Asthma | Reversibility | pre bronchodilator | FEV1
Item
diagnosis of asthma, and presently has reversibility over pre-bronchodilator fev1 of
boolean
C0004096 (UMLS CUI [1,1])
C0449261 (UMLS CUI [1,2])
C2599602 (UMLS CUI [1,3])
C0748133 (UMLS CUI [1,4])
FEV1
Item
≥ 20 percent at screening
boolean
C0748133 (UMLS CUI [1])
Percent predicted FEV1
Item
percent of predicted fev1 ≥ 40% and ≤ 80% at screening
boolean
C0730561 (UMLS CUI [1])
Inhaled steroids | fluticasone
Item
ics ≥ 200 and ≤ 1000/μg/day fluticasone powder or equivalent
boolean
C2065041 (UMLS CUI [1,1])
C0082607 (UMLS CUI [1,2])
Score | Asthma control questionnaire | Asthma | Symptoms | Continuous
Item
ongoing asthma symptoms with acq composite score at screening and baseline ≥ 1.5 points
boolean
C0449820 (UMLS CUI [1,1])
C2919686 (UMLS CUI [1,2])
C0004096 (UMLS CUI [1,3])
C1457887 (UMLS CUI [1,4])
C0549178 (UMLS CUI [1,5])
Chronic Obstructive Airway Disease | Other chronic pulmonary disease
Item
history of chronic obstructive pulmonary disease or other chronic pulmonary condition other than asthma
boolean
C0024117 (UMLS CUI [1])
C0810290 (UMLS CUI [2,1])
C0004096 (UMLS CUI [2,2])
Aspergillosis, Allergic Bronchopulmonary
Item
history of allergic bronchopulmonary aspergillosis
boolean
C0004031 (UMLS CUI [1])
Respiratory Tract Infections
Item
respiratory infection within 4 weeks of screening or 1 week of baseline visit
boolean
C0035243 (UMLS CUI [1])
Crohn Disease | Comorbidity | Laboratory abnormalities
Item
subject has known history of crohn's disease subject has any other significant concurrent medical condition of laboratory abnormalities, as defined in the study protocol
boolean
C0010346 (UMLS CUI [1])
C0009488 (UMLS CUI [2,1])
C1853129 (UMLS CUI [2,2])
Interleukin-17 | Therapeutic procedure
Item
subject has previously used any anti-il17 biologic therapy
boolean
C0384648 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
Pregnancy | Breast Feeding | Pregnancy, Planned
Item
subject is pregnant or breastfeeding, or planning to become pregnant while enrolled in the study
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0032992 (UMLS CUI [3])
Female | Unwilling | Contraceptive methods
Item
female subject is unwilling to use highly effective methods of birth control unless 2 years post-menopausal or surgically sterile
boolean
C0086287 (UMLS CUI [1,1])
C0558080 (UMLS CUI [1,2])
C0700589 (UMLS CUI [1,3])
Severe depression | Suicidal behavior
Item
subject has severe depression measured by personal health questionnaire depression scale (phq-8) or suicidal ideation/behavior as measured by and columbia suicide severity rating scale (e-cssrs)
boolean
C0588008 (UMLS CUI [1,1])
C0679604 (UMLS CUI [1,2])
C1760428 (UMLS CUI [2,1])
C3888485 (UMLS CUI [2,2])
Mental disorders | Substance abuse problem
Item
subject has a history or evidence of psychiatric disorder or substance abuse considered by the investigator to pose a risk to subject safety
boolean
C0004936 (UMLS CUI [1])
C0740858 (UMLS CUI [2,1])
C0035647 (UMLS CUI [2,2])
C1113679 (UMLS CUI [2,3])