Information:
Error:
ID
14256
Description
A Study of Safety and Efficacy of CNTO 148 in Patients With Severe Persistent Asthma; ODM derived from: https://clinicaltrials.gov/show/NCT00207740
Link
https://clinicaltrials.gov/show/NCT00207740
Keywords
Versions (1)
- 4/5/16 4/5/16 -
Copyright Holder
CC BY-NC 3.0
Uploaded on
April 5, 2016
DOI
To request one please log in.
License
Creative Commons BY-NC 3.0
Model comments :
You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.
Itemgroup comments for :
Item comments for :
In order to download data models you must be logged in. Please log in or register for free.
Eligibility Asthma NCT00207740
Eligibility Asthma NCT00207740
- StudyEvent: Eligibility
Similar models
Eligibility Asthma NCT00207740
- StudyEvent: Eligibility
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
asthma
Item
physician diagnosis of asthma for greater than or equal to 3 years and a diagnosis of severe persistent asthma forgreater than or equal to 1 year prior to screening
boolean
C0004096 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,2])
inhaled corticosteroids and LABA
Item
continuous treatment with high dose inhaled corticosteroids (ics) and long acting beta-agonist for at least 3 months prior to screening
boolean
C2065041 (UMLS CUI [1])
C2936789 (UMLS CUI [2])
C0040223 (UMLS CUI [3])
C2936789 (UMLS CUI [2])
C0040223 (UMLS CUI [3])
airway obstruction
Item
have evidence of at least 1 of the following in the 5 years prior to screening or during screening, reversible airway obstruction greater than or equal to 12 percentage change in forced expiratory volume in 1 second (fev1) postbronchodilator; diurnal variation in peak expiratory flow rate (pefr) greater than or equal to 30 percentage change) and airway hyperresponsiveness
boolean
C0001883 (UMLS CUI [1])
C0748133 (UMLS CUI [2])
C0748133 (UMLS CUI [2])
symptom frequency
Item
estimated frequency of symptoms on more than one-third of days for at least 3 months prior to screening (eg, wheezing, breathlessness, chest tightness, cough, nocturnal awakening) despite treatment with high dose ics and long-acting β2-agonist (laba), with or without continuous oral corticosteroids
boolean
C0436350 (UMLS CUI [1])
asthma control questionnaire
Item
score of greater than or equal to 2 points on the asthma control questionnaire at screening.
boolean
C2919686 (UMLS CUI [1])
copd, cystic fibrosis or other significant respiratory disorder
Item
diagnosis of chronic obstructive pulmoanry disease (copd), cystic fibrosis, or other significant respiratory disorder
boolean
C0024117 (UMLS CUI [1])
C0010674 (UMLS CUI [2])
C0035204 (UMLS CUI [3])
C0010674 (UMLS CUI [2])
C0035204 (UMLS CUI [3])
worsening of asthma symptoms
Item
worsening of asthma symptoms that required treatment with an addition or increase in oral corticosteroids dose (steroid burst) in the 4-week period prior to the screening visit
boolean
C0004096 (UMLS CUI [1,1])
C1457887 (UMLS CUI [1,2])
C1457868 (UMLS CUI [1,3])
C0001617 (UMLS CUI [2])
C1457887 (UMLS CUI [1,2])
C1457868 (UMLS CUI [1,3])
C0001617 (UMLS CUI [2])
life-threatening asthma
Item
life-threatening asthma attack requiring cardiopulmonary support (eg, intubation) in the 6-month period prior to screening
boolean
C0004096 (UMLS CUI [1,1])
C2826244 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
C2826244 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
alkylating agents
Item
have ever used alkylating agents (eg, chlorambucil or cyclophosphamide)
boolean
C0002073 (UMLS CUI [1])
congestive heart failure
Item
concomitant diagnosis or any history of congestive heart failure (chf), including medically controlled chf.
boolean
C0018802 (UMLS CUI [1])