Informações:
Falhas:
ID
33735
Descrição
Pharmacokinetics, Safety and Tolerability of Oral Semaglutide in Subjects With Hepatic Impairment; ODM derived from: https://clinicaltrials.gov/show/NCT02016911
Link
https://clinicaltrials.gov/show/NCT02016911
Palavras-chave
Versões (1)
- 21/12/2018 21/12/2018 -
Titular dos direitos
See clinicaltrials.gov
Transferido a
21 de dezembro de 2018
DOI
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Licença
Creative Commons BY 4.0
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Eligibility Diabetes NCT02016911
Eligibility Diabetes NCT02016911
- StudyEvent: Eligibility
Similar models
Eligibility Diabetes NCT02016911
- StudyEvent: Eligibility
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Liver function | Hepatic impairment Mild | Hepatic impairment Moderate | Hepatic impairment Severe
Item
subject with normal hepatic function or hepatic impairment (mild, moderate or severe)
boolean
C0232741 (UMLS CUI [1])
C0948807 (UMLS CUI [2,1])
C2945599 (UMLS CUI [2,2])
C0948807 (UMLS CUI [3,1])
C0205081 (UMLS CUI [3,2])
C0948807 (UMLS CUI [4,1])
C0205082 (UMLS CUI [4,2])
C0948807 (UMLS CUI [2,1])
C2945599 (UMLS CUI [2,2])
C0948807 (UMLS CUI [3,1])
C0205081 (UMLS CUI [3,2])
C0948807 (UMLS CUI [4,1])
C0205082 (UMLS CUI [4,2])
Body mass index
Item
body mass index (bmi) 18.5-40.0 kg/m^2 (both inclusive)
boolean
C1305855 (UMLS CUI [1])
Pregnancy | Breast Feeding | Pregnancy, Planned | Childbearing Potential Contraceptive methods Absent
Item
female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using adequate contraceptive methods
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0032992 (UMLS CUI [3])
C3831118 (UMLS CUI [4,1])
C0700589 (UMLS CUI [4,2])
C0332197 (UMLS CUI [4,3])
C0006147 (UMLS CUI [2])
C0032992 (UMLS CUI [3])
C3831118 (UMLS CUI [4,1])
C0700589 (UMLS CUI [4,2])
C0332197 (UMLS CUI [4,3])
Crohn Disease | Ulcerative Colitis | Inflammatory Bowel Disease
Item
history of crohn's disease, ulcerative colitis, or other inflammatory bowel disease
boolean
C0010346 (UMLS CUI [1])
C0009324 (UMLS CUI [2])
C0021390 (UMLS CUI [3])
C0009324 (UMLS CUI [2])
C0021390 (UMLS CUI [3])
Uncontrolled hypertension | Systolic Pressure | Diastolic blood pressure
Item
uncontrolled hypertension (defined as systolic blood pressure above or equal to 180 mmhg and/or diastolic blood pressure above or equal to 100 mmhg)
boolean
C1868885 (UMLS CUI [1])
C0871470 (UMLS CUI [2])
C0428883 (UMLS CUI [3])
C0871470 (UMLS CUI [2])
C0428883 (UMLS CUI [3])
Blood Donation Excessive Amount | Plasma Donation Excessive Amount
Item
any donation of blood or plasma in excess of 400 ml within the 3 months preceding screening
boolean
C0005794 (UMLS CUI [1,1])
C0442802 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C0032105 (UMLS CUI [2,1])
C0005794 (UMLS CUI [2,2])
C0442802 (UMLS CUI [2,3])
C1265611 (UMLS CUI [2,4])
C0442802 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C0032105 (UMLS CUI [2,1])
C0005794 (UMLS CUI [2,2])
C0442802 (UMLS CUI [2,3])
C1265611 (UMLS CUI [2,4])
Drug abuse | Drug screening test Positive
Item
history of significant drug abuse, or a positive drug test at the screening visit (visit 2)
boolean
C0013146 (UMLS CUI [1])
C0373483 (UMLS CUI [2,1])
C1514241 (UMLS CUI [2,2])
C0373483 (UMLS CUI [2,1])
C1514241 (UMLS CUI [2,2])