ID

14496

Description

A Study in Asthma Patients to Evaluate Efficacy, Safety and Tolerability of 14 Days Once Daily Inhaled Interferon Beta-1a After the Onset of Symptoms of an Upper Respiratory Tract Infection; ODM derived from: https://clinicaltrials.gov/show/NCT02491684

Lien

https://clinicaltrials.gov/show/NCT02491684

Mots-clés

Versions (2)
  1. 18/04/2016 18/04/2016 -
  2. 20/09/2021 20/09/2021 -
Téléchargé le

18 avril 2016

DOI

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Licence

Creative Commons BY 4.0
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Eligibility Asthma NCT02491684

Anglais

Eligibility Asthma NCT02491684

1 Formulaires  
  1. StudyEvent: Eligibility
    1. Eligibility Asthma NCT02491684
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
for inclusion in the study patients should fulfil the following criteria:
Description

Inclusion

Type de données

boolean

Alias
UMLS CUI [1]
C1512693
1. provision of signed and dated written informed consent prior to any study specific procedures
Description

Informed Consent

Type de données

boolean

Alias
UMLS CUI [1]
C0021430
2. male or female aged 18 and above at the time of enrolment
Description

Age

Type de données

boolean

Alias
UMLS CUI [1]
C0001779
3. history of physician-diagnosed asthma requiring treatment with medium-to-high dose ics (>250 μg fluticasone dry powder formulation equivalents total daily dose, as defined in gina 2014; see appendix chapter 5) and a second controller medication (eg, laba or leukotriene receptor antagonist). the medium or high dose ics plus laba can be any combination inhaler or 2 separate inhalers. patients must have taken ics (>250
Description

Asthma Therapeutic procedure | inhaled steroids | fluticasone Dry Powder Inhaler | Adrenergic beta-2 Receptor Agonists | Leukotriene Antagonists

Type de données

boolean

Alias
UMLS CUI [1,1]
C0004096
UMLS CUI [1,2]
C0087111
UMLS CUI [2]
C2065041
UMLS CUI [3]
C1967989
UMLS CUI [4]
C2936789
UMLS CUI [5]
C0595726
μg fluticasone or the equivalent daily) plus second controller medication for at least 12 months prior to the date the informed consent is obtained, with or without another controller such as oral corticosteroids (ocs), theophylline, tiotropium, or leukotriene receptor antagonists
Description

Adrenal Cortex Hormones | Theophylline | tiotropium | Leukotriene Antagonists

Type de données

boolean

Alias
UMLS CUI [1]
C0001617
UMLS CUI [2]
C0039771
UMLS CUI [3]
C0213771
UMLS CUI [4]
C0595726
4. proof of post-bronchodilator reversibility in fev1 of ≥12% and ≥200 ml (pellegrino et al 2005) documented within 5 years prior to visit 1, or proof of a positive response to a methacholine or histamine challenge (a decrease in fev1 by 20% [pc20] at ≤8 mg/ml) performed according to ats/ers guidelines (american thoracic society 2000) documented within 5 years prior to visit 1. if historical documentation is not available, reversibility or proof of a positive response to a methacholine challenge must be demonstrated and documented at visit 1
Description

post bronchodilator Forced Expiratory Volume in 1 Second Reversibility | Methacholine challenge Positive | Histamine challenge Positive | FEV1 Decrease

Type de données

boolean

Alias
UMLS CUI [1,1]
C2599594
UMLS CUI [1,2]
C3830088
UMLS CUI [2,1]
C0430567
UMLS CUI [2,2]
C1446409
UMLS CUI [3,1]
C0430566
UMLS CUI [3,2]
C1446409
UMLS CUI [4,1]
C0748133
UMLS CUI [4,2]
C0547047
5. must answer "yes" to the question "does a cold or flu make your asthma worse?"
Description

Common Cold | Influenza | Asthma

Type de données

boolean

Alias
UMLS CUI [1]
C0009443
UMLS CUI [2]
C0021400
UMLS CUI [3]
C0004096
6. to have had at least two documented severe asthma exacerbations within the last 24 months that were suspected by the patient to have been caused by a common cold or flu and to have had at least one documented severe asthma exacerbation within the last 12 months that was suspected by the patient to have been caused by a common cold or flu
Description

Exacerbation of severe persistent asthma | Common Cold | Influenza

Type de données

boolean

Alias
UMLS CUI [1]
C3508930
UMLS CUI [2]
C0009443
UMLS CUI [3]
C0021400
7. female patients must be 1 year post-menopausal, surgically sterile, or using an acceptable method of contraception.
Description

Postmenopausal state | Female Sterilization | Contraceptive methods Female

Type de données

boolean

Alias
UMLS CUI [1]
C0232970
UMLS CUI [2]
C0015787
UMLS CUI [3,1]
C0700589
UMLS CUI [3,2]
C0015780
8. negative pregnancy test (urine) for female patients of childbearing potential
Description

Childbearing Potential | Urine pregnancy test negative

Type de données

boolean

Alias
UMLS CUI [1]
C3831118
UMLS CUI [2]
C0430057
9. motivation (in the investigator's opinion) to complete all study visits, the ability to communicate well with the investigator and be capable of understanding the nature of the research and its treatment including its risks and benefits
Description

Compliance behavior

Type de données

boolean

Alias
UMLS CUI [1]
C1321605
10. ability to read and write and use the electronic devices
Description

Able to read | Able to write | Ability Use of Electronics--Equipment and supplies

Type de données

boolean

Alias
UMLS CUI [1]
C0586740
UMLS CUI [2]
C0584993
UMLS CUI [3,1]
C0085732
UMLS CUI [3,2]
C1524063
UMLS CUI [3,3]
C3826411
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients should not enter the study if any of the following exclusion criteria are fulfilled:
Description

Exclusion Criteria

Type de données

boolean

Alias
UMLS CUI [1]
C0680251
1. involvement in the planning and/or conduct of the study (applies to both astrazeneca staff and staff at third party vendors or staff at the study sites)
Description

Involvement with study planning | Involvement with Study Execution

Type de données

boolean

Alias
UMLS CUI [1,1]
C1314939
UMLS CUI [1,2]
C0681871
UMLS CUI [2,1]
C1314939
UMLS CUI [2,2]
C0681872
2. previous randomization to treatment in the present study
Description

Previous Randomization Therapeutic procedure

Type de données

boolean

Alias
UMLS CUI [1,1]
C0205156
UMLS CUI [1,2]
C0034656
UMLS CUI [1,3]
C0087111
3. any condition, including findings in the medical history or in the pre-study assessments that, in the opinion of the investigator, constitutes a risk or a contraindication for the participation of the patient in the study or that could interfere with the study objectives, conduct or evaluation
Description

Disease Study Subject Participation Status Limited

Type de données

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C2348568
UMLS CUI [1,3]
C0439801
4. lung disease other than asthma (eg, chronic obstructive pulmonary disease, cystic fibrosis, allergic bronchopulmonary aspergillosis)
Description

Lung diseases | Asthma | Chronic Obstructive Airway Disease | Cystic Fibrosis | Aspergillosis, Allergic Bronchopulmonary

Type de données

boolean

Alias
UMLS CUI [1]
C0024115
UMLS CUI [2]
C0004096
UMLS CUI [3]
C0024117
UMLS CUI [4]
C0010674
UMLS CUI [5]
C0004031
5. patients with ≥4 severe exacerbations during the last 12 months that the patient suspected were triggered by something else than an upper respiratory tract infection
Description

Exacerbation of severe persistent asthma | Upper Respiratory Infections

Type de données

boolean

Alias
UMLS CUI [1]
C3508930
UMLS CUI [2]
C0041912
6. current participation in another clinical trial or participation in a clinical trial where the patient has received a dose of a test product (imp) within 12 weeks prior to entry into the study for small molecules and within 12 months prior to entry into the study for biologicals
Description

Study Subject Participation Status | Investigational New Drugs | Biological Factors

Type de données

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0013230
UMLS CUI [3]
C0005515
7. patients who currently have, or have had within the past 3 months, any significant underlying medical condition(s) that could impact interpretation of results eg, infections, haematological disease, malignancy, renal, hepatic, coronary heart disease or other cardiovascular disease, including arrhythmias, endocrinological or gastrointestinal disease
Description

Disease Affecting Research results | Communicable Diseases | Hematological Disease | Malignant Neoplasms | Kidney Diseases | Liver diseases | Coronary heart disease | Cardiovascular Diseases | Cardiac Arrhythmia | Endocrine System Diseases | Gastrointestinal Diseases

Type de données

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0392760
UMLS CUI [1,3]
C0683954
UMLS CUI [2]
C0009450
UMLS CUI [3]
C0018939
UMLS CUI [4]
C0006826
UMLS CUI [5]
C0022658
UMLS CUI [6]
C0023895
UMLS CUI [7]
C0010068
UMLS CUI [8]
C0007222
UMLS CUI [9]
C0003811
UMLS CUI [10]
C0014130
UMLS CUI [11]
C0017178
8. abnormal vital signs, after at least 10 minutes supine rest, defined as any of the following:
Description

Abnormal vital signs

Type de données

boolean

Alias
UMLS CUI [1]
C0277804
in patients < 60 years old, systolic blood pressure <90 mmhg or ≥150 mmhg
Description

Systolic Pressure | Age

Type de données

boolean

Alias
UMLS CUI [1]
C0871470
UMLS CUI [2]
C0001779
in patients > 60 years old, systolic blood pressure <90 mmhg or ≥160 mmhg
Description

Systolic Pressure | Age

Type de données

boolean

Alias
UMLS CUI [1]
C0871470
UMLS CUI [2]
C0001779
diastolic blood pressure <50 mmhg or ≥100 mmhg
Description

Diastolic blood pressure

Type de données

boolean

Alias
UMLS CUI [1]
C0428883
hr <45 or >95 beats per minute
Description

heart rate | beats per minute

Type de données

boolean

Alias
UMLS CUI [1]
C0018810
UMLS CUI [2]
C0439385
9. any clinically important abnormalities in rhythm, conduction or morphology of the resting ecg and any abnormalities in the 12-lead ecg that, as considered by the investigator, may interfere with the interpretation of qtc interval changes, including abnormal st-t-wave morphology (particularly in the protocol defined primary lead) or left ventricular hypertrophy
Description

Resting ECG Changes Abnormal | 12 lead ECG Abnormal | qtc interval Changing | ST segment ECG: T wave abnormal | Left Ventricular Hypertrophy

Type de données

boolean

Alias
UMLS CUI [1,1]
C3897699
UMLS CUI [1,2]
C0205161
UMLS CUI [2,1]
C0430456
UMLS CUI [2,2]
C0205161
UMLS CUI [3,1]
C0489625
UMLS CUI [3,2]
C0392747
UMLS CUI [4,1]
C1287081
UMLS CUI [4,2]
C0438167
UMLS CUI [5]
C0149721
10. prolonged qtcf >450 ms (for both gender) or shortened qtcf <340 ms or family history of long qt syndrome
Description

QTcF Prolongation | QTcF Shortened | Family history of long QT syndrome

Type de données

boolean

Alias
UMLS CUI [1]
C3828431
UMLS CUI [2]
C3828430
UMLS CUI [3]
C3839836
11. pr(pq) interval shortening <120ms (pr<120 ms but >110 ms is acceptable if there is no evidence of ventricular pre-excitation).
Description

Shortened PR interval | PQ interval shortened | Ventricular preexcitation

Type de données

boolean

Alias
UMLS CUI [1]
C0520878
UMLS CUI [2]
C3854646
UMLS CUI [3]
C0559106
12. pr(pq) interval prolongation (>240ms), intermittent second or third degree av block, or av dissociation
Description

Prolonged PR interval | Electrocardiogram PQ interval prolonged | Intermittent Second degree atrioventricular block | Intermittent Complete atrioventricular block | Atrioventricular [AV] dissociation

Type de données

boolean

Alias
UMLS CUI [1]
C0600125
UMLS CUI [2]
C0858527
UMLS CUI [3,1]
C0205267
UMLS CUI [3,2]
C0264906
UMLS CUI [4,1]
C0205267
UMLS CUI [4,2]
C0151517
UMLS CUI [5]
C2882262
13. qrs duration >120ms including persistent or intermittent bundle branch block
Description

QRS complex duration | Intermittent Bundle-Branch Block | persistent Bundle-Branch Block

Type de données

boolean

Alias
UMLS CUI [1]
C0429025
UMLS CUI [2,1]
C0205267
UMLS CUI [2,2]
C0006384
UMLS CUI [3,1]
C0205322
UMLS CUI [3,2]
C0006384
14. patients with implantable cardiac defibrillator (icd) or a permanent pacemaker and patients with symptomatic ventricular and / or atrial tachyarrhythmias
Description

Implantable defibrillator | permanent pacemaker | Tachycardia, Ventricular | Heart Atrium Tachyarrhythmia

Type de données

boolean

Alias
UMLS CUI [1]
C0162589
UMLS CUI [2]
C0281945
UMLS CUI [3]
C0042514
UMLS CUI [4,1]
C0018792
UMLS CUI [4,2]
C0080203
15. patients with unstable angina pectoris or stable angina pectoris classified higher than canadian cardiovascular society (css) class ii or a myocardial infarction or stroke within 6 months
Description

Angina, Unstable | Stable angina | Canadian Cardiovascular Society classification of angina | Myocardial Infarction | Cerebrovascular accident

Type de données

boolean

Alias
UMLS CUI [1]
C0002965
UMLS CUI [2]
C0340288
UMLS CUI [3]
C1277207
UMLS CUI [4]
C0027051
UMLS CUI [5]
C0038454
16. history of hospitalization within 12 months caused by heart failure or a diagnosis of heart failure higher than new york heart association (nyha) class ii
Description

Heart failure Hospitalization | New York Heart Association Classification

Type de données

boolean

Alias
UMLS CUI [1,1]
C0018801
UMLS CUI [1,2]
C0019993
UMLS CUI [2]
C1275491
17. history of hypersensitivity to natural or recombinant interferon beta-1a or to any of the drug preparation excipients
Description

Hypersensitivity Interferon beta-1a | Hypersensitivity Pharmaceutical Excipient

Type de données

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0254119
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0015237
18. received any marketed biologic agent (eg, omalizumab) within 12 months or 5 times the half-life (whichever is the longer) of the agent prior to enrolment
Description

Biological Factors | omalizumab

Type de données

boolean

Alias
UMLS CUI [1]
C0005515
UMLS CUI [2]
C0966225
19. significant history of depressive disorder or suicidal ideation. specifically; individuals with current severe depression (ie, a low mood, which pervades all aspects of life and an inability to experience pleasure in activities that formerly were enjoyed); individuals with a past history of depression that required hospitalization or referral to psychiatric services in the past 5 years; individuals who currently feel suicidal or have attempted suicide in the past
Description

Depressive disorder | Feeling suicidal | Severe depression | H/O: depression | Hospitalization | Referral to psychiatry service

Type de données

boolean

Alias
UMLS CUI [1]
C0011581
UMLS CUI [2]
C0424000
UMLS CUI [3]
C0588008
UMLS CUI [4]
C0455503
UMLS CUI [5]
C0019993
UMLS CUI [6]
C0420390
20. history of epilepsy or seizures after the age of 5 years, other than febrile childhood seizure(s)
Description

H/O: epilepsy | Age | Febrile Convulsions

Type de données

boolean

Alias
UMLS CUI [1]
C0455511
UMLS CUI [2]
C0001779
UMLS CUI [3]
C0009952
21. history of drug or alcohol abuse within 12 months prior to enrolment
Description

Substance Use Disorders

Type de données

boolean

Alias
UMLS CUI [1]
C0038586
22. patients who have hepatic serum enzyme levels ≥2.5 times the normal range
Description

High enzyme level in serum Hepatic

Type de données

boolean

Alias
UMLS CUI [1,1]
C0476322
UMLS CUI [1,2]
C0205054
23. positive test for serum hepatitis b surface antigen, hepatitis c antibody, or hiv
Description

Hepatitis B surface antigen positive | Hepatitis C antibody test positive | HIV Seropositivity

Type de données

boolean

Alias
UMLS CUI [1]
C0149709
UMLS CUI [2]
C1277805
UMLS CUI [3]
C0019699
24. patients with a smoking history of ≥20 pack-years (1 pack year = 20 cigarettes smoked per day for one year)
Description

smoking cigarettes: ____ pack-years history

Type de données

boolean

Alias
UMLS CUI [1]
C2230126
25. female who is breast-feeding, pregnant (verified by urine dipstick pregnancy test) or intends to become pregnant during the study
Description

Pregnancy Urine dipstick test | Breast Feeding | Pregnancy, Planned

Type de données

boolean

Alias
UMLS CUI [1,1]
C0032961
UMLS CUI [1,2]
C0430370
UMLS CUI [2]
C0006147
UMLS CUI [3]
C0032992
26. patients who are unable to demonstrate an acceptable spirometry technique
Description

Unable Spirometry

Type de données

boolean

Alias
UMLS CUI [1,1]
C1299582
UMLS CUI [1,2]
C0037981
27. patients that have previously been included in studies evaluating the investigational medicinal product
Description

Study Subject Participation Status | Drug Evaluation

Type de données

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0013175
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Similar models

Eligibility Asthma NCT02491684

1 Formulaires
  1. StudyEvent: Eligibility
    1. Eligibility Asthma NCT02491684
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
C1512693 (UMLS CUI)
Inclusion
Item
for inclusion in the study patients should fulfil the following criteria:
boolean
C1512693 (UMLS CUI [1])
Informed Consent
Item
1. provision of signed and dated written informed consent prior to any study specific procedures
boolean
C0021430 (UMLS CUI [1])
Age
Item
2. male or female aged 18 and above at the time of enrolment
boolean
C0001779 (UMLS CUI [1])
Asthma Therapeutic procedure | inhaled steroids | fluticasone Dry Powder Inhaler | Adrenergic beta-2 Receptor Agonists | Leukotriene Antagonists
Item
3. history of physician-diagnosed asthma requiring treatment with medium-to-high dose ics (>250 μg fluticasone dry powder formulation equivalents total daily dose, as defined in gina 2014; see appendix chapter 5) and a second controller medication (eg, laba or leukotriene receptor antagonist). the medium or high dose ics plus laba can be any combination inhaler or 2 separate inhalers. patients must have taken ics (>250
boolean
C0004096 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
C2065041 (UMLS CUI [2])
C1967989 (UMLS CUI [3])
C2936789 (UMLS CUI [4])
C0595726 (UMLS CUI [5])
Adrenal Cortex Hormones | Theophylline | tiotropium | Leukotriene Antagonists
Item
μg fluticasone or the equivalent daily) plus second controller medication for at least 12 months prior to the date the informed consent is obtained, with or without another controller such as oral corticosteroids (ocs), theophylline, tiotropium, or leukotriene receptor antagonists
boolean
C0001617 (UMLS CUI [1])
C0039771 (UMLS CUI [2])
C0213771 (UMLS CUI [3])
C0595726 (UMLS CUI [4])
post bronchodilator Forced Expiratory Volume in 1 Second Reversibility | Methacholine challenge Positive | Histamine challenge Positive | FEV1 Decrease
Item
4. proof of post-bronchodilator reversibility in fev1 of ≥12% and ≥200 ml (pellegrino et al 2005) documented within 5 years prior to visit 1, or proof of a positive response to a methacholine or histamine challenge (a decrease in fev1 by 20% [pc20] at ≤8 mg/ml) performed according to ats/ers guidelines (american thoracic society 2000) documented within 5 years prior to visit 1. if historical documentation is not available, reversibility or proof of a positive response to a methacholine challenge must be demonstrated and documented at visit 1
boolean
C2599594 (UMLS CUI [1,1])
C3830088 (UMLS CUI [1,2])
C0430567 (UMLS CUI [2,1])
C1446409 (UMLS CUI [2,2])
C0430566 (UMLS CUI [3,1])
C1446409 (UMLS CUI [3,2])
C0748133 (UMLS CUI [4,1])
C0547047 (UMLS CUI [4,2])
Common Cold | Influenza | Asthma
Item
5. must answer "yes" to the question "does a cold or flu make your asthma worse?"
boolean
C0009443 (UMLS CUI [1])
C0021400 (UMLS CUI [2])
C0004096 (UMLS CUI [3])
Exacerbation of severe persistent asthma | Common Cold | Influenza
Item
6. to have had at least two documented severe asthma exacerbations within the last 24 months that were suspected by the patient to have been caused by a common cold or flu and to have had at least one documented severe asthma exacerbation within the last 12 months that was suspected by the patient to have been caused by a common cold or flu
boolean
C3508930 (UMLS CUI [1])
C0009443 (UMLS CUI [2])
C0021400 (UMLS CUI [3])
Postmenopausal state | Female Sterilization | Contraceptive methods Female
Item
7. female patients must be 1 year post-menopausal, surgically sterile, or using an acceptable method of contraception.
boolean
C0232970 (UMLS CUI [1])
C0015787 (UMLS CUI [2])
C0700589 (UMLS CUI [3,1])
C0015780 (UMLS CUI [3,2])
Childbearing Potential | Urine pregnancy test negative
Item
8. negative pregnancy test (urine) for female patients of childbearing potential
boolean
C3831118 (UMLS CUI [1])
C0430057 (UMLS CUI [2])
Compliance behavior
Item
9. motivation (in the investigator's opinion) to complete all study visits, the ability to communicate well with the investigator and be capable of understanding the nature of the research and its treatment including its risks and benefits
boolean
C1321605 (UMLS CUI [1])
Able to read | Able to write | Ability Use of Electronics--Equipment and supplies
Item
10. ability to read and write and use the electronic devices
boolean
C0586740 (UMLS CUI [1])
C0584993 (UMLS CUI [2])
C0085732 (UMLS CUI [3,1])
C1524063 (UMLS CUI [3,2])
C3826411 (UMLS CUI [3,3])
Item Group
C0680251 (UMLS CUI)
Exclusion Criteria
Item
patients should not enter the study if any of the following exclusion criteria are fulfilled:
boolean
C0680251 (UMLS CUI [1])
Involvement with study planning | Involvement with Study Execution
Item
1. involvement in the planning and/or conduct of the study (applies to both astrazeneca staff and staff at third party vendors or staff at the study sites)
boolean
C1314939 (UMLS CUI [1,1])
C0681871 (UMLS CUI [1,2])
C1314939 (UMLS CUI [2,1])
C0681872 (UMLS CUI [2,2])
Previous Randomization Therapeutic procedure
Item
2. previous randomization to treatment in the present study
boolean
C0205156 (UMLS CUI [1,1])
C0034656 (UMLS CUI [1,2])
C0087111 (UMLS CUI [1,3])
Disease Study Subject Participation Status Limited
Item
3. any condition, including findings in the medical history or in the pre-study assessments that, in the opinion of the investigator, constitutes a risk or a contraindication for the participation of the patient in the study or that could interfere with the study objectives, conduct or evaluation
boolean
C0012634 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
C0439801 (UMLS CUI [1,3])
Lung diseases | Asthma | Chronic Obstructive Airway Disease | Cystic Fibrosis | Aspergillosis, Allergic Bronchopulmonary
Item
4. lung disease other than asthma (eg, chronic obstructive pulmonary disease, cystic fibrosis, allergic bronchopulmonary aspergillosis)
boolean
C0024115 (UMLS CUI [1])
C0004096 (UMLS CUI [2])
C0024117 (UMLS CUI [3])
C0010674 (UMLS CUI [4])
C0004031 (UMLS CUI [5])
Exacerbation of severe persistent asthma | Upper Respiratory Infections
Item
5. patients with ≥4 severe exacerbations during the last 12 months that the patient suspected were triggered by something else than an upper respiratory tract infection
boolean
C3508930 (UMLS CUI [1])
C0041912 (UMLS CUI [2])
Study Subject Participation Status | Investigational New Drugs | Biological Factors
Item
6. current participation in another clinical trial or participation in a clinical trial where the patient has received a dose of a test product (imp) within 12 weeks prior to entry into the study for small molecules and within 12 months prior to entry into the study for biologicals
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
C0005515 (UMLS CUI [3])
Disease Affecting Research results | Communicable Diseases | Hematological Disease | Malignant Neoplasms | Kidney Diseases | Liver diseases | Coronary heart disease | Cardiovascular Diseases | Cardiac Arrhythmia | Endocrine System Diseases | Gastrointestinal Diseases
Item
7. patients who currently have, or have had within the past 3 months, any significant underlying medical condition(s) that could impact interpretation of results eg, infections, haematological disease, malignancy, renal, hepatic, coronary heart disease or other cardiovascular disease, including arrhythmias, endocrinological or gastrointestinal disease
boolean
C0012634 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C0683954 (UMLS CUI [1,3])
C0009450 (UMLS CUI [2])
C0018939 (UMLS CUI [3])
C0006826 (UMLS CUI [4])
C0022658 (UMLS CUI [5])
C0023895 (UMLS CUI [6])
C0010068 (UMLS CUI [7])
C0007222 (UMLS CUI [8])
C0003811 (UMLS CUI [9])
C0014130 (UMLS CUI [10])
C0017178 (UMLS CUI [11])
Abnormal vital signs
Item
8. abnormal vital signs, after at least 10 minutes supine rest, defined as any of the following:
boolean
C0277804 (UMLS CUI [1])
Systolic Pressure | Age
Item
in patients < 60 years old, systolic blood pressure <90 mmhg or ≥150 mmhg
boolean
C0871470 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Systolic Pressure | Age
Item
in patients > 60 years old, systolic blood pressure <90 mmhg or ≥160 mmhg
boolean
C0871470 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Diastolic blood pressure
Item
diastolic blood pressure <50 mmhg or ≥100 mmhg
boolean
C0428883 (UMLS CUI [1])
heart rate | beats per minute
Item
hr <45 or >95 beats per minute
boolean
C0018810 (UMLS CUI [1])
C0439385 (UMLS CUI [2])
Resting ECG Changes Abnormal | 12 lead ECG Abnormal | qtc interval Changing | ST segment ECG: T wave abnormal | Left Ventricular Hypertrophy
Item
9. any clinically important abnormalities in rhythm, conduction or morphology of the resting ecg and any abnormalities in the 12-lead ecg that, as considered by the investigator, may interfere with the interpretation of qtc interval changes, including abnormal st-t-wave morphology (particularly in the protocol defined primary lead) or left ventricular hypertrophy
boolean
C3897699 (UMLS CUI [1,1])
C0205161 (UMLS CUI [1,2])
C0430456 (UMLS CUI [2,1])
C0205161 (UMLS CUI [2,2])
C0489625 (UMLS CUI [3,1])
C0392747 (UMLS CUI [3,2])
C1287081 (UMLS CUI [4,1])
C0438167 (UMLS CUI [4,2])
C0149721 (UMLS CUI [5])
QTcF Prolongation | QTcF Shortened | Family history of long QT syndrome
Item
10. prolonged qtcf >450 ms (for both gender) or shortened qtcf <340 ms or family history of long qt syndrome
boolean
C3828431 (UMLS CUI [1])
C3828430 (UMLS CUI [2])
C3839836 (UMLS CUI [3])
Shortened PR interval | PQ interval shortened | Ventricular preexcitation
Item
11. pr(pq) interval shortening <120ms (pr<120 ms but >110 ms is acceptable if there is no evidence of ventricular pre-excitation).
boolean
C0520878 (UMLS CUI [1])
C3854646 (UMLS CUI [2])
C0559106 (UMLS CUI [3])
Prolonged PR interval | Electrocardiogram PQ interval prolonged | Intermittent Second degree atrioventricular block | Intermittent Complete atrioventricular block | Atrioventricular [AV] dissociation
Item
12. pr(pq) interval prolongation (>240ms), intermittent second or third degree av block, or av dissociation
boolean
C0600125 (UMLS CUI [1])
C0858527 (UMLS CUI [2])
C0205267 (UMLS CUI [3,1])
C0264906 (UMLS CUI [3,2])
C0205267 (UMLS CUI [4,1])
C0151517 (UMLS CUI [4,2])
C2882262 (UMLS CUI [5])
QRS complex duration | Intermittent Bundle-Branch Block | persistent Bundle-Branch Block
Item
13. qrs duration >120ms including persistent or intermittent bundle branch block
boolean
C0429025 (UMLS CUI [1])
C0205267 (UMLS CUI [2,1])
C0006384 (UMLS CUI [2,2])
C0205322 (UMLS CUI [3,1])
C0006384 (UMLS CUI [3,2])
Implantable defibrillator | permanent pacemaker | Tachycardia, Ventricular | Heart Atrium Tachyarrhythmia
Item
14. patients with implantable cardiac defibrillator (icd) or a permanent pacemaker and patients with symptomatic ventricular and / or atrial tachyarrhythmias
boolean
C0162589 (UMLS CUI [1])
C0281945 (UMLS CUI [2])
C0042514 (UMLS CUI [3])
C0018792 (UMLS CUI [4,1])
C0080203 (UMLS CUI [4,2])
Angina, Unstable | Stable angina | Canadian Cardiovascular Society classification of angina | Myocardial Infarction | Cerebrovascular accident
Item
15. patients with unstable angina pectoris or stable angina pectoris classified higher than canadian cardiovascular society (css) class ii or a myocardial infarction or stroke within 6 months
boolean
C0002965 (UMLS CUI [1])
C0340288 (UMLS CUI [2])
C1277207 (UMLS CUI [3])
C0027051 (UMLS CUI [4])
C0038454 (UMLS CUI [5])
Heart failure Hospitalization | New York Heart Association Classification
Item
16. history of hospitalization within 12 months caused by heart failure or a diagnosis of heart failure higher than new york heart association (nyha) class ii
boolean
C0018801 (UMLS CUI [1,1])
C0019993 (UMLS CUI [1,2])
C1275491 (UMLS CUI [2])
Hypersensitivity Interferon beta-1a | Hypersensitivity Pharmaceutical Excipient
Item
17. history of hypersensitivity to natural or recombinant interferon beta-1a or to any of the drug preparation excipients
boolean
C0020517 (UMLS CUI [1,1])
C0254119 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0015237 (UMLS CUI [2,2])
Biological Factors | omalizumab
Item
18. received any marketed biologic agent (eg, omalizumab) within 12 months or 5 times the half-life (whichever is the longer) of the agent prior to enrolment
boolean
C0005515 (UMLS CUI [1])
C0966225 (UMLS CUI [2])
Depressive disorder | Feeling suicidal | Severe depression | H/O: depression | Hospitalization | Referral to psychiatry service
Item
19. significant history of depressive disorder or suicidal ideation. specifically; individuals with current severe depression (ie, a low mood, which pervades all aspects of life and an inability to experience pleasure in activities that formerly were enjoyed); individuals with a past history of depression that required hospitalization or referral to psychiatric services in the past 5 years; individuals who currently feel suicidal or have attempted suicide in the past
boolean
C0011581 (UMLS CUI [1])
C0424000 (UMLS CUI [2])
C0588008 (UMLS CUI [3])
C0455503 (UMLS CUI [4])
C0019993 (UMLS CUI [5])
C0420390 (UMLS CUI [6])
H/O: epilepsy | Age | Febrile Convulsions
Item
20. history of epilepsy or seizures after the age of 5 years, other than febrile childhood seizure(s)
boolean
C0455511 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
C0009952 (UMLS CUI [3])
Substance Use Disorders
Item
21. history of drug or alcohol abuse within 12 months prior to enrolment
boolean
C0038586 (UMLS CUI [1])
High enzyme level in serum Hepatic
Item
22. patients who have hepatic serum enzyme levels ≥2.5 times the normal range
boolean
C0476322 (UMLS CUI [1,1])
C0205054 (UMLS CUI [1,2])
Hepatitis B surface antigen positive | Hepatitis C antibody test positive | HIV Seropositivity
Item
23. positive test for serum hepatitis b surface antigen, hepatitis c antibody, or hiv
boolean
C0149709 (UMLS CUI [1])
C1277805 (UMLS CUI [2])
C0019699 (UMLS CUI [3])
smoking cigarettes: ____ pack-years history
Item
24. patients with a smoking history of ≥20 pack-years (1 pack year = 20 cigarettes smoked per day for one year)
boolean
C2230126 (UMLS CUI [1])
Pregnancy Urine dipstick test | Breast Feeding | Pregnancy, Planned
Item
25. female who is breast-feeding, pregnant (verified by urine dipstick pregnancy test) or intends to become pregnant during the study
boolean
C0032961 (UMLS CUI [1,1])
C0430370 (UMLS CUI [1,2])
C0006147 (UMLS CUI [2])
C0032992 (UMLS CUI [3])
Unable Spirometry
Item
26. patients who are unable to demonstrate an acceptable spirometry technique
boolean
C1299582 (UMLS CUI [1,1])
C0037981 (UMLS CUI [1,2])
Study Subject Participation Status | Drug Evaluation
Item
27. patients that have previously been included in studies evaluating the investigational medicinal product
boolean
C2348568 (UMLS CUI [1])
C0013175 (UMLS CUI [2])
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