ID

14281

Descrizione

Long-Term Safety Evaluation of Dupilumab in Patients With Asthma (LIBERTY ASTHMA TRAVERSE); ODM derived from: https://clinicaltrials.gov/show/NCT02134028

collegamento

https://clinicaltrials.gov/show/NCT02134028

Keywords

versioni (1)
  1. 07/04/16 07/04/16 -
Caricato su

7 aprile 2016

DOI

Per favore, per richiedere un accesso.

Licenza

Creative Commons BY 4.0
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Eligibility Asthma NCT02134028

Inglese

Eligibility Asthma NCT02134028

1 moduli  
  1. StudyEvent: Eligibility
    1. Eligibility Asthma NCT02134028
Inclusion Criteria
Descrizione

Inclusion Criteria

Alias
UMLS CUI
C1512693
eligible patients who have completed the entire study duration of dri12544, or who completed the treatment period in the other previous asthma studies.
Descrizione

Patient eligible for clinical trial | Compliance behavior | Asthma Clinical Research

Tipo di dati

boolean

Alias
UMLS CUI [1]
C1302261
UMLS CUI [2]
C1321605
UMLS CUI [3,1]
C0004096
UMLS CUI [3,2]
C0008972
Exclusion Criteria
Descrizione

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients who did not complete the dri12544 study or the treatment period in other previous asthma studies.
Descrizione

Compliance behavior | Asthma Clinical Research

Tipo di dati

boolean

Alias
UMLS CUI [1]
C1321605
UMLS CUI [2,1]
C0004096
UMLS CUI [2,2]
C0008972
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.
Descrizione

Hypersensitivity dupilumab | Study Subject Participation Status Limited

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C3660996
UMLS CUI [2,1]
C2348568
UMLS CUI [2,2]
C0439801
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.
Descrizione

Parasitic infection

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0747256
medical history of human immunodeficiency virus (hiv) infection.
Descrizione

HIV Infections

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0019693
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.
Descrizione

Therapeutic immunosuppression | Opportunistic Infections | Tuberculosis | Histoplasmosis | Listeriosis | Coccidioidomycosis | Pneumocystis jiroveci pneumonia | Aspergillosis

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0021079
UMLS CUI [2]
C0029118
UMLS CUI [3]
C0041296
UMLS CUI [4]
C0019655
UMLS CUI [5]
C0023860
UMLS CUI [6]
C0009186
UMLS CUI [7]
C1535939
UMLS CUI [8]
C0004030
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).
Descrizione

Communicable Diseases | Anti-Bacterial Agents | Antiviral Agents | Antifungal Agents | Antiparasitic Agents | Antiprotozoal Agents | Virus Diseases | Influenza

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0009450
UMLS CUI [2]
C0279516
UMLS CUI [3]
C0003451
UMLS CUI [4]
C0003308
UMLS CUI [5]
C0003404
UMLS CUI [6]
C0003416
UMLS CUI [7]
C0042769
UMLS CUI [8]
C0021400
patients with any event or laboratory abnormality that, as per investigator judgment, would adversely affect participation of the patient in this study.
Descrizione

Laboratory test result abnormal | Study Subject Participation Status Limited

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0438215
UMLS CUI [2,1]
C2348568
UMLS CUI [2,2]
C0439801
patients who have traveled to parasitic endemic area within 6 months prior to screening.
Descrizione

travel | contact with persons from endemic areas parasitic

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0040802
UMLS CUI [2,1]
C2108011
UMLS CUI [2,2]
C0521066
for patients from dri12544 study, drug induced liver injury related criteria at screening:
Descrizione

Drug-Induced Liver Injury

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0860207
underlying clinically significant hepatobiliary disease or
Descrizione

Hepatobiliary disease

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0267792
alanine aminotransferase (alt) >3 upper limit of normal (uln).
Descrizione

Alanine aminotransferase measurement | Upper Limit of Normal

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0201836
UMLS CUI [2]
C1519815
for patients from dri12544 study, abnormal lab values at screening:
Descrizione

Laboratory test result abnormal

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0438215
creatine phosphokinase (cpk) >10 uln or
Descrizione

Creatine Kinase

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0010287
platelets <100.000 cells/mm^3 or
Descrizione

Platelet Count measurement

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0032181
eosinophils >1500 cells/mm^3
Descrizione

Eosinophil count procedure

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0200638
the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Descrizione

Study Subject Participation Status

Tipo di dati

boolean

Alias
UMLS CUI [1]
C2348568
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Similar models

Eligibility Asthma NCT02134028

1 moduli
  1. StudyEvent: Eligibility
    1. Eligibility Asthma NCT02134028
Name
genere
Description | Question | Decode (Coded Value)
Tipo di dati
Alias
Item Group
C1512693 (UMLS CUI)
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])
Item Group
C0680251 (UMLS CUI)
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])
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