUI [1,2])
C2985739 (UMLS CUI [1,2])
RBC
Item
RBC
float
C0014772 (UMLS CUI [1,1])
C0587081 (UMLS CUI [1,2])
C0587081 (UMLS CUI [1,2])
Item
RBC Primary reason for clinically significant abnormality
text
C0014772 (UMLS CUI [1,1])
C2985739 (UMLS CUI [1,2])
C2985739 (UMLS CUI [1,2])
CL Item
Due to disease under study, (D)
CL Item
Due to other concurrent disease, (C)
CL Item
Reasonable possibility due to investigational product, (T)
CL Item
Reasonable possibility due to other concomitant medication, (M)
CL Item
Other, specify text in the box (X)
Other clinically significant abnormalities
Item
Other clinically significant abnormalities
text
C0497168 (UMLS CUI [1,1])
C2985739 (UMLS CUI [1,2])
C2985739 (UMLS CUI [1,2])
MCV
Item
Mean Corpuscular Volume
float
C0524587 (UMLS CUI [1])
Item
Mean Corpuscular Volume Primary reason for clinically significant abnormality
text
C0524587 (UMLS CUI [1,1])
C2985739 (UMLS CUI [1,2])
C2985739 (UMLS CUI [1,2])
CL Item
Due to disease under study, (D)
CL Item
Due to other concurrent disease, (C)
CL Item
Reasonable possibility due to investigational product, (T)
CL Item
Reasonable possibility due to other concomitant medication, (M)
CL Item
Other, specify text in the box (X)
Other clinically significant abnormalities
Item
Other clinically significant abnormalities
text
C0497168 (UMLS CUI [1,1])
C2985739 (UMLS CUI [1,2])
C2985739 (UMLS CUI [1,2])
MCH
Item
MCH
float
C0369183 (UMLS CUI [1,1])
C0587081 (UMLS CUI [1,2])
C0587081 (UMLS CUI [1,2])
Item
MCH Primary reason for clinically significant abnormality
text
C0369183 (UMLS CUI [1,1])
C2985739 (UMLS CUI [1,2])
C2985739 (UMLS CUI [1,2])
CL Item
Due to disease under study, (D)
CL Item
Due to other concurrent disease, (C)
CL Item
Reasonable possibility due to investigational product, (T)
CL Item
Reasonable possibility due to other concomitant medication, (M)
CL Item
Other, specify text in the box (X)
Other clinically significant abnormalities
Item
Other clinically significant abnormalities
text
C0497168 (UMLS CUI [1,1])
C2985739 (UMLS CUI [1,2])
C2985739 (UMLS CUI [1,2])
MCHC
Item
MCHC
float
C0474535 (UMLS CUI [1,1])
C0587081 (UMLS CUI [1,2])
C0587081 (UMLS CUI [1,2])
Item
MCHC Primary reason for clinically significant abnormality
text
C0474535 (UMLS CUI [1,1])
C2985739 (UMLS CUI [1,2])
C2985739 (UMLS CUI [1,2])
CL Item
Due to disease under study, (D)
CL Item
Due to other concurrent disease, (C)
CL Item
Reasonable possibility due to investigational product, (T)
CL Item
Reasonable possibility due to other concomitant medication, (M)
CL Item
Other, specify text in the box (X)
Other clinically significant abnormalities
Item
Other clinically significant abnormalities
text
C0497168 (UMLS CUI [1,1])
C2985739 (UMLS CUI [1,2])
C2985739 (UMLS CUI [1,2])
Platelets
Item
Platelets
float
C0032181 (UMLS CUI [1,1])
C0587081 (UMLS CUI [1,2])
C0587081 (UMLS CUI [1,2])
Item
Platelets Primary reason for clinically significant abnormality
text
C0032181 (UMLS CUI [1,1])
C2985739 (UMLS CUI [1,2])
C2985739 (UMLS CUI [1,2])
CL Item
Due to disease under study, (D)
CL Item
Due to other concurrent disease, (C)
CL Item
Reasonable possibility due to investigational product, (T)
CL Item
Reasonable possibility due to other concomitant medication, (M)
CL Item
Other, specify text in the box (X)
Other clinically significant abnormalities
Item
Other clinically significant abnormalities
text
C0497168 (UMLS CUI [1,1])
C2985739 (UMLS CUI [1,2])
C2985739 (UMLS CUI [1,2])
Total WBC
Item
Total WBC
integer
C0023508 (UMLS CUI [1,1])
C0587081 (UMLS CUI [1,2])
C0587081 (UMLS CUI [1,2])
Item
Total WBC Primary reason for clinically significant abnormality
text
C0023508 (UMLS CUI [1,1])
C2985739 (UMLS CUI [1,2])
C2985739 (UMLS CUI [1,2])
CL Item
Due to disease under study, (D)
CL Item
Due to other concurrent disease, (C)
CL Item
Reasonable possibility due to investigational product, (T)
CL Item
Reasonable possibility due to other concomitant medication, (M)
CL Item
Other, specify text in the box (X)
Other clinically significant abnormalities
Item
Other clinically significant abnormalities
text
C0497168 (UMLS CUI [1,1])
C2985739 (UMLS CUI [1,2])
C2985739 (UMLS CUI [1,2])
Neutrophils
Item
Neutrophils
float
C0200633 (UMLS CUI [1,1])
C0587081 (UMLS CUI [1,2])
C0587081 (UMLS CUI [1,2])
Item
Neutrophils Primary reason for clinically significant abnormality
text
C0200633 (UMLS CUI [1,1])
C2985739 (UMLS CUI [1,2])
C2985739 (UMLS CUI [1,2])
CL Item
Due to disease under study, (D)
CL Item
Due to other concurrent disease, (C)
CL Item
Reasonable possibility due to investigational product, (T)
CL Item
Reasonable possibility due to other concomitant medication, (M)
CL Item
Other, specify text in the box (X)
Other clinically significant abnormalities
Item
Other clinically significant abnormalities
text
C0497168 (UMLS CUI [1,1])
C2985739 (UMLS CUI [1,2])
C2985739 (UMLS CUI [1,2])
Lymphocytes
Item
Lymphocytes
float
C0200635 (UMLS CUI [1,1])
C0587081 (UMLS CUI [1,2])
C0587081 (UMLS CUI [1,2])
Item
Lymphocytes Primary reason for clinically significant abnormality
text
C0200635 (UMLS CUI [1,1])
C2985739 (UMLS CUI [1,2])
C2985739 (UMLS CUI [1,2])
CL Item
Due to disease under study, (D)
CL Item
Due to other concurrent disease, (C)
CL Item
Reasonable possibility due to investigational product, (T)
CL Item
Reasonable possibility due to other concomitant medication, (M)
CL Item
Other, specify text in the box (X)
Other clinically significant abnormalities
Item
Other clinically significant abnormalities
text
C0497168 (UMLS CUI [1,1])
C2985739 (UMLS CUI [1,2])
C2985739 (UMLS CUI [1,2])
Monocytes count
Item
Monocytes
float
C0200637 (UMLS CUI [1,1])
C0587081 (UMLS CUI [1,2])
C0587081 (UMLS CUI [1,2])
Item
Monocytes Primary reason for clinically significant abnormality
text
C0200637 (UMLS CUI [1,1])
C2985739 (UMLS CUI [1,2])
C2985739 (UMLS CUI [1,2])
CL Item
Due to disease under study, (D)
CL Item
Due to other concurrent disease, (C)
CL Item
Reasonable possibility due to investigational product, (T)
CL Item
Reasonable possibility due to other concomitant medication, (M)
CL Item
Other, specify text in the box (X)
Other clinically significant abnormalities
Item
Other clinically significant abnormalities
text
C0497168 (UMLS CUI [1,1])
C2985739 (UMLS CUI [1,2])
C2985739 (UMLS CUI [1,2])
Eosinophils count
Item
Eosinophils
float
C0750879 (UMLS CUI [1])
Item
Eosinophils Primary reason for clinically significant abnormality
text
C0750879 (UMLS CUI [1,1])
C2985739 (UMLS CUI [1,2])
C2985739 (UMLS CUI [1,2])
CL Item
Due to disease under study, (D)
CL Item
Due to other concurrent disease, (C)
CL Item
Reasonable possibility due to investigational product, (T)
CL Item
Reasonable possibility due to other concomitant medication, (M)
CL Item
Other, specify text in the box (X)
Other clinically significant abnormalities
Item
Other clinically significant abnormalities
text
C0497168 (UMLS CUI [1,1])
C2985739 (UMLS CUI [1,2])
C2985739 (UMLS CUI [1,2])
Basophils
Item
Basophils
float
C0200641 (UMLS CUI [1,1])
C0587081 (UMLS CUI [1,2])
C0587081 (UMLS CUI [1,2])
Item
Basophils Primary reason for clinically significant abnormality
text
C0200641 (UMLS CUI [1,1])
C2985739 (UMLS CUI [1,2])
C2985739 (UMLS CUI [1,2])
CL Item
Due to disease under study, (D)
CL Item
Due to other concurrent disease, (C)
CL Item
Reasonable possibility due to investigational product, (T)
CL Item
Reasonable possibility due to other concomitant medication, (M)
CL Item
Other, specify text in the box (X)
Other clinically significant abnormalities
Item
Other clinically significant abnormalities
text
C0497168 (UMLS CUI [1,1])
C2985739 (UMLS CUI [1,2])
C2985739 (UMLS CUI [1,2])
Laboratory code
Item
Lab code
integer
C0022885 (UMLS CUI [1,1])
C0805701 (UMLS CUI [1,2])
C0805701 (UMLS CUI [1,2])
Investigator Instructions
Item
If some results are abnormal, but none are clinically significant, answer NO to the abnormality question.
text
C0008961 (UMLS CUI [1,1])
C1442085 (UMLS CUI [1,2])
C1442085 (UMLS CUI [1,2])
Monitor Data Validation Checks Hematology
Item
- Check that the sample taken date on this page matches the sample taken date on the lab source document - Check that the sample time is recorded in 24-hour-clock format (00:00 - 23:59). - Check that the sample time on this page matches the sample time on the lab source document. - Check that the abnormality leading questions are marked. - If an abnormality question is answered NO, check that no reasons for abnormalities are present. - If an abnormality question is answered YES, check that at least one analyte contains an abnormality code. - Check that no box contains more than one abnormality code. - If the abnormality code is X (other), check that a concise text entry is present within the space - If there are any lab abnormalities of clinical significance, check that they are recorded on the appropriate ADVERSE EVENTS page(s).
text
C1519941 (UMLS CUI [1,1])
C0200627 (UMLS CUI [1,2])
C0200627 (UMLS CUI [1,2])
Date clinical chemistry sample taken
Item
Date clinical chemistry sample taken
date
C0011008 (UMLS CUI [1,1])
C0200345 (UMLS CUI [1,2])
C0008000 (UMLS CUI [1,3])
C0200345 (UMLS CUI [1,2])
C0008000 (UMLS CUI [1,3])
Time of sample
Item
Time of sample
time
C0040223 (UMLS CUI [1,1])
C0200345 (UMLS CUI [1,2])
C0008000 (UMLS CUI [1,3])
C0200345 (UMLS CUI [1,2])
C0008000 (UMLS CUI [1,3])
Item
Were there any clinically significant clinical chemistry abnormalities?
text
C2985739 (UMLS CUI [1,1])
C0008000 (UMLS CUI [1,2])
C1704258 (UMLS CUI [1,3])
C0008000 (UMLS CUI [1,2])
C1704258 (UMLS CUI [1,3])
CL Item
Yes (Y)
CL Item
No (N)
Sodium
Item
Sodium result
float
C0337443 (UMLS CUI [1,1])
C0587081 (UMLS CUI [1,2])
C0587081 (UMLS CUI [1,2])
Item
Sodium result Primary reason for clinically significant abnormality
text
C0337443 (UMLS CUI [1,1])
C2985739 (UMLS CUI [1,2])
C2985739 (UMLS CUI [1,2])
CL Item
Due to disease under study, (D)
CL Item
Due to other concurrent disease, (C)
CL Item
Reasonable possibility due to investigational product, (T)
CL Item
Reasonable possibility due to other concomitant medication, (M)
CL Item
Other, specify text in the box (X)
Other clinically significant abnormalities
Item
Other clinically significant abnormalities
text
C0029481 (UMLS CUI [1,1])
C2985739 (UMLS CUI [1,2])
C2985739 (UMLS CUI [1,2])
Potassium
Item
Potassium
float
C0202194 (UMLS CUI [1,1])
C0587081 (UMLS CUI [1,2])
C0587081 (UMLS CUI [1,2])
Item
Potassium Primary reason for clinically significant abnormality
text
C0202194 (UMLS CUI [1,1])
C2985739 (UMLS CUI [1,2])
C2985739 (UMLS CUI [1,2])
CL Item
Due to disease under study, (D)
CL Item
Due to other concurrent disease, (C)
CL Item
Reasonable possibility due to investigational product, (T)
CL Item
Reasonable possibility due to other concomitant medication, (M)
CL Item
Other, specify text in the box (X)
Other clinically significant abnormalities
Item
Other clinically significant abnormalities
text
C0029481 (UMLS CUI [1,1])
C2985739 (UMLS CUI [1,2])
C2985739 (UMLS CUI [1,2])
Chloride
Item
Chloride
float
C0201952 (UMLS CUI [1,1])
C0587081 (UMLS CUI [1,2])
C0587081 (UMLS CUI [1,2])
Item
Chloride Primary reason for clinically significant abnormality
text
C0201952 (UMLS CUI [1,1])
C2985739 (UMLS CUI [1,2])
C2985739 (UMLS CUI [1,2])
CL Item
Due to disease under study, (D)
CL Item
Due to other concurrent disease, (C)
CL Item
Reasonable possibility due to investigational product, (T)
CL Item
Reasonable possibility due to other concomitant medication, (M)
CL Item
Other, specify text in the box (X)
Other clinically significant abnormalities
Item
Other clinically significant abnormalities
text
C0029481 (UMLS CUI [1,1])
C2985739 (UMLS CUI [1,2])
C2985739 (UMLS CUI [1,2])
Bicarbonate
Item
Bicarbonate
float
C0202059 (UMLS CUI [1,1])
C0587081 (UMLS CUI [1,2])
C0587081 (UMLS CUI [1,2])
Item
Bicarbonate Primary reason for clinically significant abnormality
text
C0202059 (UMLS CUI [1,1])
C2985739 (UMLS CUI [1,2])
C2985739 (UMLS CUI [1,2])
CL Item
Due to disease under study, (D)
CL Item
Due to other concurrent disease, (C)
CL Item
Reasonable possibility due to investigational product, (T)
CL Item
Reasonable possibility due to other concomitant medication, (M)
CL Item
Other, specify text in the box (X)
Other clinically significant abnormalities
Item
Other clinically significant abnormalities
text
C0029481 (UMLS CUI [1,1])
C2985739 (UMLS CUI [1,2])
C2985739 (UMLS CUI [1,2])
Glucose
Item
Glucose
float
C0202042 (UMLS CUI [1,1])
C0587081 (UMLS CUI [1,2])
C0587081 (UMLS CUI [1,2])
Item
Glucose Primary reason for clinically significant abnormality
text
C0202042 (UMLS CUI [1,1])
C2985739 (UMLS CUI [1,2])
C2985739 (UMLS CUI [1,2])
CL Item
Due to disease under study, (D)
CL Item
Due to other concurrent disease, (C)
CL Item
Reasonable possibility due to investigational product, (T)
CL Item
Reasonable possibility due to other concomitant medication, (M)
CL Item
Other, specify text in the box (X)
Other clinically significant abnormalities
Item
Other clinically significant abnormalities
text
C0029481 (UMLS CUI [1,1])
C2985739 (UMLS CUI [1,2])
C2985739 (UMLS CUI [1,2])
Total Protein
Item
Total Protein
float
C0555903 (UMLS CUI [1,1])
C0587081 (UMLS CUI [1,2])
C0587081 (UMLS CUI [1,2])
Item
Total Protein Primary reason for clinically significant abnormality
text
C0555903 (UMLS CUI [1,1])
C2985739 (UMLS CUI [1,2])
C2985739 (UMLS CUI [1,2])
CL Item
Due to disease under study, (D)
CL Item
Due to other concurrent disease, (C)
CL Item
Reasonable possibility due to investigational product, (T)
CL Item
Reasonable possibility due to other concomitant medication, (M)
CL Item
Other, specify text in the box (X)
Other clinically significant abnormalities
Item
Other clinically significant abnormalities
text
C0029481 (UMLS CUI [1,1])
C2985739 (UMLS CUI [1,2])
C2985739 (UMLS CUI [1,2])
Albumin
Item
Albumin
float
C0201838 (UMLS CUI [1,1])
C0587081 (UMLS CUI [1,2])
C0587081 (UMLS CUI [1,2])
Item
Albumin Primary reason for clinically significant abnormality
text
C0201838 (UMLS CUI [1,1])
C2985739 (UMLS CUI [1,2])
C2985739 (UMLS CUI [1,2])
CL Item
Due to disease under study, (D)
CL Item
Due to other concurrent disease, (C)
CL Item
Reasonable possibility due to investigational product, (T)
CL Item
Reasonable possibility due to other concomitant medication, (M)
CL Item
Other, specify text in the box (X)
Other clinically significant abnormalities
Item
Other clinically significant abnormalities
text
C0029481 (UMLS CUI [1,1])
C2985739 (UMLS CUI [1,2])
C2985739 (UMLS CUI [1,2])
Creatinine
Item
Creatinine
float
C0201976 (UMLS CUI [1,1])
C0587081 (UMLS CUI [1,2])
C0587081 (UMLS CUI [1,2])
Item
Creatinine Primary reason for clinically significant abnormality
text
C0201976 (UMLS CUI [1,1])
C2985739 (UMLS CUI [1,2])
C2985739 (UMLS CUI [1,2])
CL Item
Due to disease under study, (D)
CL Item
Due to other concurrent disease, (C)
CL Item
Reasonable possibility due to investigational product, (T)
CL Item
Reasonable possibility due to other concomitant medication, (M)
CL Item
Other, specify text in the box (X)
Other clinically significant abnormalities
Item
Other clinically significant abnormalities
text
C0029481 (UMLS CUI [1,1])
C2985739 (UMLS CUI [1,2])
C2985739 (UMLS CUI [1,2])
Urea/BUN
Item
Urea/BUN
float
C0005845 (UMLS CUI [1,1])
C0587081 (UMLS CUI [1,2])
C0587081 (UMLS CUI [1,2])
Item
Urea/BUN Primary reason for clinically significant abnormality
text
C0005845 (UMLS CUI [1,1])
C2985739 (UMLS CUI [1,2])
C2985739 (UMLS CUI [1,2])
CL Item
Due to disease under study, (D)
CL Item
Due to other concurrent disease, (C)
CL Item
Reasonable possibility due to investigational product, (T)
CL Item
Reasonable possibility due to other concomitant medication, (M)
CL Item
Other, specify text in the box (X)
Other clinically significant abnormalities
Item
Other clinically significant abnormalities
text
C0029481 (UMLS CUI [1,1])
C2985739 (UMLS CUI [1,2])
C2985739 (UMLS CUI [1,2])
Total Bilirubin
Item
Total Bilirubin
float
C0201913 (UMLS CUI [1,1])
C0587081 (UMLS CUI [1,2])
C0587081 (UMLS CUI [1,2])
Item
Total Bilirubin Primary reason for clinically significant abnormality
text
C0201913 (UMLS CUI [1,1])
C2985739 (UMLS CUI [1,2])
C2985739 (UMLS CUI [1,2])
CL Item
Due to disease under study, (D)
CL Item
Due to other concurrent disease, (C)
CL Item
Reasonable possibility due to investigational product, (T)
CL Item
Reasonable possibility due to other concomitant medication, (M)
CL Item
Other, specify text in the box (X)
Other clinically significant abnormalities
Item
Other clinically significant abnormalities
text
C0029481 (UMLS CUI [1,1])
C2985739 (UMLS CUI [1,2])
C2985739 (UMLS CUI [1,2])
Alkaline Phosphatase
Item
Alkaline Phosphatase
float
C0201850 (UMLS CUI [1,1])
C0587081 (UMLS CUI [1,2])
C0587081 (UMLS CUI [1,2])
Item
Alkaline Phosphatase Primary reason for clinically significant abnormality
text
C0201850 (UMLS CUI [1,1])
C2985739 (UMLS CUI [1,2])
C2985739 (UMLS CUI [1,2])
CL Item
Due to disease under study, (D)
CL Item
Due to other concurrent disease, (C)
CL Item
Reasonable possibility due to investigational product, (T)
CL Item
Reasonable possibility due to other concomitant medication, (M)
CL Item
Other, specify text in the box (X)
Other clinically significant abnormalities
Item
Other clinically significant abnormalities
text
C0029481 (UMLS CUI [1,1])
C2985739 (UMLS CUI [1,2])
C2985739 (UMLS CUI [1,2])
AST
Item
AST (SGOT)
float
C0201899 (UMLS CUI [1,1])
C0587081 (UMLS CUI [1,2])
C0587081 (UMLS CUI [1,2])
Item
AST (SGOT) Primary reason for clinically significant abnormality
text
C0201899 (UMLS CUI [1,1])
C2985739 (UMLS CUI [1,2])
C2985739 (UMLS CUI [1,2])
CL Item
Due to disease under study, (D)
CL Item
Due to other concurrent disease, (C)
CL Item
Reasonable possibility due to investigational product, (T)
CL Item
Reasonable possibility due to other concomitant medication, (M)
CL Item
Other, specify text in the box (X)
Other clinically significant abnormalities
Item
Other clinically significant abnormalities
text
C0029481 (UMLS CUI [1,1])
C2985739 (UMLS CUI [1,2])
C2985739 (UMLS CUI [1,2])
ALT
Item
ALT (SGPT)
float
C0201836 (UMLS CUI [1,1])
C0587081 (UMLS CUI [1,2])
C0587081 (UMLS CUI [1,2])
Item
ALT (SGPT) Primary reason for clinically significant abnormality
text
C0201836 (UMLS CUI [1,1])
C2985739 (UMLS CUI [1,2])
C2985739 (UMLS CUI [1,2])
CL Item
Due to disease under study, (D)
CL Item
Due to other concurrent disease, (C)
CL Item
Reasonable possibility due to investigational product, (T)
CL Item
Reasonable possibility due to other concomitant medication, (M)
CL Item
Other, specify text in the box (X)
Other clinically significant abnormalities
Item
Other clinically significant abnormalities
text
C0029481 (UMLS CUI [1,1])
C2985739 (UMLS CUI [1,2])
C2985739 (UMLS CUI [1,2])
GGT
Item
GGT
float
C0202035 (UMLS CUI [1,1])
C0587081 (UMLS CUI [1,2])
C0587081 (UMLS CUI [1,2])
Item
GGT Primary reason for clinically significant abnormality
text
C0202035 (UMLS CUI [1,1])
C2985739 (UMLS CUI [1,2])
C2985739 (UMLS CUI [1,2])
CL Item
Due to disease under study, (D)
CL Item
Due to other concurrent disease, (C)
CL Item
Reasonable possibility due to investigational product, (T)
CL Item
Reasonable possibility due to other concomitant medication, (M)
CL Item
Other, specify text in the box (X)
Other clinically significant abnormalities
Item
Other clinically significant abnormalities
text
C0029481 (UMLS CUI [1,1])
C2985739 (UMLS CUI [1,2])
C2985739 (UMLS CUI [1,2])
Monitor Data Validation Checks Urinalysis
Item
- Check that the sample taken date on this page matches the sample taken date on the lab source document - Check that the sample time is recorded in 24-hour-clock format (00:00 - 23:59). - Check that the sample time on this page matches the sample time on the lab source document. - Check that the abnormality leading questions are marked. - If an abnormality question is answered NO, check that no reasons for abnormalities are present. - If an abnormality question is answered YES, check that at least one analyte contains an abnormality code. - Check that no box contains more than one abnormality code. - If the abnormality code is X (other), check that a concise text entry is present within the space - If there are any lab abnormalities of clinical significance, check that they are recorded on the appropriate ADVERSE EVENTS page(s).
text
C1519941 (UMLS CUI [1,1])
C0042014 (UMLS CUI [1,2])
C0042014 (UMLS CUI [1,2])
Laboratory code
Item
Lab code
integer
C0022885 (UMLS CUI [1,1])
C0805701 (UMLS CUI [1,2])
C0805701 (UMLS CUI [1,2])
Date urinalysis sample taken
Item
Date urinalysis sample taken
date
C0011008 (UMLS CUI [1,1])
C0200345 (UMLS CUI [1,2])
C0042014 (UMLS CUI [1,3])
C0200345 (UMLS CUI [1,2])
C0042014 (UMLS CUI [1,3])
Time of sample
Item
Time of sample
time
C0040223 (UMLS CUI [1,1])
C0200345 (UMLS CUI [1,2])
C0042014 (UMLS CUI [1,3])
C0200345 (UMLS CUI [1,2])
C0042014 (UMLS CUI [1,3])
Item
Were there any clinically significant clinical chemistry abnormalities?
text
C2985739 (UMLS CUI [1,1])
C0042014 (UMLS CUI [1,2])
C1704258 (UMLS CUI [1,3])
C0042014 (UMLS CUI [1,2])
C1704258 (UMLS CUI [1,3])
CL Item
Yes (Y)
CL Item
No (N)
CL Item
Protein (1)
CL Item
Blood (2)
CL Item
Ketones (3)
CL Item
Glucose (4)
CL Item
Leucocytes (5)
CL Item
Total Bilirubin (6)
Item
Dipstick test result
integer
C0430370 (UMLS CUI [1,1])
C0587081 (UMLS CUI [1,2])
C0587081 (UMLS CUI [1,2])
CL Item
none or negative (0)
CL Item
trace (0.5)
CL Item
+ (1)
CL Item
++ (2)
CL Item
+++ (3)
CL Item
++++ (4)
Item
Dipstick testing Primary reason for clinically significant abnormality
text
C2985739 (UMLS CUI [1,1])
C0749990 (UMLS CUI [1,2])
C0749990 (UMLS CUI [1,2])
CL Item
Due to disease under study, (D)
CL Item
Due to other concurrent disease, (C)
CL Item
Reasonable possibility due to investigational product, (T)
CL Item
Reasonable possibility due to other concomitant medication, (M)
CL Item
Other, specify text in the box (X)
Other clinically significant abnormalities
Item
Other clinically significant abnormalities
text
C0749990 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C2985739 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,2])
C2985739 (UMLS CUI [1,3])
CL Item
WBC (1)
CL Item
RBC (2)
CL Item
Hyaline casts (3)
CL Item
Granular casts (4)
CL Item
Cellular casts (5)
Item
Sedimentary microscopy Primary reason for clinically significant abnormality
text
C2985739 (UMLS CUI [1,1])
C0427860 (UMLS CUI [1,2])
C0427860 (UMLS CUI [1,2])
CL Item
Due to disease under study, (D)
CL Item
Due to other concurrent disease, (C)
CL Item
Reasonable possibility due to investigational product, (T)
CL Item
Reasonable possibility due to other concomitant medication, (M)
CL Item
Other, specify text in the box (X)
Other clinically significant abnormalities
Item
Other clinically significant abnormalities
text
C0427860 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C2985739 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,2])
C2985739 (UMLS CUI [1,3])
Date sample taken
Item
Date sample taken
date
C1302413 (UMLS CUI [1])
Item
Substance Abuse Detection
integer
C0038577 (UMLS CUI [1,1])
C1514241 (UMLS CUI [1,2])
C1514241 (UMLS CUI [1,2])
CL Item
Opiates (1)
CL Item
Cocaine (2)
CL Item
Barbiturates (3)
CL Item
Amphetamines (4)
CL Item
Benzodiazepines (5)
CL Item
Cannabinoids (6)
CL Item
Cotinine (7)
Item
Substance Abuse Detection negative
integer
C0038577 (UMLS CUI [1,1])
C1513916 (UMLS CUI [1,2])
C1513916 (UMLS CUI [1,2])
CL Item
Opiates (1)
CL Item
Cocaine (2)
CL Item
Barbiturates (3)
CL Item
Amphetamines (4)
CL Item
Benzodiazepines (5)
CL Item
Cannabinoids (6)
CL Item
Cotinine (7)
Date sample taken
Item
Date serology sample taken
date
C0036743 (UMLS CUI [1,1])
C1302413 (UMLS CUI [1,2])
C1302413 (UMLS CUI [1,2])
CL Item
Hepatitis B (HbsAg) (1)
CL Item
Hepatitis C antibody (2)
CL Item
HIV antibodies (3)
CL Item
Hepatitis B (HbsAg) (1)
CL Item
Hepatitis C antibody (2)
CL Item
HIV antibodies (3)
Inhaler Training
Item
Has the subject received training on how to use the inhaler?
boolean
C0030688 (UMLS CUI [1,1])
C0021461 (UMLS CUI [1,2])
C0021461 (UMLS CUI [1,2])
Inhaler usage
Item
Is the subject able to use the inhaler correctly?
boolean
C0021461 (UMLS CUI [1,1])
C0457083 (UMLS CUI [1,2])
C0457083 (UMLS CUI [1,2])
Monitor Data Validation Checks
Item
Check that either the YES or NO box at the top of the page is 'checked'. If NO is 'checked', check that no concomitant medications are present. If YES is 'checked', check that at least one concomitant medication is present. Check that either the 'Date started' is completed or 'check' if started pre-study' is 'checked'. At least one must be completed, but it is acceptable if both are completed. If a pre-investigational product start date is unknown, check that a 'check' is recorded for 'checked' if started Pre-study. If both 'Date started' and 'check' if started Pre-study' are completed , check that the start date is pre-study Check that the drug start date is before or equal to the drug stop date, if a stop date has been entered. Check that the drug name (trade name preferred) is spelled correctly. If the drug was started and stopped on the same date, check that the start time is before the stop time. (For single dose, start and stop times may be the same) Check that start and stop times are recorded in the 24-hour-clock format (00:00-23:59). If the subject is female, cross-check with the DEMOGRAPHY FOR FEMALES page that any contraceptive drugs taken by the subject are recorded. If a concomitant medication was started pre-study, check that the indication is recorded on the CURRENT MEDICAL CONDITIONS page. If the concomitant medication was taken for an adverse event, check that the event is entered on the appropriate ADVERSE EVENTS page(s) and that the dates are consistent with the event. Ensure that information entered on the page opposite is transcribed into the main CRF.
text
C1519941 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C2347852 (UMLS CUI [1,2])
Concomitant medications during screening period
Item
Were any concomitant medications taken by the subject during the screening period?
boolean
C2347852 (UMLS CUI [1,1])
C1710477 (UMLS CUI [1,2])
C1710477 (UMLS CUI [1,2])
Drug Name
Item
Drug (Trade name preferred)
text
C2347852 (UMLS CUI [1])
Medication Dose
Item
Dose
float
C3174092 (UMLS CUI [1])
CL Item
Gram (G)
CL Item
Litre (L)
CL Item
Microgram (MCG)
CL Item
Microlitre (MCL)
CL Item
Milligram (MG)
CL Item
Millilitre (ML)
CL Item
Tablet (TAB)
Frequency
Item
Frequency
text
C3476109 (UMLS CUI [1])
Administration Route
Item
Route
text
C0013153 (UMLS CUI [1])
Concomitant Medication Start Date
Item
Date started
date
C2826734 (UMLS CUI [1])
Started Pre-Study
Item
Started Pre-Study
boolean
C0013227 (UMLS CUI [1,1])
C0451613 (UMLS CUI [1,2])
C0451613 (UMLS CUI [1,2])
Concomitant medication start time
Item
start time
time
C1301880 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C2347852 (UMLS CUI [1,2])
Concomitant Medication Stop Date
Item
Concomitant Medication Stop Date
date
C2826744 (UMLS CUI [1])
Ongoing Medication
Item
Medication continued post-study
boolean
C2826666 (UMLS CUI [1])
Concomitant medication end time
Item
Stop time
time
C1522314 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C2347852 (UMLS CUI [1,2])
Condition treated/Indication
Item
Condition treated/Indication
text
C0392360 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C2347852 (UMLS CUI [1,2])
Adverse event treatment
Item
Was drug administered for an adverse event?
boolean
C2981656 (UMLS CUI [1])
Rescue Medication
Item
Was drug administered as a rescue medication?
boolean
C0013227 (UMLS CUI [1,1])
C0884980 (UMLS CUI [1,2])
C0884980 (UMLS CUI [1,2])