ID

14281

Beskrivning

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

Länk

https://clinicaltrials.gov/show/NCT02134028

Nyckelord

Versioner (1)
  1. 2016-04-07 2016-04-07 -
Uppladdad den

7 april 2016

DOI

För en begäran logga in.

Licens

Creative Commons BY 4.0
Modellkommentarer :

Här kan du kommentera modellen. Med hjälp av pratbubblor i Item-grupperna och Item kan du lägga in specifika kommentarer.

Tillbaka till modellkommentarer
Itemgroup-kommentar för :

Item-kommentar för :

Du måste vara inloggad för att kunna ladda ner formulär. Var vänlig logga in eller registrera dig utan kostnad.

Eligibility Asthma NCT02134028

Engelsk

Eligibility Asthma NCT02134028

1 Formulär  
  1. StudyEvent: Eligibility
    1. Eligibility Asthma NCT02134028
Inclusion Criteria
Beskrivning

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.
Beskrivning

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

Datatyp

boolean

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

Exclusion Criteria

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

Compliance behavior | Asthma Clinical Research

Datatyp

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.
Beskrivning

Hypersensitivity dupilumab | Study Subject Participation Status Limited

Datatyp

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.
Beskrivning

Parasitic infection

Datatyp

boolean

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

HIV Infections

Datatyp

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.
Beskrivning

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

Datatyp

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).
Beskrivning

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

Datatyp

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.
Beskrivning

Laboratory test result abnormal | Study Subject Participation Status Limited

Datatyp

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.
Beskrivning

travel | contact with persons from endemic areas parasitic

Datatyp

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:
Beskrivning

Drug-Induced Liver Injury

Datatyp

boolean

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

Hepatobiliary disease

Datatyp

boolean

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

Alanine aminotransferase measurement | Upper Limit of Normal

Datatyp

boolean

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

Laboratory test result abnormal

Datatyp

boolean

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

Creatine Kinase

Datatyp

boolean

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

Platelet Count measurement

Datatyp

boolean

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

Eosinophil count procedure

Datatyp

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.
Beskrivning

Study Subject Participation Status

Datatyp

boolean

Alias
UMLS CUI [1]
C2348568
Tillbaka till toppen

Similar models

Eligibility Asthma NCT02134028

1 Formulär
  1. StudyEvent: Eligibility
    1. Eligibility Asthma NCT02134028
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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])
Tillbaka till toppen 

Kontakt

Använd detta formulär för feedback, frågor och förslag på förbättringar.

Fält markerade med * är obligatoriska.

Hjälp

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial