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.

Keywords

Versions (2)
  1. 9/27/17 9/27/17 -
  2. 9/20/21 9/20/21 -
Copyright Holder

Glaxo Smith Kline

Uploaded on

September 20, 2021

DOI

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License

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

English

Screening Visit

1 forms  
  1. StudyEvent: ODM
    1. Screening Visit
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI-1
C1512693
UMLS CUI-2
C1516637
Is the subject a COPD patient, defined as either Stage III to Stage IV COPD diagnosis according to GOLD criteria
Description

NOTE: Individuals must be otherwise healthy, individuals who are free from significant cardiac, gastrointestinal, hepatic, renal, haematological, malignancy, endocrine, neurological and psychiatric disease as determined by history, physical examination and screening investigations.

Data type

boolean

Alias
UMLS CUI [1,1]
C0024117
UMLS CUI [1,2]
C0205563
UMLS CUI [1,3]
C0162793
Is the subject aged 40-75 years inclusive?
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
Is the subject male or an eligible female?
Description

NOTE: In order to be eligible a female must either be of non-child bearing potential or agrees to complete abstinence from intercourse for 2 weeks before exposure to study drug, throughout the clinical trial until follow up or commit to consistent and correct use of an acceptable method of birth control.

Data type

boolean

Alias
UMLS CUI [1]
C0079399
Does the subject have a body mass index within the range 19-32kg/m2 inclusive?
Description

Body mass index

Data type

boolean

Alias
UMLS CUI [1]
C1305855
Does the subject have a post-bronchodilator FEV1 <= 50 percent predicted?
Description

post-bronchodilator FEV1

Data type

boolean

Alias
UMLS CUI [1,1]
C0748133
UMLS CUI [1,2]
C2599594
Does the subject have a post-bronchodilator FEV1/FVC ratio < 70 percent?
Description

post-bronchodilator FEV1/FVC ratio

Data type

boolean

Alias
UMLS CUI [1,1]
C2599594
UMLS CUI [1,2]
C0429745
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?
Description

Post-Bronchodilator FEV1

Data type

boolean

Alias
UMLS CUI [1]
C2021518
Is the subject capable of giving informed consent, which includes compliance with the requirements and restrictions listed in the consent form?
Description

Informed consent and compliance behavior

Data type

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C0085732
UMLS CUI [2,1]
C1321605
UMLS CUI [2,2]
C0085732
Is the subject able to use inhaler device adequately after training?
Description

Compliance behavior

Data type

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C0085732
Is the subject an ex smoker for at least the past 6 months with a pack history > 10 pack years?
Description

NOTE: [number of pack years= (number of cigarettes per day 120) x number of years smoked]

Data type

boolean

Alias
UMLS CUI [1,1]
C1519384
UMLS CUI [1,2]
C1277691
Is the subject available to complete the study?
Description

Compliance behavior

Data type

boolean

Alias
UMLS CUI [1]
C1321605
Exclusion criteria
Description

Exclusion criteria

Alias
UMLS CUI-1
C0680251
Has the subject any clinically relevant abnormality identified on the screening medical assessment, physical examination, laboratory examination (including clinical chemistry and haematology), or ECG?
Description

Comorbidities

Data type

boolean

Alias
UMLS CUI [1]
C0009488
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.)?
Description

Lung disease, circulatory system disorder

Data type

boolean

Alias
UMLS CUI [1,1]
C0024115
UMLS CUI [1,2]
C0728936
Does the subject have regular oxygen or nebulised bronchodilator therapy?
Description

Concomitant therapy

Data type

boolean

Alias
UMLS CUI [1]
C1707479
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?
Description

Study subject participation status

Data type

boolean

Alias
UMLS CUI [1]
C2348568
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)?
Description

NOTE: 1 unit is equivalent to a half-pint (220mL) of beer or 1 (25ml) measure of spirits or 1 glass (125ml) of wine.

Data type

boolean

Alias
UMLS CUI [1]
C0038586
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)?
Description

Concomitant medication

Data type

boolean

Alias
UMLS CUI [1]
C2347852
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)
Description

Concomitant medication systemic steroids

Data type

boolean

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C2825233
Has the subject a history of a respiratory infection (including sinusitis) within 4 weeks prior to first study visit?
Description

Respiratory infection

Data type

boolean

Alias
UMLS CUI [1,1]
C0035243
UMLS CUI [1,2]
C0262926
Inclusion/Exclusion Criteria
Description

Inclusion/Exclusion Criteria

Alias
UMLS CUI-1
C1704756
Did the subject meet all entry criteria?
Description

(i.e., All `YES` answers for inclusion criteria, all `NO` answers for exclusion criteria)?

Data type

boolean

Alias
UMLS CUI [1]
C1704756
Inclusion Criteria: check all boxes that represent a violation of the inclusion/exclusion criteria
Description

Inclusion Criteria

Data type

integer

Alias
UMLS CUI [1,1]
C1512693
UMLS CUI [1,2]
C1516637
Exclusion Criteria: check all boxes that represent a violation of the inclusion/exclusion criteria
Description

Exclusion Criteria

Data type

integer

Alias
UMLS CUI [1]
C0680251
Compliance Restrictions Worksheet
Description

Compliance Restrictions Worksheet

Alias
UMLS CUI-1
C1321605
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.
Description

Compliance Restrictions Worksheet

Data type

text

Alias
UMLS CUI [1]
C1321605
Did the subject comply with the Requirements and Restrictions as listed in the protocol as appropriate thus far?
Description

Compliance behavior

Data type

boolean

Alias
UMLS CUI [1]
C1321605
Is the subject aware of any forthcoming requirements?
Description

Compliance behavior limited

Data type

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C0439801
Date of Assessment
Description

Date of Assessment

Data type

date

Alias
UMLS CUI [1]
C2985720
Comments
Description

Comments

Data type

text

Alias
UMLS CUI [1]
C0947611
Demography
Description

Demography

Alias
UMLS CUI-1
C0011298
Date of assessment
Description

Date of assessment

Data type

date

Alias
UMLS CUI [1]
C2985720
Date of Birth
Description

Date of Birth

Data type

date

Alias
UMLS CUI [1]
C0421451
Sex
Description

Gender

Data type

text

Alias
UMLS CUI [1]
C0079399
Race
Description

Race

Data type

text

Alias
UMLS CUI [1]
C0034510
Height
Description

Height

Data type

integer

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

Weight

Data type

float

Measurement units
  • kg
Alias
UMLS CUI [1]
C0005910
kg
Body Mass Index
Description

BMI

Data type

float

Measurement units
  • kg/m2
Alias
UMLS CUI [1]
C1305855
kg/m2
Demography for Females
Description

Demography for Females

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

Childbearing potential

Data type

integer

Alias
UMLS CUI [1]
C3831118
If potentially able to conceive children check all type(s) of contraception used below
Description

Details of any contraceptive drugs must be added to the CONCOMITANT MEDICATIONS page, Barrier method only if used in combination with any of the other acceptable contraception methods.

Data type

integer

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
Contraceptive methods, please specify other
Description

Contraceptive methods

Data type

text

Alias
UMLS CUI [1,1]
C0700589
UMLS CUI [1,2]
C3845569
Pregnancy test result
Description

Pregnancy test result

Data type

integer

Alias
UMLS CUI [1]
C0427777
Medical History
Description

Medical History

Alias
UMLS CUI-1
C0262926
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 (/ )].
Description

Medical History

Data type

text

Alias
UMLS CUI [1]
C0262926
Ear, Nose and Throat:
Description

Ear, Nose and Throat Disorder

Data type

boolean

Alias
UMLS CUI [1]
C0395797
If YES, specify condition(s):
Description

Ear, Nose and Throat Disorders

Data type

text

Alias
UMLS CUI [1,1]
C0395797
UMLS CUI [1,2]
C2348235
Eyes:
Description

Eye Disorders

Data type

boolean

Alias
UMLS CUI [1]
C0015397
If Yes, please specify Eye disorders
Description

Eye disorders

Data type

text

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0015397
Respiratory
Description

Respiratory System Disorder

Data type

boolean

Alias
UMLS CUI [1]
C0035204
Respiratory: If yes, please specify
Description

Respiratory System Disorder

Data type

text

Alias
UMLS CUI [1]
C0035204
Cardiovascular
Description

Cardiovascular Diseases

Data type

boolean

Alias
UMLS CUI [1]
C0007222
Cardiovascular: If yes, please specify
Description

Cardiovascular Diseases

Data type

text

Alias
UMLS CUI [1]
C0007222
Gastrointestinal
Description

Gastrointestinal Diseases

Data type

boolean

Alias
UMLS CUI [1]
C0017178
Gastrointestinal: If Yes, please specify
Description

Gastrointestinal Diseases

Data type

text

Alias
UMLS CUI [1]
C0017178
Hepatobiliary and pancreas
Description

Hepatobiliary and pancreas Diseases

Data type

boolean

Alias
UMLS CUI [1]
C0267792
UMLS CUI [2]
C0030286
Hepatobiliary and pancreas: If Yes, please specify
Description

Hepatobiliary and pancreas Diseases

Data type

text

Alias
UMLS CUI [1]
C0267792
UMLS CUI [2]
C0030286
Urology
Description

Urologic diseases

Data type

boolean

Alias
UMLS CUI [1]
C0042075
Urology: If yes, please specify
Description

Urologic diseases

Data type

text

Alias
UMLS CUI [1]
C0042075
Reproduction
Description

Reproductive System Disorders

Data type

boolean

Alias
UMLS CUI [1]
C0178829
Reproduction: If Yes, please specify
Description

Reproductive System Disorders

Data type

text

Alias
UMLS CUI [1]
C0178829
Neurology
Description

Neurology

Data type

boolean

Alias
UMLS CUI [1]
C0027765
Neurology:If yes, please specify
Description

Neurology

Data type

text

Alias
UMLS CUI [1]
C0027765
Blood and lymphatic
Description

Blood and lymphatic system disorders

Data type

boolean

Alias
UMLS CUI [1]
C0851353
Blood and lymphatic: If yes, please specify
Description

Blood and lymphatic system disorders

Data type

text

Alias
UMLS CUI [1]
C0851353
Endocrine and metabolic
Description

Endocrine and metabolic system disorder

Data type

boolean

Alias
UMLS CUI [1]
C0025517
UMLS CUI [2]
C0014130
Endocrine and Metabolic: If Yes, please specify
Description

Endocrine and Metabolic System Disorders

Data type

text

Alias
UMLS CUI [1]
C0025517
UMLS CUI [2]
C0014130
Musculoskeletal
Description

Musculoskeletal Diseases

Data type

boolean

Alias
UMLS CUI [1]
C0026857
Musculoskeletal: If Yes, please specify
Description

Musculoskeletal Diseases

Data type

text

Alias
UMLS CUI [1]
C0026857
Skin
Description

Skin Diseases

Data type

boolean

Alias
UMLS CUI [1]
C0037274
Skin: If Yes, please specify
Description

Skin Diseases

Data type

text

Alias
UMLS CUI [1]
C0037274
Psychiatry
Description

Psychiatric disorders

Data type

boolean

Alias
UMLS CUI [1]
C0004936
Psychiatry: If Yes, please specify
Description

Psychiatric disorders

Data type

text

Alias
UMLS CUI [1]
C0004936
Allergies
Description

Allergies

Data type

boolean

Alias
UMLS CUI [1]
C0020517
Allergies:If Yes, please specify
Description

Allergies

Data type

text

Alias
UMLS CUI [1]
C0020517
Physical Examination
Description

Physical Examination

Alias
UMLS CUI-1
C0031809
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 (/)].
Description

Physical Examination

Data type

text

Alias
UMLS CUI [1]
C0031809
Hair and skin
Description

Hair and skin

Data type

integer

Alias
UMLS CUI [1,1]
C0018494
UMLS CUI [1,2]
C0558035
Hair and Skin: If Abnormal, please specify
Description

Hair and Skin

Data type

text

Alias
UMLS CUI [1,1]
C0018494
UMLS CUI [1,2]
C0558035
Lymph nodes
Description

Lymph nodes

Data type

integer

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0024204
Lymph nodes: If Abnormal, please specify
Description

Lymph nodes

Data type

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0024204
Eyes
Description

Eyes

Data type

integer

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0200149
Eyes: If Abnormal, please specify
Description

Eyes

Data type

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0200149
Ears, Nose and Throat
Description

Ears, Nose and Throat

Data type

integer

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0278350
Ears, Nose and Throat: If Abnormal, please specify
Description

Ears, Nose and Throat

Data type

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0278350
Breasts
Description

Breasts

Data type

integer

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0199850
Breasts: If Abnormal or not done, please specify
Description

Breasts

Data type

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0199850
Respiratory
Description

Respiratory

Data type

integer

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0436121
Respiratory: If Abnormal, please specify
Description

Respiratory

Data type

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0436121
Cardiovascular
Description

Cardiovascular

Data type

integer

Alias
UMLS CUI [1]
C3854344
Cardiovascular: If Abnormal, please specify
Description

Cardiovascular

Data type

text

Alias
UMLS CUI [1]
C3854344
Abdomen
Description

Abdomen

Data type

integer

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0000726
Abdomen: If Abnormal, please specify
Description

Abdomen

Data type

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0000726
Urogenital
Description

Urogenital

Data type

integer

Alias
UMLS CUI [1]
C1828035
Urogenital: If abnormal or not done, please specify
Description

Urogenital

Data type

text

Alias
UMLS CUI [1]
C1828035
Pelvic
Description

Pelvic

Data type

integer

Alias
UMLS CUI [1]
C0200045
Pelvic: If Abnormal or not done, please specify
Description

Pelvic

Data type

text

Alias
UMLS CUI [1]
C0200045
Rectal
Description

Rectal

Data type

integer

Alias
UMLS CUI [1]
C0199900
Rectal: If abnormal or not done, please specify
Description

Rectal

Data type

text

Alias
UMLS CUI [1]
C0199900
Musculoskeletal
Description

Musculoskeletal

Data type

integer

Alias
UMLS CUI [1]
C0475091
Musculoskeletal: If Abnormal, please specify
Description

Musculoskeletal

Data type

text

Alias
UMLS CUI [1]
C0475091
Neurological
Description

Neurological

Data type

integer

Alias
UMLS CUI [1]
C0027853
Neurological: If Abnormal, please specify
Description

Neurological

Data type

text

Alias
UMLS CUI [1]
C0027853
Mental status
Description

Mental status

Data type

integer

Alias
UMLS CUI [1]
C3260990
Mental Status: If Abnormal, please specify
Description

Mental Status

Data type

text

Alias
UMLS CUI [1]
C3260990
Vital Signs
Description

Vital Signs

Alias
UMLS CUI-1
C0518766
UMLS CUI-2
C0031809
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.
Description

Monitor Data Validation Checks Vital Signs

Data type

text

Alias
UMLS CUI [1,1]
C1519941
UMLS CUI [1,2]
C0518766
Vital Signs Row Number
Description

Three consecutive measurements (heart rate, systolic and diastolic blood pressure) will be taken.

Data type

integer

Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C0750480
Date
Description

Assessment Date

Data type

date

Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C2985720
Planned relative time
Description

time relative to dosing

Data type

integer

Alias
UMLS CUI [1]
C3641100
Actual Time
Description

00:00-23:59

Data type

time

Alias
UMLS CUI [1]
C1320304
Systolic Blood Pressure
Description

Systolic Blood Pressure

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
Diastolic blood pressure
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
Electrocardiogram
Description

Electrocardiogram

Alias
UMLS CUI-1
C1623258
- 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.
Description

Monitor Data Validation Checks Electrocardiogram

Data type

text

Alias
UMLS CUI [1,1]
C1519941
UMLS CUI [1,2]
C1623258
Date of ECG
Description

Day Month Year

Data type

date

Alias
UMLS CUI [1]
C2826640
Time of ECG
Description

00:00-23:59

Data type

time

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

Ventricular rate

Data type

integer

Measurement units
  • bpm
Alias
UMLS CUI [1]
C2189285
bpm
PR Interval
Description

PR Interval

Data type

integer

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

QRS Duration

Data type

integer

Measurement units
  • msec
Alias
UMLS CUI [1]
C0429025
msec
QT Interval
Description

QT Interval

Data type

integer

Measurement units
  • msec
Alias
UMLS CUI [1]
C0577807
msec
QTc Interval
Description

QTc Interval

Data type

integer

Measurement units
  • msec
Alias
UMLS CUI [1]
C0855331
msec
ECG
Description

ECG result

Data type

text

Alias
UMLS CUI [1,1]
C1623258
UMLS CUI [1,2]
C0456984
Were any of the abnormalities clinically significant?
Description

ECG Result

Data type

text

Alias
UMLS CUI [1,1]
C1623258
UMLS CUI [1,2]
C0456984
ECG Abnormalities:If YES, check all that apply
Description

ECG Abnormalities

Data type

text

Alias
UMLS CUI [1]
C0522055
Sinus bradycardia
Description

Sinus bradycardia

Data type

boolean

Alias
UMLS CUI [1]
C0085610
Sinus tachycardia
Description

Sinus tachycardia

Data type

boolean

Alias
UMLS CUI [1]
C0039239
Sinus pause
Description

Sinus pause

Data type

boolean

Alias
UMLS CUI [1]
C1955864
Ectopic supraventricular beats
Description

Ectopic supraventricular beats

Data type

boolean

Alias
UMLS CUI [1]
C0033036
Junctional rhythm (<= 100/min)
Description

Junctional rhythm

Data type

boolean

Alias
UMLS CUI [1]
C0232208
Supraventricular tachycardia (>100/min)
Description

Supraventricular tachycardia

Data type

boolean

Alias
UMLS CUI [1]
C0039240
Atrial flutter
Description

Atrial flutter

Data type

boolean

Alias
UMLS CUI [1]
C0004239
Atrial Fibrillation
Description

Atrial Fibrillation

Data type

boolean

Alias
UMLS CUI [1]
C0004238
Ectopic ventricular beats
Description

Ectopic ventricular beats

Data type

boolean

Alias
UMLS CUI [1]
C0151636
Ventricular rhythm, comment below
Description

Ventricular rhythm

Data type

boolean

Alias
UMLS CUI [1]
C0232216
Pacemaker
Description

Pacemaker

Data type

boolean

Alias
UMLS CUI [1,1]
C0030163
UMLS CUI [1,2]
C2981711
Left atrial abnormality (P mitrale)
Description

Left atrial abnormality (P mitrale)

Data type

boolean

Alias
UMLS CUI [1,1]
C0344711
UMLS CUI [1,2]
C0232310
Right atrial abnormality (P pulmonale)
Description

Right atrial abnormality (P pulmonale)

Data type

boolean

Alias
UMLS CUI [1,1]
C0344696
UMLS CUI [1,2]
C0232308
First degree AV block (PR interval> 0.20 sec)
Description

First degree AV block

Data type

boolean

Alias
UMLS CUI [1]
C0085614
Second degree AV block (Mobitz type 1)
Description

Second degree AV block (Mobitz type 1)

Data type

boolean

Alias
UMLS CUI [1]
C0264907
Second degree AV block (Mobitz type 2)
Description

Second degree AV block (Mobitz type 2)

Data type

boolean

Alias
UMLS CUI [1]
C0155700
Third degree AV block
Description

Third degree AV block

Data type

boolean

Alias
UMLS CUI [1]
C0151517
Left axis deviation (QRS axis more negative than - 30 degrees)
Description

Left axis deviation (QRS axis more negative than - 30 degrees)

Data type

boolean

Alias
UMLS CUI [1]
C0232297
Right axis deviation (ORS axis more positive than + 110 degrees)
Description

Right axis deviation

Data type

boolean

Alias
UMLS CUI [1]
C0232296
Incomplete right bundle branch block
Description

Incomplete right bundle branch block

Data type

boolean

Alias
UMLS CUI [1]
C0262525
Right bundle branch block
Description

Right bundle branch block

Data type

boolean

Alias
UMLS CUI [1]
C0085615
Left bundle branch block
Description

Left bundle branch block

Data type

boolean

Alias
UMLS CUI [1]
C0023211
Nonspecific intraventricular conduction delay (QRS greater than 0,12sec)
Description

Nonspecific intraventricular conduction delay

Data type

boolean

Alias
UMLS CUI [1]
C1882112
Accessory pathway (Wolff-Parkinson White, Lown-Ganong-Levine)
Description

Accessory pathway (Wolff-Parkinson White, Lown-Ganong-Levine)

Data type

boolean

Alias
UMLS CUI [1,1]
C0264897
UMLS CUI [1,2]
C0043202
QT/QTc prolongation
Description

QT/QTc prolongation

Data type

boolean

Alias
UMLS CUI [1]
C0855333
Myocardial infarction, old
Description

Myocardial infarction, old

Data type

boolean

Alias
UMLS CUI [1]
C0155668
Myocardial infarction, other
Description

comment below

Data type

boolean

Alias
UMLS CUI [1,1]
C0027051
UMLS CUI [1,2]
C0205394
Non-specific ST-T changes
Description

Non-specific ST-T changes

Data type

boolean

Alias
UMLS CUI [1]
C1112720
Low QRS voltage
Description

Low QRS voltage

Data type

boolean

Alias
UMLS CUI [1]
C2349945
Other, specify in comments
Description

Other

Data type

boolean

Alias
UMLS CUI [1]
C0205394
Comment
Description

ECG Abnormalities

Data type

text

Alias
UMLS CUI [1,1]
C0522055
UMLS CUI [1,2]
C3845569
Lung Function Tests
Description

Lung Function Tests

Alias
UMLS CUI-1
C0024119
Date
Description

Day Month Year

Data type

date

Alias
UMLS CUI [1]
C2985720
Lung function tests mus/ be performed with the subject in a STANDING position .
Description

Lung Function Tests

Data type

text

Alias
UMLS CUI [1]
C0024119
Planned time Test type
Description

Planned time Test type

Data type

integer

Alias
UMLS CUI [1,1]
C2348792
UMLS CUI [1,2]
C0449570
Actual time of first reading
Description

00:00-23:59

Data type

time

Alias
UMLS CUI [1,1]
C0040223
UMLS CUI [1,2]
C0024119
Reading 1
Description

Test Result pulmonary function test

Data type

float

Alias
UMLS CUI [1,1]
C0456984
UMLS CUI [1,2]
C0024119
Reading 2
Description

Test Result pulmonary function test

Data type

float

Alias
UMLS CUI [1,1]
C0456984
UMLS CUI [1,2]
C0024119
Reading 3
Description

Test Result pulmonary function test

Data type

float

Alias
UMLS CUI [1,1]
C0456984
UMLS CUI [1,2]
C0024119
Highest Reading
Description

Test Result pulmonary function test

Data type

float

Alias
UMLS CUI [1,1]
C0456984
UMLS CUI [1,2]
C0024119
Predicted Normal
Description

Predicted Normal

Data type

float

Alias
UMLS CUI [1,1]
C0024119
UMLS CUI [1,2]
C0086715
Percent Predicted Normal
Description

NOTE: A post-bronchodilator FEV1 of <=50% of predicted normal and an FEV1/FVC ratio of <70% must be demonstrated at this visit. Subjects who do not meet these criteria cannot be enrolled in the study.

Data type

float

Alias
UMLS CUI [1,1]
C0024119
UMLS CUI [1,2]
C0086715
Postbronchodilator FEV1/FVC ratio
Description

NOTE: A post-bronchodilator FEV1 of <=50% of predicted normal and an FEV1/FVC ratio of <70% must be demonstrated at this visit. Subjects who do not meet these criteria cannot be enrolled in the study.

Data type

float

Measurement units
  • %
Alias
UMLS CUI [1,1]
C2599594
UMLS CUI [1,2]
C0429745
%
Reversibility
Description

NOTE: The subject must demonstrate an increase of less than 15% from baseline FEV1, 30 minutes after inhalation of 400mcg of salbutamol. Subjects who do not meet this criterion cannot be entered into the study.

Data type

float

Measurement units
  • %
Alias
UMLS CUI [1,1]
C3548479
UMLS CUI [1,2]
C0024119
%
Hematology
Description

Hematology

Alias
UMLS CUI-1
C0018941
Lab code
Description

For GSK use only

Data type

integer

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0805701
If some results are abnormal, but none are clinically significant, answer NO to the abnormality question.
Description

Investigator Instructions

Data type

text

Alias
UMLS CUI [1,1]
C0008961
UMLS CUI [1,2]
C1442085
- 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).
Description

Monitor Data Validation Checks Hematology

Data type

text

Alias
UMLS CUI [1,1]
C1519941
UMLS CUI [1,2]
C0200627
Date hematology sample taken
Description

Date hematology sample taken

Data type

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0200345
UMLS CUI [1,3]
C0018941
Time of sample
Description

Time of blood sample

Data type

time

Alias
UMLS CUI [1,1]
C0200345
UMLS CUI [1,2]
C0040223
UMLS CUI [1,3]
C0018941
Were there any clinically significant hematology abnormalities?
Description

If YES, record primary reason for the clinically significant abnormality in the column below, by using the following key: D - Due to disease under study, C - Due to other concurrent disease, T - Reasonable possibility due to investigational product, M- Reasonable possibility due to other concomitant medication, X - Other, specify text in the box

Data type

boolean

Alias
UMLS CUI [1,1]
C0850715
UMLS CUI [1,2]
C2985739
Hemoglobin
Description

Hemoglobin

Data type

float

Alias
UMLS CUI [1,1]
C0518015
UMLS CUI [1,2]
C0587081
Hemoglobin if abnormal: Primary reason for clinically significant abnormality
Description

Hemoglobin

Data type

text

Alias
UMLS CUI [1,1]
C0518015
UMLS CUI [1,2]
C2985739
Other clinically significant abnormalities
Description

Other clinically significant abnormalities

Data type

text

Alias
UMLS CUI [1,1]
C0497168
UMLS CUI [1,2]
C2985739
Hematocrit (PCV)
Description

Hematocrit

Data type

float

Alias
UMLS CUI [1,1]
C0518014
UMLS CUI [1,2]
C0587081
Hematocrit (PCV) Primary reason for clinically significant abnormality
Description

Hematocrit

Data type

text

Alias
UMLS CUI [1,1]
C0518014
UMLS CUI [1,2]
C2985739
Other clinically significant abnormalities
Description

Other clinically significant abnormalities

Data type

text

Alias
UMLS CUI [1,1]
C0497168
UMLS CUI [1,2]
C2985739
RBC
Description

RBC

Data type

float

Alias
UMLS CUI [1,1]
C0014772
UMLS CUI [1,2]
C0587081
RBC Primary reason for clinically significant abnormality
Description

RBC

Data type

text

Alias
UMLS CUI [1,1]
C0014772
UMLS CUI [1,2]
C2985739
Other clinically significant abnormalities
Description

Other clinically significant abnormalities

Data type

text

Alias
UMLS CUI [1,1]
C0497168
UMLS CUI [1,2]
C2985739
Mean Corpuscular Volume
Description

MCV

Data type

float

Measurement units
  • fl
Alias
UMLS CUI [1]
C0524587
fl
Mean Corpuscular Volume Primary reason for clinically significant abnormality
Description

MCV

Data type

text

Alias
UMLS CUI [1,1]
C0524587
UMLS CUI [1,2]
C2985739
Other clinically significant abnormalities
Description

Other clinically significant abnormalities

Data type

text

Alias
UMLS CUI [1,1]
C0497168
UMLS CUI [1,2]
C2985739
MCH
Description

MCH

Data type

float

Measurement units
  • pg
Alias
UMLS CUI [1,1]
C0369183
UMLS CUI [1,2]
C0587081
pg
MCH Primary reason for clinically significant abnormality
Description

MCH

Data type

text

Alias
UMLS CUI [1,1]
C0369183
UMLS CUI [1,2]
C2985739
Other clinically significant abnormalities
Description

Other clinically significant abnormalities

Data type

text

Alias
UMLS CUI [1,1]
C0497168
UMLS CUI [1,2]
C2985739
MCHC
Description

MCHC

Data type

float

Alias
UMLS CUI [1,1]
C0474535
UMLS CUI [1,2]
C0587081
MCHC Primary reason for clinically significant abnormality
Description

MCHC

Data type

text

Alias
UMLS CUI [1,1]
C0474535
UMLS CUI [1,2]
C2985739
Other clinically significant abnormalities
Description

Other clinically significant abnormalities

Data type

text

Alias
UMLS CUI [1,1]
C0497168
UMLS CUI [1,2]
C2985739
Platelets
Description

Platelets

Data type

float

Alias
UMLS CUI [1,1]
C0032181
UMLS CUI [1,2]
C0587081
Platelets Primary reason for clinically significant abnormality
Description

Platelets

Data type

text

Alias
UMLS CUI [1,1]
C0032181
UMLS CUI [1,2]
C2985739
Other clinically significant abnormalities
Description

Other clinically significant abnormalities

Data type

text

Alias
UMLS CUI [1,1]
C0497168
UMLS CUI [1,2]
C2985739
Total WBC
Description

Total WBC

Data type

integer

Alias
UMLS CUI [1,1]
C0023508
UMLS CUI [1,2]
C0587081
Total WBC Primary reason for clinically significant abnormality
Description

Total WBC

Data type

text

Alias
UMLS CUI [1,1]
C0023508
UMLS CUI [1,2]
C2985739
Other clinically significant abnormalities
Description

Other clinically significant abnormalities

Data type

text

Alias
UMLS CUI [1,1]
C0497168
UMLS CUI [1,2]
C2985739
Neutrophils
Description

Neutrophils

Data type

float

Alias
UMLS CUI [1,1]
C0200633
UMLS CUI [1,2]
C0587081
Neutrophils Primary reason for clinically significant abnormality
Description

Neutrophils

Data type

text

Alias
UMLS CUI [1,1]
C0200633
UMLS CUI [1,2]
C2985739
Other clinically significant abnormalities
Description

Other clinically significant abnormalities

Data type

text

Alias
UMLS CUI [1,1]
C0497168
UMLS CUI [1,2]
C2985739
Lymphocytes
Description

Lymphocytes

Data type

float

Alias
UMLS CUI [1,1]
C0200635
UMLS CUI [1,2]
C0587081
Lymphocytes Primary reason for clinically significant abnormality
Description

Lymphocytes

Data type

text

Alias
UMLS CUI [1,1]
C0200635
UMLS CUI [1,2]
C2985739
Other clinically significant abnormalities
Description

Other clinically significant abnormalities

Data type

text

Alias
UMLS CUI [1,1]
C0497168
UMLS CUI [1,2]
C2985739
Monocytes
Description

Monocytes count

Data type

float

Alias
UMLS CUI [1,1]
C0200637
UMLS CUI [1,2]
C0587081
Monocytes Primary reason for clinically significant abnormality
Description

Monocytes count

Data type

text

Alias
UMLS CUI [1,1]
C0200637
UMLS CUI [1,2]
C2985739
Other clinically significant abnormalities
Description

Other clinically significant abnormalities

Data type

text

Alias
UMLS CUI [1,1]
C0497168
UMLS CUI [1,2]
C2985739
Eosinophils
Description

Eosinophils count

Data type

float

Alias
UMLS CUI [1]
C0750879
Eosinophils Primary reason for clinically significant abnormality
Description

Eosinophils count

Data type

text

Alias
UMLS CUI [1,1]
C0750879
UMLS CUI [1,2]
C2985739
Other clinically significant abnormalities
Description

Other clinically significant abnormalities

Data type

text

Alias
UMLS CUI [1,1]
C0497168
UMLS CUI [1,2]
C2985739
Basophils
Description

Basophils

Data type

float

Alias
UMLS CUI [1,1]
C0200641
UMLS CUI [1,2]
C0587081
Basophils Primary reason for clinically significant abnormality
Description

Basophils

Data type

text

Alias
UMLS CUI [1,1]
C0200641
UMLS CUI [1,2]
C2985739
Other clinically significant abnormalities
Description

Other clinically significant abnormalities

Data type

text

Alias
UMLS CUI [1,1]
C0497168
UMLS CUI [1,2]
C2985739
Clinical Chemistry
Description

Clinical Chemistry

Alias
UMLS CUI-1
C0008000
Lab code
Description

For GSK use only

Data type

integer

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0805701
If some results are abnormal, but none are clinically significant, answer NO to the abnormality question.
Description

Investigator Instructions

Data type

text

Alias
UMLS CUI [1,1]
C0008961
UMLS CUI [1,2]
C1442085
- 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).
Description

Monitor Data Validation Checks Hematology

Data type

text

Alias
UMLS CUI [1,1]
C1519941
UMLS CUI [1,2]
C0200627
Date clinical chemistry sample taken
Description

Date clinical chemistry sample taken

Data type

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0200345
UMLS CUI [1,3]
C0008000
Time of sample
Description

Time of sample

Data type

time

Alias
UMLS CUI [1,1]
C0040223
UMLS CUI [1,2]
C0200345
UMLS CUI [1,3]
C0008000
Were there any clinically significant clinical chemistry abnormalities?
Description

If YES, record primary reason for the clinically significant abnormality in the column below, by using the following key: D - Due to disease under study C - Due to other concurrent disease T - Reasonable possibility due to investigational product M - Reasonable possibility due to other concomitant medication X - Other, specify text in the box

Data type

text

Alias
UMLS CUI [1,1]
C2985739
UMLS CUI [1,2]
C0008000
UMLS CUI [1,3]
C1704258
Sodium result
Description

Sodium

Data type

float

Alias
UMLS CUI [1,1]
C0337443
UMLS CUI [1,2]
C0587081
Sodium result Primary reason for clinically significant abnormality
Description

Sodium

Data type

text

Alias
UMLS CUI [1,1]
C0337443
UMLS CUI [1,2]
C2985739
Other clinically significant abnormalities
Description

Other clinically significant abnormalities

Data type

text

Alias
UMLS CUI [1,1]
C0029481
UMLS CUI [1,2]
C2985739
Potassium
Description

Potassium

Data type

float

Alias
UMLS CUI [1,1]
C0202194
UMLS CUI [1,2]
C0587081
Potassium Primary reason for clinically significant abnormality
Description

Potassium

Data type

text

Alias
UMLS CUI [1,1]
C0202194
UMLS CUI [1,2]
C2985739
Other clinically significant abnormalities
Description

Other clinically significant abnormalities

Data type

text

Alias
UMLS CUI [1,1]
C0029481
UMLS CUI [1,2]
C2985739
Chloride
Description

Chloride

Data type

float

Alias
UMLS CUI [1,1]
C0201952
UMLS CUI [1,2]
C0587081
Chloride Primary reason for clinically significant abnormality
Description

Chloride

Data type

text

Alias
UMLS CUI [1,1]
C0201952
UMLS CUI [1,2]
C2985739
Other clinically significant abnormalities
Description

Other clinically significant abnormalities

Data type

text

Alias
UMLS CUI [1,1]
C0029481
UMLS CUI [1,2]
C2985739
Bicarbonate
Description

Bicarbonate

Data type

float

Alias
UMLS CUI [1,1]
C0202059
UMLS CUI [1,2]
C0587081
Bicarbonate Primary reason for clinically significant abnormality
Description

Bicarbonate

Data type

text

Alias
UMLS CUI [1,1]
C0202059
UMLS CUI [1,2]
C2985739
Other clinically significant abnormalities
Description

Other clinically significant abnormalities

Data type

text

Alias
UMLS CUI [1,1]
C0029481
UMLS CUI [1,2]
C2985739
Glucose
Description

Glucose

Data type

float

Alias
UMLS CUI [1,1]
C0202042
UMLS CUI [1,2]
C0587081
Glucose Primary reason for clinically significant abnormality
Description

Glucose

Data type

text

Alias
UMLS CUI [1,1]
C0202042
UMLS CUI [1,2]
C2985739
Other clinically significant abnormalities
Description

Other clinically significant abnormalities

Data type

text

Alias
UMLS CUI [1,1]
C0029481
UMLS CUI [1,2]
C2985739
Total Protein
Description

Total Protein

Data type

float

Alias
UMLS CUI [1,1]
C0555903
UMLS CUI [1,2]
C0587081
Total Protein Primary reason for clinically significant abnormality
Description

Total Protein

Data type

text

Alias
UMLS CUI [1,1]
C0555903
UMLS CUI [1,2]
C2985739
Other clinically significant abnormalities
Description

Other clinically significant abnormalities

Data type

text

Alias
UMLS CUI [1,1]
C0029481
UMLS CUI [1,2]
C2985739
Albumin
Description

Albumin

Data type

float

Alias
UMLS CUI [1,1]
C0201838
UMLS CUI [1,2]
C0587081
Albumin Primary reason for clinically significant abnormality
Description

Albumin

Data type

text

Alias
UMLS CUI [1,1]
C0201838
UMLS CUI [1,2]
C2985739
Other clinically significant abnormalities
Description

Other clinically significant abnormalities

Data type

text

Alias
UMLS CUI [1,1]
C0029481
UMLS CUI [1,2]
C2985739
Creatinine
Description

Creatinine

Data type

float

Alias
UMLS CUI [1,1]
C0201976
UMLS CUI [1,2]
C0587081
Creatinine Primary reason for clinically significant abnormality
Description

Creatinine

Data type

text

Alias
UMLS CUI [1,1]
C0201976
UMLS CUI [1,2]
C2985739
Other clinically significant abnormalities
Description

Other clinically significant abnormalities

Data type

text

Alias
UMLS CUI [1,1]
C0029481
UMLS CUI [1,2]
C2985739
Urea/BUN
Description

Urea/BUN

Data type

float

Alias
UMLS CUI [1,1]
C0005845
UMLS CUI [1,2]
C0587081
Urea/BUN Primary reason for clinically significant abnormality
Description

Urea/BUN

Data type

text

Alias
UMLS CUI [1,1]
C0005845
UMLS CUI [1,2]
C2985739
Other clinically significant abnormalities
Description

Other clinically significant abnormalities

Data type

text

Alias
UMLS CUI [1,1]
C0029481
UMLS CUI [1,2]
C2985739
Total Bilirubin
Description

Total Bilirubin

Data type

float

Alias
UMLS CUI [1,1]
C0201913
UMLS CUI [1,2]
C0587081
Total Bilirubin Primary reason for clinically significant abnormality
Description

Total Bilirubin

Data type

text

Alias
UMLS CUI [1,1]
C0201913
UMLS CUI [1,2]
C2985739
Other clinically significant abnormalities
Description

Other clinically significant abnormalities

Data type

text

Alias
UMLS CUI [1,1]
C0029481
UMLS CUI [1,2]
C2985739
Alkaline Phosphatase
Description

Alkaline Phosphatase

Data type

float

Alias
UMLS CUI [1,1]
C0201850
UMLS CUI [1,2]
C0587081
Alkaline Phosphatase Primary reason for clinically significant abnormality
Description

Alkaline Phosphatase

Data type

text

Alias
UMLS CUI [1,1]
C0201850
UMLS CUI [1,2]
C2985739
Other clinically significant abnormalities
Description

Other clinically significant abnormalities

Data type

text

Alias
UMLS CUI [1,1]
C0029481
UMLS CUI [1,2]
C2985739
AST (SGOT)
Description

AST

Data type

float

Alias
UMLS CUI [1,1]
C0201899
UMLS CUI [1,2]
C0587081
AST (SGOT) Primary reason for clinically significant abnormality
Description

AST

Data type

text

Alias
UMLS CUI [1,1]
C0201899
UMLS CUI [1,2]
C2985739
Other clinically significant abnormalities
Description

Other clinically significant abnormalities

Data type

text

Alias
UMLS CUI [1,1]
C0029481
UMLS CUI [1,2]
C2985739
ALT (SGPT)
Description

ALT

Data type

float

Alias
UMLS CUI [1,1]
C0201836
UMLS CUI [1,2]
C0587081
ALT (SGPT) Primary reason for clinically significant abnormality
Description

ALT

Data type

text

Alias
UMLS CUI [1,1]
C0201836
UMLS CUI [1,2]
C2985739
Other clinically significant abnormalities
Description

Other clinically significant abnormalities

Data type

text

Alias
UMLS CUI [1,1]
C0029481
UMLS CUI [1,2]
C2985739
GGT
Description

GGT

Data type

float

Alias
UMLS CUI [1,1]
C0202035
UMLS CUI [1,2]
C0587081
GGT Primary reason for clinically significant abnormality
Description

GGT

Data type

text

Alias
UMLS CUI [1,1]
C0202035
UMLS CUI [1,2]
C2985739
Other clinically significant abnormalities
Description

Other clinically significant abnormalities

Data type

text

Alias
UMLS CUI [1,1]
C0029481
UMLS CUI [1,2]
C2985739
Urinalysis
Description

Urinalysis

Alias
UMLS CUI-1
C0042014
- 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).
Description

Monitor Data Validation Checks Urinalysis

Data type

text

Alias
UMLS CUI [1,1]
C1519941
UMLS CUI [1,2]
C0042014
Lab code
Description

(For GSK use only)

Data type

integer

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0805701
Date urinalysis sample taken
Description

Date urinalysis sample taken

Data type

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0200345
UMLS CUI [1,3]
C0042014
Time of sample
Description

Time of sample

Data type

time

Alias
UMLS CUI [1,1]
C0040223
UMLS CUI [1,2]
C0200345
UMLS CUI [1,3]
C0042014
Were there any clinically significant clinical chemistry abnormalities?
Description

If YES, record primary reason for the clinically significant abnormality in the column below, by using the following key: D - Due to disease under study C - Due to other concurrent disease T - Reasonable possibility due to investigational product M - Reasonable possibility due to other concomitant medication X - Other, specify text in the box

Data type

text

Alias
UMLS CUI [1,1]
C2985739
UMLS CUI [1,2]
C0042014
UMLS CUI [1,3]
C1704258
Dipstick test
Description

Urinalysis dipstick

Data type

integer

Alias
UMLS CUI [1,1]
C0430370
UMLS CUI [1,2]
C0332307
Dipstick test result
Description

Dipstick test result

Data type

integer

Alias
UMLS CUI [1,1]
C0430370
UMLS CUI [1,2]
C0587081
Dipstick testing Primary reason for clinically significant abnormality
Description

clinically significant abnormality

Data type

text

Alias
UMLS CUI [1,1]
C2985739
UMLS CUI [1,2]
C0749990
Other clinically significant abnormalities
Description

Other clinically significant abnormalities

Data type

text

Alias
UMLS CUI [1,1]
C0749990
UMLS CUI [1,2]
C0205394
UMLS CUI [1,3]
C2985739
Sedimentary microscopy
Description

Sedimentary microscopy

Data type

integer

Alias
UMLS CUI [1]
C0430397
Sedimentary microscopy Primary reason for clinically significant abnormality
Description

clinically significant abnormality

Data type

text

Alias
UMLS CUI [1,1]
C2985739
UMLS CUI [1,2]
C0427860
Other clinically significant abnormalities
Description

Other clinically significant abnormalities

Data type

text

Alias
UMLS CUI [1,1]
C0427860
UMLS CUI [1,2]
C0205394
UMLS CUI [1,3]
C2985739
Substance Abuse Detection
Description

Substance Abuse Detection

Alias
UMLS CUI-1
C0038577
Date sample taken
Description

Date sample taken

Data type

date

Alias
UMLS CUI [1]
C1302413
Substance Abuse Detection
Description

If any of the above are positive, EXCLUDE subject from the study.

Data type

integer

Alias
UMLS CUI [1,1]
C0038577
UMLS CUI [1,2]
C1514241
Substance Abuse Detection negative
Description

Substance Abuse Detection negative

Data type

integer

Alias
UMLS CUI [1,1]
C0038577
UMLS CUI [1,2]
C1513916
Serology Screen
Description

Serology Screen

Alias
UMLS CUI-1
C0036743
Date serology sample taken
Description

Date sample taken

Data type

date

Alias
UMLS CUI [1,1]
C0036743
UMLS CUI [1,2]
C1302413
Serology Screen positive
Description

If any of the above are positive, EXCLUDE subject from the study.

Data type

integer

Alias
UMLS CUI [1]
C0242089
Serology Screen negative
Description

Serology Screen negative

Data type

integer

Alias
UMLS CUI [1]
C0919674
Inhaler Training
Description

Inhaler Training

Alias
UMLS CUI-1
C0021461
UMLS CUI-2
C0220931
Has the subject received training on how to use the inhaler?
Description

Inhaler Training

Data type

boolean

Alias
UMLS CUI [1,1]
C0030688
UMLS CUI [1,2]
C0021461
Is the subject able to use the inhaler correctly?
Description

Inhaler usage

Data type

boolean

Alias
UMLS CUI [1,1]
C0021461
UMLS CUI [1,2]
C0457083
Concomitant Medications
Description

Concomitant Medications

Alias
UMLS CUI-1
C2347852
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.
Description

Monitor Data Validation Checks

Data type

text

Alias
UMLS CUI [1,1]
C1519941
UMLS CUI [1,2]
C2347852
Were any concomitant medications taken by the subject during the screening period?
Description

If YES, record below

Data type

boolean

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C1710477
Drug (Trade name preferred)
Description

Drug Name

Data type

text

Alias
UMLS CUI [1]
C2347852
Dose
Description

Medication Dose

Data type

float

Alias
UMLS CUI [1]
C3174092
Units
Description

Units

Data type

text

Alias
UMLS CUI [1,1]
C1519795
UMLS CUI [1,2]
C0013227
Frequency
Description

e.g.: BID=2 x Daily OD=1 x Daily PRN=As required QID=4 x Daily TID=3 x Daily

Data type

text

Alias
UMLS CUI [1]
C3476109
Route
Description

e.g.: EXT=External ID=Intradermal IH=Inhalation IM=Intramuscular IR=Intraarticular IT=Intrathecal IV=Intravenous NA=Intranasal OTH=Other PE=Parenteral PO=Oral PR=Rectal SC=Subcutaneous SL=Sublingual TD=Transdermal TO=Topical UNK=Unknown VA=Vaginal

Data type

text

Alias
UMLS CUI [1]
C0013153
Date started
Description

Concomitant Medication Start Date

Data type

date

Alias
UMLS CUI [1]
C2826734
Started Pre-Study
Description

Started Pre-Study

Data type

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0451613
start time
Description

Concomitant medication start time

Data type

time

Alias
UMLS CUI [1,1]
C1301880
UMLS CUI [1,2]
C2347852
Concomitant Medication Stop Date
Description

Concomitant Medication Stop Date

Data type

date

Alias
UMLS CUI [1]
C2826744
Medication continued post-study
Description

Ongoing Medication

Data type

boolean

Alias
UMLS CUI [1]
C2826666
Stop time
Description

Concomitant medication end time

Data type

time

Alias
UMLS CUI [1,1]
C1522314
UMLS CUI [1,2]
C2347852
Condition treated/Indication
Description

Condition treated/Indication

Data type

text

Alias
UMLS CUI [1,1]
C0392360
UMLS CUI [1,2]
C2347852
Was drug administered for an adverse event?
Description

If medication is given to treat an adverse event, then the ADVERSE EVENT must be recorded on the NON-SERIOUS ADVERSE EVENT or SERIOUS ADVERSE EVENT page(s) at the back of the CRF.

Data type

boolean

Alias
UMLS CUI [1]
C2981656
Was drug administered as a rescue medication?
Description

Rescue Medication

Data type

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0884980
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Similar models

Screening Visit

1 forms
  1. StudyEvent: ODM
    1. Screening Visit
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Inclusion Criteria
C1512693 (UMLS CUI-1)
C1516637 (UMLS CUI-2)
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])
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])
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])
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])
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])
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])
Compliance behavior
Item
Is the subject available to complete the study?
boolean
C1321605 (UMLS CUI [1])
Item Group
Exclusion criteria
C0680251 (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])
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])
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])
Item Group
Inclusion/Exclusion Criteria
C1704756 (UMLS CUI-1)
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])
Inclusion Criteria
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])
Exclusion Criteria
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])
Date of Assessment
Item
Date of Assessment
date
C2985720 (UMLS CUI [1])
Comments
Item
Comments
text
C0947611 (UMLS CUI [1])
Item Group
Demography
C0011298 (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])
Item
Sex
text
C0079399 (UMLS CUI [1])
Gender
Code List
Sex
CL Item
Male (M)
CL Item
Female (F)
Item
Race
text
C0034510 (UMLS CUI [1])
Race
Code List
Race
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)
Item
Childbearing potential
integer
C3831118 (UMLS CUI [1])
Childbearing potential
Code List
Childbearing potential
CL Item
Premenarcheal (1)
CL Item
Sterile (of childbearing age) (2)
CL Item
Postmenopausal (3)
CL Item
Potentially able to conceive children (4)
Item
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])
Childbearing potential contraceptive methods
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])
Item
Pregnancy test result
integer
C0427777 (UMLS CUI [1])
Pregnancy test result
Code List
Pregnancy test result
CL Item
Positive (1)
CL Item
Negative (2)
CL Item
Not applicable (Not of childbearing potential) (3)
Item Group
Medical History
C0262926 (UMLS CUI-1)
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])
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])
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])
Hepatobiliary and pancreas Diseases
Item
Hepatobiliary and pancreas: If Yes, please specify
text
C0267792 (UMLS CUI [1])
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])
Endocrine and Metabolic System Disorders
Item
Endocrine and Metabolic: If Yes, please specify
text
C0025517 (UMLS CUI [1])
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])
Item Group
Physical Examination
C0031809 (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])
Item
Hair and skin
integer
C0018494 (UMLS CUI [1,1])
C0558035 (UMLS CUI [1,2])
Hair and skin
Code List
Hair and skin
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])
Item
Lymph nodes
integer
C0031809 (UMLS CUI [1,1])
C0024204 (UMLS CUI [1,2])
Lymph nodes
Code List
Lymph nodes
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])
Item
Eyes
integer
C0031809 (UMLS CUI [1,1])
C0200149 (UMLS CUI [1,2])
Eyes
Code List
Eyes
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])
Item
Ears, Nose and Throat
integer
C0031809 (UMLS CUI [1,1])
C0278350 (UMLS CUI [1,2])
Ears, Nose and Throat
Code List
Ears, Nose and Throat
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])
Item
Breasts
integer
C0031809 (UMLS CUI [1,1])
C0199850 (UMLS CUI [1,2])
Breasts
Code List
Breasts
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])
Item
Respiratory
integer
C0031809 (UMLS CUI [1,1])
C0436121 (UMLS CUI [1,2])
Respiratory
Code List
Respiratory
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])
Item
Cardiovascular
integer
C3854344 (UMLS CUI [1])
Cardiovascular
Code List
Cardiovascular
CL Item
Normal (1)
CL Item
Abnormal (2)
Cardiovascular
Item
Cardiovascular: If Abnormal, please specify
text
C3854344 (UMLS CUI [1])
Item
Abdomen
integer
C0031809 (UMLS CUI [1,1])
C0000726 (UMLS CUI [1,2])
Abdomen
Code List
Abdomen
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])
Item
Urogenital
integer
C1828035 (UMLS CUI [1])
Urogenital
Code List
Urogenital
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])
Item
Pelvic
integer
C0200045 (UMLS CUI [1])
Pelvic
Code List
Pelvic
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])
Item
Rectal
integer
C0199900 (UMLS CUI [1])
Rectal
Code List
Rectal
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])
Item
Musculoskeletal
integer
C0475091 (UMLS CUI [1])
Musculoskeletal
Code List
Musculoskeletal
CL Item
Normal (1)
CL Item
Abnormal (2)
Musculoskeletal
Item
Musculoskeletal: If Abnormal, please specify
text
C0475091 (UMLS CUI [1])
Item
Neurological
integer
C0027853 (UMLS CUI [1])
Neurological
Code List
Neurological
CL Item
Normal (1)
CL Item
Abnormal (2)
Neurological
Item
Neurological: If Abnormal, please specify
text
C0027853 (UMLS CUI [1])
Item
Mental status
integer
C3260990 (UMLS CUI [1])
Mental status
Code List
Mental status
CL Item
Normal (0)
CL Item
Abnormal (1)
Mental Status
Item
Mental Status: If Abnormal, please specify
text
C3260990 (UMLS CUI [1])
Item Group
Vital Signs
C0518766 (UMLS CUI-1)
C0031809 (UMLS CUI-2)
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])
Item
Vital Signs Row Number
integer
C0518766 (UMLS CUI [1,1])
C0750480 (UMLS CUI [1,2])
Vital Signs
Code List
Vital Signs Row Number
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])
Item
Planned relative time
integer
C3641100 (UMLS CUI [1])
Visit type
Code List
Planned relative time
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])
Item Group
Electrocardiogram
C1623258 (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])
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])
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])
Item
ECG
text
C1623258 (UMLS CUI [1,1])
C0456984 (UMLS CUI [1,2])
ECG result
Code List
ECG
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])
ECG Result
Code List
Were any of the abnormalities clinically significant?
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])
Left atrial abnormality (P mitrale)
Item
Left atrial abnormality (P mitrale)
boolean
C0344711 (UMLS CUI [1,1])
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])
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])
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])
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])
Item Group
Lung Function Tests
C0024119 (UMLS CUI-1)
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])
Test modality
Code List
Planned time Test type
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])
Test Result pulmonary function test
Item
Reading 1
float
C0456984 (UMLS CUI [1,1])
C0024119 (UMLS CUI [1,2])
Test Result pulmonary function test
Item
Reading 2
float
C0456984 (UMLS CUI [1,1])
C0024119 (UMLS CUI [1,2])
Test Result pulmonary function test
Item
Reading 3
float
C0456984 (UMLS CUI [1,1])
C0024119 (UMLS CUI [1,2])
Test Result pulmonary function test
Item
Highest Reading
float
C0456984 (UMLS CUI [1,1])
C0024119 (UMLS CUI [1,2])
Predicted Normal
Item
Predicted Normal
float
C0024119 (UMLS CUI [1,1])
C0086715 (UMLS CUI [1,2])
Percent Predicted Normal
Item
Percent Predicted Normal
float
C0024119 (UMLS CUI [1,1])
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])
Reversibility
Item
Reversibility
float
C3548479 (UMLS CUI [1,1])
C0024119 (UMLS CUI [1,2])
Item Group
Hematology
C0018941 (UMLS CUI-1)
Laboratory code
Item
Lab code
integer
C0022885 (UMLS CUI [1,1])
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])
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])
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])
Time of blood sample
Item
Time of sample
time
C0200345 (UMLS CUI [1,1])
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])
Hemoglobin
Item
Hemoglobin
float
C0518015 (UMLS CUI [1,1])
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])
Hemoglobin
Code List
Hemoglobin if abnormal: Primary reason for clinically significant abnormality
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])
Hematocrit
Item
Hematocrit (PCV)
float
C0518014 (UMLS CUI [1,1])
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])
Hemoglobin
Code List
Hematocrit (PCV) Primary reason for clinically significant abnormality
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])
RBC
Item
RBC
float
C0014772 (UMLS CUI [1,1])
C0587081 (UMLS CUI [1,2])
Item
RBC Primary reason for clinically significant abnormality
text
C0014772 (UMLS CUI [1,1])
C2985739 (UMLS CUI [1,2])
Hemoglobin
Code List
RBC Primary reason for clinically significant abnormality
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])
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])
Hemoglobin
Code List
Mean Corpuscular Volume Primary reason for clinically significant abnormality
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])
MCH
Item
MCH
float
C0369183 (UMLS CUI [1,1])
C0587081 (UMLS CUI [1,2])
Item
MCH Primary reason for clinically significant abnormality
text
C0369183 (UMLS CUI [1,1])
C2985739 (UMLS CUI [1,2])
Hemoglobin
Code List
MCH Primary reason for clinically significant abnormality
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])
MCHC
Item
MCHC
float
C0474535 (UMLS CUI [1,1])
C0587081 (UMLS CUI [1,2])
Item
MCHC Primary reason for clinically significant abnormality
text
C0474535 (UMLS CUI [1,1])
C2985739 (UMLS CUI [1,2])
Hemoglobin
Code List
MCHC Primary reason for clinically significant abnormality
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])
Platelets
Item
Platelets
float
C0032181 (UMLS CUI [1,1])
C0587081 (UMLS CUI [1,2])
Item
Platelets Primary reason for clinically significant abnormality
text
C0032181 (UMLS CUI [1,1])
C2985739 (UMLS CUI [1,2])
Hemoglobin
Code List
Platelets Primary reason for clinically significant abnormality
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])
Total WBC
Item
Total WBC
integer
C0023508 (UMLS CUI [1,1])
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])
Hemoglobin
Code List
Total WBC Primary reason for clinically significant abnormality
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])
Neutrophils
Item
Neutrophils
float
C0200633 (UMLS CUI [1,1])
C0587081 (UMLS CUI [1,2])
Item
Neutrophils Primary reason for clinically significant abnormality
text
C0200633 (UMLS CUI [1,1])
C2985739 (UMLS CUI [1,2])
Hemoglobin
Code List
Neutrophils Primary reason for clinically significant abnormality
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])
Lymphocytes
Item
Lymphocytes
float
C0200635 (UMLS CUI [1,1])
C0587081 (UMLS CUI [1,2])
Item
Lymphocytes Primary reason for clinically significant abnormality
text
C0200635 (UMLS CUI [1,1])
C2985739 (UMLS CUI [1,2])
Hemoglobin
Code List
Lymphocytes Primary reason for clinically significant abnormality
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])
Monocytes count
Item
Monocytes
float
C0200637 (UMLS CUI [1,1])
C0587081 (UMLS CUI [1,2])
Item
Monocytes Primary reason for clinically significant abnormality
text
C0200637 (UMLS CUI [1,1])
C2985739 (UMLS CUI [1,2])
Hemoglobin
Code List
Monocytes Primary reason for clinically significant abnormality
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])
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])
Hemoglobin
Code List
Eosinophils Primary reason for clinically significant abnormality
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])
Basophils
Item
Basophils
float
C0200641 (UMLS CUI [1,1])
C0587081 (UMLS CUI [1,2])
Item
Basophils Primary reason for clinically significant abnormality
text
C0200641 (UMLS CUI [1,1])
C2985739 (UMLS CUI [1,2])
Hemoglobin
Code List
Basophils Primary reason for clinically significant abnormality
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])
Item Group
Clinical Chemistry
C0008000 (UMLS CUI-1)
Laboratory code
Item
Lab code
integer
C0022885 (UMLS CUI [1,1])
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])
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])
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])
Time of sample
Item
Time of sample
time
C0040223 (UMLS CUI [1,1])
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])
ECG Result
Code List
Were there any clinically significant clinical chemistry abnormalities?
CL Item
Yes (Y)
CL Item
No (N)
Sodium
Item
Sodium result
float
C0337443 (UMLS CUI [1,1])
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])
Hemoglobin
Code List
Sodium result Primary reason for clinically significant abnormality
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])
Potassium
Item
Potassium
float
C0202194 (UMLS CUI [1,1])
C0587081 (UMLS CUI [1,2])
Item
Potassium Primary reason for clinically significant abnormality
text
C0202194 (UMLS CUI [1,1])
C2985739 (UMLS CUI [1,2])
Hemoglobin
Code List
Potassium Primary reason for clinically significant abnormality
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])
Chloride
Item
Chloride
float
C0201952 (UMLS CUI [1,1])
C0587081 (UMLS CUI [1,2])
Item
Chloride Primary reason for clinically significant abnormality
text
C0201952 (UMLS CUI [1,1])
C2985739 (UMLS CUI [1,2])
Hemoglobin
Code List
Chloride Primary reason for clinically significant abnormality
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])
Bicarbonate
Item
Bicarbonate
float
C0202059 (UMLS CUI [1,1])
C0587081 (UMLS CUI [1,2])
Item
Bicarbonate Primary reason for clinically significant abnormality
text
C0202059 (UMLS CUI [1,1])
C2985739 (UMLS CUI [1,2])
Hemoglobin
Code List
Bicarbonate Primary reason for clinically significant abnormality
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])
Glucose
Item
Glucose
float
C0202042 (UMLS CUI [1,1])
C0587081 (UMLS CUI [1,2])
Item
Glucose Primary reason for clinically significant abnormality
text
C0202042 (UMLS CUI [1,1])
C2985739 (UMLS CUI [1,2])
Hemoglobin
Code List
Glucose Primary reason for clinically significant abnormality
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])
Total Protein
Item
Total Protein
float
C0555903 (UMLS CUI [1,1])
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])
Hemoglobin
Code List
Total Protein Primary reason for clinically significant abnormality
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])
Albumin
Item
Albumin
float
C0201838 (UMLS CUI [1,1])
C0587081 (UMLS CUI [1,2])
Item
Albumin Primary reason for clinically significant abnormality
text
C0201838 (UMLS CUI [1,1])
C2985739 (UMLS CUI [1,2])
Hemoglobin
Code List
Albumin Primary reason for clinically significant abnormality
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])
Creatinine
Item
Creatinine
float
C0201976 (UMLS CUI [1,1])
C0587081 (UMLS CUI [1,2])
Item
Creatinine Primary reason for clinically significant abnormality
text
C0201976 (UMLS CUI [1,1])
C2985739 (UMLS CUI [1,2])
Hemoglobin
Code List
Creatinine Primary reason for clinically significant abnormality
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])
Urea/BUN
Item
Urea/BUN
float
C0005845 (UMLS CUI [1,1])
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])
Hemoglobin
Code List
Urea/BUN Primary reason for clinically significant abnormality
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])
Total Bilirubin
Item
Total Bilirubin
float
C0201913 (UMLS CUI [1,1])
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])
Hemoglobin
Code List
Total Bilirubin Primary reason for clinically significant abnormality
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])
Alkaline Phosphatase
Item
Alkaline Phosphatase
float
C0201850 (UMLS CUI [1,1])
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])
Hemoglobin
Code List
Alkaline Phosphatase Primary reason for clinically significant abnormality
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])
AST
Item
AST (SGOT)
float
C0201899 (UMLS CUI [1,1])
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])
Hemoglobin
Code List
AST (SGOT) Primary reason for clinically significant abnormality
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])
ALT
Item
ALT (SGPT)
float
C0201836 (UMLS CUI [1,1])
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])
Hemoglobin
Code List
ALT (SGPT) Primary reason for clinically significant abnormality
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])
GGT
Item
GGT
float
C0202035 (UMLS CUI [1,1])
C0587081 (UMLS CUI [1,2])
Item
GGT Primary reason for clinically significant abnormality
text
C0202035 (UMLS CUI [1,1])
C2985739 (UMLS CUI [1,2])
Hemoglobin
Code List
GGT Primary reason for clinically significant abnormality
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])
Item Group
Urinalysis
C0042014 (UMLS CUI-1)
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])
Laboratory code
Item
Lab code
integer
C0022885 (UMLS CUI [1,1])
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])
Time of sample
Item
Time of sample
time
C0040223 (UMLS CUI [1,1])
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])
ECG Result
Code List
Were there any clinically significant clinical chemistry abnormalities?
CL Item
Yes (Y)
CL Item
No (N)
Item
Dipstick test
integer
C0430370 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
Urinalysis dipstick
Code List
Dipstick test
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])
Dipstick test result
Code List
Dipstick test result
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])
Hemoglobin
Code List
Dipstick testing Primary reason for clinically significant abnormality
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])
Item
Sedimentary microscopy
integer
C0430397 (UMLS CUI [1])
Sedimentary microscopy
Code List
Sedimentary microscopy
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])
Hemoglobin
Code List
Sedimentary microscopy Primary reason for clinically significant abnormality
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])
Item Group
Substance Abuse Detection
C0038577 (UMLS CUI-1)
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])
Substance Abuse Detection positive
Code List
Substance Abuse Detection
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])
Substance Abuse Detection positive
Code List
Substance Abuse Detection negative
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 Group
Serology Screen
C0036743 (UMLS CUI-1)
Date sample taken
Item
Date serology sample taken
date
C0036743 (UMLS CUI [1,1])
C1302413 (UMLS CUI [1,2])
Item
Serology Screen positive
integer
C0242089 (UMLS CUI [1])
Serology Screen positive
Code List
Serology Screen positive
CL Item
Hepatitis B (HbsAg) (1)
CL Item
Hepatitis C antibody (2)
CL Item
HIV antibodies (3)
Item
Serology Screen negative
integer
C0919674 (UMLS CUI [1])
Serology Screen positive
Code List
Serology Screen negative
CL Item
Hepatitis B (HbsAg) (1)
CL Item
Hepatitis C antibody (2)
CL Item
HIV antibodies (3)
Item Group
Inhaler Training
C0021461 (UMLS CUI-1)
C0220931 (UMLS CUI-2)
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])
Inhaler usage
Item
Is the subject able to use the inhaler correctly?
boolean
C0021461 (UMLS CUI [1,1])
C0457083 (UMLS CUI [1,2])
Item Group
Concomitant Medications
C2347852 (UMLS CUI-1)
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])
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])
Drug Name
Item
Drug (Trade name preferred)
text
C2347852 (UMLS CUI [1])
Medication Dose
Item
Dose
float
C3174092 (UMLS CUI [1])
Item
Units
text
C1519795 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
Units
Code List
Units
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])
Concomitant medication start time
Item
start time
time
C1301880 (UMLS CUI [1,1])
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])
Condition treated/Indication
Item
Condition treated/Indication
text
C0392360 (UMLS CUI [1,1])
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])
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