Informações:
Falhas:
ID
15745
Descrição
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Liraglutide in Healthy Japanese Volunteers; ODM derived from: https://clinicaltrials.gov/show/NCT01620463
Link
https://clinicaltrials.gov/show/NCT01620463
Palavras-chave
Versões (1)
- 10/06/2016 10/06/2016 -
Transferido a
10 de junho de 2016
DOI
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Licença
Creative Commons BY 4.0
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Eligibility Diabetes NCT01620463
Eligibility Diabetes NCT01620463
- StudyEvent: Eligibility
Similar models
Eligibility Diabetes NCT01620463
- StudyEvent: Eligibility
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
BMI
Item
body mass index (bmi) between 18 and 27 kg/m^2, inclusive
boolean
C1305855 (UMLS CUI [1])
clinically relevant abnormalities
Item
clinically relevant abnormalities of physical examination, laboratory values, vital signs or ecg findings at the screening, as judged by the investigator or sub-investigator
boolean
C0031809 (UMLS CUI [1,1])
C0205161 (UMLS CUI [1,2])
C1254595 (UMLS CUI [2,1])
C0205161 (UMLS CUI [2,2])
C0518766 (UMLS CUI [3,1])
C0205161 (UMLS CUI [3,2])
C0438154 (UMLS CUI [4,1])
C0205161 (UMLS CUI [4,2])
C0205161 (UMLS CUI [1,2])
C1254595 (UMLS CUI [2,1])
C0205161 (UMLS CUI [2,2])
C0518766 (UMLS CUI [3,1])
C0205161 (UMLS CUI [3,2])
C0438154 (UMLS CUI [4,1])
C0205161 (UMLS CUI [4,2])
presence of acute or chronic illness
Item
presence of acute or chronic illness sufficient to invalidate the subject's participation in the study or to make it unnecessarily hazardous, as judged by the investigator
boolean
C1321605 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0009488 (UMLS CUI [1,3])
C0439801 (UMLS CUI [1,2])
C0009488 (UMLS CUI [1,3])
blood pressure
Item
blood pressure in supine position at the screening, after resting for 5 min, outside the ranges 90-150 mmhg systolic or 40-90 mmhg diastolic
boolean
C0005823 (UMLS CUI [1,1])
C0038846 (UMLS CUI [1,2])
C0038846 (UMLS CUI [1,2])
heart rate
Item
heart rate in supine position at the screening, after resting for 5 min, outside the range 40-100 beats/min
boolean
C0018810 (UMLS CUI [1,1])
C0038846 (UMLS CUI [1,2])
C0038846 (UMLS CUI [1,2])
alcohol intake
Item
alcohol intake within 48 hours prior to the screening
boolean
C0001948 (UMLS CUI [1])
antibodies
Item
hepatitis b surface antigen, hepatitis c antibodies or hiv (human immunodeficiency virus) antibodies positive
boolean
C0019168 (UMLS CUI [1])
C0166049 (UMLS CUI [2])
C0019683 (UMLS CUI [3])
C0166049 (UMLS CUI [2])
C0019683 (UMLS CUI [3])
abnormal history or physical findings
Item
clinically relevant abnormal history or physical findings at the screening, which could interfere with the objectives of the study or the safety of the subject's participation, as judged by the investigator
boolean
C1321605 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0009488 (UMLS CUI [1,3])
C0439801 (UMLS CUI [1,2])
C0009488 (UMLS CUI [1,3])
allergy
Item
history of significant allergy or hypersensitivity
boolean
C0020517 (UMLS CUI [1])
allergy to trial product
Item
known or suspected allergy to trial product or related products
boolean
C0020517 (UMLS CUI [1,1])
C3854006 (UMLS CUI [1,2])
C3854006 (UMLS CUI [1,2])
drug or alcohol abuse
Item
history of drug or alcohol abuse
boolean
C0038586 (UMLS CUI [1])
smoking
Item
smoking 10 cigarettes or more, or the equivalent, per day and is unwilling to refrain from smoking during 3 days prior to dosing and during the confinement period
boolean
C0543414 (UMLS CUI [1])