Patient eligible for clinical trial | Compliance behavior | Asthma Clinical Research
Item
eligible patients who have completed the entire study duration of dri12544, or who completed the treatment period in the other previous asthma studies.
boolean
C1302261 (UMLS CUI [1])
C1321605 (UMLS CUI [2])
C0004096 (UMLS CUI [3,1])
C0008972 (UMLS CUI [3,2])
Compliance behavior | Asthma Clinical Research
Item
patients who did not complete the dri12544 study or the treatment period in other previous asthma studies.
boolean
C1321605 (UMLS CUI [1])
C0004096 (UMLS CUI [2,1])
C0008972 (UMLS CUI [2,2])
Hypersensitivity dupilumab | Study Subject Participation Status Limited
Item
patients who have experienced hypersensitivity reactions to dupilumab which, in the opinion of the investigator, could indicate that continued treatment with dupilumab may present an unreasonable risk for the patient.
boolean
C0020517 (UMLS CUI [1,1])
C3660996 (UMLS CUI [1,2])
C2348568 (UMLS CUI [2,1])
C0439801 (UMLS CUI [2,2])
Parasitic infection
Item
patients diagnosed with active parasitic infection; suspected or at high risk of parasitic infection, unless clinical and/or laboratory assessments before enrollment have ruled out an active infection.
boolean
C0747256 (UMLS CUI [1])
HIV Infections
Item
medical history of human immunodeficiency virus (hiv) infection.
boolean
C0019693 (UMLS CUI [1])
Therapeutic immunosuppression | Opportunistic Infections | Tuberculosis | Histoplasmosis | Listeriosis | Coccidioidomycosis | Pneumocystis jiroveci pneumonia | Aspergillosis
Item
known or suspected medical history of immunosuppression, including history of invasive opportunistic infections (eg, tuberculosis, histoplasmosis, listeriosis, coccidioidomycosis, pneumocystosis, aspergillosis) despite infection resolution; or unusually frequent, recurrent or prolonged infections, as per investigator judgment.
boolean
C0021079 (UMLS CUI [1])
C0029118 (UMLS CUI [2])
C0041296 (UMLS CUI [3])
C0019655 (UMLS CUI [4])
C0023860 (UMLS CUI [5])
C0009186 (UMLS CUI [6])
C1535939 (UMLS CUI [7])
C0004030 (UMLS CUI [8])
Communicable Diseases | Anti-Bacterial Agents | Antiviral Agents | Antifungal Agents | Antiparasitic Agents | Antiprotozoal Agents | Virus Diseases | Influenza
Item
evidence of acute or chronic infection requiring treatment with antibacterials, antivirals, antifungals, antiparasitics or antiprotozoals within 4 weeks before visit 1; significant viral infections within 4 weeks before visit 1 that may not have received antiviral treatment (eg, influenza receiving only symptomatic treatment).
boolean
C0009450 (UMLS CUI [1])
C0279516 (UMLS CUI [2])
C0003451 (UMLS CUI [3])
C0003308 (UMLS CUI [4])
C0003404 (UMLS CUI [5])
C0003416 (UMLS CUI [6])
C0042769 (UMLS CUI [7])
C0021400 (UMLS CUI [8])
Laboratory test result abnormal | Study Subject Participation Status Limited
Item
patients with any event or laboratory abnormality that, as per investigator judgment, would adversely affect participation of the patient in this study.
boolean
C0438215 (UMLS CUI [1])
C2348568 (UMLS CUI [2,1])
C0439801 (UMLS CUI [2,2])
travel | contact with persons from endemic areas parasitic
Item
patients who have traveled to parasitic endemic area within 6 months prior to screening.
boolean
C0040802 (UMLS CUI [1])
C2108011 (UMLS CUI [2,1])
C0521066 (UMLS CUI [2,2])
Drug-Induced Liver Injury
Item
for patients from dri12544 study, drug induced liver injury related criteria at screening:
boolean
C0860207 (UMLS CUI [1])
Hepatobiliary disease
Item
underlying clinically significant hepatobiliary disease or
boolean
C0267792 (UMLS CUI [1])
Alanine aminotransferase measurement | Upper Limit of Normal
Item
alanine aminotransferase (alt) >3 upper limit of normal (uln).
boolean
C0201836 (UMLS CUI [1])
C1519815 (UMLS CUI [2])
Laboratory test result abnormal
Item
for patients from dri12544 study, abnormal lab values at screening:
boolean
C0438215 (UMLS CUI [1])
Creatine Kinase
Item
creatine phosphokinase (cpk) >10 uln or
boolean
C0010287 (UMLS CUI [1])
Platelet Count measurement
Item
platelets <100.000 cells/mm^3 or
boolean
C0032181 (UMLS CUI [1])
Eosinophil count procedure
Item
eosinophils >1500 cells/mm^3
boolean
C0200638 (UMLS CUI [1])
Study Subject Participation Status
Item
the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
boolean
C2348568 (UMLS CUI [1])